ambrisentan (Letairis, Volibris)
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Indications
* ok despite LEAP note below
Dosage
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]
More general terms
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
- ↑ 4.0 4.1 4.2 4.3 Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260704&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 5.0 5.1 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