STEMGEN KIT

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ANCESTIM; WATER

Disponible des:

BIOVITRUM AB (PUBL)

Codi ATC:

L03AA12

Designació comuna internacional (DCI):

ANCESTIM

Dosis:

1875MCG; 5ML

formulario farmacéutico:

KIT

Composición:

ANCESTIM 1875MCG; WATER 5ML

Vía de administración:

SUBCUTANEOUS

Unidades en paquete:

1.2ML

tipo de receta:

Prescription

Área terapéutica:

HEMATOPOIETIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0237442003; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2012-12-31

Fitxa tècnica

1
PRODUCT MONOGRAPH
STEMGEN
®
(ancestim)
Sterile, Lyophilized Powder for Reconstitution
Subcutaneous Use Only
(1875 mcg/vial)
Hematopoietic Agent
BioVitrum AB
SE-11276
Stockholm, Sweden
Imported by:
C.R.I.
4 Innovation Drive
Dundas, Ontario
L9H 7P3
Date of approval: January 26, 2009
Submission Control No.: 126645
2
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 patients receiving the cytokine
combination, this
3
increase in circulating PBPC resu