Embryo-Fetal Toxicity

• Do not administer Adempas to a pregnant female because it may cause fetal harm [see Contraindications (4) and 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, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program [see Warnings and Precautions (5.2)