País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LAPATINIB DITOSYLATE
NOVARTIS INDONESIA - Indonesia
LAPATINIB DITOSYLATE
405.0 MG
TABLET SALUT SELAPUT
DUS, 1 BOTOL @ 70 TABLET SALUT SELAPUT
SANDOZ S.R.L. - Romania
2020-12-23
Novartis Page 1 Leaflet TYKERB TM 1 TRADE NAME TYKERB TM 250 film-coated tablet 2 DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM FILM-COATED TABLET Tykerb 250 mg film-coated tablet (yellow film-coated tablets). Tykerb 250 mg film-coated tablet are oval, biconvex, with one side plain and the other opposite side debossed with GS XJG. ACTIVE SUBSTANCE Lapatinib ditosylate monohydrate. The 250 mg film-coated tablets contain 405 mg of lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib free base. EXCIPIENTS ALL FILM-COATED TABLETS - Microcrystalline cellulose - Povidone - Sodium starch glycolate - Magnesium stearate YELLOW TABLET FILM-COAT - Hypromellose - Titanium dioxide - Macrogol/PEG 400 - Polysorbate 80 - Iron oxide yellow - Iron oxide red 3 INDICATIONS TYKERB, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer, whose tumors overexpress HER2/neu (ErbB2) and who have progressed on prior-therapy including trastuzumab therapy in the metastatic setting (see section 12 Clinical studies). TYKERB, in combination with trastuzumab, is indicated for the treatment of patients with hormone receptor-negative metastatic breast cancer whose tumors overexpress HER2+/neu (ErbB2) and who have progressed on prior trastuzumab therapy(s) in combination with chemotherapy in the metastatic setting (see section 12 Clinical studies). DISETUJUI OLEH BPOM: 05/11/2021 ID: EREG100005VR12100205 Novartis Page 2 Leaflet TYKERB TM TYKERB, in combination with an letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer, that overexpress HER2 receptor (immunohistochemistry/ICH2+) for whom hormonal therapy is indicated (see section 12 Clinical studies). No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor or chemotherapy in this patient population. 4 DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN AND METHOD OF ADMINISTRATION TYKERB should only be Llegiu el document complet