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Generic Name: elbasvir and grazoprevir (ELB as vir and graz OH pre vir)
Brand Names: Zepatier

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 is used to treat chronic hepatitis C genotype 1 or 4 in adults. This medicine is sometimes given together with another drug called ribavirin (Copegus, Rebetol, Moderiba, Ribasphere).

Zepatier is used only if your HCV has a specific genetic marker, for which your doctor will test.

Important information

You should not use Zepatier if you have moderate or severe liver disease.

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.

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.

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.

Some medicines can cause unwanted or dangerous effects when used with elbasvir and grazoprevir. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cyclosporine;

  • rifampin;

  • 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:

  • a history of hepatitis B;

  • liver problems other than hepatitis, or if you have had a liver transplant;

  • HIV (human immunodeficiency virus); or

  • if you are waiting to have a liver transplant.

It is not known whether Zepatier will harm an unborn baby. Elbasvir and grazoprevir is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. 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 Zepatier 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 at least 2 effective forms of non-hormonal birth control (condom, diaphragm with spermicide) while either sexual partner is using these medications together. Keep using 2 forms of 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 Zepatier with 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 Zepatier.

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.

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 this medicine suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, elbasvir and grazoprevir 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 Zepatier 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 and 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 and ribavirin for 12 weeks
-Genotype 4, therapy-naive: Elbasvir-grazoprevir for 12 weeks
-Genotype 4, peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir and ribavirin for 16 weeks

-Patients with HCV genotype 1a infection should be tested for virus with NS5A resistance-associated polymorphisms (at amino acid positions 28, 30, 31, or 93) before starting this drug to determine regimen and duration.
-Hepatic laboratory testing recommended prior to and during therapy.
-Peginterferon alfa/ribavirin-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin
-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 should be consulted for recommended ribavirin dose in patients with CrCl greater than 50 mL/min; the manufacturer product information for ribavirin should be consulted for further information on ribavirin dosing, including dose adjustments.

Use: With or without ribavirin, for the treatment of chronic HCV genotypes 1 or 4 infection

Dosage Information (comprehensive)

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?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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:

  • nausea, vomiting, upper stomach pain, loss of appetite;

  • tiredness;

  • dark urine, clay-colored stools;

  • jaundice (yellowing of the skin or eyes); or

  • (if you also take ribavirin) pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Common Zepatier side effects may include:

  • headache;

  • nausea, diarrhea;

  • sleep problems (insomnia); or

  • feeling tired.

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.

Side Effects (complete list)

What other drugs will affect Zepatier?

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

  • bosentan;

  • modafinil;

  • tacrolimus;

  • antibiotic or antifungal medicine;

  • antiviral medicine to treat hepatitis or HIV/AIDS;

  • cholesterol medication;

  • heart or blood pressure medicine; or

  • tuberculosis medicine.

This list is not complete and many other drugs can interact with Zepatier. 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 Zepatier.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zepatier only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. 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 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 1996-2017 Cerner Multum, Inc. Version: 1.03. Revision Date: 2017-02-28, 2:40:41 PM.