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HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do Not Include All the Information Needed to Use MAVYRET Safely and Effec

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HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do Not Include All the Information Needed to Use MAVYRET Safely and Effec HIGHLIGHTS OF PRESCRIBING INFORMATION 1, 2, 4, 5, or PRS3 8 weeks 12 weeks These highlights do not include all the information needed to use 6 MAVYRET safely and effectively. See full prescribing information for 3 PRS3 16 weeks 16 weeks MAVYRET. 1. Treated with prior regimens containing ledipasvir and sofosbuvir or MAVYRETTM (glecaprevir and pibrentasvir) tablets, for oral use daclatasvir with (peg) interferon and ribavirin. Initial U.S. Approval: 2017 2. Treated with prior regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg) interferon and ribavirin. WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION 3. PRS=Prior treatment experience with regimens containing (peg) interferon, IN PATIENTS COINFECTED WITH HCV AND HBV ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor. See full prescribing information for complete boxed warning. • HCV/HIV-1 co-infection and patients with any degree of renal impairment: Hepatitis B virus (HBV) reactivation has been reported, in some Follow the dosage recommendations in the tables above. (2.2) cases resulting in fulminant hepatitis, hepatic failure, and death. • Liver or Kidney Transplant Recipients: MAVYRET is recommended for 12 (5.1) weeks in adult and pediatric patients 12 years and older or weighing at least 45 kg who are liver or kidney transplant recipients. A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A RECENT MAJOR CHANGES inhibitor-experienced without prior treatment with an NS3/4A PI or in Indications and Usage (1) 4/2019 genotype 3-infected patients who are PRS treatment-experienced. (2.3) Dosage and Administration, DOSAGE FORMS AND STRENGTHS Recommended Dosage in Adult and Pediatric Patients 12 years 9/2019 and older or Weighing at Least 45 kg (2.2) Tablets: 100 mg glecaprevir and 40 mg pibrentasvir. (3) Liver or Kidney Transplant Recipients (2.3) 4/2019 CONTRAINDICATIONS Hepatic Impairment (2.4) 9/2019 • Patients with moderate or severe hepatic impairment (Child-Pugh B or C) Contraindications (4) 9/2019 or those with any history of prior hepatic decompensation. (4, 5.2) Warnings and Precautions (5.2) 9/2019 • Coadministration with atazanavir and rifampin. (4) INDICATIONS AND USAGE WARNINGS AND PRECAUTIONS • MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus • Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A current or prior HBV infection before initiation of HCV treatment. Monitor inhibitor, and is indicated for the treatment of adult and pediatric patients HCV/HBV coinfected patients for HBV reactivation and hepatitis flare 12 years and older or weighing at least 45 kg with chronic HCV genotype during HCV treatment and post-treatment follow-up. Initiate appropriate (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated patient management for HBV infection as clinically indicated. (5.1) cirrhosis (Child-Pugh A). • Risk of Hepatic Decompensation/Failure in Patients with Evidence of • MAVYRET is indicated for the treatment of adult and pediatric patients 12 Advanced Liver Disease: Hepatic decompensation/failure, including fatal years and older or weighing at least 45 kg with HCV genotype 1 infection, outcomes, have been reported mostly in patients with cirrhosis and baseline who previously have been treated with a regimen containing an HCV NS5A moderate or severe liver impairment (Child-Pugh B or C). Monitor for inhibitor or an NS3/4A protease inhibitor, but not both. (1) clinical and laboratory evidence of hepatic decompensation. Discontinue MAVYRET in patients who develop evidence of hepatic DOSAGE AND ADMINISTRATION decompensation/failure. (5.2) • Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. (2.1) ADVERSE REACTIONS • Recommended dosage in adult and pediatric patients 12 years and older or In subjects receiving MAVYRET, the most commonly reported adverse weighing at least 45 kg: Three tablets taken at the same time orally once reactions (greater than 10%) are headache and fatigue. (6.1) daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) with food. (2.2) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. • See recommended treatment duration in tables