STEMGEN KIT

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ANCESTIM; WATER

Fáanlegur frá:

BIOVITRUM AB (PUBL)

ATC númer:

L03AA12

INN (Alþjóðlegt nafn):

ANCESTIM

Skammtar:

2500MCG; 5ML

Lyfjaform:

KIT

Samsetning:

ANCESTIM 2500MCG; WATER 5ML

Stjórnsýsluleið:

SUBCUTANEOUS

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

HEMATOPOIETIC AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0237442004; AHFS:

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2017-09-07

Vara einkenni

PRODUCT MONOGRAPH
STEMGEN
®
ANCESTIM
HEMATOPOIETIC AGENT
STERILE, LYOPHILIZED POWDER FOR RECONSTITUTION
SUBCUTANEOUS USE ONLY
(1875 MCG/VIAL)
Manufactured by:
Amgen
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California U.S.A.
91320-1799
Distributed by:
Amgen Canada Inc.
6755 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 7Y2
Date of Approval: February 13, 2004
MECS #: 04-103170-301
-1-
PRODUCT MONOGRAPH
STEMGEN
®
ANCESTIM
STERILE, LYOPHILIZED POWDER FOR RECONSTITUTION
SUBCUTANEOUS USE ONLY
(1875 MCG/VIAL)
THERAPEUTIC
CLASSIFICATION
HEMATOPOIETIC AGENT
CAUTION:
STEMGEN
®
MAY
CAUSE
SEVERE
OR
LIFE-THREATENING
SYSTEMIC
ALLERGIC
REACTIONS (SEE WARNINGS).
ACTION AND CLINICAL PHARMACOLOGY
GENERAL
STEMGEN
®
(ancestim) is recombinant-methionyl human stem cell factor
(r-metHuSCF),
a homologue of endogenous human stem cell factor (SCF), produced by
recombinant
DNA technology.
1
Hematopoietic growth factors, including SCF, are glycoproteins
which act on hematopoietic cells by binding to specific cell surface
receptors and
stimulating
proliferation,
differentiation,
commitment,
and/or
functional
activation.
Receptors for SCF are found on a range of early to more mature
hematopoietic
progenitor cells, as well as mast cells, melanocytes, and germ cells.
Endogenous SCF is a multilineage hematopoietic growth factor which is
produced by
bone marrow fibroblasts.
2,3
In humans, the serum concentration of soluble SCF
averages 3.3 ± 1.1 ng/mL.
2,3
PHARMACOLOGIC EFFECTS OF STEMGEN
® (ANCESTIM) IN COMBINATION WITH
NEUPOGEN
® (FILGRASTIM)
In
phase
1/2
studies
involving
367
patients
with
breast
cancer,
non-Hodgkin’s
lymphoma, and ovarian cancer, STEMGEN
®
administration over a dose range of 5 to 25
mcg/kg/day in combination with a fixed dose of NEUPOGEN
®
resulted in a dose-
dependent increase in circulating peripheral blood progenitor cells
(PBPC) compared to
NEUPOGEN
®
alone.
4
The PBPCs included CD34
+
cells, granulocyte macrophage
colony-forming units (CFU-GM), and erythroid burst-forming units
(BFU-E). For pat