PATIENT OR CAREGIVER
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Storing Veletri

Follow all instructions to ensure that Veletri retains its stability and that the proper dosage is delivered.

Storage options

When reconstituted and immediately diluted in the cassette

  • Patients can now change cassettes every 24 hours when Veletri is prepared as directed and used immediately after reconstitution and dilution at concentrations ≥6,000 ng/mL.

  • Patients can now store cassettes in the refrigerator (36°F to 46°F/2°C to 8°C) for 1 day and then administer at room temperature (77°F/25°C) for up to 24 hours when Veletri is reconstituted and immediately diluted at concentrations ≥12,000 ng/mL and <30,000 ng/mL.

  • Patients can now store cassettes in the refrigerator (36°F to 46°F/2°C to 8°C) for 1 day and then administer at room temperature (77°F/25°C) for up to 48 hours when Veletri is reconstituted and immediately diluted at concentrations ≥30,000 ng/mL.

  • Patients can now prepare up to 7 days’ worth of medication in advance and store fully diluted cassettes in their refrigerator (36°F to 46°F/2°C to 8°C) and administer at room temperature for up to 24 hours at concentrations ≥30,000 ng/mL.
† If reconstituted solution has been stored prior to dilution to final concentration, this does not apply. Please see section 2.4 of accompanying full prescribing information for complete information about use after storage of reconstituted solution. Note: The pump design prevents users from running the cassette beyond 48 hours.

Reconstitution1

  • Veletri must be reconstituted and diluted only as directed using Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP. Veletri must not be reconstituted or mixed with any other parenteral medications or solutions prior to or during administration.
  • Do not freeze reconstituted Veletri. Discard any reconstituted solution that has been frozen, refrigerated (36°F to 46°F/2°C to 8°C) for more than 5 days, or kept at room temperature (77°F/25°C) for more than 48 hours. Do not expose Veletri to direct sunlight.

Dilution1

  • Reconstituted product should be further diluted as directed with the same diluent used for reconstitution. The diluted solution may be used for up to 24 hours at room temperature. Concentrations of less than 6,000 ng/mL may be used for no longer than 12 hours at a time at room temperature (77°F/25°C), when Veletri is prepared for immediate administration.
  • Solution for chronic delivery should be prepared in a drug delivery reservoir appropriate for the infusion pump.
  • Stability depends on concentration, temperature, and timing of reconstitution, dilution, and administration. Do not freeze Veletri or expose to direct sunlight.

See step-by-step instructions for your patients for reconstitution, dilution, and storage of Veletri.

For more information about storing Veletri, please see the full prescribing information.


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.