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

mylan pharmaceuticals inc. - sorafenib tosylate (unii: 5t62q3b36j) (sorafenib - unii:9zoq3tzi87) - sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (hcc). sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (rcc). sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (dtc) that is refractory to radioactive iodine treatment. based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , sorafenib may cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose of 400 mg twice daily (see data) . advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. in animal reproduction studies, sorafenib was teratogenic and induced embryo-fetal toxicity (including increased post-implantation loss, resorptions, skeletal retardations, and retarded fetal weight) when administered orally to pregnant rats and rabbits during the period of organogenesis. the effects occurred at doses considerably below the recommended human dose of 400 mg twice daily (approximately 500 mg/m2 /day on a body surface area basis). adverse intrauterine development effects were seen at doses > 0.2 mg/kg/day (1.2 mg/m2 /day) in rats and ≥ 0.3 mg/kg/day (≥ 3.6 mg/m2 /day) in rabbits. these doses result in exposures (auc) that are approximately 0.008 times the auc in patients at the recommended dose. there are no data on the presence of sorafenib or its metabolites in human milk, or its effects on the breast-fed child or on milk production. sorafenib was present in milk of lactating rats (see data) . because of the potential for serious adverse reactions in a breastfed child from sorafenib, advise women not to breastfeed during treatment with sorafenib and for 2 weeks after the last dose. following administration of radiolabeled sorafenib to lactating wistar rats, approximately 27% of the radioactivity was secreted into milk. the milk to plasma auc ratio was approximately 5:1. sorafenib may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . verify the pregnancy status of females of reproductive potential prior to the initiation of sorafenib. advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of sorafenib. based on genotoxicity and findings in animal reproduction studies, advise males with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with sorafenib and for 3 months following the last dose of sorafenib [see use in specific populations (8.1), nonclinical toxicology (13.1)]. based on findings in animal studies, sorafenib may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and effectiveness of sorafenib have not been established in pediatric patients. repeat dosing of sorafenib to young and growing dogs resulted in irregular thickening of the femoral growth plate at daily sorafenib doses ≥ 600 mg/m2 (approximately 0.3 times the auc at the recommended human dose), hypocellularity of the bone marrow adjoining the growth plate at 200 mg/m2 /day (approximately 0.1 times the auc at the recommended human dose), and alterations of the dentin composition at 600 mg/m2 /day. similar effects were not observed in adult dogs when dosed for 4 weeks or less. in total, 59% of hcc patients treated with sorafenib were age 65 years or older and 19% were 75 and older. in total, 32% of rcc patients treated with sorafenib were age 65 years or older and 4% were 75 and older. no differences in safety or efficacy were observed between older and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is necessary for patients with mild, moderate or severe renal impairment who are not on dialysis. the pharmacokinetics of sorafenib have not been studied in patients who are on dialysis [see clinical pharmacology (12.3)]. no dose adjustment is necessary for patients with mild or moderate hepatic impairment. the pharmacokinetics of sorafenib have not been studied in patients with severe (child-pugh c) hepatic impairment [see clinical pharmacology (12.3)] .

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

teva pharmaceuticals, inc. - sorafenib tosylate (unii: 5t62q3b36j) (sorafenib - unii:9zoq3tzi87) - sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (hcc). sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (rcc). sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (dtc) that is refractory to radioactive iodine treatment. - sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. - sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer [see warnings and precautions (5.8)] . risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , sorafenib may cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform a drug-associated risk. in animal reproduction studies, o

