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Black Box Warnings .
restricted distribution program (Opsumit REMS) for all female pts due to fetal harm risk; prescribers, pharmacies, and female pts must enroll at 1-866-228-3546 or www.opsumitrems.com
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: 10
Restricted Distribution in US
- [1-866-228-3546 or www.opsumitrems.com for more info]
- Info: female pts may only receive tx through Opsumit REMS program
pulmonary arterial HTN
- [10 mg PO qd]
- Max: 10 mg/day; Info: do not cut/crush/chew tab
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined; HD: not defined
- [no adjustment]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
- hypersens. to drug/class/compon.
- pulmonary veno-occlusive dz
Drug Interactions .
endothelin receptor antagonist
- CYP3A4 substrate
- St. John's wort
Adverse Reactions .
- embryo-fetal toxicity
- ALT, AST elevated
- sperm count decr.
Lactation: Safety Unknown
use 2 reliable forms of contraception (one non-hormonal) during tx and x1mo after D/C in women of childbearing potential; no additional contraception needed if tubal sterilization hx or current IUD or contraceptive implant use
pregnancy test at baseline, then qmo during tx, and 1mo after D/C; Hgb, LFTs at baseline, then as clinically indicated
Metabolism: liver; CYP450: 3A4 (primary), 2C19 substrate; Info: active metabolite
Excretion: urine 50%, feces 24%; Half-life: 16h (parent drug), 48h (active metabolite)
Subclass: Pulmonary Arterial HTN
Mechanism of Action
binds to endothelin receptors, blocking vasoconstrictive effects of endothelin-1; reduces pulmonary vascular resistance (endothelin receptor antagonist)
Manufacturer: Actelion Pharmaceuticals US, Inc.
Approximate Retail Price
This information is currently not available for this drug.
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