MAVYRET- pibrentasvir and glecaprevir tablet, film coated
MAVYRET- pibrentasvir and glecaprevir pellet
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 )] .
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 compensated cirrhosis (Child-Pugh A).
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both [see Dosage and Administration ( 2.2) and Clinical Studies ( 14)].
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with MAVYRET [see Warnings and Precautions ( 5.1) ].
Tables 1 and 2 provide the recommended MAVYRET treatment duration based on the patient population in HCV mono-infected and HCV/HIV-1 co-infected patients with compensated liver disease (with or without cirrhosis) and with or without renal impairment including patients receiving dialysis [see Contraindications ( 4) and Clinical Studies ( 14)]. Refer to Drug Interactions ( 7) for dosage recommendations for concomitant HIV-1 antiviral drugs.
|Table 1. Recommended Duration for Treatment-Naïve Patients|
|HCV Genotype||Treatment Duration|
|No Cirrhosis||Compensated Cirrhosis (Child-Pugh A)|
|1, 2, 3, 4, 5, or 6||8 weeks||8 weeks|
|Table 2. Recommended Duration for Treatment-Experienced Patients|
|HCV Genotype||Patients Previously Treated with a Regimen Containing:||No Cirrhosis||Compensated Cirrhosis (Child-Pugh A)|
|1||An NS5A inhibitor1 without prior treatment with an NS3/4A protease inhibitor (PI)||16 weeks||16 weeks|
|An NS3/4A PI2 without prior treatment with an NS5A inhibitor||12 weeks||12 weeks|
|1, 2, 4, 5, or 6||PRS3||8 weeks||12 weeks|
|3||PRS3||16 weeks||16 weeks|
MAVYRET tablets are a fixed combination drug product containing glecaprevir 100 mg and pibrentasvir 40 mg in each tablet.
The recommended oral dosage of MAVYRET in adults is 3 tablets taken at the same time once daily with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) [see Clinical Pharmacology ( 12.3)].
The recommended dosage of MAVYRET in pediatric patients 3 to less than 12 years of age is based on weight. MAVYRET oral pellets are recommended for pediatric patients 3 to less than 12 years old weighing less than 45 kg. MAVYRET oral pellets in packets are a fixed combination drug product containing glecaprevir 50 mg and pibrentasvir 20 mg in each packet.
The recommended dosage of MAVYRET in pediatric patients 12 years of age and older, or in pediatric patients weighing at least 45 kg, is three tablets taken at the same time once daily with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).
The dosages for pediatric patients are shown in Table 3.
|Table 3: Recommended Dosage in Pediatric Patients 3 Years of Age and Older|
|Body Weight (kg) or Age (yrs)||Daily Dose of glecaprevir/ pibrentasvir||Dosing of MAVYRET|
|Less than 20 kg||150 mg/60 mg per day||Three 50 mg/20 mg packets of oral pellets once daily|
|20 kg to less than 30 kg||200 mg/80 mg per day||Four 50 mg/20 mg packets of oral pellets once daily|
|30 kg to less than 45 kg||250 mg/100 mg per day||Five 50 mg/20 mg packets of oral pellets once daily|
|45 kg and greaterOR 12 years of age and older||300 mg/120 mg per day||Three 100 mg/40 mg tablets once daily1 (see Recommended Dosage in Adults)|
|1 Pediatric patients weighing 45 kg and greater who are unable to swallow tablets may take six 50 mg/20 mg packets of oral pellets once daily. Dosing with oral pellets has not been studied for pediatric patients weighing greater than 45 kg [see Clinical Pharmacology ( 12.3) ].|
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