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Treprostinil

Generic Name
Treprostinil
Brand Names
Orenitram, Remodulin, Tyvaso, Trepulmix
Drug Type
Small Molecule
Chemical Formula
C23H34O5
CAS Number
81846-19-7
Unique Ingredient Identifier
RUM6K67ESG

Overview

Treprostinil is a stable tricyclic analogue of prostacyclin that promotes the vasodilation of pulmonary and systemic arterial vascular beds and the inhibition of platelet aggregation. It reduces symptoms in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. The first agent approved for the treatment of PAH was epoprostenol, a synthetic prostacyclin that significantly increases patients' quality of life. However, the use of epoprostenol is limited due to its short half-life (3-5 min) and instability at room temperature. The use of more stable alternatives such as treprostinil provides patients with PAH with more treatment options. Treprostinil was approved by the FDA in 2002 for the treatment of pulmonary arterial hypertension. It is available in the following routes of administration: subcutaneous, intravenous, inhaled and oral. The first generic form of treprostinil became available in 2019.

Background

Treprostinil is a stable tricyclic analogue of prostacyclin that promotes the vasodilation of pulmonary and systemic arterial vascular beds and the inhibition of platelet aggregation. It reduces symptoms in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. The first agent approved for the treatment of PAH was epoprostenol, a synthetic prostacyclin that significantly increases patients' quality of life. However, the use of epoprostenol is limited due to its short half-life (3-5 min) and instability at room temperature. The use of more stable alternatives such as treprostinil provides patients with PAH with more treatment options. Treprostinil was approved by the FDA in 2002 for the treatment of pulmonary arterial hypertension. It is available in the following routes of administration: subcutaneous, intravenous, inhaled and oral. The first generic form of treprostinil became available in 2019.

Indication

The FDA has indicated treprostinil for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to improve exercise ability. It is also used to treat pulmonary arterial hypertension in patients requiring transition from epoprostenol. The Health Canada label specifies that treprostinil is indicated for the long-term treatment of pulmonary arterial hypertension in NYHA Class III and IV patients who did not respond adequately to conventional therapy. L24244

Associated Conditions

  • Pulmonary Arterial Hypertension (PAH)
  • Pulmonary Hypertension (PH)

FDA Approved Products

Tyvaso DPI
Manufacturer:United Therapeutics Corporation
Route:ORAL
Strength:64 ug in 1 1
Approved: 2023/11/30
NDC:66302-664
Treprostinil
Manufacturer:Sandoz Inc
Route:SUBCUTANEOUS, INTRAVENOUS
Strength:50 mg in 20 mL
Approved: 2018/10/03
NDC:0781-3425
Tyvaso DPI
Manufacturer:United Therapeutics Corporation
Route:ORAL
Strength:16 ug in 1 1
Approved: 2023/11/30
NDC:66302-616
Tyvaso DPI
Manufacturer:United Therapeutics Corporation
Route:ORAL
Strength:48 ug in 1 1
Approved: 2023/11/30
NDC:66302-648
Remodulin
Manufacturer:United Therapeutics Corporation
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:100 mg in 20 mL
Approved: 2023/10/09
NDC:66302-105

Singapore Approved Products

No Singapore products found for this drug

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