VELETRI epoprostenol sodium injection powder lyophilized for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

epoprostenol sodium (UNII: 4K04IQ1OF4) (epoprostenol - UNII:DCR9Z582X0)

Available from:

Actelion Pharmaceuticals US, Inc.

INN (International Name):

epoprostenol sodium

Composition:

epoprostenol sodium 1500000 ng in 10 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

VELETRI- EPOPROSTENOL SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
ACTELION PHARMACEUTICALS US, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
Dosage
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-
Administration
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-
-
Re constitution
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DOSAGE FORMS AND STRENGTHS
1.5 mg (1,500,000 ng) VELETRI is in a 10 mL vial with a red flip-off
seal. (3)
CONTRAINDICATIONS
Congestive heart failure due to severe left ventricular systolic
dysfunction (4)
Pulmonary edema (4)
Hypersensitivity to the drug or to structurally related compounds (4)
WARNINGS AND PRECAUTIONS
VELETRI should be used only by clinicians experienced in the diagnosis
and treatment of pulmonary hypertension.
(5.1)
Reconstitute only as directed, with Sterile Water for Injection or
Sodium Chloride 0.9% Injection.(5.1)
Do not abruptly lower the dose or withdraw dosing. All dosing
initiation and changes should be closely monitored. (5.3,
5.4)
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)
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)
VELETRI is administered by continuous intravenous inf