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

golden state medical supply, inc. - sorafenib (unii: 9zoq3tzi87) (sorafenib - unii:9zoq3tzi87) - sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (hcc). sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (dtc) that is refractory to radioactive iodine treatment. sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. sorafenib tablets in combination with carboplatin and paclitaxel are contraindicated in patients with squamous cell lung cancer [see warnings and precautions (5.8)]. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], sorafenib tablets may cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose of 400 mg twice daily (see data). advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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 animal reproduction studies, sorafenib was teratogenic and induced embryo-fetal toxicity (including increased post-implantation loss, resorptions, skeletal retardations, and retarded fetal weight) when administered orally to pregnant rats and rabbits during the period of organogenesis. the effects occurred at doses considerably below the recommended human dose of 400 mg twice daily (approximately 500 mg/m2/day on a body surface area basis). adverse intrauterine development effects were seen at doses >0.2 .mg/kg/day (1.2 mg/m2/day) in rats and ≥0.3 mg/kg/day (≥3.6 mg/m2/day) in rabbits. these doses result in exposures (auc) that are approximately 0.008 times the auc in patients at the recommended dose. risk summary there are no data on the presence of sorafenib or its metabolites in human milk, or its effects on the breast-fed child or on milk production. sorafenib was present in milk of lactating rats (see data). because of the potential for serious adverse reactions in a breastfed child from sorafenib, advise women not to breastfeed during treatment with sorafenib and for 2 weeks after the last dose. data animal data following administration of radiolabeled sorafenib to lactating wistar rats, approximately 27% of the radioactivity was secreted into milk. the milk to plasma auc ratio was approximately 5:1. sorafenib tablets may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of sorafenib tablets. contraception females advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of sorafenib tablets. males based on genotoxicity and findings in animal reproduction studies, advise males with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with sorafenib tablets and for 3 months following the last dose of sorafenib tablets [see use in specific populations (8.1), nonclinical toxicology (13.1)]. infertility males based on findings in animal studies, sorafenib tablets may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. the safety and effectiveness of sorafenib tablets have not been established in pediatric patients. juvenile animal toxicity data repeat dosing of sorafenib to young and growing dogs resulted in irregular thickening of the femoral growth plate at daily sorafenib doses ≥600 mg/m2 (approximately 0.3 times the auc at the recommended human dose), hypocellularity of the bone marrow adjoining the growth plate at 200 mg/m2/day (approximately 0.1 times the auc at the recommended human dose), and alterations of the dentin composition at 600 mg/m2/day. similar effects were not observed in adult dogs when dosed for 4 weeks or less. in total, 59% of hcc patients treated with sorafenib tablets were age 65 years or older and 19% were 75 and older. no differences in safety or efficacy were observed between older and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is necessary for patients with mild, moderate or severe renal impairment who are not on dialysis. the pharmacokinetics of sorafenib have not been studied in patients who are on dialysis [see clinical pharmacology (12.3)].

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

bora pharmaceutical laboratories inc. - sorafenib (unii: 9zoq3tzi87) (sorafenib - unii:9zoq3tzi87) - sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (hcc). sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (dtc) that is refractory to radioactive iodine treatment. sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. sorafenib tablets in combination with carboplatin and paclitaxel are contraindicated in patients with squamous cell lung cancer [see warnings and precautions (5.8)]. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], sorafenib tablets may cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose of 400 mg twice daily (see data). advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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 animal reproduction studies, sorafenib was teratogenic and induced embryo-fetal toxicity (including increased post-implantation loss, resorptions, skeletal retardations, and retarded fetal weight) when administered orally to pregnant rats and rabbits during the period of organogenesis. the effects occurred at doses considerably below the recommended human dose of 400 mg twice daily (approximately 500 mg/m2/day on a body surface area basis). adverse intrauterine development effects were seen at doses >0.2 .mg/kg/day (1.2 mg/m2/day) in rats and ≥0.3 mg/kg/day (≥3.6 mg/m2/day) in rabbits. these doses result in exposures (auc) that are approximately 0.008 times the auc in patients at the recommended dose. risk summary there are no data on the presence of sorafenib or its metabolites in human milk, or its effects on the breast-fed child or on milk production. sorafenib was present in milk of lactating rats (see data). because of the potential for serious adverse reactions in a breastfed child from sorafenib, advise women not to breastfeed during treatment with sorafenib and for 2 weeks after the last dose. data animal data following administration of radiolabeled sorafenib to lactating wistar rats, approximately 27% of the radioactivity was secreted into milk. the milk to plasma auc ratio was approximately 5:1. sorafenib tablets may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of sorafenib tablets. contraception females advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of sorafenib tablets. males based on genotoxicity and findings in animal reproduction studies, advise males with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with sorafenib tablets and for 3 months following the last dose of sorafenib tablets [see use in specific populations (8.1), nonclinical toxicology (13.1)]. infertility males based on findings in animal studies, sorafenib tablets may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. the safety and effectiveness of sorafenib tablets have not been established in pediatric patients. juvenile animal toxicity data repeat dosing of sorafenib to young and growing dogs resulted in irregular thickening of the femoral growth plate at daily sorafenib doses ≥600 mg/m2 (approximately 0.3 times the auc at the recommended human dose), hypocellularity of the bone marrow adjoining the growth plate at 200 mg/m2/day (approximately 0.1 times the auc at the recommended human dose), and alterations of the dentin composition at 600 mg/m2/day. similar effects were not observed in adult dogs when dosed for 4 weeks or less. in total, 59% of hcc patients treated with sorafenib tablets were age 65 years or older and 19% were 75 and older. no differences in safety or efficacy were observed between older and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is necessary for patients with mild, moderate or severe renal impairment who are not on dialysis. the pharmacokinetics of sorafenib have not been studied in patients who are on dialysis [see clinical pharmacology (12.3)].

