Canada - English - Health Canada

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

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.

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)] .

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).

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.

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

merck serono ltd - tepotinib hydrochloride - tablet - 225mg

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

Israel - English - Ministry of Health

taro international ltd, israel - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 100 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib taro is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations. erlotinib taro is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations and stable disease after first-line chemotherapy. erlotinib taro is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.pancreatic cancer: erlotinib taro is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Israel - English - Ministry of Health

taro international ltd, israel - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 150 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib taro is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations. erlotinib taro is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations and stable disease after first-line chemotherapy. erlotinib taro is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.pancreatic cancer: erlotinib taro is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.