Embryo-fetal Toxicity

Macitentan-Containing Products may cause fetal harm when administered during pregnancy and is contraindicated for use in females who are pregnant. In females of reproductive potential, exclude pregnancy prior to initiation of therapy, ensure use of acceptable contraceptive methods and obtain monthly pregnancy tests [see DOSAGE AND ADMINISTRATION (2.2) and USE IN SPECIFIC POPULATIONS (8.1, 8.3)].

OPSYNVI is available for females through the Macitentan-Containing Products REMS, a restricted distribution program [see WARNINGS AND PRECAUTIONS (5.2)].