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Generic Name: glecaprevir and pibrentasvir
Dosage Form: Tablets
Date of Approval: August 3, 2017
Company: AbbVie Inc.

Treatment for: Chronic Hepatitis C

FDA Approves Mavyret

The U.S. Food and Drug Administration (FDA) approved Mavyret (glecaprevir/pibrentasvir), an NS3/4A protease inhibitor and NS5A inhibitor fixed-dose combination indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Mavyret can cause serious side effects, including:

Hepatitis B virus reactivation. Before starting treatment, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with Mavyret. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during, and after you stop treatment.

For more information about side effects, see Mavyret side effects.

What is Mavyret?

  • Mavyret is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis.

Mavyret contains the two medicines: glecaprevir and pibrentasvir.

It is not known if this medicine is safe and effective in children under 18 years of age.

Who should not take Mavyret?

Do not take Mavyret if you:

  • have certain liver problems
  • also take any of the following medicines:
    • atazanavir (Evotaz, Reyataz)
    • rifampin (Rifadin, Rifamate, Rifater, Rimactane)

Before taking Mavyret

Before starting treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • have ever had hepatitis B virus infection
  • have liver problems other than hepatitis C virus infection.
  • are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Mavyret and other medicines may affect each other. This may affect the way Mavyret or your other medicines work, or may cause side effects.

Keep a list of your medicines to show your healthcare provider and pharmacist.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with Mavyret.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Mavyret with other medicines.

How should I take Mavyret?

  • Take this medicine 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 treatment without first talking with your healthcare provider.
  • Take three tablets at one time each day.
  • Take the tablets with food.
  • It is important that you do not miss or skip doses during treatment.
  • If you miss a dose and it is:
    • Less than 18 hours from the time you usually take Mavyret, take the missed dose with food as soon as possible. Then take your next dose at your usual time.
    • More than 18 hours from the time you usually take Mavyret, do not take the missed dose. Take your next dose as usual with food.

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

Mavyret side effects

Mavyret can cause serious side effects, including:

  • Hepatitis B virus reactivation. See Important information.

The most common side effects include headache and tiredness.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Mavyret?

  • Store the tablets at or below 86°F (30°C).
  • Keep the tablets in the original blister package until you are ready to take them.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Mavyret

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Mavyret?

Active ingredients: glecaprevir and pibrentasvir

Inactive ingredients: colloidal silicon dioxide, copovidone (type K 28), croscarmellose sodium, hypromellose 2910, iron oxide red, lactose monohydrate, polyethylene glycol 3350, propylene glycol monocaprylate (type II), sodium stearyl fumarate, titanium dioxide, and vitamin E (tocopherol) polyethylene glycol succinate. The tablets do not contain gluten.

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