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 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.
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:
- St. John’s wort;
- HIV or AIDS medication – atazanavir, darunavir, efavirenz, lopinavir, saquinavir, tipranavir; or
- seizure medicine – carbamazepine, phenytoin.
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 (warfarin, Coumadin, Jantoven) 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
-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., boceprevir, simeprevir, telaprevir)
-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:
- nausea, vomiting, upper stomach pain, loss of appetite;
- 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:
- depression, feeling tired or irritable;
- shortness of breath;
- itching or rash;
- sleep problems (insomnia); or
- joint pain.
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.