MACITENTAN TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Known pregnancy
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 (mPAP) >25 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mm Hg, and pulmonary vascular resistance (PVR) >3 Wood Units
- Baseline liver enzyme testing (with repeat testing as clinically indicated)
- Intolerance, inadequate response, or unable to use ambrisentan (ambrisentan is the preferred endothelin receptor antagonist in VA when clinically appropriate)
Reproductive & Pregnancy Management
- For females who can become pregnant: Pregnancy must be excluded prior to receiving macitentan. Counseling provided on potential risk vs benefit of treatment and the 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 macitentan to adversely affect spermatogenesis and impair fertility.