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ambrisentan (Letairis, Volibris)
Indications:
- pulmonary hypertension
* ok despite LEAP note below
Dosage: 5-10 mg PO QD
Tabs: 5 & 10 mg
Monitor:
- prior to 2011, serum AST & serum ALT baseline & monthly
- discontinue if ALT or AST is > 5 times upper limit of normal or is increased & accompanied by serum bilirubin > 2 times upper limit of normal or if signs/symptoms of liver dysfunction [4]
- monthly liver enzyme testing is no longer required [5]
Adverse effects:
- pedal edema
- nasal congestion, sinusitis
- flushing
- hepatoxicity
- fetotoxicity
Mechanism of action:
- endothelin receptor antagonist
- may be related to epoprostenol
Notes:
- physicians & pharmacies must register with the Letairis Education and Access Program (LEAP) [4]
- patients must enroll in LEAP initially & every 6 months [4]
Interactions
drug adverse effects of antihypertensive agents
General
endothelin receptor antagonist
Properties
MISC-INFO: pregnancy-category X
safety in lactation ?
Database Correlations
PUBCHEM correlations
References
- FDA News Release
http://www.fda.gov/bbs/topics/news/2007/new01653.html296:474, 2002
- Once-Daily LETAIRIS
http://www.letairis.com/
- Letairis Education and Access Program (LEAP)
(866) 664-5327
- Prescriber's Letter 17(7): 2010
Recommended Lab Monitoring for Common Medications
Liver Function Test Scheduling
Detail-Document#: 260704
(subscription needed) http://www.prescribersletter.com
- FDA NEWS RELEASE: March 4, 2011
FDA modifies boxed warning for pulmonary arterial hypertension
drug Letairis: Monthly liver enzyme testing is no longer required
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245848.htm