treprostinil

FDA Drug Profile — Treprostinil, Tyvaso DPI, TYVASO, Yutrepia, Orenitram

Drug Details

Generic Name
treprostinil
Brand Names
Treprostinil, Tyvaso DPI, TYVASO, Yutrepia, Orenitram, Remodulin
Application Number
ANDA203649
Sponsor
Sandoz Inc
NDC Codes
40
Dosage Forms
INJECTION, INHALANT, KIT, CAPSULE, TABLET, EXTENDED RELEASE, INJECTION, SOLUTION
Routes
INTRAVENOUS, SUBCUTANEOUS, ORAL, RESPIRATORY (INHALATION)
Active Ingredients
TREPROSTINIL, TREPROSTINIL SODIUM

Indications and Usage

1 INDICATIONS AND USAGE Treprostinil injection is a prostacyclin vasodilator indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). ( 1.1 ) Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition. ( 1.2 ) 1.1 Pulmonary Arterial Hypertension Treprostinil injection is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%) [see Clinical Studies (14.1) ] . 1.2 Pulmonary Arterial Hypertension in Patients Requiring Transition from Epoprostenol In patients with PAH requiring transition from epoprostenol, treprostinil injection is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.