These highlights do not include all the information needed to use VELETRI safely and effectively. See full prescribing information for VELETRI.
VELETRI (epoprostenol) for Injection
Initial U.S. Approval: 1995
INDICATIONS AND USAGE
VELETRI is a prostanoid vasodilator 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. (1)
DOSAGE AND ADMINISTRATION
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Dosage
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Infusion of VELETRI should be initiated at 2 ng/kg/min and increased in increments of 2 ng/kg/min every 15 minutes or longer until dose-limiting pharmacologic effects are elicited or until a tolerance limit to the drug is established. ( 2.1)
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If symptoms of pulmonary hypertension persist or recur after improving - the infusion should be increased by 1- to 2-ng/kg/min increments at intervals sufficient to allow assessment of clinical response; these intervals should be at least 15 minutes. ( 2.2)
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Administration
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VELETRI is administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump. ( 2.3)
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Do not mix with any other parenteral medications or solutions prior to or during administration. ( 2.4)
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During initiation of treatment, VELETRI may be administered peripherally. ( 2.3)
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Reconstitution
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Reconstituted in vial with only 5 mL of either Sterile Water for Injection or Sodium Chloride 0.9% Injection. This solution may be refrigerated at 2°C to 8°C (36° to 46°F) for as long as 5 days or held at up to 25°C (77°F) for up to 48 hours prior to use. ( 2.4)
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Reconstituted product should be further diluted as directed with the same diluent used for reconstitution. This solution of 15000 ng/mL or above of VELETRI may be used for up to 24 hours at room temperature. (Lower concentrations may be used with pump reservoir changed every 12 hours when used
