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.
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.
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.
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Veletri® (Epoprostenol for Injection) pharmacologic data:
Veletri® (Epoprostenol for Injection) product technical data:
Veletri® (Epoprostenol for Injection) clinical data: