Flolan® (epoprostenol sodium), a prostacyclin analogue delivered by continuous intravenous infusion, is a highly effective therapy for the treatment of pulmonary arterial hypertension. Since April 2008, a generic formulation of epoprostenol (Teva Pharmaceuticals) has been available, with 81 patients on the drug as of April 2009. We assessed safety and early experience with this agent.
Retrospective, observational review of 39 patients either being initiated with epoprostenol or being transitioned from Flolan®.
Twelve patients were newly initiated on epoprostenol and 27 were transitioned from Flolan®. For newly initiated patients, all were started in-hospital. Average dose upon last follow-up was 13 ng/kg/min. Typical epoprostenol side effects were noted in all patients including jaw pain, diarrhea, and flushing. For transitioned patients, 25/27 were switched at home (rapid 1:1 transition). No change in dosing occurred with transition, although increased diarrhea (3 patients) and jaw pain (2 patients) were noted. There were no episodes of acute clinical deterioration, except in one patient, who experienced transient hypotension and chest pain during a 3 day transition. This patient had progressive symptomatic worsening during the weeks following transition, with dosing limited by anorexia and weight loss, and was switched to Remodulin. One patient died of progressive right ventricular failure, 5 months after transition. Two patients were switched back to Flolan®, one for worsening diarrhea and one for itching (unclear if due to epoprostenol vs. tanning bed). The remaining 23 patients remain stable with average follow-up of 4 ± 2 months (range 2 weeks–9 months).
Early experience suggests that generic epoprostenol is safe, both as de-novo therapy and in patients being transitioned from Flolan®. Whether generic epoprostenol is “identical” to Flolan®, in safety and efficacy, however, awaits more long-term experience.
Generic epoprostenol may be an effective, less expensive alternative to Flolan® in the treatment of pulmonary arterial hypertension.
Richard Channick, No Financial Disclosure Information; No Product/Research Disclosure Information