Macitentan
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)].
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information
Medication Guides
Package Inserts
Updated January 2018