ecommended dosage (three tablets) once daily with food as directed. Inform patients that it is important not to miss or skip doses and to take MAVYRET for the duration that is recommended by the physician [see Dosage and Administration (2.2)].
If a dose is missed and it is:
Less than 18 hours from the usual time that MAVYRET should have been taken – advise the patient to take the dose as soon as possible and then to take the next dose at the usual time.
More than 18 hours from the usual time that MAVYRET should have been taken – advise the patient not to take the missed dose and to take the next dose at the usual time.
Manufactured by AbbVie Inc., North Chicago, IL 60064
MAVYRET is a trademark of AbbVie Inc.
© 2017 AbbVie Inc. All rights reserved.
03-B632
PATIENT PACKAGE INSERT
Patient Information
MAVYRETTM (MAV-ih-reht)
(glecaprevir and pibrentasvir)
Tablets
What is the most important information I should know about MAVYRET?
MAVYRET can cause serious side effects, including:
Hepatitis B virus reactivation. Before starting treatment with MAVYRET, 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 treatment and after you stop taking MAVYRET.
For more information about side effects, see the section “What are the possible side effects of MAVYRET?”
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 MAVYRET is safe and effective in children under 18 years of age.
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, 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 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 healthcare provider about the best way to feed your baby if you take MAVYRET.
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 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 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 tak |
