PATIENT OR CAREGIVER
Home  |  Privacy Policy  |  Terms and Conditions  |  Contact Us  |  Sign Up For Updates  |  Site Map

Survival Data in Idiopathic or Heritable Pulmonary Arterial Hypertension (IPAH/HPAH*) at 12 weeks

Improved Survival in IPAH/HPAH* patients1

Survival was improved in NYHA Class III and IV IPAH/HPAH* patients treated with epoprostenol sodium plus conventional therapy as compared to patients treated with conventional therapy alone.

At the end of the treatment1:

  • None of the 41 patients receiving epoprostenol sodium died. ‡
  • 8 of 40 (20%) patients receiving conventional therapy alone had died (p=0.003). ‡

Select Safety Information

  • Abrupt withdrawal or reductions in delivery of Veletri, as well as overdoses, may result in hemodynamic instability, including rebound pulmonary hypertension or fatal hypotension. Abrupt withdrawal should be avoided.
  • Adverse events included flushing, jaw pain, headache, hypotension, tachycardia, nausea, vomiting, flu-like symptoms, anxiety/nervousness and diarrhea.

Read about dyspnea and fatigue data in IPAH/HPAH*

† In a 12-week, multicenter, open-label, randomized, parallel study in patients treated with epoprostenol sodium plus conventional therapy or conventional therapy alone. Conventional therapy could include anticoagulants, oral vasodilators, diuretic agents, cardiac glycosides, and supplemental oxygen.1 In this study, the primary endpoint was a change from baseline in exercise capacity as measured by the 6-minute walk test; the secondary endpoint was a change from baseline in cardiopulmonary hemodynamics, the Chronic Heart Failure Questionnaire, the Dyspnea-Fatigue Index, and NYHA functional class; survival was determined by Kaplan-Meier analysis.2

INDICATION
Veletri is indicated for the treatment of pulmonary arterial hypertension (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.

IMPORTANT SAFETY INFORMATION
Veletri is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction, in patients who develop pulmonary edema during dose initiation, and in patients who have known hypersensitivity to the drug or to structurally related compounds.

Veletri should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension after establishing the diagnosis of idiopathic or heritable PAH or PAH/CTD.

Reconstitute Veletri only as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Do not mix Veletri with any other parenteral medications or solutions prior to or during administration. Do not abruptly lower the dose or withdraw dosing. All dosing initiation and changes should be closely monitored.

The most common and dose-limiting adverse events during dose initiation and escalation were flushing (58%), headache (49%), nausea/vomiting (32%), hypotension (16%), chest pain (11%), and anxiety (11%).

Adverse events occurring in patients with idiopathic or heritable PAH with =10% difference between epoprostenol and conventional therapy alone were chills/fever/sepsis/flu-like symptoms (25% vs 11%), tachycardia (35% vs 24%), flushing (42% vs 2%), diarrhea (37% vs 6%), nausea/vomiting (67% vs 48%), jaw pain (54% vs 0%), myalgia (44% vs 31%), nonspecific musculoskeletal pain (35% vs 15%), anxiety/nervousness/tremor (21% vs 9%), dizziness (83% vs 70%), headache (83% vs 33%), and hypesthesia/hyperesthesia/paresthesia (12% vs 2%).

Adverse events occurring in patients with PAH/CTD with =10% difference between epoprostenol and conventional therapy alone were flushing (23% vs 0%), hypotension (13% vs 0%), anorexia (66% vs 47%), nausea/vomiting (41% vs 16%), diarrhea (50% vs 5%), jaw pain (75% vs 0%), pain/neck pain/arthralgia (84% vs 65%), headache (46% vs 5%), skin ulcer (39% vs 24%), and eczema/rash/urticaria (25% vs 4%).

Additional reductions in blood pressure may occur when Veletri is administered with diuretics, antihypertensive agents, or other vasodilators. There is the potential for Veletri to increase the risk of bleeding when administered with antiplatelet agents or anticoagulants. Patients on digoxin who receive Veletri may show elevations of digoxin concentration, which may be clinically significant in patients prone to digoxin toxicity.

Please see full Prescribing Information

1. Veletri (epoprostenol for injection) Full Prescribing Information. Actelion Pharmaceuticals US, Inc. March 2011.

2. Barst RJ, Rubin LJ, Long WA, 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;334:296-302.