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mylan institutional llc - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 250 mg in 25 ml - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)] . dexrazoxane resulted in maternal toxicity in rats at doses of

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

breckenridge pharmaceutical, inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane hydrochloride 500 mg in 50 ml - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)]. animal data dexrazoxane resu

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alvogen inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 500 mg in 50 ml - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)]. animal data dexrazoxane res

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hikma pharmaceuticals usa inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 10 mg in 1 ml - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2 )] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. teratogenic effects. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)] .  ani

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gland pharma limited - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 500 mg in 50 ml - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)]. do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)]. animal data dexrazoxane resulted in maternal toxicity in rats at doses of ≥2 mg/kg (1/40 the human dose on a mg/m2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m2 basis) when given daily to pregnant rats during the period of organogenesis. teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. in offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. in rabbits, doses of ≥5 mg/kg (approximately 1/10 the human dose on a mg/m2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m2 basis) were embryotoxic and teratogenic. teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung. it is not known whether dexrazoxane or its metabolites are excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dexrazoxane, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of dexrazoxane in pediatric patients have not been established [see warnings and precautions (5.4)]. clinical studies of dexrazoxane for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. contraception dexrazoxane for injection can cause fetal harm when administered during pregnancy.  advise female patients of reproductive potential to use highly effective contraception during treatment [see use in specific populations (8.1)]. greater exposure to dexrazoxane may occur in patients with compromised renal function. reduce the dexrazoxane for injection dose by 50% in patients with creatinine clearance values <40 ml/min [see dosage and administration (2.2) and clinical pharmacology (12.3)].

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cumberland pharmaceuticals inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 500 mg - totect® is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. none. risk summary based on findings from animal studies and its mechanism of action, totect can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with totect use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at maternal doses that were approximately 0.1 and 0.2 times, respectively, the human dose of 1000 mg/m². advise pregnant women of the potential risk to a 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 ma

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

almaject, inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)]. animal data dexrazoxane res

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

fosun pharma usa inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg /m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2 ) ] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precaut

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

almaject, inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)]. animal data dexrazoxane res

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

eugia us llc - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. risk summary dexrazoxane can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5)] . animal data dexrazoxane resulted in maternal toxicity in rats