s:
St. John’s wort
(hypericum perforatum) ↓ glecaprevir
↓ pibrentasvir Coadministration may lead to reduced therapeutic effect of MAVYRET and is not recommended.
HIV-Antiviral Agents:
Atazanavir ↑ glecaprevir
↑ pibrentasvir Coadministration is contraindicated due to increased risk of ALT elevations [see Contraindications (4)].
Darunavir
Lopinavir
Ritonavir ↑ glecaprevir
↑ pibrentasvir Coadministration is not recommended.
Efavirenz ↓ glecaprevir
↓ pibrentasvir Coadministration may lead to reduced therapeutic effect of MAVYRET and is not recommended.
HMG-CoA Reductase Inhibitors:
Atorvastatin
Lovastatin
Simvastatin ↑ atorvastatin
↑ lovastatin
↑ simvastatin Coadministration may increase the concentration of atorvastatin, lovastatin, and simvastatin. Increased statin concentrations may increase the risk of myopathy, including rhabdomyolysis. Coadministration with these statins is not recommended.
Pravastatin
↑ pravastatin
Coadministration may increase the concentration of pravastatin. Increased statin concentrations may increase the risk of myopathy, including rhabdomyolysis. Reduce pravastatin dose by 50% when coadministered with MAVYRET.
Rosuvastatin ↑ rosuvastatin Coadministration may significantly increase the concentration of rosuvastatin. Increased statin concentrations may increase the risk of myopathy, including rhabdomyolysis. Rosuvastatin may be administered with MAVYRET at a dose that does not exceed 10 mg.
Fluvastatin
Pitavastatin ↑ fluvastatin
↑ pitavastatin Coadministration may increase the concentrations of fluvastatin and pitavastatin. Increased statin concentrations may increase the risk of myopathy, including rhabdomyolysis. Use the lowest approved dose of fluvastatin or pitavastatin. If higher doses are needed, use the lowest necessary statin dose based on a risk/benefit assessment.
Immunosuppressants:
Cyclosporine ↑ glecaprevir
↑ pibrentasvir MAVYRET is not recommended for use in patients requiring stable cyclosporine doses > 100 mg per day.
See Clinical Pharmacology, Tables 8 and 9.
↑= increase; ↓= decrease; ↔ = no effect
7.4 Drugs with No Observed Clinically Significant Interactions with MAVYRET
No dose adjustment is required when MAVYRET is coadministered with the following medications: abacavir, amlodipine, buprenorphine, caffeine, dextromethorphan, dolutegravir, elvitegravir/cobicistat, emtricitabine, felodipine, lamivudine, lamotrigine, losartan, methadone, midazolam, naloxone, norethindrone or other progestin-only contraceptives, omeprazole, raltegravir, rilpivirine, sofosbuvir, tacrolimus, tenofovir alafenamide, tenofovir disoproxil fumarate, tolbutamide, and valsartan.
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 developmental effects were observed when the components of MAVYRET were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommen |
