Comment
Author: Admin | 2025-04-28
4-fold based on physiologically based pharmacokinetic (PBPK) modelling; avoid concomitant use of drug with moderate dual inhibitors of CYP3A4 and CYP2C9 (such as fluconazole and amiodarone) Concomitant treatment of both a moderate CYP3A4 inhibitor and moderate CYP2C9 inhibitor with macitentan should also be avoided Pregnancy & LactationPregnancy Based on data from animal reproduction studies, therapy may cause embryo-fetal toxicity, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy; there are risks to mother and fetus associated with pulmonary arterial hypertension in pregnancy; there are limited data on use in pregnant women; the drug was teratogenic in rabbits and rats at all doses tested; if drug is used during pregnancy, or if patient becomes pregnant while taking this drug, advise the patient of risk to a fetus In patients with pulmonary arterial hypertension, pregnancy is associated with increased rate of maternal and fetal morbidity and mortality, including spontaneous abortion, intrauterine growth restriction and premature labor Pregnancy testing Verify pregnancy status of females of reproductive potential prior to initiating therapy, monthly during treatment and one month after stopping treatment; the patient should contact her physician immediately for pregnancy testing if onset of menses is delayed or pregnancy is suspected; if pregnancy test is positive, the physician and patient must discuss risks to her, the pregnancy, and fetus Contraception Female patients of reproductive potential must use acceptable methods of contraception during treatment and for 1 month after stopping Patients may choose 1 highly effective form
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