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What is Viekira?

Viekira is an antiviral medicine containing a combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir. Dasabuvir, ombitasvir, paritaprevir, and ritonavir are antiviral medicines that prevent the hepatitis C virus (HCV) from multiplying in your body.

Viekira is used to treat chronic hepatitis C in adults. It is sometimes given in combination with another antiviral medicine called ribavirin.

Viekira treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Viekira is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.

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Important Information

If you have ever had hepatitis B, Viekira can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Before you start taking Viekira, you must stop using certain birth control pills or hormone replacement medicines. Ask your doctor about using non-hormonal birth control to prevent pregnancy.

Before taking this medicine

You should not use Viekira if you are allergic to dasabuvir, ombitasvir, paritaprevir, or ritonavir, or if:

If you take Viekira with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

Some medicines can interact with Viekira and should not be used at the same time. Your doctor may need to change your treatment plan if you use:

Before you start taking Viekira, you must stop using medicine that contains ethinyl estradiol. This includes certain birth control pills or hormone replacement medicines. Ask your doctor about using non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Viekira and for 2 weeks after your treatment ends.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

It is not known whether Viekira will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Viekira is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Viekira with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take this medicine?

Viekira is usually taken for 12 to 24 weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

Take this medicine with food.

Viekira XR is an extended-release form of this combination medicine to be taken once daily. Viekira XR is supplied as 3 pale yellow tablets that are taken all at once with a daily meal.

The Viekira Pak contains two different types of tablets. The pink tablet contains only ombitasvir, paritaprevir, and ritonavir. The beige tablet contains only dasabuvir.

Take 2 pink tablets plus 1 beige tablet at the same time every morning. Take 1 beige tablet at the same time every evening.

The monthly Viekira XR or Viekira Pak carton contains enough tablets for you to take this medicine for 4 weeks (28 days in a row).

You will need frequent blood tests to check your liver function.

If you have ever had hepatitis B, Viekira can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor’s advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Viekira suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store this medicine at room temperature away from moisture and heat. Do not remove the tablets from a daily dose package until you are ready to take the medicine.

Viekira dosing information

Usual Adult Dose for Chronic Hepatitis C:

Viekira Pak:
-Dasabuvir: 250 mg orally twice a day (morning and evening)
-Ombitasvir/paritaprevir/ritonavir fixed-dose combination tablet: 2 tablets orally once a day (in the morning)

Extended-release tablets (fixed-dose combination): 3 tablets orally once a day

Recommended Regimen and Duration of Therapy:
-Genotype 1a, without cirrhosis: Viekira Pak plus ribavirin OR extended-release tablets plus ribavirin for 12 weeks
-Genotype 1a, with compensated cirrhosis (Child-Pugh A): Viekira Pak plus ribavirin OR extended-release tablets plus ribavirin for 24 weeks
—For some patients based on prior treatment history: May consider Viekira Pak plus ribavirin OR extended-release tablets plus ribavirin for 12 weeks
-Genotype 1b, with or without compensated cirrhosis (Child-Pugh A): Viekira Pak OR extended-release tablets for 12 weeks
-Liver transplant recipients with normal liver function and mild fibrosis (Metavir fibrosis score 2 or lower), regardless of HCV genotype 1 subtype: Viekira Pak plus ribavirin OR extended-release tablets plus ribavirin for 24 weeks

Comments:
-Recommended for therapy-naive or interferon-experienced patients, including those with HCV/HIV-1 coinfection
-The dosing recommendations for genotype 1a should be followed for patients with unknown genotype 1 subtype or with mixed genotype 1 infection.
-The manufacturer product information should be consulted for ribavirin dosing recommendations (if applicable), regarding dosing of concomitant HIV-1 antiviral drugs in HCV/HIV-1-coinfected patients, and regarding use with calcineurin inhibitors in liver transplant recipients.
-The manufacturer product information for ribavirin should be consulted regarding dose adjustments (if applicable).

Uses: For the treatment of chronic HCV infection
-In genotype 1b-infected patients without cirrhosis or with compensated cirrhosis
-In combination with ribavirin: In genotype 1a-infected patients without cirrhosis or with compensated cirrhosis

See also: Dosage Information (in more detail)

What happens if I miss a dose?

If you miss a dose of the pink tablets, take the missed dose with a meal as soon as you remember. If you are more than 12 hours late, skip the missed dose and take your next dose at the usual time with a meal.

If you forget to take the beige tablet, take it with a meal as soon as you remember. If you are more than 6 hours late in taking the beige tablet, skip the missed dose and take your next dose at the usual time with a meal.

Do not take extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking this medicine?

Taking Viekira will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

This medicine side effects

Get emergency medical help if you have signs of an allergic reaction to Viekira: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

  • confusion;
  • loss of appetite, upper stomach pain;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Common Viekira side effects may include:

  • nausea;
  • itching, skin rash or redness;
  • sleep problems (insomnia); or
  • feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dermatomyositis and Polymyositis
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Symptomatic Sarcoidosis
Systemic Lupus Erythematosus

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H.P. Acthar® Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for:

  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
  • Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
  • The treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
  • Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
  • The treatment of symptomatic sarcoidosis
  • Adjunctive therapy for short‐term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low‐dose maintenance therapy), ankylosing spondylitis
  • Treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation

IMPORTANT SAFETY INFORMATION

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Contraindications

  • Acthar should never be administered intravenously
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar
  • Acthar is contraindicated where congenital infections are suspected in infants
  • Acthar is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origins

Warnings and Precautions

  • The adverse effects of Acthar are related primarily to its steroidogenic effects
  • Acthar may increase susceptibility to new infection or reactivation of latent infections
  • Suppression of the hypothalamic-pituitary-axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment
  • Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
  • Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitored
  • Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
  • Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding
  • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and psychosis. Existing conditions may be aggravated
  • Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
  • Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptoms
  • Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity
  • There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
  • Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
  • Decrease in bone density may occur. Bone density should be monitored for patients on long-term therapy
  • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Adverse Reactions

  • Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain
  • Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve

Other adverse events reported are included in the full Prescribing Information.

Please see full Prescribing Information.

For parents and caregivers of IS patients, please also see Medication Guide.

Indications

H.P. Acthar® Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for:

  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
  • Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
  • The treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
  • Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
  • The treatment of symptomatic sarcoidosis
  • Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low‐dose maintenance therapy), ankylosing spondylitis
  • Treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation

What is Daklinza?

Daklinza (daclatasvir) is an antiviral medicine that prevents hepatitis C virus (HCV) from multiplying in your body.

Daklinza is used in combination with other medications to treat chronic hepatitis C in adults.

Daklinza treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Daklinza must be given in combination with other antiviral medications and should not be used alone.Daclatasvir is usually given with sofosbuvir, with or without ribavirin.

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Daklinza is sometimes used in people who also have HIV. Daclatasvir is not a treatment for HIV or AIDS.

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Important Information

If you have ever had hepatitis B, Daklinza can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Daklinza used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor’s advice.

Before taking this medicine

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You should not use Daklinza if you are allergic to daclatasvir. If you take daclatasvir with sofosbuvir: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

If you take daclatasvir with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

Some medicines can interact with daclatasvir and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

To make sure Daklinza is safe for you, tell your doctor if you have ever had:

Daklinza is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Daklinza with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

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Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It is not known whether daclatasvir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Daklinza is not approved for use by anyone younger than 18 years old.

How should I take Daklinza?

Daklinza must be given in combination with sofosbuvir and it should not be used alone.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

Daklinza is usually taken with other antiviral medicines once per day for 12 weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

You will need frequent blood tests to check your liver function.

