VIEKIRA PAK, VIEKIRA XR and TECHNIVIE Label Updated

VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets, 12.5 mg/75 mg/50 mg; dasabuvir tablets, 250 mg), VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir), and TECHNIVIE (ombitasvir, paritaprevir, and ritonavir) labels were updated to include information pertaining to changes in International Normalized Ratio (INR) values in patients receiving warfarin.

The following sections were updated:

• Section 6: Adverse Reactions the following statement was deleted - There were no serious events or severe cutaneous reactions, such as Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme (EM) or drug rash with eosinophilia and systemic symptoms (DRESS).
• Section 6.2 Post-Marketing Experience the following information was added to Skin and Subcutaneous Tissue Disorders: Erythema multiforme (EM).
• Section 7: Drug Interactions was updated to state fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment. If coadministered with warfarin, close monitoring of INR values is recommended during treatment and post-treatment follow-up.

The updated labels 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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