VELCADE

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

BORTEZOMIB

Tersedia dari:

SOHO INDUSTRI PHARMASI - Indonesia

INN (Nama Internasional):

BORTEZOMIB

Dosis:

3.5 MG

Bentuk farmasi:

SERBUK INJEKSI

Unit dalam paket:

DUS, 1 VIAL @ 3,5 MG

Diproduksi oleh:

BSP PHARMACEUTICALS S.P.A. - Italy

Tanggal Otorisasi:

2020-10-13

Karakteristik produk

VELCADE
TM
Bortezomib
COMPOSITION
Velcade (bortezomib) for injection is an antineoplastic agent
available for intravenous injection
(IV) use only. Each single dose vial contains 3.5 mg of bortezomib as
a sterile lyophilized
powder. Inactive ingredient: 35 mg amnnitol, USP/EP.
PHARMACEUTICAL FORM
Velcade (bortezomib) for injection is supplied as individually
cartooned 10 ml vials containingb
3.5 mg of bortezomib as a white to off-white cake or powder.
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 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 cell. This disruption of normal homeostatic
menchanism can lead to
call 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
non clinical tumor models,
including multiple myeloma.
CLINICAL TRIALS
Phase 2 Clinical Studies in Relapsed Multiple Myeloma:
The safety and efficacy of Velcade were evaluated in an open-label,
single-arm, multicenter
study 0f 202 patients who had received at least 2 prior therapies and
demonstrated disease
progression on their most recent therapy. The median number of prior
therapies was six.
Baseline patient and disease characteristics are summarized in Table
5.
An IV bolus injection of Velcade 1.3 mg/m
2
/dose was administered twice weekly for 2 week,
followed by a 10-day rest period (21 day treatment cycle) for a
maximum of 8 treatment cycles.
The study employed dose modifications for toxicity (see Posology and
Method of Admnistration).
Patients who experienced a response to velcade treatment were allowed
to continue Velcade
tereatment in an extension study.
Table 5: Su