SUTENT

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

SUNITINIB MALATE

متاح من:

PFIZER INDONESIA - Indonesia

INN (الاسم الدولي):

SUNITINIB MALATE

جرعة:

12,5 MG

الشكل الصيدلاني:

KAPSUL

الوحدات في الحزمة:

DUS, BOTOL @ 30 KAPSUL

المصنعة من قبل:

PFIZER ITALIA S.R.L - Italy

تاريخ الترخيص:

2018-01-04

خصائص المنتج

Generic Name
: Sunitinib Malate
Trade Name
: SUTENT
®
CDS Effective Date
: February 12, 2015
Supersedes
: October 13, 2009
Approved by BPOM
:
2020-0
061098
Page 1 of 27
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name
: Sunitinib Malate
Trade Name
: SUTENT
®
CDS Effective Date
: February 12, 2015
Supersedes
: October 13, 2009
DESCRIPTION
SUTENT
®
, an oral multi-kinase inhibitor targeting several receptor tyrosine
kinases (RTK), is the
malate salt of sunitinib. Sunitinib malate is described chemically as
butanedioic acid, hydroxy-,
(2S)-, compound with
_N_-[2-(diethylamino)ethyl]-5-[(_Z_)-(5-fluoro-1,2-dihydro-2-oxo-_3H_-indol-3-
ylidine)methyl]-2,4-dimethyl-_1H_-pyrrole-3-carboxamide
(1:1).
The
molecular
formula
is
C
22
H
27
FN
4
O
2
.C
4
H
6
O
5
and the molecular weight is 532.6 Daltons. The chemical structure of
sunitinib malate is:
Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The
solubility of sunitinib
malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess
of 25 mg/mL. The log of
the distribution coefficient (octanol/water) at pH 7 is 5.2.
SUTENT
®
(sunitinib malate) capsules are supplied as printed hard shell
capsules containing
sunitinib malate equivalent to 12.5 mg, 25 mg or 50 mg of sunitinib
together with mannitol,
croscarmellose sodium, povidone (K-25) and magnesium stearate as
inactive ingredients.
The orange gelatin capsule shells contain titanium dioxide, and red
iron oxide. The caramel
gelatin capsule shells also contain yellow iron oxide and black iron
oxide. The printing ink
contains shellac, propylene glycol, sodium hydroxide, povidone and
titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Sunitinib malate is a small molecule that inhibits multiple RTKs, some
of which are implicated in
tumor growth, pathologic angiogenesis, and metastatic progression of
cancer. Sunitinib was
evaluated for its inhibitory activity against a variety of kinases
(>80 kinases) and was identified
as an inhibitor of platelet-derived growth factor receptors (