If you have ever had hepatitis B, Daklinza can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor’s advice. Every person with chronic hepatitis C should remain under the care of a doctor.

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You should not stop using this medicine suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store at room temperature away from moisture and heat.

Daklinza dosing information

Usual Adult Dose for Chronic Hepatitis C:

60 mg orally once a day

Recommended Regimen and Duration of Therapy:
Genotype 1:
-Without cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
-Compensated (Child-Pugh A) cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
-Decompensated (Child-Pugh B or C) cirrhosis: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks
-Posttransplant: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

Genotype 3:
-Without cirrhosis: Daclatasvir plus sofosbuvir for 12 weeks
-Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks
-Posttransplant: Daclatasvir plus sofosbuvir plus ribavirin for 12 weeks

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Comments:
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Optimal duration of therapy has not been established for HCV genotype 3-infected patients with cirrhosis or for HCV genotype 1-infected patients with Child-Pugh C cirrhosis.
-The manufacturer product information for sofosbuvir should be consulted regarding dosing. The manufacturer product information should be consulted regarding ribavirin dosing and dose adjustments (if applicable).

Use: With sofosbuvir (with or without ribavirin), for the treatment chronic HCV genotype 1 or 3 infection

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See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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Use Daklinza regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Daklinza?

Taking daclatasvir will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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Daklinza side effects

Get emergency medical help if you have signs of an allergic reaction to Daklinza: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • new or worsening liver symptoms – loss of appetite, upper stomach pain; dark urine, clay-colored stools; jaundice (yellowing of the skin or eyes).

If you take Daklinza with sofosbuvir and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

  • very slow heartbeats, chest pain, shortness of breath;
  • confusion, memory problems; or
  • weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common Daklinza side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Daklinza?

When you start or stop taking Daklinza, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can interact with daclatasvir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment. Give a list of all your medicines to any healthcare provider who treats you.

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Trade name: Targretin®

Chemocare.com uses generic names in all descriptions of drugs. Targretin is the trade name for bexarotene. In some cases, health care professionals may use the trade name targretin when referring to the generic drug name bexarotene.

Drug type:  Bexarotene is an anti-cancer drug.  This medication is classified as a retinoid. (For more detail, see “How this drug works” section below).

What Bexarotene Is Used For:

  • Cutaneous T-cell lymphoma (mycosis fungoides) in patients who have not responded to at least one previous treatment regimen.

Note:  If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Bexarotene Is Given:

  • Bexarotene is a capsule taken by mouth, once a day with a meal.
  • The amount of bexarotene that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated.  Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of bexarotene:

  • Most people do not experience all of the side effects listed.
  • Side effects are often predictable in terms of their onset and duration.
  • Side effects are almost always reversible and will go away after treatment is complete.
  • There are many options to help minimize or prevent side effects.
  • There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
  • The side effects of bexarotene and their severity depend on how much of the drug is given.  (In other words, high doses may produce more severe side effects).

The following side effects are common (occurring in greater than 30%) for patients taking bexarotene:

  • Blood test abnormalities: Elevated blood lipid levels (including cholesterol and triglycerides).
  • Headache.

These are less common (occurring in 10-29%) side effects for patients receiving bexarotene:

  • Blood test abnormalities: Low thyroid hormone levels
  • Weakness
  • Rash, dermatitis or dry skin
  • Lowered white blood cell levels (This can increase your risk for infection).
  • Nausea
  • Infection
  • Swelling of the hands or feet
  • Chills (see flu like symptoms)
  • Abdominal pain
  • Cataracts (some evidence of new or worsening of existing cataracts) (see eye problems).
  • Sensitivity to sunlight (photosensitivity) (see skin reactions).

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here.  However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4(F (38 C or higher) or chills (possible signs of infection)

The following symptoms require medical attention, but are not an emergency.  Contact your health care provider within 24 hours of noticing any of the following:

  • Headache (moderate to severe)
  • Nausea (interferes with ability to eat and unrelieved with prescribed medication).
  • Vomiting (vomiting more than 4-5 times in a 24 hour period)
  • Diarrhea (4-6 episodes in a 24-hour period)
  • Changes is vision
  • Swelling in feet or hands
  • Extreme weakness or fatigue (interfering with ability to do daily activities).

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

  • Before starting bexarotene treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, or herbal remedies).  Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
  • The manufacturer recommends limiting vitamin A supplementation less than 15,000IU/day but you should discuss taking any vitamin supplements with your doctor BEFORE you take them.
  • Do not receive any kind of immunization or vaccination without your doctor’s approval while taking bexarotene.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment.  Pregnancy category X (Bexarotene capsules may cause fetal harm when given to a pregnant woman.  This drug must not be given to a pregnant woman or a woman who intends to become pregnant.  If a woman becomes pregnant while taking bexarotene, the medication must be stopped immediately and the woman given appropriate counseling).
  • Because of the extremely high risk that a deformed infant can result if pregnancy occurs while taking bexarotene in any amount even for short periods of time, for both men and women: Do not conceive a child (get pregnant) while taking bexarotene. Two methods of effective contraception are recommended for women of childbearing potential, unless absolute abstinence is the chosen method.  Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
  • Do not breast feed while taking this medication.

Self-Care Tips:

  • Take this medication at about the same time every day along with a meal that includes some fats.
  • Avoid grapefruit juice.
  • Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
  • You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
  • Wash your hands often
  • For flu-like symptoms, keep warm with blankets and drink plenty of liquids.  There are medications that can help reduce the discomfort caused by chills.
  • To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
  • Avoid sun exposure.  Wear SPF 15 (or higher) sunblock and protective clothing.
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely.  You should discuss this with your doctor.
  • Get plenty of rest
  • Maintain good nutrition
  • If you experience symptoms or side effects, be sure to discuss them with your health care team.  They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be monitored regularly by your health care professional while you are taking bexarotene to monitor side effects and check your response to therapy.  For women of child-bearing age, a pregnancy test is required one week prior to beginning this therapy and every month during treatment.  Blood counts and lipid (fats, cholesterol) levels, liver function and thyroid gland function all need to be analyzed before treatment begins and regularly during treatment.  These are measured through blood tests.

How Bexarotene Works:

Retinoids are drugs that are relatives of vitamin A.  Retinoids control normal cell growth, cell differentiation (the normal process of making cells different from each other), and cell death during embryonic development and in certain tissues later in life.  Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors).

There are two major classes of retinoid nuclear receptors:  retinoic acid receptors (RAR) and retinoid-X-receptors (RXR).  There are also subtypes within each class.  Each of these types of receptors has different functions in different tissues.  The different retinoid drugs work by binding to different receptors; which, in turn, affect cell growth and differentiation.

Retinoids are relatively new types of anti-cancer drugs.  They have been used alone or in combination to treat a variety of cancers such as skin cancers, cutaneous T-cell lymphoma, acute promyelocytic leukemia, lung cancer, breast cancer, ovarian cancer, bladder cancer, kidney cancer, and head and neck cancers.  Retinoids have also been used experimentally in an attempt to prevent certain types of cancer.  There is ongoing research to determine their role in both cancer treatment and prevention.

Retinoids have been associated with side effects such as skin problems (dryness, peeling, itching, sun sensitivity), reversible elevation in liver enzymes, temporary abnormal lipid levels, low thyroid levels (hypothyroidism), and headaches.  Taking supplemental doses of vitamin A may increase the side effects.  Vitamin supplementation should be discussed with your physician.

Note:  We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

What is Zepatier?

