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

apotex corp. - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine 1 mg in 1 ml - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m2  based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated popu

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

winthrop u.s, a business of sanofi-aventis u.s. llc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine 1 mg in 1 ml - clofarabine is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. this indication is based upon response rate. there are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m 2 based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 intravenous administration of clofarabine to pregnant rats during organogenesis (gestation days [gd] 7–17) at doses of 1, 3 or 9 mg/kg/day (equivalent to 6, 18, 54 mg/m 2 /day) resulted in maternal toxicities at the 9 mg/kg dose, as indicated by reduced body weights and food consumption. developmental toxicity (i.e., reduced fetal body weights and increased postimplantation loss) and increased incidences of external, soft tissue, and skeletal malformations and variations (including retarded ossification) were observed at 9 mg/kg/day (54 mg/m 2 ; approximately equivalent to the recommended human dose based on bsa). altered ossification patterns (extra metacarpal or metatarsal ossification) were observed in single fetuses at lower doses of clofarabine (1 and 3 mg/kg/day; 0.1- and 0.3-times the recommended human dose based on bsa). when clofarabine was administered intravenously to pregnant rabbits during organogenesis (gd 6–18) at doses of 0.1, 0.3, or 1 mg/kg/day (equivalent to 1.2, 3.6, 12 mg/m 2 /day), developmental toxicity (i.e., reduced fetal body weights and increased postimplantation loss) and increased incidences of external, soft tissue, and skeletal malformations and variations (including retarded ossification) were observed at the 1 mg/kg/day dose (12 mg/m 2 ; 0.2-times the recommended human dose based on bsa). alterations in ossification patterns (increase in the average numbers of ossified thoracic vertebrae and rib pairs, and reduction in the average number of forepaw metacarpals) and abdominal wall defect were observed at 0.3 mg/kg/day (3.6 mg/m 2 ; 0.1-times the recommended human dose based on bsa). risk summary there are no data on the presence of clofarabine in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child including genotoxicity, advise patients not to breastfeed during treatment with clofarabine, and for at least 2 weeks after the last dose. pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating clofarabine. contraception females clofarabine can cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . advise female patients to use effective contraception during treatment with clofarabine and for 6 months after the last dose. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with clofarabine and for at least 3 months after the last dose [see nonclinical toxicology (13.1)] . infertility females based on findings from animal studies, clofarabine may impair female fertility [see nonclinical toxicology (13.1)]. the reversibility of the effect on fertility is unknown. males based on findings from animal studies, clofarabine may impair male fertility [see nonclinical toxicology (13.1)]. the reversibility of the effect on fertility is unknown. safety and effectiveness have been established in pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia. safety and effectiveness of clofarabine has not been established in geriatric patients aged 65 and older. safety and effectiveness have not been established in adults. reduce the clofarabine starting dose by 50% in patients with crcl of 30 to 60 ml/min. there is insufficient information to make a dosage recommendation in patients with crcl less than 30 ml/min or in patients on dialysis. the pharmacokinetics of clofarabine in patients with renal impairment and normal renal function were obtained from a population pharmacokinetic analysis of three pediatric and two adult studies. in patients with crcl 60 to less than 90 ml/min (n=47) and crcl 30 to less than 60 ml/min (n=30), the average auc of clofarabine increased by 60% and 140%, respectively, compared to patients with normal (n=66) renal function (crcl greater than 90 ml/min).

