WHAT YOU SHOULD KNOW

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Jeanne, a MAVYRET patient
Wife, grandmother, and zookeeper

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MAVYRET is a prescription medicine used to treat adults with chronic (lasting a long time) hep 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 MAVYRET is safe and effective in children under 18 years of age.

MAVYRET can cause serious side effects, including:

Hepatitis B virus reactivation. Before starting treatment with MAVYRET, your doctor 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 hep C virus with MAVYRET. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your doctor will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking MAVYRET. For more information about side effects, see the section “What are the possible side effects of 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®)

The hep C virus can make about a trillion copies per day. MAVYRET is a combination of 2 medications, glecaprevir and pibrentasvir, that work together to attack the hep C virus and help stop it from multiplying.

Treatment with MAVYRET does not require the addition of ribavirin.

Before taking MAVYRET, tell your doctor about all of your medical conditions, including if you:

  • have ever had hepatitis B virus infection.
  • have liver problems other than hep C virus infection.
  • are pregnant or plan to become pregnant. It is not known if MAVYRET will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if MAVYRET passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAVYRET.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not take MAVYRET if you take any of the following medicines:

  • atazanavir (EVOTAZ®, REYATAZ®)
  • rifampin (RIFADIN®, RIFAMATE®, RIFATER®, RIMACTANE®)

MAVYRET and other medicines may affect each other. This can cause you to have too much or not enough MAVYRET or other medicines in your body. 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 doctor and pharmacist.

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

You may take MAVYRET for 8, 12, or 16 weeks depending on your hep C genotype, previous hep C treatment experience, and if you have compensated cirrhosis. Your doctor will tell you how long you need to take MAVYRET.

  • Take MAVYRET exactly as your doctor tells you to take it. Do not change your dose unless your doctor tells you to.
  • Do not stop taking MAVYRET without first talking with your doctor.
  • Take 3 MAVYRET tablets at one time each day.
  • Take MAVYRET with food.
  • It is important that you do not miss or skip doses of MAVYRET during treatment.
  • If you miss a dose of MAVYRET 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 MAVYRET, call your doctor or go to the nearest hospital emergency room right away.

MAVYRET can cause serious side effects, including:

Hepatitis B virus reactivation. See “What is the most important information I should know about MAVYRET?”

The most common side effects of MAVYRET include headache and tiredness.

These are not all the possible side effects of MAVYRET. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

  • Store MAVYRET at or below 86°F (30°C).
  • Keep MAVYRET in its original blister package until you are ready to take it.
Keep MAVYRET and all medicines out of the reach of children.

If you’re traveling, make sure to pack enough medicine to last longer than the number of days you will be away from home. Let your doctor or pharmacist know your plans.

Be sure to pack MAVYRET in your carry-on luggage instead of your checked bags so it doesn’t get misplaced during your trip.

MAVYRET can be used by people with chronic kidney disease. Your doctor will tell you if MAVYRET is right for you and how long you will need to take it.

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HELPFUL QUESTIONS TO ASK YOUR DOCTOR ABOUT MAVYRET

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