title: A new epoprostenol formulation for the treatment of pulmonary arterial hypertension.
abstract: OBJECTIVE
  The pharmacology and pharmacokinetics of a novel formulation of epoprostenol for the treatment of pulmonary arterial hypertension (PAH) are reviewed, with guidance on addressing a number of important safety considerations.
  
  
  CONCLUSIONS
  Epoprostenol is a direct vasodilator of the pulmonary and systemic vasculature indicated for improving exercise capacity in patients with PAH. Veletri, a recently approved formulation of epoprostenol for continuous i.v. infusion, offers increased stability relative to other available epoprostenol products. Therefore, the use of Veletri can lessen the therapy burden associated with the other available formulation of the drug by allowing for the advance preparation of infusion pump cassettes (at certain concentrations) and administration at room temperature without the need for cooling with ice packs. Sterility, however, is of concern with outpatient preparation of epoprostenol-containing cassettes stored for the maximum duration according to stability guidelines. All epoprostenol infusions are classified as high-risk therapies due to complex dosing, the drug's short half-life, and the potential for life-threatening rebound PAH with abrupt discontinuation. Adverse effects reported in ≥10% of participants in clinical trials of Veletri included flushing (58%), headache (49%), nausea or vomiting (32%), hypotension (16%), chest pain (11%), and anxiety, nervousness, or agitation (11%). As with other epoprostenol formulations, the use of Veletri requires an evaluation of health-system medication-use practices to ensure patient safety.
  
  
  CONCLUSIONS
  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.
authors.affiliation: The Methodist Hospital, 6565 Fannin Street, DB1-09, Houston, TX 77030, USA. afuentes@tmhs.org
authors.forename: Amaris
authors.initials: A
authors.lastname: Fuentes
authors.forename: Aida
authors.initials: A
authors.lastname: Coralic
authors.forename: Kyle L
authors.initials: KL
authors.lastname: Dawson
mesh_terms: D000959:Antihypertensive Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004356:Drug Storage; D011464:Epoprostenol / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D017079:Exercise Tolerance / Q000187:drug effects*; D065627:Familial Primary Pulmonary Hypertension; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D007262:Infusions, Intravenous; D008508:Medication Errors / Q000009:adverse effects / Q000517:prevention & control; D010353:Patient Education as Topic; D011725:Pyridines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013777:Tetrazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D014665:Vasodilator Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000959:Antihypertensive Agents; D011725:Pyridines; D013777:Tetrazoles; D014665:Vasodilator Agents; C120582:tezosentan; D011464:Epoprostenol