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Remodulin (Treprostinil Sodium Subcutaneous) - 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.

See all Remodulin indications & dosage >>


Media Articles Related to Remodulin (Treprostinil Subcutaneous)

Guidelines first to focus on children with pulmonary hypertension
Source: Hypertension News From Medical News Today [2015.11.04]
For the first time, guidelines have been developed for children with pulmonary hypertension, a sometimes fatal heart and lung disease that affects nearly two of every 1,000 babies born each year.

New Guidelines Focus on Pulmonary Hypertension in Kids
Source: MedicineNet Pulmonary Hypertension Specialty [2015.11.04]
Title: New Guidelines Focus on Pulmonary Hypertension in Kids
Category: Health News
Created: 11/3/2015 12:00:00 AM
Last Editorial Review: 11/4/2015 12:00:00 AM

Pulmonary Hypertension
Source: MedicineNet sildenafil Specialty [2015.02.19]
Title: Pulmonary Hypertension
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 2/19/2015 12:00:00 AM

Sildenafil Improves Risk Markers in Prediabetes, Small Study Shows
Source: Medscape Diabetes & Endocrinology Headlines [2015.11.20]
In an admittedly small study, the drug that treats both erectile dysfunction and pulmonary hypertension improved insulin sensitivity and reduced microalbuminuria in people with prediabetes.
Medscape Medical News

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Published Studies Related to Remodulin (Treprostinil Subcutaneous)

Cutaneous iontophoresis of treprostinil in systemic sclerosis: a proof-of-concept study. [2014]
Ischemic digital ulcer (DU) is a serious complication of systemic sclerosis (SSc)...

Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients. [2014]
trepostinil-induced pain... CONCLUSIONS: Further investigation of the efficacy of capsaicin 8% patch in this

Pharmacokinetics of oral treprostinil sustained release tablets during chronic administration to patients with pulmonary arterial hypertension. [2013]
Pulmonary arterial hypertension (PAH) is a progressive vascular disease that ultimately leads to right ventricular failure and death. Treprostinil diolamine is an oral prostacyclin analogue; sustained release tablets of oral treprostinil are currently being evaluated for efficacy and safety as a potential therapy in patients with PAH...

Long-term effects of inhaled treprostinil in patients with pulmonary arterial hypertension: the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) study open-label extension. [2011]
patients concurrently receiving oral background therapy... CONCLUSIONS: Long-term therapy with inhaled treprostinil demonstrated persistent

Lack of a pharmacokinetic interaction between oral treprostinil and bosentan in healthy adult volunteers. [2010.07]
Treprostinil diethanolamine is an oral prostacyclin analog currently being evaluated for the treatment of pulmonary arterial hypertension (PAH). Treprostinil is metabolized primarily by cytochrome P450 (CYP) 2C8 with minor contribution from CYP2C9... In conclusion, because the GMR and 90% CI are within the equivalence interval of 0.8 to 1.25, co-administration of oral treprostinil and bosentan did not result in a pharmacokinetic interaction for either agent.

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Clinical Trials Related to Remodulin (Treprostinil Subcutaneous)

Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH [Terminated]
The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.

Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years [Recruiting]
This is a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who are, (1) transitioning from parenteral Remodulin therapy; (2) transitioning from inhaled prostacyclin therapy; or (3) not currently receiving prostacyclin therapy.

Rapid Switch From Flolan to Remodulin in the Outpatient Clinic [Terminated]
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.

Safety, Efficacy and Treatment Satisfaction in Patients With PAH 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.

Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation [Recruiting]
The overall purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of a two-day peri-operative course of Treprostinil in liver transplant patients. The hypothesis of this study is that Treprostinil can be safely administered perioperatively in liver transplant patients. Once safety is documented future studies will address its ability to ameliorate or prevent reperfusion mediated dysfunction of the liver graft and thereby reduce morbidity, leading to shorter hospital stays as compared to historical controls.

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Reports of Suspected Remodulin (Treprostinil Subcutaneous) Side Effects

Death (93)Dyspnoea (33)Infusion Site Infection (23)Nausea (23)Vomiting (22)Pain in Extremity (20)Headache (19)Pyrexia (18)Diarrhoea (18)Pulmonary Arterial Hypertension (17)more >>

Page last updated: 2015-11-20

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