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AMBRISENTAN TAB

Clinical Criteria Summary

Exclusion Criteria

  • Known pregnancy
  • Moderate or severe liver impairment (e.g., Child-Pugh Class B or C)

Inclusion Criteria

  • Care provided by a VA/VA Community Care provider experienced in the management of pulmonary arterial hypertension (PAH)
  • World Health Organization (WHO) Group 1 PAH
  • Definitive PAH confirmed by right-heart catheterization and hemodynamic diagnosis: mean pulmonary artery pressure >25 mmHg, pulmonary artery wedge pressure ≤15 mm Hg, and pulmonary vascular resistance >3 Wood Units

Additional Inclusion Criteria

  • Females who can become pregnant: Excluded pregnancy prior to receiving ambrisentan. Provided counseling on potential risk vs benefit of treatment and use of effective contraception prior to, during, and one month after stopping treatment.
  • For males of reproductive potential: Counseling provided on the potential risk of ambrisentan to adversely affect spermatogenesis and impair fertility.

Source Documents