TYKERB

Land: Indonesien

Sprog: indonesisk

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

Aktiv bestanddel:

LAPATINIB DITOSYLATE

Tilgængelig fra:

NOVARTIS INDONESIA - Indonesia

INN (International Name):

LAPATINIB DITOSYLATE

Dosering:

405.0 MG

Lægemiddelform:

TABLET SALUT SELAPUT

Enheder i pakken:

DUS, 1 BOTOL @ 70 TABLET SALUT SELAPUT

Fremstillet af:

SANDOZ S.R.L. - Romania

Autorisation dato:

2020-12-23

Produktets egenskaber

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