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Opsynvi
macitentan/ tadalafil
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/20 mg, 10 mg/40 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
- [tx-naive pts or pts converting from ERA monotx]
- Dose: 10 mg/20 mg-10 mg/40 mg PO qd; Start: 10 mg/20 mg PO qd x1wk, then may incr. to 10 mg/40 mg PO qd; Info: do not cut/crush/chew tab
- [pts converting from PDE5 inhibitor monotx or PDE5 inhibitor + ERA combo tx]
- Dose: 10 mg/40 mg PO qd; Info: do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl 15-29: avoid use; CrCl <15: not defined
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.