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

amneal pharmaceuticals llc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine 1 mg in 1 ml - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m2 based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 intravenous administration of clofarabine to pregnant rats during organogenesis (gestation days [gd] 7 to 17) at doses of 1 mg/kg/day, 3 mg/kg/day or 9 mg/kg/day (equivalent to 6 mg/m2 /day, 18 mg/m2 /day, 54 mg/m2 /day) resulted in maternal toxicities at the 9 mg/kg dose, as indicated by reduced body weights and food consumption. developmental toxicity (i.e. reduced fetal body weights and increased post implantation loss) and increased incidences of external, soft tissue, and skeletal malformations and variations (including retarded ossification) were observed at 9 mg/kg/day (54 mg/m2 ; approximately equivalent to the recommended human dose based on bsa). altered ossification patterns (extra metacarpal or metatarsal ossification) were observed in single fetuses at lower doses of clofarabine (1 mg/kg/day and 3 mg/kg/day; 0.1- and 0.3-times the recommended human dose based on bsa). when clofarabine was administered intravenously to pregnant rabbits during organogenesis (gd 6 to 18) at doses of 0.1 mg/kg/day, 0.3 mg/kg/day or 1 mg/kg/day (equivalent to 1.2 mg/m2 /day, 3.6 mg/m2 /day, 12 mg/m2 /day), developmental toxicity (i.e. reduced fetal body weights and increased post implantation loss) and increased incidences of external, soft tissue, and skeletal malformations and variations (including retarded ossification) were observed at the 1 mg/kg/day dose (12 mg/m2 ; 0.2-times the recommended human dose based on bsa). alterations in ossification patterns (increase in the average numbers of ossified thoracic vertebrae and rib pairs, and reduction in the average number of forepaw metacarpals) and abdominal wall defect were observed at 0.3 mg/kg/day (3.6 mg/m2 ; 0.1-times the recommended human dose based on bsa). risk summary there are no data on the presence of clofarabine in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child including genotoxicity, advise patients not to breastfeed during treatment with clofarabine, and for 2 weeks after the last dose. clofarabine can cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating clofarabine. contraception females advise female patients to use effective contraception during treatment with clofarabine and for 6 months after the last dose. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with clofarabine and for 3 months after the last dose [see nonclinical toxicology (13.1)] . infertility females based on findings from animal studies, clofarabine may impair female fertility [see nonclinical toxicology (13.1)]. the reversibility of the effect on fertility is unknown. males based on findings from animal studies, clofarabine may impair male fertility [see nonclinical toxicology (13.1)]. the reversibility of the effect on fertility is unknown. safety and effectiveness have been established in pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia. safety and effectiveness of clofarabine has not been established in geriatric patients aged 65 and older. reduce the clofarabine starting dose by 50% in patients with crcl of 30 ml/min to 60 ml/min. there is insufficient information to make a dosage recommendation in patients with crcl less than 30 ml/min or in patients on dialysis. the pharmacokinetics of clofarabine in patients with renal impairment and normal renal function were obtained from a population pharmacokinetic analysis of three pediatric and two adult studies. in patients with crcl 60 to less than 90 ml/min (n=47) and crcl 30 to less than 60 ml/min (n=30), the average auc of clofarabine increased by 60% and 140%, respectively, compared to patients with normal (n=66) renal function (crcl greater than 90 ml/min).

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

mylan institutional llc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine 1 mg in 1 ml - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m2 based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated popu

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

dr.reddy's laboratories inc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine 1 mg in 1 ml - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.   none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m2  based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data). advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated pop

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

fresenius kabi usa, llc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine 1 mg in 1 ml - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. this indication is based upon response rate. there are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine injection. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m2 based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potential benefi

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

accord healthcare inc. - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. this indication is based upon response rate. there are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine injection. none pregnancy category d clofarabine injection may cause fetal harm when administered to a pregnant woman. clofarabine was teratogenic in rats and rabbits. developmental toxicity (reduced fetal body weight and increased post-implantation loss) and increased incidences of malformations and variations (gross external, soft tissue, skeletal and retarded ossification) were observed in rats receiving 54 mg/m 2 /day (approximately equivalent to the recommended clinical dose on a mg/m 2 basis), and in rabbits receiving 12 mg/m 2 /day (approximately 23% of the recommended clinical dose on a mg/m 2 basis).

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

ingenus pharmaceuticals, llc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. this indication is based upon response rate. there are no trials verifying an improvement in disease-related symptoms or increased survival with clofarabine injection. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m2 based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potent

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

fosun pharma usa inc. - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. none pregnancy category d clofarabine injection may cause fetal harm when administered to a pregnant woman. clofarabine was teratogenic in rats and rabbits. developmental toxicity (reduced fetal body weight and increased post-implantation loss) and increased incidences of malformations and variations (gross external, soft tissue, skeletal and retarded ossification) were observed in rats receiving 54 mg/m 2 /day (approximately equivalent to the recommended clinical dose on a mg/m 2 basis), and in rabbits receiving 12 mg/m 2 /day (approximately 23% of the recommended clinical dose on a mg/m 2  basis). there are no adequate and well-controlled studies in pregnant women using clofarabine. if this drug is used during pregnancy, or if the patient becomes pregnant while taking t

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

meitheal pharmaceuticals inc. - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2- to 1-times the maximum recommended human dose of 52 mg/m2 based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clofarabine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated pop