Zepatier contains a combination of elbasvir and grazoprevir. Elbasvir and grazoprevir are antiviral medicines that prevent hepatitis C (HCV) from multiplying in your body.

Zepatier is used to treat chronic hepatitis C in adults. This medicine is sometimes given together with another drug called ribavirin.

Zepatier treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Zepatier is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.

14 Essential Health Screenings That All Men Should Consider

Important Information

You should not use Zepatier if you have moderate or severe liver disease.

Serious drug interactions can occur when certain medicines are used together. Tell your doctor about all your current medicines and any you start or stop using.

If you have ever had hepatitis B, Zepatier can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Serious drug interactions can occur when certain medicines are used together with elbasvir and grazoprevir. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Before taking this medicine

You should not use Zepatier if you are allergic to elbasvir or grazoprevir, or if you have:

  • moderate or severe liver disease.

If you take Zepatier with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

Some medicines can cause unwanted or dangerous effects when used with Zepatier. Your doctor may need to change your treatment plan if you use any of the following drugs:

To make sure Zepatier is safe for you, tell your doctor if you have ever had:

  • hepatitis B;
  • liver problems other than hepatitis C;
  • HIV (human immunodeficiency virus);
  • if you have had a liver transplant, or if you are waiting to have a liver transplant; or
  • if you use a blood thinner (warfarinCoumadinJantoven) and you have routine “INR” or prothrombin time tests.

It is not known whether Zepatier will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Elbasvir and grazoprevir is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Zepatier with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It is not known whether elbasvir and grazoprevir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Zepatier is not approved for use by anyone younger than 18 years old.

How should I take Zepatier?

Take Zepatier exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

You may take Zepatier with or without food.

Take the medicine at the same time each day.

You will need frequent blood tests to check your liver function.

If you have ever had hepatitis B, Zepatier can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor’s advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Zepatier suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store at room temperature away from moisture and heat. Keep each tablet in the foil blister pack until you are ready to take it.

Zepatier dosing information

Usual Adult Dose of Zepatier for Chronic Hepatitis C:

1 tablet orally once a day

Recommended Regimen and Duration of Therapy:
-Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced without baseline nonstructural protein 5A (NS5A) polymorphisms: Elbasvir-grazoprevir for 12 weeks
-Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced with baseline NS5A polymorphisms: Elbasvir-grazoprevir plus ribavirin for 16 weeks
-Genotype 1b, therapy-naive or peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir for 12 weeks
-Genotype 1a or 1b, peginterferon alfa/ribavirin/HCV protease inhibitor-experienced: Elbasvir-grazoprevir plus ribavirin for 12 weeks
-Genotype 4, therapy-naive: Elbasvir-grazoprevir for 12 weeks
-Genotype 4, peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir plus ribavirin for 16 weeks

Comments:
-This drug should be used with ribavirin in certain patient populations.
-Hepatic laboratory testing recommended prior to and during therapy.
-Peginterferon alfa/ribavirin-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin
-Baseline NS5A polymorphisms: NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93.
-Peginterferon alfa/ribavirin/HCV protease inhibitor-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin plus HCV NS3/4A protease inhibitor (e.g., boceprevirsimeprevirtelaprevir)
-Optimal regimen and duration of therapy not established for peginterferon alfa/ribavirin/HCV protease inhibitor-experienced genotype 1a-infected patients with at least 1 baseline NS5A resistance-associated polymorphism at positions 28, 30, 31, and 93.
-The manufacturer product information for ribavirin should be consulted regarding dosing and dose adjustments (if applicable).

Use: For the treatment of chronic HCV genotype 1 or 4 infection

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Zepatier?

Taking this medication will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Zepatier side effects

Get emergency medical help if you have signs of an allergic reaction to Zepatier: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

  • nauseavomiting, upper stomach pain, loss of appetite;
  • tiredness;
  • dark urine, clay-colored stools;
  • jaundice (yellowing of the skin or eyes); or
  • (if you also take ribavirin) low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Zepatier side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Zepatier?

When you start or stop taking Zepatier, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can interact with elbasvir and grazoprevir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with daclatasvir. Give a list of all your medicines to any healthcare provider who treats you.

What is Epclusa?

Epclusa contains a combination of sofosbuvir and velpatasvir. Sofosbuvir and velpatasvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.

Epclusa is used to treat chronic hepatitis C in adults. It is sometimes given in combination with another antiviral medicine called ribavirin in people who also have advanced cirrhosis.

Epclusa treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Epclusa is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.

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Important Information

If you have ever had hepatitis B, Epclusa can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor’s advice.

Epclusa is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby. Do not use ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant. Use effective birth control to prevent pregnancy while using these medicines together and for at least 6 months after treatment ends.

Before taking this medicine

You should not use Epclusa if you are allergic to sofosbuvir or velpatasvir. If you take sofosbuvir and valpatasvir with other antiviral medicines: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

To make sure Epclusa is safe for you, tell your doctor if you have ever had:

It is not known whether Epclusa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Epclusa is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Epclusa with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It is not known whether sofosbuvir and velpatasvir passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How should I take Epclusa?

Epclusa is usually taken once per day for 12 weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

You may take this medicine with or without food.

You will need frequent blood tests to check your liver function.

If you have ever had hepatitis B, Epclusa can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor’s advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Epclusa suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store this medicine in the original container at room temperature away from moisture and heat.

Epclusa dosing information

Usual Adult Dose of Epclusa for Chronic Hepatitis C:

1 tablet orally once a day

Recommended Regimen and Duration of Therapy:
-Therapy-naive and therapy-experienced, without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks
-Therapy-naive and therapy-experienced, with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir plus ribavirin for 12 weeks

Comments:
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-In clinical trials, therapy-experienced patients received a peginterferon alfa/ribavirin-based regimen with or without an HCV nonstructural protein 3/4A (NS3/4A) protease inhibitor (boceprevirsimeprevir, or telaprevir).
-The manufacturer product information for ribavirin should be consulted regarding dosing and dose adjustments (if applicable).

Uses: For the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection
-In patients without cirrhosis or with compensated cirrhosis
-In combination with ribavirin: In patients with decompensated cirrhosis

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Epclusa?

If you also take omeprazole (Prilosec) or an antacid, do not take it for at least 4 hours after you have taken your dose of Epclusa (with food).

Taking this medication will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Epclusa side effects

Get emergency medical help if you have signs of an allergic reaction to Epclusa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

  • loss of appetite, upper stomach pain;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

If you also take a heart rhythm medicine called amiodarone: Taking amiodarone with Epclusa can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

  • very slow heartbeats, chest pain, shortness of breath;
  • confusion, memory problems; or
  • weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common Epclusa side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Epclusa?

When you start or stop taking Epclusa, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with sofosbuvir and velpatasvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is Sovaldi?

Sovaldi (sofosbuvir) is an antiviral medication that prevents hepatitis C virus (HCV) from multiplying in your body.

Sovaldi is used in combination with other medications to treat chronic hepatitis C in adults and children who are at least 12 years old or who weigh at least 77 pounds (35 kilograms).

Sovaldi treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Sovaldi must be given in combination with other antiviral medications and should not be used alone. Sofosbuvir is usually given with ribavirin, with or without peginterferon alfa.

Sovaldi is sometimes used in people who also have HIV, or people who have liver cancer and are going to have a liver transplant. This medicine is not a treatment for HIV or AIDS.

14 Essential Health Screenings That All Men Should Consider

Important Information

If you have ever had hepatitis B, Sovaldi can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Sovaldi is used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor’s advice.

