Clinical Information About Idiopathic or Heritable PAH*
Study Design in IPAH/HPAH*1
Veletri was studied in 2 prospective, open-label, randomized trials of 8 and 12 weeks' duration in patients with IPAH/HPAH* NYHA functional class III or IV (pooled data results). Treatment consisted of epoprostenol plus conventional therapy or conventional therapy alone.
Dosage of epoprostenol was determined as described under dosage and administration and averaged 9.2 ng/kg/min at study's end.
Conventional therapy varied among patients and included some or all of the following: anticoagulants in essentially all patients; oral vasodilators, diuretics, and digoxin in one-half to two-thirds of patients; and supplemental oxygen in about half of the patients.
Select Safety Information
Patients with congestive heart failure due to severe left ventricular systolic dysfunction should not use Veletri. Veletri should not be used chronically in patients who develop pulmonary edema during dose initiation. Veletri is also contraindicated in patients with known hypersensitivity to the drug or structurally related compounds.
Unless contraindicated, anticoagulant therapy should be administered to patients receiving Veletri to reduce the risk of pulmonary thromboembolism or systemic embolism. Use of anticoagulants or antiplatelet agents may increase the risk of bleeding. Blood pressure and heart rate should be monitored closely following dosage adjustments.
Study populations:
- Primary pulmonary hypertension (IPAH/HPAH*) patients
- Patients with pulmonary hypertension associated with the scleroderma spectrum of disease (PAH/CTD)
Read about exercise data in Idiopathic or Heritable PAH*
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.
