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Treprostinil

Brand and Other Names: REMODULIN
Mechanism of Action:

The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.

Indications:

Remodulin 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%). 

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. 

Route: Oral
Dose:

PAH WHO Group 1 in patients with NYHA Class II-IV symptoms:

Initial dose for patients new to prostacyclin infusion therapy: 1.25 ng/kg/min; increase based on clinical response (increments of 1.25 ng/kg/min per week for the first 4 weeks of treatment, later 2.5 ng/kg/min per week). Avoid abrupt cessation. 

Mild to moderate hepatic insufficiency: Decrease initial dose to 0.625 ng/kg/min. Severe hepatic insufficiency: No studies performed. 

Transition from Epoprostenol:

Increase the Remodulin dose gradually as the epoprostenol dose is decreased, based on constant observation of response. 

Administration:
Continuous subcutaneous infusion is the preferred mode. Use intravenous (IV) infusion if subcutaneous infusion is not tolerated. 

Adverse Reactions:

Most common adverse reactions (incidence >3%) reported in clinical studies with Remodulin: subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, and hypotension. 

Contraindication:

None.

Warnings and Precautions:
  • Chronic intravenous infusions delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. 
  • Do not abruptly lower the dose or withdraw dosing. (
  • Remodulin may cause symptomatic hypotension.
  • Remodulin inhibits platelet aggregation and increases the risk of bleeding. 
See package insert for full prescribing information.