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Ambrisentan: Wikis

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Ambrisentan
Systematic (IUPAC) name
(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy- 3,3-diphenylpropanoic acid
Identifiers
CAS number 177036-94-1
ATC code C02KX02
PubChem 6918493
ChemSpider 5293690
Chemical data
Formula C 22H22N2O4  
Mol. mass 378.421 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability Undetermined
Protein binding 99%
Metabolism  ?
Half life 15 hours (terminal)
Excretion  ?
Therapeutic considerations
Licence data

EU EMEA:linkUS FDA:link

Pregnancy cat. X(US) May cause harm to fetus
Legal status POM (UK) -only (US)
Routes Oral

Ambrisentan (U.S. trade name Letairis; E.U. trade name Volibris) is a drug indicated for use in the treatment of pulmonary hypertension.

It functions as an endothelin receptor antagonist, and is selective for the type A endothelin receptor (ETA).[1]

Ambrisentan was approved for sale by the U.S. Food and Drug Administration (FDA) on June 15, 2007 for the once-daily treatment of pulmonary arterial hypertension.[2][3][4] It was later approved by the European Medicines Agency for use in the EU on April 2008.[5] Ambrisentan had previously been designated an orphan drug by both the FDA and the European Commission, in August 2004 and May 2005 respectively.[6]

Contents

Clinical uses

Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.

The LETAIRIS Education and Access Program

The LETAIRIS Education and Access Program (LEAP) is a program to help physicians and patients learn about the risks of LETAIRIS, including the serious risks of liver injury and birth defects.

LEAP works by:

  • Providing information to prescribers on the risks of LETAIRIS
  • Providing comprehensive education to patients and assistance with obtaining LETAIRIS
  • Requiring enrollment of both prescriber and patient in LEAP
  • Controlling dispensing through a specialized distribution network (specialty pharmacies)

External links

References

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