Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - cyclophosphamide monohydrate - coated tablets - 50 milligram - cyclophosphamide

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

ax pharmaceutical corp - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide anhydrous 495 g in 500 g

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

ax pharmaceutical corp - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide anhydrous 99 g in 100 g

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - cyclophosphamide monohydrate - powder for solution for injection - cyclophosphamide monohydrate 1000 mg - antineoplastic agents

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - cyclophosphamide - coated tablet - cyclophosphamide 50 mg - antineoplastic agents

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

dr. reddy's laboratories inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - malignant diseases cyclophosphamide injection is indicated for the treatment of adult and pediatric patients with: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma burkitt’s lymphoma - multiple myeloma · - leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) - mycosis fungoides (advanced disease) - neuroblastoma (disseminated disease) - adenocarcinoma of the ovary - retinoblastoma - carcinoma of the breast  cyclophosphamide injection, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. hypersensitivity cyclophosphamide injection is contraindicated in pat

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

nevakar injectables inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - malignant diseases cyclophosphamide injection is indicated for the treatment of adult and pediatric patients with: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, burkitt's lymphoma - multiple myeloma - leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) - mycosis fungoides (advanced disease) - neuroblastoma (disseminated disease) - adenocarcinoma of the ovary - retinoblastoma - carcinoma of the breast cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. hypersensitivity cyclophosphamide is contraindicated in patients who have a history of severe hypersensitivity reactions to it, any of its metabolites, or to other components of the product. anaphylactic reactions including death have been reported with cyclophosphamide. possible cross-sensitivity with other alkylating agents can occur. urinary outflow obstruction cyclophosphamide is contraindicated in patients with urinary outflow obstruction [see warnings and precautions (5.2)] . risk summary based on its mechanism of action and published reports of effects in pregnant patients or animals, cyclophosphamide injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn [see data] . cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monkeys [see data] . advise pregnant women and females of reproductive potential of the potential risk to the fetus. the estimated 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 is 2% - 4% and of miscarriage is 15% - 20% of clinically recognized pregnancies. data human data malformations of the skeleton, palate, limbs and eyes as well as miscarriage have been reported after exposure to cyclophosphamide in the first trimester. fetal growth retardation and toxic effects manifesting in the newborn, including leukopenia, anemia, pancytopenia, severe bone marrow hypoplasia, and gastroenteritis have been reported after exposure to cyclophosphamide. animal data administration of cyclophosphamide to pregnant mice, rats, rabbits and monkeys during the period of organogenesis at doses at or below the dose in patients based on body surface area resulted in various malformations, which included neural tube defects, limb and digit defects and other skeletal anomalies, cleft lip and palate, and reduced skeletal ossification. risk summary cyclophosphamide is present in breast milk. neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide. because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with cyclophosphamide injection and for 1 week after the last dose. cyclophosphamide injection can 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 cyclophosphamide injection [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during treatment with cyclophosphamide injection and for up to 1 year after completion of therapy [see use in specific populations (8.1)] . males based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with cyclophosphamide injection and for 4 months after completion of therapy [see use in specific populations (8.1) and nonclinical toxicology (13.1)] . infertility females amenorrhea, transient or permanent, associated with decreased estrogen and increased gonadotropin secretion develops in a proportion of women treated with cyclophosphamide. affected patients generally resume regular menses within a few months after cessation of therapy. the risk of premature menopause with cyclophosphamide increases with age. oligomenorrhea has also been reported in association with cyclophosphamide treatment. animal data suggest an increased risk of failed pregnancy and malformations may persist after discontinuation of cyclophosphamide as long as oocytes/follicles exist that were exposed to cyclophosphamide during any of their maturation phases. the exact duration of follicular development in humans is not known but may be longer than 12 months [see nonclinical toxicology (13.1)] . males men treated with cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion. the safety and effectiveness of cyclophosphamide injection have been established in pediatric patients and information on this use is discussed throughout the labeling. the alcohol content of cyclophosphamide injection should be taken into account when given to pediatric patients [see warnings and precautions (5.7)] . pre-pubescent girls treated with cyclophosphamide generally develop secondary sexual characteristics normally and have regular menses. ovarian fibrosis with apparently complete loss of germ cells after prolonged cyclophosphamide treatment in late pre-pubescence has been reported. girls treated with cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause. pre-pubescent boys treated with cyclophosphamide develop secondary sexual characteristics normally, but may have oligospermia or azoospermia and increased gonadotropin secretion. some degree of testicular atrophy may occur. cyclophosphamide-induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy. there is insufficient data from clinical studies of cyclophosphamide available for patients 65 years of age and older to determine whether they respond differently than 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 functioning, and of concomitant disease or other drug therapy. in patients with severe renal impairment, decreased renal excretion may result in increased plasma levels of cyclophosphamide and its metabolites. this may result in increased toxicity [see clinical pharmacology (12.3)] . monitor patients with severe renal impairment (clcr=10 ml/min to 24 ml/min) for signs and symptoms of toxicity. cyclophosphamide and its metabolites are dialyzable although there are probably quantitative differences depending upon the dialysis system being used. use of a consistent interval between cyclophosphamide administration and dialysis should be considered in patients requiring dialysis. patients with severe hepatic impairment have reduced conversion of cyclophosphamide to the active 4- hydroxyl metabolite, potentially reducing efficacy [see clinical pharmacology (12.3)] . the alcohol content of cyclophosphamide injection should be taken into account when given to patients with hepatic impairment [see warnings and precautions (5.7)] .

