Veletri (epoprostenol for injection), an intravenous prostacyclin, is stable at room temperature (77°F/25°C) for up to 24 hours, removing the need for patients to carry ice packs.

 

CURRENT INDICATIONS

In the US, Veletri is indicated for the treatment of PAH (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.

In some EU countries, Veletri is indicated for the treatment of PAH (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with WHO Functional Class III–IV symptoms to improve exercise capacity. Veletri is also indicated for use in haemodialysis in emergency situations, when the use of heparin carries a high risk of causing or exacerbating bleeding or when heparin is otherwise contraindicated.

Veletri (Epoprostenol for Injection) must be reconstituted and diluted only as directed using Sterile Water for Injection, or Sodium Chloride 0.9% Injection. Veletri must not be reconstituted or mixed with any other intravenous medications or solutions prior to or during administration. Most common side effects include headache, jaw pain, flushing, diarrhea, nausea and vomiting, hypotension, abdominal pain, arthralgia, flu-like symptoms, decreased platelet count, bleeding, tachycardia, bradycardia, chest pain, rash, pain, and anxiety/nervousness. Sepsis and septicemia, mostly related to delivery system for Veletri were commonly reported.  In order to reduce the risk of catheter related blood stream infections, the care of the central venous catheter and the catheter exit site should follow established medical principles. Excessive doses of Veletri may acutely result in systemic low blood pressure, rapid heartbeat, jaw pain, headache, flushing, nausea and vomiting, diarrhea, flu-like symptoms, or anxiety; excessive doses administered continuously can lead to extreme restlessness and high-output cardiac failure.

Abrupt withdrawal or sudden large reductions in dosage of Veletri may result in symptoms associated with rebound pulmonary hypertension, including dyspnea, dizziness, and asthenia and may result in death. Therefore abrupt withdrawal should be avoided.

PRODUCT AVAILABILITY & REGULATORY STATUS

Veletri is commercially available in 17 markets, including the US (since 2010), Switzerland and Canada - marketed as Caripul® - (since 2012), Japan, marketed as Epoprostenol "ACT", and some European markets (since 2013).The registration process for other countries is ongoing.

For full information please see the download.

KEY SCIENTIFIC LITERATURE

Veletri® (Epoprostenol for Injection) pharmacologic data:

  • Nicolas LB, Gutierrez MM, Dingemanse J. Comparative pharmacokinetic, pharmacodynamic, safety, and tolerability profiles of 3 different formulations of epoprostenol sodium for injection in healthy men. Clin Ther. 2013;35:440-49

Veletri® (Epoprostenol for Injection) product technical data:

  • Lambert O and Bandilla D. Stability and preservation of a new formulation of epoprostenol sodium for treatment of pulmonary arterial hypertension. Drug Design Dev Ther. 2012;6:235-244

Veletri® (Epoprostenol for Injection) clinical data:

  • Sitbon O, Delcroix M, Bergot E, Boonstra A, Escribano Subias P, Galie N, Granton J, Langleben D, Pfister T, Lemarie JC Simonneau G. EPITOME-2, An Open-Label Study Evaluating A New Formulation Of Epoprostenol Sodium In Pulmonary Arterial Hypertension Patients Switched From Flolan(R). Am. J. Respir. Crit. Care Med. 2012; 185: A2500.
  • Tamura Y, Ono T, Fukuda K, Satoh T, Sasayama S. Evaluation of a new formulation of epoprostenol sodium in Japanese patients with pulmonary arterial hypertension (EPITOME-4). Adv Ther 2013;30:459-71

Prostacyclin therapy

  • Rubin LJ, et al. Treatment of primary pulmonary hypertension with continuous intravenous prostacyclin (epoprostenol). Results of a randomized trial. Ann Intern Med 1990;112(7):485-91.
  • Barst RJ, Rubin L, Long W, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. The Primary Pulmonary Hypertension Study Group. N Engl J Med 1996;334(5):296-302.
  • Bergot E, Sitbon O, Cottin V, Yaïci A, Rottat L, Gressin V, Humbert M, Simonneau G. Current epoprostenol use in patients with severe pulmonary hypertension (PH): data from the French PH registry. Eur Heart J. 2011;32(Abstract supplement):172-173.
  • Bergot E, Sitbon O, Cottin V, Yaïci A, Rottat L, Gressin V, Humbert M, Simonneau G. Current epoprostenol use in patients with severe pulmonary hypertension (PH): data from the French PH registry. Eur Respir J. 2011;38(Suppl 55):430s.
  • Farber HW, Miller DP, Beery FS, McGoon MD. Use of Parenteral Prostanoids at Time of Death in Patients With Pulmonary Arterial Hypertension Enrolled in REVEAL. American College of Chest Physicians - CHEST 2011. 2011;140(4):903A.

US RESIDENTS

Please note that the information contained in this section of the website is not intended for US residents. Please visit our US webpage.

Please note that the information contained in this section of the website is not intended for US residents. Please visit our US webpage.