treprostinil
treprostinil is listed in the FDA National Drug Code directory with 45 NDC codes, marketed under brand names including Yutrepia, Tyvaso DPI, Remodulin. Available dosage forms: capsule, inhalant, injection, solution, tablet, extended release, kit.
Drug Details
- Generic Name
- treprostinil
- Brand Names
- Yutrepia, Tyvaso DPI, Remodulin, Orenitram, Treprostinil, TYVASO
- Application Number
- NDA213005
- Sponsor
- Liquidia Technologies, Inc.
- NDC Codes
- 45
- Dosage Forms
- CAPSULE, INHALANT, INJECTION, SOLUTION, TABLET, EXTENDED RELEASE, KIT, INJECTION
- Routes
- RESPIRATORY (INHALATION), ORAL, INTRAVENOUS, SUBCUTANEOUS
- Active Ingredients
- TREPROSTINIL SODIUM, TREPROSTINIL
Indications and Usage
1 INDICATIONS AND USAGE Treprostinil Injection is a prostacyclin mimetic 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.