ent. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. (5.1)
ADVERSE REACTIONS
In subjects receiving MAVYRET, the most commonly reported adverse reactions (greater than 10%) are headache and fatigue. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Carbamazepine, efavirenz, and St. John’s wort may decrease concentrations of glecaprevir and pibrentasvir. Coadministration of carbamazepine, efavirenz containing regimens, and St. John’s wort with MAVYRET is not recommended. (5.2)
Frequent monitoring of international normalized ratio (INR) values is recommended in patients receiving warfarin. (7.1)
Consult the full prescribing information prior to and during treatment for potential drug interactions. (4,7, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to the Initiation of Therapy
2.2 Recommended Dosage in Adults
2.3 Hepatic Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
5.2 Risk of Reduced Therapeutic Effect Due to Concomitant Use of MAVYRET with Carbamazepine, Efavirenz Containing Regimens, or St. John’s Wort
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Mechanisms for the Potential Effect of MAVYRET on Other Drugs
7.2 Mechanisms for the Potential Effect of Other Drugs on MAVYRET
7.3 Established and Other Potential Drug Interactions
7.4 Drugs with No Observed Clinically Significant Interactions with MAVYRET
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Description of Clinical Trials
14.2 Treatment-Naïve or PRS Treatment-Experienced Adults With HCV Genotype 1, 2, 4, 5, or 6 Infection Without Cirrhosis
14.3 Treatment-Naïve or PRS Treatment-Experienced Adults With HCV Genotype 1, 2, 4, 5, or 6 Infection With Compensated Cirrhosis
14.4 Treatment-Naïve or PRS Treatment-Experienced Adults With HCV Genotype 3 Infection Without Cirrhosis or With Compensated Cirrhosis
14.5 Treatment-Naïve and PRS Treatment-Experienced Adults With CKD Stage 4 and 5 and Chronic HCV Infection Without Cirrhosis or With Compensated Cirrhosis
14.6 Adults Who are NS5A Inhibitor or NS3/4A-Protease Inhibitor (PI)-Experienced, Without Cirrhosis or With Compensated Cirrhosis
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
MAVYRET is indicated for the treatment of |
