Clinical Support

Transition From Flolan: 93% Success Rate Transitioning Patients From Flolan® (epoprostenol sodium) for Injection to REMODULIN® (treprostinil sodium) Injection1

In an 8-week, multicenter, randomized, double-blind, placebo-controlled trial of 22 patients with PAH who transitioned from IV Flolan to SC REMODULIN:

  • 93% (13/14) of patients receiving REMODULIN were able to successfully transition from Flolan compared to only 13% (1/8) of patients receiving placebo (P=0.0002)1
  • The mean dose of SC REMODULIN upon completion of the transition period was 25.3 ± 3.5 ng/kg/min; the mean maximum dose during the 8-week study was 32.2 ± 4.9 ng/kg/min2

Chart
  • "Seven of 8 patients (88%) transitioned to placebo had clinical deterioration..."
  • "Mean times to complete the transition to study drug in patients who completed the transition were 7 days and 7.5 days in the treprostinil and placebo groups, respectively"

Safety

The three most frequently experienced adverse events in the 14 patients receiving REMODULIN were infusion site pain (93%), infusion site erythema (71%), and diarrhea (50%); other adverse events included nausea, headache, dizziness, flushing, upper respiratory infection, vomiting, and jaw pain.2

Please see the REMODULIN package insert for approved safety and dosing information.

References: 1. REMODULIN [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2006. 2. Data on file. United Therapeutics Corporation. 3. Gomberg-Maitland M, Tapson VF, Benza RL, et al. Transition from intravenous epoprostenol to intravenous treprostinil in pulmonary hypertension. Am J Respir Crit Care Med. 2005;172:1586-1589. 4. Tapson VF, Gomberg-Maitland M, McLaughlin VV, et al. Safety and efficacy of IV treprostinil for pulmonary arterial hypertension. CHEST. 2006;129:683-688.

REMODULIN is a registered trademark of United Therapeutics Corporation. Flolan is a registered trademark of GlaxoSmithKline.