Clinical Support

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

Indication

REMODULIN is indicated for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.

In patients with PAH requiring transition from Flolan® (epoprostenol sodium), REMODULIN is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

Important Safety Information:

Chronic intravenous infusions of REMODULIN are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion is the preferred mode of administration. REMODULIN should be used only by clinicians experienced in the diagnosis and treatment of PAH. REMODULIN is a potent pulmonary and systemic vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure. REMODULIN inhibits platelet aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants. REMODULIN dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. Initiation of REMODULIN must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care. 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. REMODULIN dosage should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacologic effects or for unacceptable infusion site symptoms. Abrupt withdrawal or sudden large reductions in dosage of REMODULIN may result in worsening of PAH symptoms and should be avoided. Caution should be used in patients with hepatic or renal insufficiency.

The most common side effects of REMODULIN included those related to the method of infusion. For subcutaneous infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of REMODULIN. For intravenous infusion, line infections, sepsis, arm swelling, tingling sensations, bruising, and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilatation, and edema.

For more information about REMODULIN, please see the Full Prescribing Information.