Ribavirin can cause birth defects or death in an unborn baby. Do not use Sovaldi with ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.Use at least 2 effective forms of non-hormonal birth control while using these medicines together and for at least 6 months after treatment ends.

Before taking this medicine

You should not use Sovaldi if you are allergic to sofosbuvir. If you take Sovaldi with other antiviral medicines: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

To make sure Sovaldi is safe for you, tell your doctor if you have ever had:

Sovaldi is used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Sovaldi with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It is not known whether sofosbuvir passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How should I take Sovaldi?

Sovaldi must be given in combination with other antiviral medications and it should not be used alone.

Sovaldi is usually taken with other antiviral medicines once per day for 12 to 24 weeks. Follow all directions on your prescription label. Do not take your medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using sofosbuvir.

You may take Sovaldi with or without food.

You will need frequent blood tests to check your liver function.

If you have ever had hepatitis B, Sovaldi can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor’s advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Sovaldi suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Store this medicine in the original container at room temperature away from moisture and heat.

Sovaldi dosing information

Usual Adult Dose for Chronic Hepatitis C:

400 mg orally once a day

Recommended Regimen and Duration of Therapy:
-Genotype 1 or 4: Sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks
-Genotype 2: Sofosbuvir and ribavirin for 12 weeks
-Genotype 3: Sofosbuvir and ribavirin for 24 weeks
Hepatocellular carcinoma awaiting liver transplantation: Sofosbuvir and ribavirin for up to 48 weeks or until liver transplantation (whichever occurs first)

Comments:
-Genotype 1, 4: This regimen is recommended for therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
-Genotype 2, 3: Both regimens are recommended for therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
-Therapy-experienced patients have failed an interferon-based regimen (with or without ribavirin).
-The dose recommendations for genotype 1, 2, 3, or 4 should be followed for HCV/HIV-1-coinfected patients.
-The manufacturer product information should be consulted for ribavirin dose recommendations; with genotype 1 or 4, the manufacturer product information for peginterferon alfa should also be consulted for dose recommendations.
-Sofosbuvir and ribavirin for 24 weeks can be considered for patients with genotype 1 infection who cannot use an interferon-based regimen; treatment decision should be guided by benefit/risk assessment for the individual patient.
-The regimen for patients with hepatocellular carcinoma awaiting liver transplantation is recommended to prevent posttransplant HCV reinfection.

Use: As a part of a combination antiviral treatment regimen, for the treatment of chronic HCV infection
-In combination with pegylated interferon and ribavirin: For genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis
-In combination with ribavirin: For genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C:

12 years and older or weighing at least 35 kg: 400 mg orally once a day

Recommended Regimen and Duration of Therapy:
-Genotype 2: Sofosbuvir and ribavirin for 12 weeks
-Genotype 3: Sofosbuvir and ribavirin for 24 weeks

Comments:
-Both regimens are recommended for therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
-Therapy-experienced patients have failed an interferon-based regimen (with or without ribavirin).
-The manufacturer product information should be consulted for ribavirin dose recommendations.
-The same dose recommendations should be followed for HCV/HIV-1-coinfected patients.

Use: In combination with ribavirin, for the treatment of chronic HCV genotype 2 or 3 infection in patients without cirrhosis or with compensated cirrhosis

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Use Sovaldi regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Sovaldi?

Taking this medication will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Sovaldi side effects

Get emergency medical help if you have signs of an allergic reaction to Sovaldi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

  • loss of appetite, upper stomach pain;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

If you take Sovaldi and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

  • very slow heartbeats, chest pain, shortness of breath;
  • confusion, memory problems; or
  • weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common Sovaldi side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Sovaldi?

When you start or stop taking Sovaldi, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with sofosbuvir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is Harvoni?

Harvoni contains a combination of ledipasvir and sofosbuvir. Ledipasvir and sofosbuvir are antiviral medications that prevent the hepatitis C virus (HCV) from multiplying in your body.

Harvoni is used to treat chronic hepatitis C in adults and children who are at least 12 years old or who weigh at least 77 pounds (35 kilograms). Ledipasvir and sofosbuvir is sometimes given in combination with another medicine called ribavirin.

Harvoni treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Harvoni is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.

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Important Information

If you have ever had hepatitis B, Harvoni can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

Harvoni is sometimes used in combination with other medication. Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor’s advice.

You should not use Harvoni if you are also taking sofosbuvir tablets (Sovaldi).

Before taking this medicine

You should not use Harvoni if you are allergic to ledipasvir or sofosbuvir.

If you take Harvoni with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • hepatitis B;
  • liver problems other than hepatitis C;
  • kidney disease (or if you are on dialysis);
  • HIV or AIDS;
  • a heart rhythm problem for which you take a medicine called amiodarone (CordaronePacerone); or
  • if you use a blood thinner (warfarinCoumadinJantoven) and you have routine “INR” or prothrombin time tests.

Harvoni is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Harvoni is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.

  • If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
  • If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.

While taking Harvoni with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.

Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It is not known whether ledipasvir and sofosbuvir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Harvoni is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds.

How should I take Harvoni?

Take Harvoni exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Harvoni.

You may take this medicine with or without food. Take it at the same time each day.

Harvoni is usually taken once per day for 12 to 24 weeks. Follow your doctor’s dosing instructions very carefully.

You will need frequent blood tests to check your liver function.

If you have ever had hepatitis B, Harvoni can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor’s advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using Harvoni suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

Store this medicine in the original container at room temperature away from moisture and heat.

Harvoni dosing information

Usual Adult Dose for Chronic Hepatitis C:

1 tablet orally once a day

Recommended Regimen and Duration of Therapy:
GENOTYPE 1:
-Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks
-Therapy-naive and therapy-experienced patients with decompensated cirrhosis (Child-Pugh B or C): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 1 OR 4:
-Therapy-naive and therapy-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir plus ribavirin for 12 weeks

GENOTYPE 4, 5, OR 6:
-Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

Comments:
-Relapse rates are affected by baseline host and viral factors and differ between durations of therapy for some subgroups.
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Therapy-naive genotype 1 patients without cirrhosis: Ledipasvir-sofosbuvir for 8 weeks can be considered in those who have pretreatment HCV RNA less than 6 million international units/mL.
-Therapy-experienced patients have failed a peginterferon alfa/ribavirin-based regimen with or without an HCV protease inhibitor.
-Therapy-experienced genotype 1 patients with cirrhosis: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks can be considered in those eligible for ribavirin.
-The manufacturer product information for ribavirin should be consulted regarding dosing and dose adjustments (if applicable).

Use: For the treatment of chronic HCV
-For genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
-In combination with ribavirin: For genotype 1 infection with decompensated cirrhosis
-In combination with ribavirin: For genotype 1 or 4 infection in liver transplant recipients without cirrhosis or with compensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C:

12 years and older or weighing at least 35 kg: 1 tablet orally once a day

Recommended Regimen and Duration of Therapy:
GENOTYPE 1:
-Therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients without cirrhosis: Ledipasvir-sofosbuvir for 12 weeks
-Therapy-experienced patients with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 24 weeks

GENOTYPE 4, 5, OR 6:
-Therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ledipasvir-sofosbuvir for 12 weeks

Comments:
-Dose recommendations also apply to HCV/HIV-1-coinfected patients.
-Therapy-experienced patients have failed an interferon-based regimen with or without ribavirin.

Use: For the treatment of HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis

What other drugs will affect Harvoni?

When you start or stop taking Harvoni, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Harvoni?

If you also take an antacid, do not take it for at least 4 hours after you have taken your dose of Harvoni.

