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Opsumit
macitentan
Black Box Warnings .
Appropriate Use
restricted distribution program (macitentan-containing products REMS) for all female pts due to fetal harm risk; prescribers, pharmacies, and female pts must enroll at 1-888-572-2934 or www.macitentanrems.com
Embryo-Fetal Toxicity
contraindicated in pregnancy; exclude pregnancy in females of reproductive potential prior to tx start, then qmo during tx and x1mo after D/C; use acceptable methods of contraception during tx and x1mo after D/C
Adult Dosing .
Dosage forms: TAB: 10 mg
Restricted Distribution in US
- [1-888-572-2934 or www.macitentanrems.com for more info]
- Info: female pts may only receive tx through macitentan-containing products REMS program
pulmonary arterial HTN
- [10 mg PO qd]
- Max: 10 mg/day
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.