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Epclusa

Generic Name: sofosbuvir and velpatasvir (soe FOS bue vir and vel PAT as vir)
Brand Names: Epclusa

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 with HCV genotype 1, 2, 3, 4, 5, or 6.

Epclusa is given in combination with another antiviral medicine called ribavirin in people who also have advanced cirrhosis.

Important information

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 Epclusa and ribavirin together and for at least 6 months after treatment ends.

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.

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.

Before taking this medicine

You should not use Epclusa if you are allergic to sofosbuvir or velpatasvir.

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

  • a history of hepatitis B;

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

  • liver problems other than hepatitis;

  • HIV (human immunodeficiency virus); or

  • if you have recently used a heart rhythm medicine called amiodarone (Cordarone, Pacerone).

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. You may need to have a negative pregnancy test before using these medications together, and every month during your treatment.

  • If you are a woman, do not use Epclusa with ribavirin if you are pregnant.

  • If you are a man, do not use this drug combination if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

  • Use effective birth control to prevent pregnancy while either sexual partner is using these medications together. Keep using this birth control for at least 6 months after treatment ends. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Epclusa with ribavirin.

It is not known whether sofosbuvir and velpatasvir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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.

You may take Epclusa with or without food.

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

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 condition harder to treat with hepatitis C antiviral medicine.

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.

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

Regimen and Duration of Therapy:
-Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks
-Patients with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir and ribavirin for 12 weeks

Comments:
-If applicable, the manufacturer product information for ribavirin should be consulted regarding dosing (including 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

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 Epclusa?

If you also take omeprazole (Prilosec), 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:

  • slow heartbeats;

  • weak or shallow breathing; or

  • low red blood cells-pale skin, weakness, rapid heart rate, trouble concentrating.

If you also take amiodarone: Seek medical help right away if you feel weak, tired, or light-headed, or if you have chest pain, shortness of breath, confusion, or memory problems.

Common Epclusa side effects may include:

  • headache;

  • tired feeling;

  • nausea, diarrhea; or

  • sleep problems (insomnia).

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?

Many drugs can interact with sofosbuvir and velpatasvir. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • amiodarone;

  • digoxin;

  • St. John's wort;

  • topotecan;

  • any medicine that contains tenofovir (such as Atripla, Complera, Stribild, Truvada, or Viread);

  • a beta-blocker-atenolol, bisoprolol, metoprolol, propranolol, sotalol, and others;

  • cholesterol medication such as atorvastatin or rosuvastatin;

  • other antiviral medicines such as efavirenz, ritonavir, or tipranavir;

  • seizure medication-carbamazepine, phenytoin; or

  • tuberculosis medication-rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with sofosbuvir and velpatasvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Epclusa.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Epclusa only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.02. Revision Date: 2016-10-06, 10:52:50 AM.

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