below. (2.2) at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Treatment-Naïve Patients DRUG INTERACTIONS Treatment Duration • Carbamazepine, efavirenz, and St. John’s wort may decrease concentrations HCV Genotype Compensated Cirrhosis of glecaprevir and pibrentasvir. Coadministration of carbamazepine, No Cirrhosis (Child-Pugh A) efavirenz containing regimens, and St. John’s wort with MAVYRET is not 1, 2, 3, 4, 5, or 6 8 weeks 8 weeks recommended. (5.3) • Clearance of HCV infection with direct-acting antivirals may lead to Treatment-Experienced Patients changes in hepatic function, which may impact safe and effective use of Treatment Duration concomitant medications. Frequent monitoring of relevant laboratory Patients Previously Compensated parameters (INR or blood glucose) and dose adjustments of certain HCV No Treated With a Cirrhosis concomitant medications may be necessary. (7.3) Genotype Cirrhosis Regimen Containing: (Child-Pugh A) • Medication- Assisted Treatment (MAT) for Opioid Use Disorder. (7.4) • Consult the full prescribing information prior to and during treatment for An NS5A inhibitor1 without prior potential drug interactions. (4, 7, 12.3) treatment with an NS3/4A protease 16 weeks 16 weeks inhibitor (PI) 1 See 17 for PATIENT COUNSELING INFORMATION and FDA- An NS3/4A PI2 without prior 12 weeks 12 weeks approved patient labeling. treatment with an NS5A inhibitor Revised: 9/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 2.1 Testing Prior to the Initiation of Therapy WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN 2.2 Recommended Dosage in Adult and Pediatric Patients 12 Years and PATIENTS COINFECTED WITH HCV AND HBV Older or Weighing at Least 45 kg 1 INDICATIONS AND USAGE 2.3 Liver or Kidney Transplant Recipients 2 DOSAGE AND ADMINISTRATION 2.4 Hepatic Impairment Reference ID: 4497729 3 DOSAGE FORMS AND STRENGTHS 12.2 Pharmacodynamics 4 CONTRAINDICATIONS 12.3 Pharmacokinetics 5 WARNINGS AND PRECAUTIONS 12.4 Microbiology 5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV 13 NONCLINICAL TOXICOLOGY and HBV 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.2 Risk of Hepatic Decompensation/Failure in Patients with Evidence of 14 CLINICAL STUDIES Advanced Liver Disease 14.1 Description of Clinical Trials 5.3 Risk of Reduced Therapeutic Effect Due to Concomitant Use of 14.2 Treatment-Naïve or PRS Treatment-Experienced Adults with HCV MAVYRET with Carbamazepine, Efavirenz Containing Regimens, or Genotype 1, 2, 4, 5, or 6 Infection without Cirrhosis St. John’s Wort 14.3 Treatment-Naïve Adults with HCV Genotype 1-6 Infection with 6 ADVERSE REACTIONS Compensated Cirrhosis or PRS Treatment-Experienced Adults with 6.1 Clinical Trials Experience HCV Genotype 1, 2, 4, 5, or 6 Infection with Compensated Cirrhosis 6.2 Postmarketing Experience 14.4 Treatment-Naïve or PRS Treatment-Experienced Adults with HCV 7 DRUG INTERACTIONS Genotype 3 Infection without Cirrhosis or with Compensated Cirrhosis 7.1 Mechanisms for the Potential Effect of MAVYRET on Other Drugs 14.5 Treatment-Naïve and PRS Treatment-Experienced Adults with CKD 7.2 Mechanisms for the Potential Effect of Other Drugs on MAVYRET Stage 4 and 5 and Chronic HCV Infection without Cirrhosis or with 7.3 Established and Other Potential Drug Interactions Compensated Cirrhosis 7.4 Medication-Assisted Treatment (MAT) for Opioid Use Disorder 14.6 Adults Who are NS5A Inhibitor or NS3/4A-Protease Inhibitor (PI)­ 7.5 Drugs with No Observed Clinically Significant Interactions with Experienced, without Cirrhosis or with Compensated Cirrhosis MAVYRET 14.7 Treatment-Naïve or PRS Treatment-Experienced Adults with 8 USE IN SPECIFIC POPULATIONS HCV/HIV-1 Coinfection without Cirrhosis or with Compensated 8.1 Pregnancy Cirrhosis 8.2 Lactation 14.8 Treatment-Naïve or PRS Treatment-Experienced Adults with Liver or 8.4 Pediatric Use Kidney Transplant without Cirrhosis 8.5 Geriatric Use 14.9 Clinical Trial in Pediatric Subjects (12 years to less than 18 years) 8.6 Renal Impairment 16 HOW SUPPLIED/STORAGE AND HANDLING 8.7 Hepatic Impairment 17 PATIENT COUNSELING INFORMATION 10 OVERDOSAGE 11 DESCRIPTION *Sections or subsections omitted from the full prescribing information are not 12 CLINICAL PHARMACOLOGY listed. 12.1 Mechanism of Action Reference ID: 4497729 FULL PRESCRIBING INFORMATION 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)]. 1 INDICATIONS AND USAGE MAVYRET is indicated for the treatment of adult and pediatric patients
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