Embryo-Fetal Toxicity

• Do not administer OPSUMIT to a pregnant female because it may cause fetal harm [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1)].
• Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception [see Use in Special Populations (8.6)].
• For all female patients, OPSUMIT is available only through a restricted program called the OPSUMIT Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and Precautions (5.2)].