Taking Harvoni will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Harvoni side effects

Get emergency medical help if you have signs of an allergic reaction to Harvoni: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

  • loss of appetite, upper stomach pain;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

If you take Harvoni and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:

  • very slow heartbeats, chest pain, shortness of breath;
  • confusion, memory problems; or
  • weakness, extreme tiredness, light-headed feeling (like you might pass out.)

Common Harvoni side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Harvoni?

When you start or stop taking Harvoni, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with ledipasvir and sofosbuvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

This information is intended for use by health professionals

1. Name of the medicinal product

Nebido 1000 mg/4 ml, solution for injection.

2. Qualitative and quantitative composition

Each ml solution for injection contains 250 mg testosterone undecanoate corresponding to 157.9 mg testosterone.

Each ampoule / vial with 4 ml solution for injection contains 1000 mg testosterone undecanoate corresponding to 631.5 mg testosterone.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection.

Clear, yellowish oily solution.

4. Clinical particulars

4.1 Therapeutic indications

Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see section 4.4).

4.2 Posology and method of administration

Posology

One ampoule / vial of Nebido (corresponding to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.

Start of treatment

Serum testosterone levels should be measured before start and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.

Maintenance and individualisation of treatment

The injection interval should be within the recommended range of 10 to 14 weeks. Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is advisable to measure testosterone serum levels regularly. Measurements should be performed at the end of an injection interval and clinical symptoms considered. These serum levels should be within the lower third of the normal range. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.

Special populations

Paediatric population

Nebido is not indicated for use in children and adolescents and it has not been clinically evaluated in males under 18 years of age (see section 4.4).

Geriatric patients

Limited data do not suggest the need for a dosage adjustment in elderly patients (see section 4.4).

Patients with hepatic impairment

No formal studies have been performed in patients with hepatic impairment. The use of Nebido is contraindicated in men with past or present liver tumours (see section 4.3).

Patients with renal impairment

No formal studies have been performed in patients with renal impairment.

Method of administration

For intramuscular use.

The injections must be administered very slowly (over two minutes). Nebido is strictly for intramuscular injection. Care should be taken to inject Nebido deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection (see section 4.4 under “Application”). The contents of an ampoule / vial are to be injected intramuscularly immediately after opening. (For the ampoule see section 6.6 for instructions on opening the ampoule safely).

4.3 Contraindications

The use of Nebido is contraindicated in men with:

• androgen-dependent carcinoma of the prostate or of the male mammary gland

• past or present liver tumours

• hypersensitivity to the active substance or to any of the excipients (listed in section 6.1).

The use of Nebido in women is contraindicated.

4.4 Special warnings and precautions for use

Nebido is not recommended for use in children and adolescents.

Nebido should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other aetiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction etc.) and confirmed by two separate blood testosterone measurements.

Elderly population

There is limited experience on the safety and efficacy of the use of Nebido in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.

Medical examination and laboratory tests

Medical examinations

Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude a risk of pre-existing prostatic cancer. Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum PSA) in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients and at risk patients (those with clinical or familial factors). Local guidelines for safety monitoring under testosterone replacement therapy should be taken into consideration.

Laboratory tests

Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels. In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin and haematocrit, liver function tests and lipid profile (see section 4.8).

Due to variability in laboratory values, all measures of testosterone should be carried out in the same laboratory.

Tumours

Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.

Nebido should be used with caution in cancer patients at risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases. Regular monitoring of serum calcium concentrations is recommended in these patients.

Cases of benign and malignant liver tumours have been reported in users of hormonal substances such as androgen compounds. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur in men using Nebido, a liver tumour should be included in the differential-diagnostic considerations.

Cardiac, hepatic or renal insufficiency

In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.

Hepatic or renal insufficiency

There are no studies undertaken to demonstrate the efficacy and safety of this medicinal product in patients with renal or hepatic impairment. Therefore, testosterone replacement therapy should be used with caution in these patients.

Cardiac insufficiency

Caution should be exercised in patients predisposed to oedema, e.g. in case of severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, as treatment with androgens may result in increased retention of sodium and water. In case of severe complications characterized by oedema with or without congestive heart failure treatment must be stopped immediately (see section 4.8).

Testosterone may cause a rise in blood pressure and Nebido should be used with caution in men with hypertension.

Clotting disorders

As a general rule, the limitations of using intramuscular injections in patients with acquired or inherited bleeding disorders always have to be observed.

Testosterone and derivatives have been reported to increase the activity of coumarin derived oral anticoagulants (see also section 4.5).

Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy.

Other conditions

Nebido should be used with caution in patients with epilepsy and migraine, as the conditions may be aggravated.

Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy.

Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment.

Pre-existing sleep apnoea may be potentiated.

Athletes treated for testosterone replacement in primary and secondary male hypogonadism should be advised that the medicinal product contains an active substance which may produce a positive reaction in anti-doping tests.

Androgens are not suitable for enhancing muscular development in healthy individuals or for increasing physical ability.

Nebido should be permanently withdrawn if symptoms of excessive androgen exposure persist or reappear during treatment with the recommended dosage regimen.

Application

As with all oily solutions, Nebido must be injected strictly intramuscularly and very slowly (over two minutes). Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. The patient should therefore be observed during and immediately after each injection in order to allow for early recognition of possible signs and symptoms of pulmonary oily microembolism. Treatment is usually supportive, e.g. by administration of supplemental oxygen.

Suspected anaphylactic reactions after Nebido injection have been reported.

4.5 Interaction with other medicinal products and other forms of interaction

Oral anti-coagulants

Testosterone and derivatives have been reported to increase the activity of coumarin derived oral anti-coagulants. Patients receiving oral anti-coagulants require close monitoring, especially at the beginning or end of androgen therapy. Increased monitoring of the prothrombin time, and INR determinations, are recommended.

Other interactions

The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation; thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema.

Laboratory test interactions: Androgens may decrease levels of thyroxin-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

4.6 Fertility, pregnancy and lactation

Fertility

Testosterone replacement therapy may reversibly reduce spermatogenesis (see sections 4.8 and 5.3).

Pregnancy and breastfeeding

Nebido is not indicated for use in women and must not be used in pregnant or breast-feeding women (see section 4.3).

4.7 Effects on ability to drive and use machines

Nebido has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of the safety profile

Regarding undesirable effects associated with the use of androgens, please also refer to section 4.4.

The most frequently reported undesirable effects during treatment with Nebido are acne and injection site pain.

Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. Cases suspected by the company or the reporter to represent oily pulmonary microembolism have been reported rarely in clinical trials (in ≥ 1/10,000 and < 1/1,000 injections) as well as from postmarketing experience (see section 4.4).

Suspected anaphylactic reactions after Nebido injection have been reported.

Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.

Table 1 below reports adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Nebido. The frequencies are based on clinical trial data and defined as common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to <1/100) and rare (≥ 1/10,000 to < 1/1,000). The ADRs were recorded in 6 clinical studies (N=422) and considered at least possibly causally related to Nebido.

