OLYSIO (simeprevir), DAKLINZA (daclatasvir) and ZEPATIER (grazoprevir/elbasvir) 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.
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.
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Division of Antiviral Products
Food and Drug Administration
Visit the FDA Patient Network for more Information about the Hepatitis Liaison Program
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