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Important Safety Information about MAVYRET including Important Warning on Hepatitis B Reactivation

USE

MAVYRET is a prescription medicine used to treat adults and children 3 years of age and older with:

Acute (recently infected) or chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
Hep C genotype 1 infection who have been previously treated with a regimen that contained a hep C NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MAVYRET?

Hepatitis B virus (hep B) reactivation: Before starting treatment with MAVYRET, your doctor will do blood tests to check for hep B infection. If you have ever had hep B infection, hep B could become active again during or after treatment for hep C with MAVYRET. Hep B that becomes 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 hep B reactivation during treatment and after you stop taking MAVYRET.

Do not take MAVYRET if you:

Have moderate or severe liver impairment (Child-Pugh B or C) or any history of prior liver decompensation
Are taking the medicines atazanavir or rifampin

What should I tell my doctor before taking MAVYRET?

If you have had hep B infection, have liver problems other than hep C infection, have HIV-1 infection, have had a liver or a kidney transplant, and all other medical conditions.
If you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAVYRET.
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 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.
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.

What are the possible side effects of MAVYRET?

In people who had or have advanced liver problems before starting treatment with MAVYRET, there is a rare risk of worsening liver problems, liver failure, and death. Your doctor will check you for signs and symptoms of worsening liver problems during treatment with MAVYRET. Tell your doctor right away if you have any of the following: nausea; tiredness; yellowing of your skin or white part of your eyes; bleeding or bruising more easily than normal; confusion; dark, black, or bloody stool; loss of appetite; diarrhea; dark or brown (tea-colored) urine; swelling or pain on the upper right side of your stomach area (abdomen); sleepiness; vomiting of blood; or lightheadedness.
The most common side effects of MAVYRET are headache and tiredness.

These are not all the possible side effects of MAVYRET. Call your doctor for medical advice about side effects.

This is the most important information to know about MAVYRET. For more information, talk to your doctor or healthcare provider.

MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit

or call 1-800-FDA-1088.

Please see full Prescribing Information, including the Patient Information.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.

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SAFETY CONSIDERATIONS