Tabulated list of adverse reactions

Table 1: Categorised relative frequency of men with ADRs, by MedDRA SOC – based on pooled data of six, clinical trials, N=422 (100.0%), i.e.N=302 hypogonadal men treated with i.m. injections of 4 ml and N=120 with 3ml of TU 250 mg/ml

System Organ Class Common

(≥ 1/100 to < 1/10)

Uncommon

(≥ 1/1000 to <1/100)

Rare

(≥ 1/10,000 to < 1/1,000)

Blood and lymphatic system disorders Polycythaemia

Haematocrit increased*

Red blood cell count increased*

Haemoglobin increased*

Immune system disorders Hypersensitivity
Metabolism and nutrition disorders Weight increased Increased appetite

Glycosylated haemoglobin increased

Hypercholesterolaemia

Blood triglycerides increased

Blood cholesterol increased

Psychiatric disorders

Depression

Emotional disorder

Insomnia

Restlessness

Aggression

Irritability

Nervous system disorders Headache

Migraine

Tremor

Vascular disorders Hot flush Cardiovascular disorder

Hypertension

Dizziness

Respiratory, thoracic and mediastinal disorders Bronchitis

Sinusitis

Cough

Dyspnoea

Snoring

Dysphonia

Gastrointestinal disorders Diarrhoea

Nausea

Hepatobiliary disorders Liver function test abnormal

Aspartate aminotransferase increased

Skin and subcutaneous tissue disorders Acne Alopecia

Erythema

Rash1

Pruritus

Dry skin

Musculoskeletal and connective tissue disorders Arthralgia

Pain in extremity

Muscle disorders2

Musculoskeletal stiffness

Blood creatine phosphokinase increased

Renal and urinary disorders Urine flow decreased

Urinary retention

Urinary tract disorder

Nocturia

Dysuria

Reproductive system and breast disorders Prostate specific antigen increased

Prostate examination abnormal

Benign prostate hyperplasia

Prostatic intraepithelial neoplasia

Prostate induration

Prostatitis

Prostatic disorder

Libido changes

Testicular pain

Breast induration

Breast pain

Gynaecomastia

Oestradiol increased

Testosterone increased

General disorders and administration site conditions Various kinds of injection site reactions3 Fatigue

Asthenia

Hyperhidrosis4

Injury, poisoning and procedural complications Pulmonary oil microembolism**

*Respective frequency has been observed in relation to the use in testosterone containing products.

** Frequency is based on the number of injections.

The most appropriate MedDRA term to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.

Rash including Rash papular

Muscle disorders: Muscle spasm, Muscle strain and Myalgia

Various kinds of injection site reaction: Injection site pain, Injection site discomfort, Injection site pruritus, Injection site erythema, Injection site haematoma, Injection site irritation, Injection site reaction

Hyperhidrosis: Hyperhidrosis and Night sweats

Description of selected adverse reactions

Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injections and are reversible. Cases suspected by the company or the reporter to represent oily pulmonary microembolism have been reported rarely in clinical trials (in ≥ 1/10,000 and < 1/1,000 injections) as well as from postmarketing experience (see section 4.4).

In addition to the above mentioned adverse reactions, nervousness, hostility, sleep apnoea, various skin reactions including seborrhoea, increased hair growth, increased frequency of erections and in very rare cases jaundice have been reported under treatment with testosterone containing preparations.

Therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can in rare cases cause persistent, painful erections (priapism). High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No special therapeutic measure apart from termination of therapy with the medicinal product or dose reduction is necessary after overdose.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Androgens, 3-oxoandrosten (4) derivatives

ATC code: G03B A03

Testosterone undecanoate is an ester of the naturally occurring androgen, testosterone. The active form, testosterone, is formed by cleavage of the side chain.

Testosterone is the most important androgen of the male, mainly synthesised in the testicles, and to a small extent in the adrenal cortex.

Testosterone is responsible for the expression of masculine characteristics during foetal, early childhood, and pubertal development and thereafter for maintaining the masculine phenotype and androgen-dependent functions (e.g. spermatogenesis, accessory sexual glands). It also performs functions, e.g. in the skin, muscles, skeleton, kidney, liver, bone marrow, and CNS.

Dependent on the target organ, the spectrum of activities of testosterone is mainly androgenic (e.g. prostate, seminal vesicles, epididymis) or protein-anabolic (muscle, bone, haematopoiesis, kidney, liver).

The effects of testosterone in some organs arise after peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the target cell nucleus e.g. the pituitary, fat, brain, bone, and testicular Leydig cells.

5.2 Pharmacokinetic properties

Absorption

Nebido is an intramuscularly administered depot preparation of testosterone undecanoate and thus circumvents the first-pass effect. Following intramuscular injection of testosterone undecanoate as an oily solution, the compound is gradually released from the depot and is almost completely cleaved by serum esterases into testosterone and undecanoic acid. An increase in serum levels of testosterone above basal values may be seen one day after administration.

Steady-state conditions

After the 1st intramuscular injection of 1000 mg testosterone undecanoate to hypogonadal men, mean Cmax values of 38 nmol/L (11 ng/mL) were obtained after 7 days. The second dose was administered 6 weeks after the 1st injection and maximum testosterone concentrations of about 50 nmol/L (15 ng/mL) were reached. A constant dosing interval of 10 weeks was maintained during the following 3 administrations and steady-state conditions were achieved between the 3rd and the 5th administration. Mean Cmax and Cmin values of testosterone at steady-state were about 37 (11 ng/mL) and 16 nmol/L (5 ng/mL), respectively. The median intra- and inter-individual variability (coefficient of variation, %) of Cmin values was 22 % (range: 9-28%) and 34% (range: 25-48%), respectively.

Distribution

In serum of men, about 98% of the circulating testosterone is bound to sex hormone binding globulin (SHBG) and albumin. Only the free fraction of testosterone is considered as biologically active. Following intravenous infusion of testosterone to elderly men, the elimination half-life of testosterone was approximately one hour and an apparent volume of distribution of about 1.0 l/kg was determined.

Biotransformation

Testosterone which is generated by ester cleavage from testosterone undecanoate is metabolised and excreted the same way as endogenous testosterone. The undecanoic acid is metabolised by ß-oxidation in the same way as other aliphatic carboxylic acids.The major active metabolites of testosterone are oestradiol and dihydrotestosterone.

Elimination

Testosterone undergoes extensive hepatic and extrahepatic metabolism. After the administration of radio-labelled testosterone, about 90% of the radioactivity appears in the urine as glucuronic and sulphuric acid conjugates and 6% appears in the faeces after undergoing enterohepatic circulation. Urinary medicinal products include androsterone and etiocholanolone. Following intramuscular administration of this depot formulation the release rate is characterised by a half life of 90±40 days.

5.3 Preclinical safety data

Toxicological studies have not revealed other effects than those which can be explained based on the hormone profile of Nebido.

Testosterone has been found to be non-mutagenic in vitro using the reverse mutation model (Ames test) or hamster ovary cells. A relationship between androgen treatment and certain cancers has been found in studies on laboratory animals. Experimental data in rats have shown increased incidences of prostate cancer after treatment with testosterone.

Sex hormones are known to facilitate the development of certain tumours induced by known carcinogenic agents. The clinical relevance of the latter observation is not known.

Fertility studies in rodents and primates have shown that treatment with testosterone can impair fertility by suppressing spermatogenesis in a dose dependent manner.

6. Pharmaceutical particulars

6.1 List of excipients

Benzyl benzoate

Castor oil, refined

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

5 years

The medicinal product must be used immediately after first opening.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Ampoule

5-ml brown glass (type I) ampoules, containing a fill volume of 4 ml.

Pack size: 1 x 4 ml

Vial

6ml brown glass (type I) vial with grey bromobutyl (foil-clad ETFE) injection stopper and bordered cap, containing a fill volume of 4 ml.

Pack size: 1 x 4 ml

6.6 Special precautions for disposal and other handling

The solution for intramuscular injection is to be visually inspected prior to use and only clear solutions free from particles should be used.

The medicinal product is for single use only and any unused solution should be discarded in accordance with local requirements.