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

dr.reddys laboratories inc - sorafenib tosylate (unii: 5t62q3b36j) (sorafenib - unii:9zoq3tzi87) - sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (hcc). sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (rcc). sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (dtc) that is refractory to radioactive iodine treatment. • sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. • sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer [see warnings and precautions ( 5.8)]. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology ( 12.1)] , sorafenib may cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform a drug-associated risk. in animal reproduction s

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

torrent pharmaceuticals limited - sorafenib (unii: 9zoq3tzi87) (sorafenib - unii:9zoq3tzi87) - sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (hcc). sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (rcc). sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (dtc) that is refractory to radioactive iodine treatment. •sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. •sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer [see warnings and precautions ( 5.8 )] . based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1 )] , sorafenib may cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform a drug-associated risk. in animal reproduction studies, ora

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

yabao pharmaceutical co., ltd. beijing - sorafenib (unii: 9zoq3tzi87) (sorafenib - unii:9zoq3tzi87) - sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (hcc). sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (dtc) that is refractory to radioactive iodine treatment. sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. sorafenib tablets in combination with carboplatin and paclitaxel are contraindicated in patients with squamous cell lung cancer [see warnings and precautions (5.8)]. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], sorafenib tablets may cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose of 400 mg twice daily (see data). advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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 animal reproduction studies, sorafenib was teratogenic and induced embryo-fetal toxicity (including increased post-implantation loss, resorptions, skeletal retardations, and retarded fetal weight) when administered orally to pregnant rats and rabbits during the period of organogenesis. the effects occurred at doses considerably below the recommended human dose of 400 mg twice daily (approximately 500 mg/m2/day on a body surface area basis). adverse intrauterine development effects were seen at doses >0.2 .mg/kg/day (1.2 mg/m2/day) in rats and ≥0.3 mg/kg/day (≥3.6 mg/m2/day) in rabbits. these doses result in exposures (auc) that are approximately 0.008 times the auc in patients at the recommended dose. risk summary there are no data on the presence of sorafenib or its metabolites in human milk, or its effects on the breast-fed child or on milk production. sorafenib was present in milk of lactating rats (see data). because of the potential for serious adverse reactions in a breastfed child from sorafenib, advise women not to breastfeed during treatment with sorafenib and for 2 weeks after the last dose. data animal data following administration of radiolabeled sorafenib to lactating wistar rats, approximately 27% of the radioactivity was secreted into milk. the milk to plasma auc ratio was approximately 5:1. sorafenib tablets may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of sorafenib tablets. contraception females advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of sorafenib tablets. males based on genotoxicity and findings in animal reproduction studies, advise males with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with sorafenib tablets and for 3 months following the last dose of sorafenib tablets [see use in specific populations (8.1), nonclinical toxicology (13.1)]. infertility males based on findings in animal studies, sorafenib tablets may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. the safety and effectiveness of sorafenib tablets have not been established in pediatric patients. juvenile animal toxicity data repeat dosing of sorafenib to young and growing dogs resulted in irregular thickening of the femoral growth plate at daily sorafenib doses ≥600 mg/m2 (approximately 0.3 times the auc at the recommended human dose), hypocellularity of the bone marrow adjoining the growth plate at 200 mg/m2/day (approximately 0.1 times the auc at the recommended human dose), and alterations of the dentin composition at 600 mg/m2/day. similar effects were not observed in adult dogs when dosed for 4 weeks or less. in total, 59% of hcc patients treated with sorafenib tablets were age 65 years or older and 19% were 75 and older. no differences in safety or efficacy were observed between older and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is necessary for patients with mild, moderate or severe renal impairment who are not on dialysis. the pharmacokinetics of sorafenib have not been studied in patients who are on dialysis [see clinical pharmacology (12.3)].

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

twi pharmaceuticals usa, inc. - sorafenib (unii: 9zoq3tzi87) (sorafenib - unii:9zoq3tzi87) - sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (hcc). sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (dtc) that is refractory to radioactive iodine treatment. sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. sorafenib tablets in combination with carboplatin and paclitaxel are contraindicated in patients with squamous cell lung cancer [see warnings and precautions (5.8)]. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], sorafenib tablets may cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organog

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

sandoz pty ltd - sorafenib tosilate, quantity: 274 mg (equivalent: sorafenib, qty 200 mg) - tablet, film coated - excipient ingredients: sodium lauryl sulfate; titanium dioxide; croscarmellose sodium; microcrystalline cellulose; hypromellose; macrogol 3350; iron oxide red; magnesium stearate - hepatocellular carcinoma,sorafenib sandoz is indicated for the treatment of patients with advanced hepatocellular carcinoma.,renal cell carcinoma,sorafenib sandoz is indicated for the treatment of patients with advanced renal cell carcinoma.,differentiated thyroid carcinoma,sorafenib sandoz is indicated for the treatment of patients with locally advanced or metastatic,,progressive, differentiated thyroid carcinoma refractory to radioactive iodine.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastic agents - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1).renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.