Treprostinil injection (Remodulin)

Remodulin (treprostinil) is covered only for FDA‑approved use in WHO Group I pulmonary arterial hypertension to diminish exercise‑related symptoms and to reduce clinical deterioration when transitioning from Flolan®; no off‑label compendial uses are covered and other WHO groups are excluded. Approval requires right heart catheterization confirmation of WHO Group I PAH, NYHA functional class II–IV, documentation that the PAH is idiopathic, heritable, associated with congenital systemic‑to‑pulmonary shunts, or associated with connective tissue disease, and a documented need to transition from Flolan for the transition indication.

"Must have a diagnosis of pulmonary arterial hypertension (WHO Group I) confirmed by right heart catheterization (required for approval)"

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