Prostacyclin is one of the most ubiquitous hormones in the human body. Prostacyclin is produced throughout the body, via an interaction between the endothelial cells that line blood vessel walls and the platelets that float through the blood vessels.  Prostacyclin also has an effect throughout the body, principally upon smooth muscle cells that surround blood vessels but also on other endothelial cells and platelets.   

Remodulin (treprostinil sodium) Injection is approved as a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. In November 2004, the FDA approved the intravenous use of Remodulin for those not able to tolerate subcutaneous infusion. Other international approvals are pending.

In clinical trials, the most common side effects reported with subcutaneous Remodulin therapy included infusion site pain (85%) and infusion site reaction (83%). Other adverse events included headache (27%), diarrhea (25%), nausea (22%), rash (14%), jaw pain (13%), vasodilatation (11%), dizziness (9%), edema (9%), pruritus (8%) and hypotension (4%). Among patients (n=38) treated for twelve weeks with intravenous Remodulin in an open-label study, two patients experienced either line infections or sepsis. Other events potentially related to intravenous dosing of Remodulin include arm swelling, paresthesias, hematoma and pain. Remodulin is a potent pulmonary and systemic vasodilator and should be used only by clinicians experienced in the diagnosis and treatment of pulmonary arterial hypertension. Remodulin should be used with caution in patients with hepatic or renal impairment. Remodulin has not been studied in conjunction with Flolan® or Tracleer®.