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Mavyret

Generic Name: glecaprevir and pibrentasvir (glec A pre vir and pi BRENT as vir)
Brand Names: Mavyret

What is Mavyret?

Mavyret contains a combination of glecaprevir and pibrentasvir. Glecaprevir and pibrentasvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.

Mavyret is used to treat chronic hepatitis C in adults with HCV genotype 1, 2, 3, 4, 5, or 6.

Mavyret is sometimes given after other medicines have been tried without success.

Important information

You should not use Mavyret if you have severe liver disease, or if you also take atazanavir or rifampin.

If you have ever had hepatitis B, Mavyret 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 Mavyret if you are allergic to glecaprevir or pibrentasvir, or if:

  • you have severe liver disease; or

  • you also take atazanavir or rifampin.

To make sure Mavyret is safe for you, tell your doctor if you have ever had:

  • hepatitis B;

  • liver problems other than hepatitis; or

  • HIV (human immunodeficiency virus).

It is not known whether Mavyret will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether glecaprevir and pibrentasvir passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How should I take Mavyret?

Take Mavyret exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Mavyret is usually taken as 3 tablets once per day for 8 to 16 weeks.

Take Mavyret tablets with 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 Mavyret suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, Mavyret 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 Mavyret in the original container at room temperature away from moisture and heat. Keep each tablet in the foil blister pack until you are ready to take it.

Mavyret dosing information

Usual Adult Dose of Mavyret for Chronic Hepatitis C:

3 tablets orally once a day with food

Duration of Therapy:
THERAPY-NAIVE PATIENTS:
HCV genotype 1, 2, 3, 4, 5, or 6:
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

THERAPY-EXPERIENCED PATIENTS:
HCV genotype 1 (prior therapy with regimen containing an NS5A inhibitor without prior therapy with an NS3/4A protease inhibitor):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

HCV genotype 1 (prior therapy with regimen containing an NS3/4A protease inhibitor without prior therapy with an NS5A inhibitor):
-No cirrhosis: 12 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 1, 2, 4, 5, or 6 (prior therapy with regimen containing PRS):
-No cirrhosis: 8 weeks
-Compensated cirrhosis (Child-Pugh A): 12 weeks

HCV genotype 3 (prior therapy with regimen containing PRS):
-No cirrhosis: 16 weeks
-Compensated cirrhosis (Child-Pugh A): 16 weeks

Comments:
-Recommended for HCV mono-infected and HCV/HIV-1-coinfected patients with compensated liver disease (with or without cirrhosis)
-NS5A: Nonstructural protein 5A; NS3/4A: Nonstructural protein 3/4A
-In clinical trials, patients with prior NS5A inhibitor experience were treated with regimens containing ledipasvir-sofosbuvir or daclatasvir with pegylated interferon and ribavirin.
-In clinical trials, patients with prior NS3/4A protease inhibitor experience were treated with regimens containing simeprevir with sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin.
-PRS: Prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir without prior treatment experience with an HCV NS3/4A protease inhibitor or NS5A inhibitor

Uses:
-For the treatment of patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
-For the treatment of HCV genotype 1-infected patients with prior treatment using a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both

Dosage Information (comprehensive)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 18 hours late, skip the missed 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 Mavyret?

Taking Mavyret 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.

Mavyret side effects

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

Common Mavyret side effects may include:

  • headache; 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 Mavyret?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • carbamazepine;

  • efavirenz; or

  • St. John's wort.

This list is not complete. Other drugs may interact with glecaprevir and pibrentasvir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Mavyret.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Mavyret 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 1996-2017 Cerner Multum, Inc. Version: 1.01.

Last reviewed: August 11, 2017
Date modified: September 09, 2017

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