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FDA - Sovaldi, Harvoni, Epclusa and Vosevi Labels Were Updated
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The Sovaldi (sofosbuvir), Harvoni (ledipasvir and sofosbuvir), Epclusa (sofosbuvir and velpatasvir) and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) labels were updated to include information pertaining to changes in International Normalized Ratio (INR) values in patients receiving warfarin.
Section 7: DRUG INTERACTIONS was updated to state fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment. Frequent monitoring of INR values is recommended during treatment and post-treatment follow-up
The Harvoni, Epclusa, and Vosevi labels were updated to include drug interaction information when these drugs are used with atorvastatin because coadministration of these drugs with atorvastatin may be associated with increased risk of myopathy, including rhabdomyolysis and to monitor closely for HMG-CoA reductase inhibitor-associated adverse reactions, such as myopathy and rhabdomyolysis.
Section 12: CLINICAL PHARMACOLOGY was updated to state when a single 40 mg dose of atorvastatin was given with Epclusa, atorvastatin AUC and Cmax increased 54% and 68%, respectively.
The updated label will soon be available at drugs@fda or DailyMed
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
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