Remodulin (Treprostinil Sodium Subcutaneous) - Summary

REMODULIN SUMMARY

Remodulin^® (treprostinil sodium) Injection is a sterile sodium salt formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20 mL multi-use vials in four strengths, containing 1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contains 4.0 mg sodium chloride), 3.0 mg metacresol, 6.3 mg sodium citrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2.

Remodulin^® is indicated as a continuous subcutaneous infusion or intravenous infusion (for those not able to tolerate a subcutaneous infusion) for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms (see CLINICAL PHARMACOLOGY: Clinical Effects) to diminish symptoms associated with exercise.

Remodulin is indicated to diminish the rate of clinical deterioration in patients requiring transition from Flolan^®; the risks and benefits of each drug should be carefully considered prior to transition.

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NEWS HIGHLIGHTS

Media Articles Related to Remodulin (Treprostinil Subcutaneous)

ED Drug Improves Heart's Pumping Action In Young Patients With Single-Ventricle Disease
Source: Cardiovascular / Cardiology News From Medical News Today [2009.11.19]
Heart function significantly improved in children and young adults with single-ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia. Single-ventricle defects are a collection of cardiac malformations that impair the heart's ability to pump blood.

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Published Studies Related to Remodulin (Treprostinil Subcutaneous)

Metered dose inhaler delivery of treprostinil for the treatment of pulmonary hypertension. [2009.02]
CONCLUSIONS: The application of inhaled treprostinil with a metered dose inhaler is feasible and well tolerated. It induced a sustained pulmonary selective vasodilatation.

Treprostinil for pulmonary hypertension. [2008]
Treprostinil is a stable, long-acting prostacyclin analogue which can be administered as a continuous subcutaneous infusion using a portable miniature delivery system. Subcutaneous treprostinil has been shown in a large multicenter randomized controlled trial to improve exercise capacity, clinical state, functional class, pulmonary hemodynamics, and quality of life in patients with pulmonary arterial hypertension, an uncommon disease of poor prognosis...

Transition from IV epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. [2007.09]
BACKGROUND: We determined the relative efficacy of subcutaneous (SC) treprostinil in stable World Health Organization class II and III patients transitioned from IV epoprostenol... CONCLUSIONS: SC treprostinil is effective in pulmonary arterial hypertension and prevents clinical deterioration and maintains functional status in patients transitioned from epoprostenol.

Transition from intravenous epoprostenol to subcutaneous treprostinil in pulmonary arterial hypertension: a controlled trial. [2007.03.30]
Background We determined the relative efficacy of subcutaneous (SC) treprostinil in stable (World Health Organization) WHO class II and III patients transitioned from intravenous epoprostenol. Methods An eight-week multicenter randomized study in which patients were transitioned from intravenous epoprostenol to SC treprostinil or placebo over a period of up to 14 days and monitored carefully during and after the transition period for signs of deterioration...

Long-term outcome in pulmonary arterial hypertension patients treated with subcutaneous treprostinil. [2006.12]
Pulmonary arterial hypertension (PAH) is fatal if untreated.The safety profile for long-term subcutaneous treprostinil was consistent with previous short-term trials with no unexpected adverse events.

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Clinical Trials Related to Remodulin (Treprostinil Subcutaneous)

Safety, Efficacy and Treatment Satisfaction in Patients With Pulmonary Arterial Hypertension Rapidly Switched From Epoprostenol to Remodulin [Completed]
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.

Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures [Terminated]
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.

Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction [Terminated]
The purpose of this study is to compare the effects of switching from inhaled Ventavis to intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis therapy. This study is intended to provide information on the safe transition from Ventavis to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life and treatment satisfaction compared to Ventavis.

Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension [Terminated]
Multi-center, double-blind, placebo-controlled, randomized, parallel study comparing continuous intravenous (IV) Remodulin® to placebo in patients with pulmonary arterial hypertension either primary (PPH) or associated with human immunodeficiency virus (HIV) infection or collagen vascular disease).

Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft [Terminated]
Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.

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