Tepotinib is a kinase inhibitor. TEPMETKO (tepotinib) tablets for oral use are formulated with tepotinib hydrochloride hydrate. The chemical name for tepotinib hydrochloride hydrate is 3-{1-[(3-{5-[(1- methylpiperidin-4-yl)methoxy]pyrimidin-2-yl}phenyl)methyl]-6-oxo-1,6-dihydropyridazin-3- yl}benzonitrile hydrochloride hydrate. The molecular formula is C29H28N6O2·HCl·H2O and the molecular weight is 547.05 g/mol for tepotinib hydrochloride hydrate and 492.58 g/mol for tepotinib (free base).
Tablets: 225 mg, white-pink, oval, biconvex film-coated tablets with embossment “M” on one side and plain on the other side.
• Select patients for treatment with TEPMETKO on the presence of METex14
skipping.
• Recommended dosage: 450 mg orally once daily with food until disease
progression or unacceptable toxicity.
TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymalepithelial transition (MET) exon 14 skipping alterations.
