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elbasvir and grazoprevir

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

What is elbasvir and grazoprevir?

Elbasvir and grazoprevir are antiviral medicines that prevent hepatitis C (HCV) from multiplying in your body.

Elbasvir and grazoprevir is a combination medicine 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).

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

Elbasvir and grazoprevir may also be used for purposes not listed in this medication guide.

What is the most important information I should know about elbasvir and grazoprevir?

You should not use this medicine 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.

What should I discuss with my healthcare provider before taking elbasvir and grazoprevir?

You should not use this medicine 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 elbasvir and grazoprevir is safe for you, tell your doctor if you have:

  • 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 this medicine 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 elbasvir and grazoprevir 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 elbasvir and grazoprevir 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.

Elbasvir and grazoprevir is not approved for use by anyone younger than 18 years old.

How should I take elbasvir and grazoprevir?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using elbasvir and grazoprevir.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take elbasvir and grazoprevir with or without food.

Take the medicine at the same time each day.

Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HCV should remain under the care of a doctor.

While using elbasvir and grazoprevir, you may need frequent blood tests to check your liver function.

Store at room temperature away from moisture and heat. Keep each tablet in the foil blister pack until you are ready to take it.

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 elbasvir and grazoprevir?

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

Elbasvir and grazoprevir side effects

Get emergency medical help if you have signs of an allergic reaction: 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 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.

See also: Side effects (in more detail)

Elbasvir and grazoprevir dosing information

Usual Adult Dose 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

Comments:
-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

What other drugs will affect elbasvir and grazoprevir?

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 elbasvir and grazoprevir. 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 elbasvir and grazoprevir.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication 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 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2016-02-10, 4:18:22 PM.

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