Flolan®, Veletri® (epoprostenol) injection

Epoprostenol (Flolan®, Veletri®) is covered for FDA‑approved pulmonary arterial hypertension (WHO Group 1) and compendial off‑label use in chronic thromboembolic pulmonary hypertension (CTEPH) (other indications not covered), with a short-term up to 30‑day supply allowed if criteria are unmet or information is insufficient. Initial approval requires right heart catheterization confirmation, NYHA class III/IV (or class II with prior oral or inhaled/parenteral prostacyclin trial), prescribing/consultation by a pulmonologist or cardiologist, specific vasodilator testing/CCB documentation for idiopathic PAH; reauthorization requires documented continued clinical benefit, approval is for 12 months with dosing limits up to 100 ng/kg/min (PAH) and 45 ng/kg/min (CTEPH).

"Epoprostenol is a prostanoid vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity."