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 and children 3 years of age and older (dosage is based on weight). 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.

If you've had hepatitis B, Epclusa can cause this condition to come back or get worse. Call your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

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

Epclusa is sometimes used in combination with other antiviral medication. Read the medication guide or patient instructions provided with each medication in your combination therapy.

When taking Epclusa with other medicine: Tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

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

• hepatitis B;

• liver problems other than hepatitis C;

• kidney disease (or if you are on dialysis);

• diabetes;

• HIV (human immunodeficiency virus); or

• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Epclusa is sometimes used in combination with ribavirin. Both men and women using ribavirin should use birth control to prevent pregnancy. Ribavirin can harm an unborn baby if the mother or father is using ribavirin. Keep using birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs.

Ask a doctor if it is safe to breastfeed while using these medicines.

Take Epclusa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take with or without food.

Place the oral pellets in your mouth and swallow without chewing. Read and follow all Instructions for Use about mixing the pellets with food to improve the taste. Ask your doctor or pharmacist if you need help.

Doses are based on weight in children and teenagers. The dose may change if the child gains or loses weight.

If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using this medicine and for several months after you stop.

You should not stop using Epclusa suddenly, or your hepatitis C could become harder to treat with antiviral medicine.

Use all medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Remain under the care of a doctor.

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

Usual Adult Dose for Chronic Hepatitis C:

Sofosbuvir 400 mg-velpatasvir 100 mg 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 (boceprevir, simeprevir, or telaprevir).
-If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

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

Usual Pediatric Dose for Chronic Hepatitis C:

6 years or older:
-Weight 17 to less than 30 kg: Sofosbuvir 200 mg-velpatasvir 50 mg orally once a day
-Weight at least 30 kg: Sofosbuvir 400 mg-velpatasvir 100 mg 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 adults received a peginterferon alfa/ribavirin-based regimen with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir).
-If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments.

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

Epclusa is sometimes used in combination with other antiviral medication. Read the medication guide or patient instructions provided with each medication in your combination therapy.

When taking Epclusa with other medicine: Tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

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

• hepatitis B;

• liver problems other than hepatitis C;

• kidney disease (or if you are on dialysis);

• diabetes;

• HIV (human immunodeficiency virus); or

• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Epclusa is sometimes used in combination with ribavirin. Both men and women using ribavirin should use birth control to prevent pregnancy. Ribavirin can harm an unborn baby if the mother or father is using ribavirin. Keep using birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs.

Ask a doctor if it is safe to breastfeed while using these medicines.

Take the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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

Using this medicine will not prevent your disease from spreading. 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.

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:

• right-sided upper stomach pain;

• vomiting, loss of appetite, not feeling well; 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 this medicine 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:

• headache, tiredness;

• nausea, vomiting, diarrhea;

• sleep problems (insomnia); or

• low red blood cells (anemia) in people with cirrhosis - pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

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.

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.

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).

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 here. Tell your doctor about all other medicines you use.