NEULASTIM

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

PEGFILGRASTIM

Tersedia dari:

PYRIDAM FARMA TBK - Indonesia

INN (Nama Internasional):

PEGFILGRASTIM

Dosis:

6 MG

Bentuk farmasi:

CAIRAN INJEKSI

Unit dalam paket:

DUS, 1 PRE-FILLED SYRINGE @ 0,6 ML

Diproduksi oleh:

AMGEN MANUFACTURING LIMITED - United States of America

Tanggal Otorisasi:

2019-09-13

Karakteristik produk

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Information for Health Professionals
NEULASTIM
®
Pegfilgrastim
HAEMATOPOIETIC GROWTH FACTOR
COMPOSITION
6 mg of pegfilgrastim in 0.6 ml (10 mg/ml*) solution for injection.
Pegfilgrastim is composed of filgrastim (recombinant methionyl human
G-CSF) with a 20 kDA
polyethylene glycol (PEG) molecule covalently bound to the N-terminal
methionine residue.
Filgrastim is produced by recombinant DNA technology in _E. coli_
(K12).
*Based on protein only. The concentration is 20 mg/ml if the PEG
moiety is included.
PRODUCT DESCRIPTION
Clear liquid, colorless and practically free from particles.
PROPERTIES AND EFFECT
PHARMACODYNAMIC PROPERTIES
Human granulocyte-colony stimulating factor (G-CSF) is a glycoprotein,
which regulates the
production and release of neutrophils from the bone marrow.
Pegfilgrastim is a covalent conjugate of
recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd
polyethylene glycol (PEG)
molecule. Pegfilgrastim is a sustained duration form of filgrastim due
to decreased renal clearance.
Pegfilgrastim and filgrastim have been shown to have identical modes
of action, causing a marked
increase in peripheral blood neutrophil counts within 24 hours, with
minor increase in monocytes
and/or lymphocytes. Similarly to filgrastim, neutrophils produced in
response to pegfilgrastim show
normal or enhanced function as demonstrated by tests of chemotactic
and phagocytic function. As
with other haematopoietic growth factors, G-CSF has shown _in vitro_
stimulating properties on human
endothelial cells. G-CSF can promote growth of myeloid cells,
including malignant cells, _in vitro_ and
similar effects may be seen on some non-myeloid cells _in vitro_.
In two randomised, double-blind, pivotal studies in patients
undergoing myelosuppressive
chemotherapy consisting of doxorubicin and docetaxel, use of
pegfilgrastim, as a single once per
cycle dose, reduced the duration of neutropenia and the incidence of
febrile neutropenia similarly to
that observed with daily administrations of filgrastim (a median o