About Remodulin® 

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.

For more information about Remodulin than is provided below, please click here.

For complete prescribing information, please refer to the Remodulin package insert.  To view the insert, please click here.

The use of Remodulin requires attention to the following:

• Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH.
• Remodulin is a potent pulmonary and systemic vasodilator. Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiologic monitoring & emergency care.
• Subcutaneous therapy with Remodulin may be used for prolonged periods, and the patient's ability to administer Remodulin and care for an infusion system should be carefully considered.
• Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms and should be avoided.
• Reduction in blood pressure caused by Remodulin may be exacerbated by drugs that also alter blood pressure, such as diuretics, antihypertensives, or vasodilators. There is also a potential for increased bleeding risk when Remodulin is given to patients on anticoagulants due to Remodulin's ability to inhibit platelet aggregation.

Effectiveness of Remodulin in Treating Pulmonary Arterial Hypertension

Clinical Trials:

• The efficacy of Remodulin was assessed in two 12-week, randomized, placebo-controlled trials in a total of 470 patients with NYHA Class II, III and IV pulmonary arterial hypertension.

Hemodynamic Effects:

• Results showed that Remodulin, administered subcutaneously for twelve (12) weeks, significantly improved cardiopulmonary hemodynamics.  Chronic therapy with Remodulin resulted in small hemodynamic changes consistent with pulmonary and systemic vasodilation.

Clinical Effects:

• The effect of Remodulin on 6-minute walk, the primary end point of the studies, was small and did not achieve conventional levels of statistical significance.  The median change from baseline on Remodulin was 10 meters and the median change from baseline on placebo was 0 meters. Although it was not the primary endpoint of the study, the Borg dyspnea score was significantly improved by Remodulin during the 6-minute walk, and Remodulin also had a significant effect, compared with placebo, on an assessment that combined walking distance with the Borg dyspnea score. Remodulin also consistently improved indices of dyspnea, fatigue and signs and symptoms of pulmonary hypertension, but these indices were difficult to interpret in the context of incomplete blinding to treatment assignment resulting from infusion site symptoms.

Adverse Events:

• Patients receiving Remodulin reported a wide range of adverse events, many potentially related to the underlying disease (dyspnea, fatigue, chest pain, right heart ventricular heart failure, and pallor). During clinical trials, infusion site pain and reaction were the most common adverse events among those treated with Remodulin. For additional information on adverse events, please refer to the Remodulin Package Insert section that reviews adverse events.