aprocitentan
Embryo-Fetal Toxicity
Aprocitentan can cause major birth defects if used by pregnant patients [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1)].
In patients who can become pregnant, obtain a negative pregnancy test prior to initiation of aprocitentan and counsel patients to take monthly pregnancy tests during treatment and one month after discontinuation of aprocitentan [see Dosage and Administration (2.2) and Use in Specific Populations (8.3)].
To prevent pregnancy, patients who can become pregnant should use acceptable methods of contraception before the start of, during, and for one month after stopping treatment [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.3)].
Because of the risk of birth defects, aprocitentan is only available through a restricted program called the aprocitentan Risk Evaluation and Mitigation Strategy (REMS) [see Warning and Precautions (5.2)]
Monitoring data
Patients should monitor for pregnancy monthly during treatment and one month after discontinuation of treatment and avoid pregnancy by using acceptable contraception methods prior to initiation of treatment with aprocitentan, during treatment, and for one month after the final dose of aprocitentan. If pregnancy is detected, discontinue aprocitentan.
REMS
IMPORTANT PROGRAM UPDATE AS OF MARCH 2025
The U.S. Food and Drug Administration (FDA) has determined the approved Risk Evaluation and Mitigation Strategies (REMS) for TRYVIO ™ are no longer necessary to ensure the benefits of the drug outweigh the risk of embryo-fetal toxicity. Prescribers and pharmacies are no longer required to interact with the REMS.