NEUPOGEN- filgrastim injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

FILGRASTIM (UNII: PVI5M0M1GW) (FILGRASTIM - UNII:PVI5M0M1GW)

Tilgjengelig fra:

Amgen Inc

INN (International Name):

FILGRASTIM

Sammensetning:

FILGRASTIM 300 ug in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

NEUPOGEN is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1)] . NEUPOGEN is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2)] . NEUPOGEN is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)] . NEUPOGEN is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4)] . NEUPOGEN is indicated for chronic administ

Produkt oppsummering:

NEUPOGEN injection is a clear, colorless, preservative-free solution supplied as: Vials Single-dose vials containing 300 mcg/mL of filgrastim. Dispensing packs of 10 vials (NDC 55513-530-10). Single-dose vials containing 480 mcg/1.6 mL (300 mcg/mL) of filgrastim. Dispensing packs of 10 vials (NDC 55513-546-10). Prefilled Syringes (SingleJect® ) Single-dose, prefilled syringe with 27 gauge, ½ inch needle with an UltraSafe® Needle Guard, containing 300 mcg/0.5 mL of filgrastim. Single-dose, prefilled syringe with 27 gauge, ½ inch needle with an UltraSafe® Needle Guard, containing 480 mcg/0.8 mL of filgrastim. The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex) [see Dosage and Administration (2.6)] . Store NEUPOGEN at 2°C to 8°C (36°F to 46°F) in the carton to protect from light. Do not leave NEUPOGEN in direct sunlight. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard NEUPOGEN if frozen more than once. Avoid shaking. Transport via a pneumatic tube has not been studied.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

NEUPOGEN- FILGRASTIM INJECTION, SOLUTION
AMGEN INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEUPOGEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEUPOGEN.
NEUPOGEN (FILGRASTIM) INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
NEUPOGEN is a leukocyte growth factor indicated to
Decrease the incidence of infection‚ as manifested by febrile
neutropenia‚ in patients with nonmyeloid
malignancies receiving myelosuppressive anti-cancer drugs associated
with a significant incidence of
severe neutropenia with fever (1.1)
Reduce the time to neutrophil recovery and the duration of fever,
following induction or consolidation
chemotherapy treatment of patients with acute myeloid leukemia (AML)
(1.2)
Reduce the duration of neutropenia and neutropenia-related clinical
sequelae‚ e.g.‚ febrile neutropenia,
in patients with nonmyeloid malignancies undergoing myeloablative
chemotherapy followed by bone
marrow transplantation (BMT) (1.3)
Mobilize autologous hematopoietic progenitor cells into the peripheral
blood for collection by
leukapheresis (1.4)
Reduce the incidence and duration of sequelae of severe neutropenia
(e.g.‚ fever‚ infections‚
oropharyngeal ulcers) in symptomatic patients with congenital
neutropenia‚ cyclic neutropenia‚ or
idiopathic neutropenia (1.5)
Increase survival in patients acutely exposed to myelosuppressive
doses of radiation (Hematopoietic
Syndrome of Acute Radiation Syndrome) (1.6)
DOSAGE AND ADMINISTRATION
Patients with cancer receiving myelosuppressive chemotherapy or
induction and/or consolidation
chemotherapy for AML
Recommended starting dose is 5 mcg/kg/day subcutaneous injection,
short intravenous infusion (15
to 30 minutes), or continuous intravenous infusion. See Full
Prescribing Information for
recommended dosage adjustments and timing of administration (2.1)
Patients with cancer undergoing bone marrow transplantation
10 mcg/kg/day given as an