Israel - English - Ministry of Health

teva israel ltd - gefitinib - film coated tablets - gefitinib 250 mg - gefitinib - gefitinib teva is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating mutations of egfr-tk.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - carcinoma, non-small-cell lung - antineoplastic agents, protein kinase inhibitors - gefitinib mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (nsclc) with activating mutations of egfr‑tk.

Canada - English - Health Canada

auro pharma inc - gefitinib - tablet - 250mg - gefitinib 250mg

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

ingenus pharmaceuticals, llc - gefitinib (unii: s65743jhbs) (gefitinib - unii:s65743jhbs) - gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an fda-approved test [see clinical studies (14) ]. limitation of use: safety and efficacy of gefitinib tablets have not been established in patients with metastatic nsclc whose tumors have egfr mutations other than exon 19 deletions or exon 21 (l858r) substitution mutations [see clinical studies (14) ]. none. risk summary based on its mechanism of action and animal data, gefitinib tablets can cause fetal harm when administered to a pregnant woman. in animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose (see animal data ). advise pregnant women of the potential hazard to a fetus or potential risk for loss of the pregnancy. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the u.s. general population of major birth defects is 2-4% and miscarriage is 15-20% of clinically recognized pregnancies. data animal data a single dose study in rats showed that gefitinib crosses the placenta after an oral dose of 5 mg/kg (30 mg/m2 , about 0.2 times the recommended human dose on a mg/m2 basis). when pregnant rats were treated with 5 mg/kg from the beginning of organogenesis to the end of weaning there was a reduction in the number of offspring born alive. this effect was more severe at 20 mg/kg (approximate the human clinical dose on a mg/m2 basis) and was accompanied by high neonatal mortality soon after parturition. in rabbits, a dose of 20 mg/kg/day (240 mg/m2 , about twice the recommended dose in humans on a mg/m2 basis) caused reduced fetal weight. risk summary it is not known whether gefitinib tablets are excreted in human milk. animal studies indicate the gefitinib and its metabolites are present in rat milk at a concentration higher than those in maternal plasma. because of the potential for serious adverse reactions in nursing infants from gefitinib tablets, advise women to discontinue breast-feeding during treatment with gefitinib tablets. data animal data levels of gefitinib and its metabolites were 11-to-19-fold higher in milk than in blood, after oral exposure of lactating rats to a dose of 5 mg/kg. contraception based on its mechanism of action and animal data, gefitinib tablets can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1) ]. advise females of reproductive potential to use effective contraception during treatment with gefitinib tablets and for at least two weeks following completion of therapy. infertility gefitinib tablets may result in reduced fertility in females of reproductive potential [see nonclinical toxicology (13.1) ]. the safety and effectiveness of gefitinib tablets in pediatric patients have not been established. of the 823 patients enrolled in two randomized, active-controlled clinical trials 374 patients (45%) were 65 years and older, and 93 patients (11%) were 75 years and older. no overall differences in safety were observed between patients 65 years and older and those younger than 65 years. there is insufficient information to assess for differences in efficacy between older and younger patients. less than four percent (<4%) of gefitinib and its metabolites are excreted via the kidney. no clinical studies were conducted with gefitinib tablets in patients with severe renal impairment. the systemic exposure of gefitinib was compared in patients with mild, moderate, or severe hepatic impairment due to cirrhosis (according to child-pugh classification) and healthy subjects with normal hepatic function (n=10/group). the mean systemic exposure (auc0-∞ ) was increased by 40% in patients with mild impairment, 263% in patients with moderate impairment, and 166% in patients with severe hepatic impairment. monitor adverse reactions when gefitinib tablets are administered to patients with moderate and severe hepatic impairment. in a study comparing 13 patients with liver metastases and moderate hepatic impairment (addition of ctc grade of baseline ast/sgot, alp, and bilirubin equals 3 to 5) to 14 patients with liver metastases and normal hepatic function, the systemic exposure of gefitinib was similar [see warnings and precautions (5.2) ].

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

qilu pharmaceutical co., ltd. - gefitinib (unii: s65743jhbs) (gefitinib - unii:s65743jhbs) - gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an fda-approved test [see clinical studies (14) ]. limitation of use: safety and efficacy of gefitinib tablets have not been established in patients with metastatic nsclc whose tumors have egfr mutations other than exon 19 deletions or exon 21 (l858r) substitution mutations [see clinical studies (14) ]. none. risk summary based on its mechanism of action and animal data, gefitinib tablets can cause fetal harm when administered to a pregnant woman. in animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose (see animal data ). advise pregnant women of the potential hazard to a fetus or potential risk for loss of the pregnancy. the bac

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

intega sdn. bhd. - gefitinib -

Canada - English - Health Canada

natco pharma (canada) inc - gefitinib - tablet - 250mg - gefitinib 250mg - antineoplastic agents

Canada - English - Health Canada

apotex inc - gefitinib - tablet - 250mg - gefitinib 250mg - antineoplastic agents

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

apotex corp. - gefitinib (unii: s65743jhbs) (gefitinib - unii:s65743jhbs) - gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an fda-approved test [see clinical studies (14)]. limitation of use: safety and efficacy of gefitinib tablets have not been established in patients with metastatic nsclc whose tumors have egfr mutations other than exon 19 deletions or exon 21 (l858r) substitution mutations [see clinical studies (14)]. none. risk summary based on its mechanism of action and animal data, gefitinib tablets can cause fetal harm when administered to a pregnant woman. in animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose (see animal data ). advise pregnant women of the potential hazard to a fetus or potential risk for loss of the pregnancy. the backg

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

cipla australia pty ltd - gefitinib, quantity: 250 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; sodium lauryl sulfate; magnesium stearate; lactose monohydrate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - treatment of patients with locally advanced or metastatic non small cell lung cancer (nsclc) whose tumours express activating mutations of the egfr tyrosine kinase.