Label: MAVYRET- glecaprevir and pibrentasvir tablet, film coated
MAVYRET- glecaprevir and pibrentasvir pellet

  • NDC Code(s): 0074-2600-28, 0074-2625-01, 0074-2625-04, 0074-2625-28, view more
  • Packager: AbbVie Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 15, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MAVYRET safely and effectively. See full prescribing information for MAVYRET.       MAVYRET® (glecaprevir and pibrentasvir ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV

    Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1)].

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  • 1  INDICATIONS AND USAGE
    MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with ...
  • 2  DOSAGE AND ADMINISTRATION
    2.1  Testing Prior to the Initiation of Therapy - Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody ...
  • 3  DOSAGE FORMS AND STRENGTHS
    MAVYRET is available as tablets or pellets for oral use. Tablets: pink, oblong-shaped, film-coated, and debossed with “NXT” on one side. Each tablet contains 100 mg glecaprevir and 40 mg of ...
  • 4  CONTRAINDICATIONS
    MAVYRET is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation [see Warnings and Precautions ...
  • 5  WARNINGS AND PRECAUTIONS
    5.1  Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV - Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing ...
  • 6  ADVERSE REACTIONS
    6.1  Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of MAVYRET cannot be directly ...
  • 7  DRUG INTERACTIONS
    7.1  Mechanisms for the Potential Effect of MAVYRET on Other Drugs - Glecaprevir and pibrentasvir are inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic ...
  • 8  USE IN SPECIFIC POPULATIONS
    8.1  Pregnancy - Risk Summary - No adequate human data are available to establish whether or not MAVYRET poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse ...
  • 10  OVERDOSAGE
    In case of overdose, the patient should be monitored for any signs and symptoms of toxicities. Appropriate symptomatic treatment should be instituted immediately. Glecaprevir and pibrentasvir are ...
  • 11  DESCRIPTION
    MAVYRET contains glecaprevir, a HCV NS3/4A PI, and pibrentasvir a HCV NS5A inhibitor. MAVYRET is available as a fixed dose combination tablet or coated pellets in unit-dose packets for oral ...
  • 12  CLINICAL PHARMACOLOGY
    12.1  Mechanism of Action - Mechanism of Action - MAVYRET is a fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral agents against the hepatitis C virus ...
  • 13  NONCLINICAL TOXICOLOGY
    13.1  Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis and Mutagenesis - Glecaprevir and pibrentasvir were not genotoxic in a battery of in vitro or in vivo assays ...
  • 14  CLINICAL STUDIES
    14.1  Description of Clinical Trials - Table 12 summarizes the clinical trials conducted to support the effectiveness of MAVYRET in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 infection and ...
  • 16  HOW SUPPLIED/STORAGE AND HANDLING
    MAVYRET Tablets - ConfigurationContentPackage SizeNDC - Monthly carton (blister pack)4 weekly cartons - 7 daily blisters/carton - 3 tablets/blister84 tablets0074-2625-04 - Monthly carton ...
  • 17  PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV - Inform patients that HBV ...
  • PATIENT PACKAGE INSERT
    Patient Information - MAVYRET® (MAV-ih-reht) (glecaprevir and pibrentasvir) tabletsMAVYRET® (MAV-ih-reht) (glecaprevir and pibrentasvir) oral pellets - What is the most important ...
  • INSTRUCTIONS FOR USE
    INSTRUCTIONS FOR USE - MAVYRET® (MAV-ih-reht) (glecaprevir and pibrentasvir) pellets for oral use
  • PRINCIPAL DISPLAY PANEL
    NDC 0074-2625-28 - Rx only - Mavyret® (glecaprevir and pibrentasvir) 100mg / 40mg - Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg - abbvie
  • PRINCIPAL DISPLAY PANEL
    NDC 0074-2625-01 - Rx only - Mavyret® (glecaprevir and pibrentasvir) 100mg / 40mg - Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg - abbvie
  • PRINCIPAL DISPLAY PANEL
    NDC 0074-2625-28 - Rx only - 4-WEEK SUPPLY - Mavyret® (glecaprevir and pibrentasvir) 100mg / 40mg - Each tablet contains glecaprevir and pibrentasvir 100mg / 40mg
  • PRINCIPAL DISPLAY PANEL
    NDC 0074-2625-80 - Rx only - MAVYRET® glecaprevir/pibrentasvir tablets - 100 mg/40 mg  - For Institutional Use Only84 Tablets - abbvie - Do not accept if seal over bottle opening is broken or ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0074-2600-28 - Rx only - MAVYRET® (glecaprevir/pibrentasivir) Oral Pellets - 50 mg/20 mg - Each packet contains pink and yellow oral pellets. abbvie
  • PRINCIPAL DISPLAY PANEL
    NDC 0074-2625-84 - Rx only - MAVYRET® glecaprevir/pibrentasvir tablets - 100 mg/40 mg - 84 Tablets - Do not accept if seal over bottle opening is broken or missing. abbvie
  • INGREDIENTS AND APPEARANCE
    Product Information