A new epoprostenol formulation for the treatment of pulmonary arterial hypertension

Abstract

Veletri provides an epoprostenol therapy option that reduces some of the inconveniences of the other formulation. Drug stability is dependent on cassette concentrations, which may be limited by sterility concerns with outpatient preparation. Use of this new agent within the health system requires an evaluation of practices to ensure patient safety.

New pharmacotherapy options for pulmonary arterial hypertension

“…New pharmacotherapies 3.1 New formulation of epoprostenol A new formulation of epoprostenol (Veletri Ò ) reconstituted with sterile water for injection or sodium chloride 0.9% with a greater chemical stability has recently been approved by FDA [114]. While there are still few clinical studies for this preparation and for transitioning patients from previous to the new formulation, this transition did not affect efficacy of treatment, without new safety or tolerability concerns [114][115][116]. Moreover, this switch allowed the patients to have a more convenient treatment [116].…”

Pulmonary Arterial Hypertension: A Current Review of Pharmacological Management

“…Patients in the epoprostenol group had functional improvement, 6MWD (362 m at 12 weeks vs. 315 m at base line) and a decrease in mPAP and pulmonary vascular resistance [15]. There exists also a thermostable form of epoprostenol that lessens its burden of use and may improve patient compliance [16].…”

Safe and effective use of prostacyclins to treat pulmonary arterial hypertension

“…The primary difference in the Veletri formulation is the substitution of glycine with arginine, which results in a higher pH (greater than 11) after reconstitution compared with Flolan and generic epoprostenol (pH of 10.2-10.8). 13,[20][21][22][23] Although the higher pH of Veletri provides improved stability at room temperature, stability ultimately depends on both temperature and concentration. Stability increases as the concentration of the diluted cassette increases; stability decreases the longer the cassette is refrigerated.…”

“…Stability increases as the concentration of the diluted cassette increases; stability decreases the longer the cassette is refrigerated. [21][22][23] With the availability of secondgeneration Veletri, clinicians must be cautious not to confuse the newly available 0.5-mg vial as Flolan or generic epoprostenol. There are also specific recommendations to prepare certain concentrations with certain vial strengths (0.5 mg for concentrations of 3,000 to <15,000 ng/mL and 1.5 mg for concentrations of ≥15,000 ng/mL).…”

“…22 Veletri appears to offer some advantages for patients in the outpatient setting, such as the ability to reconstitute vials in advance of cassette preparation, decreased frequency of cassette preparation, and avoidance of the need to keep most concentrations of prepared medication cassettes under refrigeration. 23 All epoprostenol formulations require reconstitution of the lyophilized powder with subsequent dilution before administration. However, both Flolan and generic epoprostenol require a sterile diluent unique to epoprostenol, whereas Veletri can only be reconstituted with sterile water for injection or 0.9% sodium chloride injection.…”