Mavyret 100 mg/1
Glecaprevir and Pibrentasvir · TABLET, FILM COATED · AbbVie Inc.
Mavyret is a tablet, film coated containing glecaprevir and pibrentasvir at 100 mg/1, taken oral. Manufactured by AbbVie Inc..
Key Facts
- Brand Name
- Mavyret
- Generic Name
- Glecaprevir and Pibrentasvir
- NDC Code (Product)
0074-2625- Manufacturer
- AbbVie Inc.
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA209394
- Drug Class
- Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]; Hepatitis C Virus NS5A Inhibitor [EPC]
- Marketing Start
- 08/03/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or 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 )]. MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic HCV genotype (GT) 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, but not both. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. ( 2.1 ) See recommended treatment duration for patients 3 years and older in tables below. ( 2.2 ) Treatment-Naïve Patients 1 HCV Genotype Treatment Duration No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1, 2, 3, 4, 5, or 6 8 weeks 8 weeks Treatment-naïve patients are those who have not received treatment for the current infection. Treatment-Experienced Patients 1 Treatment Duration HCV Genotype Patients Previously Treated With a Regimen Containing: No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1 An NS5A inhibitor 2 without prior treatment with an NS3/4A protease inhibitor (PI) 16 weeks 16 weeks An NS3/4A PI 3 without prior treatment with an NS5A inhibitor 12 weeks 12 weeks 1, 2, 4, 5, or 6 PRS 4 8 weeks 12 weeks 3 PRS 4 16 weeks 16 weeks Treatment-experienced patients are those who previously received treatment for the current infection. Treated with prior regimens containing ledipasvir and sofosbuvir or daclatasvir with (peg) interferon and ribavirin. Treated with prior regimens containing simeprevir and sofosbuvir, or simeprevir, bo…
Contraindications
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 ( 5.2 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . MAVYRET is contraindicated with atazanavir or rifampin [see Drug Interaction ( 7.3 ) and Clinical Pharmacology ( 12.3 )] . Patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation. ( 4 , 5.2 ) Coadministration with atazanavir or rifampin. ( 4 )
Drug Interactions
7 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. ( 5.3 ) Clearance of HCV infection with direct-acting antivirals may lead to changes in hepatic function, which may impact safe and effective use of concomitant medications. Frequent monitoring of relevant laboratory parameters (INR or blood glucose) and dose adjustments of certain concomitant medications may be necessary. ( 7.3 ) Medication- Assisted Treatment (MAT) for Opioid Use Disorder. ( 7.4 ) Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 4 , 7 , 12.3 ) 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 anion transporting polypeptide (OATP) 1B1/3. Coadministration with MAVYRET may increase plasma concentration of drugs that are substrates of P-gp, BCRP, OATP1B1 or OATP1B3. Glecaprevir and pibrentasvir are weak inhibitors of cytochrome P450 …
Adverse Reactions
6 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. 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overall Adverse Reactions in Subjects with Chronic HCV Infection without Cirrhosis or with Compensated Cirrhosis (Child-Pugh A) The adverse reactions data for MAVYRET in subjects without cirrhosis or with compensated cirrhosis (Child-Pugh A) were derived from nine registrational Phase 2 and 3 trials which evaluated approximately 2,300 adults infected with genotype 1, 2, 3, 4, 5, or 6 HCV who received MAVYRET for 8, 12 or 16 weeks [see Clinical Studies ( 14 ) ] . The overall proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.1% for subjects who received MAVYRET for 8, 12 or 16 weeks. …
Frequently Asked Questions
What is Mavyret used for?
Mavyret contains Glecaprevir and Pibrentasvir. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Mavyret a controlled substance?
Mavyret is not classified as a controlled substance by the DEA.
What is the generic name for Mavyret?
The generic name for Mavyret is Glecaprevir and Pibrentasvir. There are no other listed brand versions of Glecaprevir and Pibrentasvir.
What is the NDC code for Mavyret 100 mg/1?
The NDC (National Drug Code) for Mavyret 100 mg/1 is 0074-2625, listed by AbbVie Inc..
Other Mavyret Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)