Each flim coated tablet contains Neratinib Maleate INN equivalent to Neratinib 40 mg

Mechanism of action
Neratinib is a kinase inhibitor that irreversibly binds to Epidermal Growth Factor Receptor
(EGFR), Human Epidermal Growth Factor Receptor 2 (HER2), and HER4. In vitro, Neratinib
reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling
pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines.
Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2 and
HER4 in vitro. In vivo, oral administration of Neratinib inhibited tumor growth in mouse
xenograft models with tumor cell lines expressing HER2 and EGFR.

Neratinib is indicated for the extended adjuvant treatment of adult patients with early stage
HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab based therapy.