Benefits of Veletri

Benefits of Veletri — Expanded stability provides flexible storage and administration options

Up to once-weekly preparation allows more drug to be prepared in advance for convenient storage.

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.

Formulated for greater drug stability §
Formulated for greater drug stability to slow the rate of drug degradation at room temperature

Eliminates the need for ice packs.

Flexible reconstitution and dilution options §

Veletri must be reconstituted with either of 2 readily available diluents: Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP.
Eliminate the restrictive need for drug-specific diluents.
Reconstituted solution must not be frozen and must be protected from light.
Do not reconstitute or mix with any other parenteral medications prior to or during administration.
Stability depends on concentration, temperature, and timing of reconstitution, dilution, and administration. Do not freeze Veletri or expose to direct sunlight.

Delivering the gold-standard efficacy and safety of epoprostenol

Includes the same active pharmaceutical ingredient as Flolan^® (epoprostenol sodium)¹
Improved survival in NYHA Class III and Class IV IPAH/HPAH^* patients²

At 12 weeks, 0/41 patients died in the Veletri group compared to 8/41 patients in the conventional therapy alone group (p=0.003)

Select Safety Information

Dose initiation with Veletri must be performed in a setting with adequate personnel and equipment for physiologic monitoring and emergency care.
To reduce the risk of infection, aseptic technique must be used in the reconstitution and administration of Veletri as well as in routine catheter care. Sepsis, attributable to the drug delivery system, was reported during the long-term follow-up in a clinical trial.
Each vial is for single use only. Discard any unused solution.
Discard any reconstituted solution that has been refrigerated for more than 5 days or if held at room temperature for more than 48 hours.
Even brief interruptions in the delivery of Veletri may result in rapid symptomatic deterioration.

^§ Clinical advantage is unknown.

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. Flolan (epoprostenol sodium) Full Prescribing Information. GlaxoSmithKline. 2008. Flolan is a registered trademark of GlaxoSmithKline.

2. Veletri (epoprostenol for injection) Full Prescribing Information. Actelion Pharmaceutical US, Inc. 2010