Epclusa

Epclusa is a prescription medication used to treat chronic hepatitis C virus. It is a single product containing two medications: sofosbuvir and velpatasvir.

Sofosbuvir and velpatasvir belong to a group of drugs called antivirals. Together these medications decrease the amount of hepatitis C virus in the body. 

This medication is available in tablet form and is typically taken once a day, with or without food. 

Common side effects of Epclusa include headache and fatigue.

Epclusa is a prescription medication used to treat chronic (lasting a long time) hepatitis C virus in adults with and without cirrhosis (advanced liver disease). Epclusa is a medication used to treat all six major forms of hepatitis C virus. 

When used to treat advanced cirrhosis (decompensated cirrhosis), Epclusa is to be given in combination with ribavirin. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Gilead Sciences, Inc.

Serious side effects may occur. See "Precautions" section.

The most common side effects of Epclusa included headache and fatigue.

The most common side effects of Epclusa when given with ribavirin included:

• fatigue
• anemia
• nausea
• headache
• insomnia
• diarrhea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Epclusa. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Acid Reducing Agents:
  • Antacids
    • aluminum hydroxide (Alternagel)
    • magnesium hydroxide (Milk of Magnesia)
    • calcium carbonate (Tums)
  • H2-receptor antagonists
    • famotidine (Pepcid)
    • ranitidine (Zantac))
    • cimetidine (Tagamet)
  • Proton-pump inhibitors
    • omeprazole (Prilosec)
    • esomeprazole (Nexium)
    • pantoprazole (Protonix)
    • lansoprazole (Prevacid)
• Antiarrhythmics:
  • amiodarone (Cordarone, Nexterone)
  • digoxin (Lanoxin)
• Anticancer medications
  • topotecan (Hycamtin)
• Antimycobacterials
  • rifabutin 
  • rifampin
  • rifapentine
• HIV Antiretrovirals
  • efavirenz (Sustiva, Stocrin)
  • regimens containing tenofovir disoproxil fumarate (Viread)
  • tipranavir/ritonavir (Aptivus/Norvir)
• Herbal Supplements
  • St. John’s Wort (Hypericum perforatum)
• Anticonvulsants:
  • carbamazepine
  • phenytoin
  • phenobarbital
  • oxcarbazepine
• HMG-CoA Reductase Inhibitors: (Monitor for statin-related adverse reactions such as myopathy (issues with the muscles that can lead to muscle weakness) and rhabdomyolysis (a rare but serious side effect in which the muscle tissue breaks down)
  • rosuvastatin (Crestor)
  • atorvastatin (Lipitor)
• warfarin (International normalized ratio (INR) values may rise and fall irregularly in those taking warfarin. As a result, frequent monitoring of INR values is recommended in patients taking warfarin)

This is not a complete list of Epclusa drug interactions. Ask your doctor or pharmacist for more information.

Epclusa may cause serious side effects such as: slow heart rate. Epclusa may result in a potentially fatal slowing of the heart rate when taken with amiodarone (Cordarone, Nexterone, Pacerone), a medicine used to treat certain heart problems.

• Slow heart rate. Epclusa may result in a potentially fatal slowing of the heart rate when taken with amiodarone (Cordarone, Nexterone, Pacerone), a medicine used to treat certain heart problems. Patients who develop signs or symptoms of a slow heart rate should seek medical evaluation immediately. Symptoms may include:
  • near-fainting or fainting
  • dizziness or lightheadedness
  • weakness
  • excessive tiredness
  • shortness of breath
  • chest pains
  • confusion
  • memory problems
• Birth defects or death of your unborn baby. Epclusa, in combination with ribavirin, may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking Epclusa with ribavirin, and for 6 months after treatment is over.
  • Females and males must use 2 effective forms of birth control during treatment and for the 6 months after treatment with Epclusa and ribavirin. Talk to your healthcare provider about forms of birth control that may be used during this time.
  • Females must have a negative pregnancy test before starting treatment with Epclusa and ribavirin, every month while being treated, and for 6 months after your treatment ends.
  • If you or your female sexual partner becomes pregnant while taking or within 6 months after taking Epclusa and ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant. 

Contact your healthcare provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite, or light-colored stools. These may be signs and symptoms of a serious liver problem. 

Do not take Epclusa if you are allergic to Epclusa or to any of its ingredients. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Epclusa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Epclusa, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Epclusa or to any of its ingredients 
• if you have a history of hepatitis B infection
• have liver problems other than hepatitis C infection
• have severe kidney problems or you are on dialysis
• have any other medical condition
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if the components of Epclusa passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how Epclusa works.

Tell your doctor if you are pregnant or plan to become pregnant.

No adequate human data are available to establish whether or not Epclusa poses a risk to pregnancy outcomes. In animal studies, no evidence of adverse developmental outcomes was observed with the components of Epclusa (sofosbuvir or velpatasvir).

If Epclusa is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. 

If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking Epclusa with ribavirin, and for 6 months after treatment is over.

• Females and males must use 2 effective forms of birth control during treatment and for the 6 months after treatment with Epclusa and ribavirin. Talk to your healthcare provider about forms of birth control that may be used during this time.
• Females must have a negative pregnancy test before starting treatment with Epclusa and ribavirin, every month while being treated, and for 6 months after your treatment ends.
• If you or your female sexual partner becomes pregnant while taking or within 6 months after you stop taking Epclusa and ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Epclusa crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Talk to your healthcare provider about the best way to feed your baby if you take Epclusa. You should not do both.

Take Epclusa exactly as your healthcare provider tells you to take it.

• Do not change your dose unless your healthcare provider tells you to.
• Do not stop taking Epclusa without first talking with your healthcare provider. If you think there is a reason to stop taking Epclusa, talk to your healthcare provider before doing so.
• This medication comes in tablet form.
• Take Epclusa 1 time each day with or without food.
• It is important that you do not miss or skip doses of Epclusa during treatment.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Epclusa is one tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily with or without food.

If you take too much Epclusa, call your healthcare provider or go to the nearest hospital emergency room right away.

• Store Epclusa at room temperature below 86°F (30°C).
• Keep Epclusa in its original container.
• Do not use Epclusa if the seal over the bottle opening is broken or missing.
• Keep Epclusa and all medicines out of the reach of children.

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C.