Epoprostenol for Injection (Veletri®)

Veletri is a new formulation of epoprostenol (i.e, Flolan®) that has been formulated for greater drug stability to slow the rate of drug degradation at room temperature.

Epoprostenol (PGI2, PGX, prostacyclin) is a naturally occuring prostglandin wih potent vasodilatory activity and inhibitory activity of platelet aggregation.


Fda approval date
August 25, 2010

Recommended for
Veletri is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.

How administered
Veletri is adminstered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.  It is administered directly into the bloodstream. A surgically implanted catheter is placed in a vein in the chest and leads directly into the heart.  A portable, battery-operated pump continuously administers the medication. The pump is worn attached to a belt around the waist or carried in a small shoulder pack. A thin plastic cannula connects the pump to the catheter.

Risks/Side Effects

Veletri is a potent pulmonary and systemic vasodilator. Dose initiation with Veletri must be performed in a setting with adequate personnel and equipment for physiologic monitoring and emergency care.

The most common adverse reactions during dose initiation and escalation are:  Nausea, vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia.

During chronic dosing, headache, jaw pain, flushing, diarrhea, nausea and vomiting, flu-like symptoms, and anxiety/nervousnes are the most common adverse reactions.


Benefits

Unlike other epoprostenol formulations approved for PAH, Veletri is stable at room temperature (77 F, 25 C), for up to 24 hours after it has been fully diluted and administered, making the use of frozen gel packs unnecessary.

After reconstituting as directed, Veletri is stable for up to 5 days when refrigerated (36°F to 46°F; 2°C to 8°C), or up to 48 hours at room temperature (77°F/25°C) which allows more drug to be prepared in advance for convenient storage.


Pathway
Epoprostenol has 2 major pharmacological actions: (1) direct vasodilation of pulmonary and systemic arterial vascular beds, and (2) inhibition of platelet aggregation.

Costs
The cost of epoprostenol is approximately $100,000 per year, depending upon patient dose.

Manufactured by
Hollister-Stier Laboratories, LLC

Distributed by
Actelion Pharmaceuticals US, Inc.

Visit the FDA Page for this drug/therapy

Visit the Official Drug Company Website

Info Source(s)
Full Prescribing Information




Page Reviewed/Edited: November 2010

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