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Exclude pregnancy and ensure use of acceptable contraceptive methods prior to initiation of treatment with Aprocitentan. Counsel patients who can become pregnant about the potential risk to a fetus. 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.
To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and repeat during treatment periodically and as clinically indicated.
Do not initiate Aprocitentan in patients with elevated aminotransferases (>3 × ULN) or moderate to severe hepatic impairment.
Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, scleral icterus, jaundice, dark urine, fever, or itching) to immediately stop treatment with Aprocitentan and seek medical attention.
If sustained, unexplained, clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin >2 × ULN, or if clinical symptoms of hepatotoxicity occur, discontinue Aprocitentan.
Monitor for signs and symptoms of fluid retention, weight gain, and worsening heart failure. If clinically significant fluid retention develops, treat appropriately, and consider discontinuation of Aprocitentan.
Measure hemoglobin prior to initiation of treatment and periodically during treatment as clinically indicated.
Aprocitentan, like other ERAs, may have an adverse effect on spermatogenesis. Counsel men about potential effects on fertility.
from FDA，2024.03