Ampoule

Notes on handling the OPC (One-Point-Cut) ampoule:

There is a pre-scored mark beneath the coloured point on the ampoule eliminating the need to file the neck. Prior to opening, ensure that any solution in the upper part of the ampoule flows down to the lower part. Use both hands to open; while holding the lower part of the ampoule in one hand, use the other hand to break off the upper part of the ampoule in the direction away from the coloured point.

Vial

The vial is for single use only. The content of a vial is to be injected intramuscularly immediately after drawing up into the syringe. After removal of the plastic cap (A) do not remove the metal ring (B)

9. Date of first authorisation/renewal of the authorisation

Omnadren

(Testosterone Blend)

Omnadren is a four-part testosterone blend that is virtually identical to Sustanon 250. While the original mixture was slightly different, the current model is a perfect mirror. As a testosterone compound, Omnadren represents a truly versatile anabolic steroid. It holds strong therapeutic benefits and as testosterone is one of the most important steroidal hormones in performance enhancement.

Omnadren was developed by Polfa in Poland under Soviet Union rule. Under the Polfa label Omnadren was dosed at 250mg/ml in the following concentration:

  • 30mg Testosterone Propionate
  • 60mg Testosterone Phenylpropionate
  • 60mg Testosterone Isocaproate
  • 100mg Testosterone Caproate

This is the precise mixture of Organon’s Sustanon 250 with the exception of the final Caproate ester. Sustanon 250 contains the same first three testosterone esters in the same concentrations, with the final 100mg being comprised of Testosterone Decanoate. However, currently the Omnadren mixture has been changed by replacing the Caproate ester with the Decanoate ester making it identical to Sustanon 250. The Omnadren brand name is now also owned by Jelfa Pharmaceuticals. The Jelfa name simply replaced the original Polfa shortly after the fall of the Soviet Union. An important note, the original Omnadren mixture containing Testosterone Caproate is no longer available. Any supposed Omnadren with this ester listed will be a counterfeit.

Omnadren Functions & Traits:

Test 600x

Omnadren is a four-part testosterone blend that is designed in an effort to provide fast acting testosterone benefits with long lasting effects. The purpose of all testosterone blends is to provide exogenous testosterone therapy to patients in a way that limits the total injection schedule while simultaneously maintaining stable testosterone levels. By this mixture, the individual can easily treat a low testosterone condition with one injection every 3-4 weeks. This is quite an improvement over standard single ester testosterones, which will require 1 injection every 7-14 days.

For the performance athlete, Omnadren and other testosterone blends do not provide an advantage over single ester testosterone forms. While Omnadren contains four distinct testosterone forms, it is no more or less potent than any testosterone hormone. Further, the performance athlete will need to inject the hormone far more frequently in order to maintain not only stable levels but also peak levels of testosterone.

For the low testosterone patient, Omnadren is a perfect remedy. If you suffer from low testosterone, the only thing that will remedy the condition is testosterone. Low testosterone can be an extremely bothersome condition that comes with numerous possible symptoms. Such symptoms can affect your physical, mental and sexual well-being. Such a condition is not life threatening, but if ignored it can be a gateway to numerous conditions that can be life threatening indeed. If you suffer from low testosterone, common symptoms include:

  • Loss of Libido
  • Erectile Dysfunction
  • Increased Body Fat (despite diet & exercise)
  • Loss of Strength (despite diet & exercise)
  • Loss of Muscle Mass (despite diet & exercise)
  • Insomnia
  • Decreased Mental Clarity
  • Decreased Focus
  • Lethargy
  • Irritability
  • Depression
  • Weakened Immune System

If you suffer from any of these symptoms, you are encouraged to have your testosterone levels checked. However, if you live in the U.S. you will not be prescribed Omnadren. This testosterone blend is predominantly found in Eastern Europe. In the U.S. single ester testosterone compounds dominate the pharmaceutical market.

For the performance athlete, Omnadren will provide enhancements in every area that affects low testosterone treatment. However, in this case, it is the enhancement of direct effects brought on by high testosterone levels that are of interest. In a therapeutic setting we are merely attempting to return levels to a normal range. In a performance setting, we are attempting to take them above and beyond what could ever be achieved naturally. Through high testosterone levels, the following is provided:

  • Enhanced Protein Synthesis: This refers to the rate by-which cells build proteins, the building block of muscle tissue.
  • Enhanced Nitrogen Retention: All muscle tissue is comprised of approximately 16% nitrogen. The more we retain the more anabolic we remain. Conversely, a nitrogen deficiency will result in a catabolic (muscle wasting) state.
  • Increased Red Blood Cell Count: Red blood cells are responsible for carrying oxygen to and through the blood. Higher levels of blood oxygenation result in greater muscular endurance, as well as improved recovery.
  • Increased IGF-1 Output: Insulin-Like Growth Factor-1 (IGF-1) is a potent and naturally produced peptide hormone. It is highly anabolic, carries numerous traits that affect our bodies recovery and further affects nearly ever cell in the human body.
  • Inhibition of Glucocorticoid Hormones: Glucocorticoid hormones (stress hormones) are in many ways the precise opposite of anabolic steroids. They destroy muscle tissue, promote fat gain and can make improvements very difficult when they become dominant.

By increasing our testosterone levels, we create the perfect anabolic atmosphere for nearly all performance related goals. Through high levels, we further enhance our metabolic rate. High testosterone levels will not directly burn body fat, but they will promote a more efficient metabolism. This will be beneficial in both an off-season and cutting phase.

Effects of Omnadren:

For the individual who suffers from low testosterone the effects of Omnadren will result in the condition no longer existing. While that may sound simple that’s really all there is to it. Your testosterone levels were low, you injected Omnadren and they no longer are. Problem solved. For the performance athlete, as a remarkably versatile anabolic steroid, the effects of Omnadren can be beneficial in many ways. In the end, the total effects will be dependent on your diet and training, especially your diet.

For the off-season athlete looking for increases in lean muscle mass, Omnadren is one of the best choices he could ever make. High testosterone levels with adequate food intake will result in growth at an accelerated rate. Further, due to the metabolic enhancement provided, the individual will gain less body fat than he would otherwise. Make no mistake, you can still gain a lot of fat, but you can control and make better use of your calories when testosterone levels are high. The individual should also find his strength increases significantly.

Then we have the cutting phase and in some circles testosterone is often viewed as a poor cutting steroid. This thinking is due to the hormone’s ability to aromatize and promote excess water retention. However, as we will see later on water retention can be controlled. More importantly, the use of Omnadren during this phase will protect your hard earned muscle tissue during the diet. In order to lose body fat, you must burn more calories than you consume, and this will put lean muscle tissue at risk. High levels of testosterone will ensure you protect as much muscle mass as possible. High testosterone levels will also ensure you burn fat at a more efficient rate than you would with normal levels. When it comes to a cutting phase, losing body fat and protecting muscle mass are the primary goals, and Omnadren will ensure they are met.

Regardless of who you are or why you’re supplementing with this steroid, all who use Omnadren will find their rate of recovery is enhanced, as well as their muscular endurance. This makes Omnadren a fantastic steroid for performance athletes. They may not be looking to add a lot of size and they won’t if their calories are not at surplus levels, but the other benefits are invaluable. Couple this with the boost in strength and you have a perfect steroid for athletic enhancement.

