Label Changes for:
Victrelis (boceprevir), 200 mg capsules
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
7 DRUG INTERACTIONS
7.3 Established and Other Potential Significant Drug Interactions
- See Table 5 ............ interactions with raltegravir, rilpivirine and sirolimus added
WARNINGS AND PRECAUTIONS
Pregnancy (Use with Ribavirin and Peginterferon Alfa)
- One of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. Oral contraceptives containing lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated. Routine monthly pregnancy tests must be performed during this time.