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ambrisentan
generic
Black Box Warnings .
Appropriate Use
restricted distribution program (ambrisentan REMS) for all female pts to minimize fetal exposure; prescribers, pharmacies, and female pts must enroll at 1-888-417-3172 or www.ambrisentanrems.us.com
Embryo-Fetal Toxicity
contraindicated in pregnancy; serious birth defect risk if used in pregnant females; exclude pregnancy in females of reproductive potential prior to tx start, then qmo during tx and 1mo after D/C; use acceptable methods of contraception during tx and x1mo after D/C
Adult Dosing .
Dosage forms: TAB: 5 mg, 10 mg
Restricted Distribution in US
- [1-888-417-3172 or www.ambrisentanrems.us.com for more info]
- Info: female pts may only receive tx through ambrisentan REMS program
pulmonary arterial HTN
- [5-10 mg PO qd]
- Start: 5 mg PO qd, may incr. to 10 mg PO qd after 4wk if tolerated; Max: 10 mg/day; Info: do not cut/crush/chew tab
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: not defined, caution advised; moderate-severe impairment: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.