Australia - English - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - tepotinib hydrochloride monohydrate, quantity: 250 mg (equivalent: tepotinib, qty 225 mg) - tablet, film coated - excipient ingredients: mannitol; crospovidone; magnesium stearate; colloidal anhydrous silica; hypromellose; titanium dioxide; lactose monohydrate; macrogol 3350; triacetin; iron oxide red; microcrystalline cellulose - tepmetko has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) harbouring mesenchymal-epithelial transition (met) exon 14 skipping alterations.,the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

United States - English - NLM (National Library of Medicine)

emd serono, inc. - tepotinib hydrochloride (unii: vy5yx2tq1f) (tepotinib - unii:1ijv77ei07) - tepmetko is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) harboring mesenchymal-epithelial transition (met ) exon 14 skipping alterations. none. risk summary based on findings in animal studies and the mechanism of action [see clinical pharmacology (12.1)], tepmetko can cause fetal harm when administered to a pregnant woman. there are no available data on the use of tepmetko in pregnant women. oral administration of tepotinib to pregnant rabbits during the period of organogenesis resulted in malformations (teratogenicity) and anomalies at maternal exposures less than the human exposure based on area under the curve (auc) at the 450 mg daily clinical dose (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in embryo-fetal development studies, pregnant rabbits received oral doses of 0.5, 5, 25, 50, 150, or 450 mg/kg tepotinib hydrochloride hydrate daily during organogenesis. severe maternal toxicity occurred at the 450 mg/kg dose (approximately 0.75 times the human exposure at the 450 mg clinical dose). at 150 mg/kg (approximately 0.5 times the human exposure by auc at the 450 mg clinical dose), two animals aborted and one animal died prematurely; mean fetal body weight was also decreased. a dose-dependent increase of skeletal malformations, including malrotations of fore and/or hind paws with concomitant misshapen scapula and/or malpositioned clavicle and/or calcaneous and/or talus, occurred at doses ≥ 5 mg/kg (approximately 0.003 times the human exposure by auc at the 450 mg clinical dose); there was also an incidence of spina bifida at the 5 mg/kg dose level. risk summary there are no data regarding the secretion of tepotinib or its metabolites in human milk or its effects on the breastfed infant or milk production. advise women not to breastfeed during treatment with tepmetko and for one week after the last dose. based on animal data, tepmetko can cause malformations at doses less than the human exposure based on auc at the 450 mg clinical dose [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating tepmetko [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during tepmetko treatment and for one week after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during tepmetko treatment and for one week after the last dose. the safety and efficacy of tepmetko in pediatric patients have not been established. of 313 patients with nsclc positive for met ex14 skipping alterations in vision who received 450 mg tepmetko once daily, 79% were 65 years or older, and 41% were 75 years or older. no clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients. no dosage modification is recommended in patients with mild or moderate renal impairment (creatinine clearance [clcr] 30 to 89 ml/min, estimated by cockcroft-gault). the recommended dosage has not been established for patients with severe renal impairment (clcr < 30 ml/min) [see clinical pharmacology (12.3)]. no dosage modification is recommended in patients with mild (child pugh class a) or moderate (child pugh class b) hepatic impairment. the pharmacokinetics and safety of tepotinib in patients with severe hepatic impairment (child pugh class c) have not been studied [see clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

merck serono ltd - tepotinib as hydrochloride hydrate - film coated tablets - tepotinib as hydrochloride hydrate 225 mg - tepotinib - tepmetko is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) harbouring a met tyrosine kinase receptor exon 14 (metex14) skipping mutation.

Singapore - English - HSA (Health Sciences Authority)

merck pte. ltd. - tepotinib hydrochloride hydrate eqv tepotinib - tablet, film coated - tepotinib hydrochloride hydrate eqv tepotinib 225mg

European Union - English - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - carcinoma, non-small-cell lung - antineoplastic agents - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Canada - English - Health Canada

emd serono, a division of emd inc., canada - tepotinib (tepotinib hydrochloride) - tablet - 225mg - tepotinib (tepotinib hydrochloride) 225mg - antineoplastic agents

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

merck biopharma co., ltd - tepotinib hydrochloride hydrate - whitish soft red tablet, major axis: 18 mm, minor axis: 9 mm, thickness: 6.9 mm

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck serono ltd - tepotinib hydrochloride - tablet - 225mg

Israel - English - Ministry of Health

novartis israel ltd - nilotinib as hydrochloride monohydrate - capsules - nilotinib as hydrochloride monohydrate 150 mg - nilotinib - nilotinib - treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - lapatinib ditosilate monohydrate 405mg equivalent to 250 mg lapatinib free base - tablet - 250 mg - active: lapatinib ditosilate monohydrate 405mg equivalent to 250 mg lapatinib free base excipient: magnesium stearate microcrystalline cellulose opadry yellow ys-1-12524-a povidone sodium starch glycolate - her2-positive (her2+) overexpressing metastatic breast cancer tykerb, in combination with capecitabine, is indicated for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting. tykerb, in combination with paclitaxel, is indicated for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate. hormone receptor-positive metastatic breast cancer tykerb, in combination with an aromatase inhibitor, is indicated for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom hormonal therapy is indicated.