Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SUNITINIB MALATE
PFIZER INDONESIA - Indonesia
SUNITINIB MALATE
16.700 MG
KAPSUL
DUS, BOTOL PLASTIK @ 30 KAPSUL
PFIZER ITALIA S.R.L - Italy
2022-01-03
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 ( Leggi il documento completo