VELCADE

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

BORTEZOMIB

Disponible depuis:

SOHO INDUSTRI PHARMASI - Indonesia

DCI (Dénomination commune internationale):

BORTEZOMIB

Dosage:

3.5 MG

forme pharmaceutique:

SERBUK INJEKSI

Unités en paquet:

DUS, 1 VIAL @ 3,5 MG

Fabriqué par:

BSP PHARMACEUTICALS S.P.A. - Italy

Date de l'autorisation:

2020-10-13

Résumé des caractéristiques du produit

VELCADE®
bortezomib
QUALITATIVE AND QUANTITATIVE COMPOSITION
Velcade (bortezomib) for Injection is an antineoplastic agent
available for intravenous injection (IV) or subcutaneous (SC). Each
single use vial contains:
•
1.0 mg of bortezomib as a sterile lyophilized powder. Inactive
ingredient: 10 mg mannitol, USP/EP (IV use only), or
•
3.5 mg of bortezomib as a sterile lyophilized powder. Inactive
ingredient: 35 mg mannitol, USP/EP (IV or SC use).
PHARMACEUTICAL FORM
Velcade (bortezomib) for Injection is supplied as individually
cartooned 5 mL vials containing 1 mg of bortezomib, or 10 mL vials
containing 3.5 mg of bortezomib as a white to off-white cake or
powder.
•
1.0 mg single use vial
•
3.5 mg single use vial
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
MECHANISM OF ACTION
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity
of the 26S proteasome
in mammalian
cells. The
26S
proteasome is a large
protein
complex that degrades
ubiquitinated proteins. The ubiquitin-proteasome pathway plays an
essential role in
regulating the intracellular concentration of specific proteins,
thereby maintaining
homeostasis within cells.
Inhibition of the 26S proteasome prevents this targeted
proteolysis which can affect multiple signaling cascades within the
cell. This disruption of
normal homeostatic
mechanisms can lead to cell death_. _ Experiments have demonstrated
that
bortezomib is cytotoxic to a variety of cancer cell types _in vitro_.
Bortezomib causes a delay in tumor growth in vivo in nonclinical
tumor models, including multiple myeloma.
Data from in vitro, ex-vivo, and animal models with bortezomib suggest
that it increases osteoblast differentiation and activity
and inhibits osteoclast function. These effects have been observed in
patients with multiple myeloma affected by an advanced
osteolytic disease and treated with bortezomib.
CLINICAL TRIALS
PHASE 2 CLINICAL STUDIES IN RELAPSED MULTIPLE MYELOMA:
The safety and efficacy of Velcade IV were evaluated in an open-label,
single-arm,