What is Epclusa?
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.
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:
- hepatitis B;
- liver problems other than hepatitis C;
- kidney disease (or if you are on dialysis);
- HIV (human immunodeficiency virus);
- if you have recently used a heart rhythm medicine called amiodarone (Cordarone, Nexterone, Pacerone); or
- if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine “INR” or prothrombin time tests.
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
-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 (boceprevir, simeprevir, 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?
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.