VELETRI- epoprostenol injection, powder, lyophilized, for solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

epoprostenol (UNII: DCR9Z582X0) (epoprostenol - UNII:DCR9Z582X0)

Disponibbli minn:

Actelion Pharmaceuticals US, Inc.

INN (Isem Internazzjonali):

epoprostenol

Kompożizzjoni:

epoprostenol 500000 ng in 10 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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. A large study evaluating the effect of epoprostenol on survival in NYHA Class III and IV patients with congestive heart failure due to severe left ventricular systolic dysfunction was terminated after an interim analysis of 471 patients revealed a higher mortality in patients receiving epoprostenol plus conventional therapy than in those receiving conventional therapy alone. The chronic use of VELETRI in patients with congestive heart failure due to severe left ventricular systolic dysfunction is therefore contraindicated. Some patients with pulmonary hypertension have developed pulmonary edema during dose initiation, which may be associated with pulmonary veno-occlusive disease. VELE

Sommarju tal-prodott:

VELETRI is supplied as a sterile lyophilized material in 10 mL vials. 10 mL vial with a white flip-off seal containing epoprostenol sodium equivalent to 0.5 mg (500,000 ng) epoprostenol, is packaged in carton of 1 vial (NDC 66215-403-01). 10 mL vial with a red flip-off seal containing epoprostenol sodium equivalent to 1.5 mg (1,500,000 ng) epoprostenol, is packaged in carton of 1 vial (NDC 66215-402-01). Store the vials of VELETRI at 68° to 77°F (20° to 25°C) [see USP Controlled Room Temperature] . Unopened vials of VELETRI are stable until the date indicated on the package when stored at 68° to 77°F (20° to 25°C). The unopened vial should be kept in the carton and not exposed to direct sunlight. Use after reconstitution and immediate dilution to final concentration can be found in Dosage and Administration (2.4) Reconstitution, Table 1: Maximum duration of administration (hours) at room temperature (77°F/25°C) of fully diluted solutions in the drug delivery reservoir. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. If either occurs, do not administer.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

VELETRI- EPOPROSTENOL 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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
VELETRI is a prostacyclin 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
-
-
Administration
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-
Reconstitution
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-
DOSAGE FORMS AND STRENGTHS
Injection: 10 mL single-dose vial with 0.5 mg (500,000 ng) or 1.5 mg
(1,500,000 ng) VELETRI. (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
Do not abruptly lower the dose or withdraw dosing. All dosing
initiation and changes should be closely
monitored. (5.2, 5.3)
ADVERSE REACTIONS
Most common adverse reactions during:
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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)
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 infusion via a
central venous catheter using an
ambulatory infusion pump. (2.3)
Do not mix with any other parenteral medications or