ceritinib - search results

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

zykadia- ceritinib tablet, film coated

novartis pharmaceuticals corporation - ceritinib (unii: k418kg2get) (ceritinib - unii:k418kg2get) - ceritinib 150 mg - zykadia® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test [see dosage and administration (2.1)] . none. risk summary based on animal studies and its mechanism of action [see clinical pharmacology (12.1)] , zykadia can cause fetal harm when administered to a pregnant woman. the limited available data on the use of zykadia in pregnant women are insufficient to inform a risk. administration of ceritinib to rats and rabbits during the period of organogenesis at maternal plasma exposures below the recommended human dose caused increases in skeletal anomalies in rats and rabbits (see data ). advise a pregnant woman 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 are 2% to 4% and 15% to 20%, respectively. data animal data in an embryo-fetal development study in which pregnant rats were administered daily doses of ceritinib during organogenesis, dose-related skeletal anomalies were observed at doses as low as 50 mg/kg (less than 0.5-fold the human exposure by auc at the recommended dose). findings included delayed ossifications and skeletal variations. in pregnant rabbits administered ceritinib daily during organogenesis, dose-related skeletal anomalies, including incomplete ossification, were observed at doses equal to or > 2 mg/kg/day (approximately 0.015-fold the human exposure by auc at the recommended dose). a low incidence of visceral anomalies, including absent or malpositioned gallbladder and retroesophageal subclavian cardiac artery, was observed at doses equal to or > 10 mg/kg/day (approximately 0.13-fold the human exposure by auc at the recommended dose). maternal toxicity and abortion occurred in rabbits at doses of 35 mg/kg or greater. in addition, embryolethality was observed in rabbits at a dose of 50 mg/kg. risk summary there are no data regarding the presence of ceritinib or its metabolites in human milk, the effects of ceritinib on the breastfed child or its effects on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with zykadia and for 2 weeks following completion of therapy. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating zykadia [see use in specific populations (8.1)] . contraception zykadia can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise females of reproductive potential to use effective contraception during treatment with zykadia and for 6 months following completion of therapy. males based on the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with zykadia and for 3 months following completion of therapy [see nonclinical toxicology (13.1)] . the safety and effectiveness of zykadia in pediatric patients have not been established. of the 925 patients in clinical studies of zykadia, 18% were 65 years or older, while 5% were 75 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. for patients with severe hepatic impairment (child-pugh c), reduce the dose of zykadia [see dosage and administration (2.5)] . no dose adjustment is recommended for patients with mild (child-pugh a) or moderate (child-pugh b) hepatic impairment.

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

zykadia ceritinib 150 mg hard capsule blister pack

novartis pharmaceuticals australia pty ltd - ceritinib, quantity: 150 mg - capsule, hard - excipient ingredients: gelatin; magnesium stearate; sodium starch glycollate type a; hyprolose; colloidal anhydrous silica; indigo carmine; microcrystalline cellulose; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - zykadia is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive.

Israel - English - Ministry of Health

zykadia 150 mg

novartis israel ltd - ceritinib - hard gelatin capsules - ceritinib 150 mg - ceritinib - zykadia is indicated for the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive.23.04.2018 בקשה לשינוי משטר מינון - dose modification for patients with severe hepatic impairment (child-pugh c), reduce the dose of zykadia by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength- new starting dose - 450 mg taken orally once daily with food (instead of 750mg taken on empty stomach).first dose reduction due to adverse reactions- 300 mg taken orally once daily with food, second dose reduction - 150 mg taken orally once daily with food. discontinue zykadia for patients unable to tolerate 150 mg daily with food.

European Union - English - EMA (European Medicines Agency)

zykadia

novartis europharm limited - ceritinib - carcinoma, non-small-cell lung - antineoplastic agents - zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk) positive advanced non small cell lung cancer (nsclc) previously treated with crizotinib.