Hemodynamic Data in Pulmonary Hypertension Associated with Connective Tissue Disease (PAH/CTD)
Significant Improvement in Hemodynamics1
The treatment-related hemodynamic changes in patients with PAH/CTD after 12 weeks of treatment with epoprostenol.
Results of a 12-week, prospective, open-label, randomized trial. Except for 5 NYHA functional class II patients, all patients were either functional class III or IV. In this clinical trial, patients received chronic continuous infusions of epoprostenol sodium plus conventional therapy (n=56) or conventional therapy alone (n=55). Conventional therapy could include anticoagulants, oral vasodilators, supplemental oxygen, digoxin, and/or diuretics.1
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.
- 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.
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.
