aprocitentan
Embryo-Fetal Toxicity
Based on data from animal reproduction studies with endothelin receptor antagonists (ERAs), aprocitentan can cause fetal harm when administered during pregnancy and is contraindicated for use in patients who are pregnant. Exclude pregnancy and ensure use of acceptable contraceptive methods prior to initiation of treatment with TRYVIO. Counsel patients who can become pregnant about the potential risk to a fetus.
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.