Side Effects of Omnadren:

As a testosterone compound the side effects of Omnadren will be identical to all testosterone compounds. This makes Omnadren a very well-tolerated steroid for most healthy adult men. While synthetic in nature, it’s still testosterone and the human body will make no distinguishing difference between it and what you naturally produce. In a therapeutic setting to treat low testosterone, while side effects are possible the odds are highly in your favor. In such cases you are merely replacing what you’re lacking and nothing more. In a performance setting, this is where the side effects of Omnadren will be the most pronounced. However, they can still be controlled. Most men can tolerate high testosterone levels fairly well, especially if they take the correct steps. In order to understand the side effects of Omnadren, we have broken them down into their respective categories along with all you need to know.

[1] Estrogenic:

Omnadren is moderately estrogenic due to its ability to aromatize. Aromatization refers to the conversion of testosterone to estrogen, and as estrogen levels rise this can lead to side effects. The primary estrogenic side effects of Omnadren are gynecomastia and excess water retention. Water retention can also promote high blood pressure if it gets out of hand.

In order to combat the estrogenic side effects of Omnadren, anti-estrogens are often recommended. You have two choices in anti-estrogenic medications for this purpose, Selective Estrogen Receptor Modulators (SERM’s) or Aromatase Inhibitors (AI’s). Common SERM’s include Nolvadex (Tamoxifen Citrate) and Clomid (Clomiphene Citrate). Common AI’s include Arimidex (Anastrozole) and Femara (Letrozole). AI’s will be the most effective as they inhibit the aromatase process and lower serum estrogen levels. Unfortunately, they can also have a negative impact on cholesterol, which can be exasperated by the use of exogenous testosterone. Cholesterol management is possible but must be taken into consideration. For many men, depending on the dose and individual sensitivity to estrogenic side effects, SERM’s will provide the protection they need. As a bonus, they appear to have a positive impact on cholesterol. If you can get the job done with a SERM this should be your first choice, but many men, especially with supraphysiological doses of testosterone will need an AI.

[2] Androgenic:

Omnadren carries with it several possible androgenic side effects. Such effects include acne, accelerated hair loss in those predisposed to male pattern baldness and body hair growth. These effects are due to the testosterone hormone’s reduction to dihydrotestosterone (DHT) due to its interaction with the 5-alpha reductase enzyme. Such effects are highly dependent on genetic predispositions, many men will be fine but some may consider the use of a 5-alpha reductase inhibitor like Finasteride. The use of an inhibitor will not completely reduce the androgenicity of the hormone, but it will make a notable difference.

The androgenic nature of Omnadren can also lead to virilization symptoms in women. Such symptoms include body hair growth, a deepening of the vocal chords and clitoral enlargement. Women need testosterone just as men; however, they need far less. There are women who need testosterone therapy, but Omnadren is not a form that’s recommended. In a performance capacity, most all women will find other steroids to be their best options. There are steroids that carry a much lower virilization rating and should be the first choice of any female athlete.

[3] Cardiovascular:

The use of Omnadren can have a negative effect on cholesterol. The noted effect will most commonly result in HDL cholesterol suppression. This can be more pronounced with the use of an AI. For this reason, a cholesterol friendly lifestyle is very important when using exogenous testosterone. A healthy lifestyle should include a healthy, cholesterol friendly diet, one that is rich in omega fatty acids and should include plenty of cardiovascular activity. While adverse cholesterol affects are possible, most men will be fine if they live a healthy lifestyle and no underlying issues exist.

[4] Testosterone:

The use of Omnadren or any testosterone hormone will suppress natural testosterone production. For the low testosterone patient this is of very little concern. Such an individual is no longer producing enough testosterone to begin with. For the individual who still produces adequate amounts of testosterone, assuming he does not supplement with reckless abandonment will find his natural production begins again once all exogenous steroidal use has come to an end.

Due to the suppression, once all steroid use has come to an end implementing a Post Cycle Therapy (PCT) plan is commonly recommended. This will speed up the rate of recovery. It will not return you to normal on its own, but it will greatly cut down on the time frame of recovery. It will also ensure you have enough testosterone for proper bodily function while your levels continue to naturally rise.

[5] Hepatotoxicity:

Omnadren does not carry a hepatotoxic nature and will present no stress or damage to the liver.

Omnadren Administration:

In a therapeutic setting, Omnadren is normally prescribed at 250mg in one single injection every 3-4 weeks. For the performance athlete, the dosing and injection frequency will be greatly enhanced. To combat testosterone suppression caused by the use of other anabolic steroids, 250mg every 7-10 days is normally recommended. For true anabolic benefits most men will find 500mg per week split into two 250mg doses per week to be beneficial and well within the realm of control. 750-1,000mg per week of Omnadren is not uncommon. Such doses will greatly increase the probability of adverse side effects but should still be very controllable for many men. However, most men will not need more than 500mg per week.

Regardless of the dose, many men find splitting their dose into smaller every other day injections to be very beneficial. This will not only maintain stable blood levels but it will ensure they are at their peak at all times. Many feel they have less dips in testosterone levels that would otherwise occur with less frequent injections due to the small/short Propionate and Phenylpropionate esters that in part make up Omnadren.

Availability of Omnadren:

Omnadren is not available on the U.S. pharmaceutical market and is very limited on the European pharmaceutical market. There are several underground labs that carry the compound, and some may even carry a testosterone blend comprised of the original mixture, but the original Omnadren mixture of Omnadren has not been available on any legitimate pharmaceutical market in a long time.

For most, the only way to obtain true Omnadren will be through a large internet based supplier. However, this can be risky as many of the labs found online are anything but quality labs. Researching your source will be imperative. If you’re supplier does not carry Omnadren, and many won’t, remember you can always buy Sustanon 250 and you will be receiving an identical testosterone compound. Most all suppliers carry Sustanon 250.

Buy Omnadren Online – Warning:

You can easily buy Omnadren online; in fact, it’s the only way most of you will ever be able to find it. You will also find that it’s a fairly affordable testosterone compound. It’s generally a little cheaper than Sustanon 250 but normally a little more expensive than single ester testosterone like Testosterone CypionateTestosterone Enanthate or Testosterone Propionate. If you decide to buy Omnadren online, another bonus is you’ll be able to buy all you want, but there are a few concerns when making an online purchase.

Anytime you buy Omnadren online or any anabolic steroid there’s always the risk of being scammed. You send your money but receive nothing in return. There’s also the risk of purchasing an under-dosed product or worse yet one that’s contaminated with bacteria. For these reasons, being patient and researching your supplier and the lab in question is beyond imperative. If you do these things, you will be able to find a quality supplier, but there’s an even bigger risk you need to be aware of. If you buy Omnadren online and you live in the United States you will be breaking the law. In the U.S. anabolic androgenic steroids are classified as Schedule III controlled substances by way of the Steroid Control Act of 1990 and the Steroid Control Act of 2004. Those who are caught violating this law risk severe punishments that can include heavy fines and jail time. The legality surrounding anabolic steroids can, however, vary greatly depending on the country in question. Some are similarly strict as the U.S. while others are far more lenient. However, most all countries will frown on online purchases.

Due to the risk associated with buying anabolic steroids, if you are looking for high quality anabolics you are encouraged to visit the sponsors here at Steroid.com. The sponsors here at Steroid.com carry high quality and clean anabolics. Equally important you will not need a prescription and you can buy them without the risk of legal consequences.

Omnadren Reviews:

Omnadren is a fantastic anabolic steroid; in this there can be no doubt. However, it is in no shape or form superior over other testosterone forms. The four ester blend does not present a more powerful testosterone compound, you will not receive better results just because you’re using Omnadren over a single ester testosterone compound. The mixture itself simply presents an advantage for therapeutic patients but presents no advantage or disadvantage to performance enhancing athletes. If this is an anabolic steroid you’d like to use, you can easily find a good deal if you do a little digging.


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