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

eugia us llc - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - malignant diseases cyclophosphamide injection is indicated for the treatment of adult and pediatric patients with: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, burkitt’s lymphoma - multiple myeloma - leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) - mycosis fungoides (advanced disease) - neuroblastoma (disseminated disease) - adenocarcinoma of the ovary - retinoblastoma - carcinoma of the breast cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. hypersensitivity cyclophosphamide injection is contraindicated in patients who have a history of severe hypersensitivity reactions to it, any of its metabolites, or to other components of the product. anaphylactic reactions including death have been reported with cyclophosphamide. possible cross-sensitivity with other alkylating agents can occur. urinary outflow obstruction cyclophosphamide injection is contraindicated in patients with urinary outflow obstruction [see warnings and precautions (5.2)]. risk summary based on its mechanism of action and published reports of effects in pregnant patients or animals, cyclophosphamide injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn [see data] . cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monkeys [see data] . advise pregnant women and females of reproductive potential of the potential risk to the fetus. the estimated 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 is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. data human data malformations of the skeleton, palate, limbs and eyes as well as miscarriage have been reported after exposure to cyclophosphamide in the first trimester. fetal growth retardation and toxic effects manifesting in the newborn, including leukopenia, anemia, pancytopenia, severe bone marrow hypoplasia, and gastroenteritis have been reported after exposure to cyclophosphamide. animal data administration of cyclophosphamide to pregnant mice, rats, rabbits and monkeys during the period of organogenesis at doses at or below the dose in patients based on body surface area resulted in various malformations, which included neural tube defects, limb and digit defects and other skeletal anomalies, cleft lip and palate, and reduced skeletal ossification. risk summary cyclophosphamide is present in breast milk. neutropenia, thrombocytopenia, low hemoglobin, and diarrhea have been reported in infants breast fed by women treated with cyclophosphamide. because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with cyclophosphamide injection and for 1 week after the last dose. cyclophosphamide injection can 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 cyclophosphamide injection [see use in specific populations (8.1) ] . contraception females advise females of reproductive potential to use effective contraception during treatment with cyclophosphamide injection and for up to 1 year after completion of therapy [see use in specific populations (8.1) ] . males based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with cyclophosphamide injection and for 4 months after completion of therapy [see use in specific populations (8.1) and nonclinical toxicology (13.1) ]. infertility females amenorrhea, transient or permanent, associated with decreased estrogen and increased gonadotropin secretion develops in a proportion of women treated with cyclophosphamide. affected patients generally resume regular menses within a few months after cessation of therapy. the risk of premature menopause with cyclophosphamide increases with age. oligomenorrhea has also been reported in association with cyclophosphamide treatment. animal data suggest an increased risk of failed pregnancy and malformations may persist after discontinuation of cyclophosphamide as long as oocytes/follicles exist that were exposed to cyclophosphamide during any of their maturation phases. the exact duration of follicular development in humans is not known but may be longer than 12 months [see nonclinical toxicology (13.1) ] . males men treated with cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion. the safety and effectiveness of cyclophosphamide have been established in pediatric patients and information on this use is discussed throughout the labeling. the alcohol content of cyclophosphamide injection should be taken into account when given to pediatric patients [see warnings and precautions (5.7)]. pre-pubescent girls treated with cyclophosphamide generally develop secondary sexual characteristics normally and have regular menses. ovarian fibrosis with apparently complete loss of germ cells after prolonged cyclophosphamide treatment in late pre-pubescence has been reported. girls treated with cyclophosphamide who have retained ovarian function after completing treatment are at increased risk of developing premature menopause. pre-pubescent boys treated with cyclophosphamide develop secondary sexual characteristics normally, but may have oligospermia or azoospermia and increased gonadotropin secretion. some degree of testicular atrophy may occur. cyclophosphamide-induced azoospermia is reversible in some patients, though the reversibility may not occur for several years after cessation of therapy. there is insufficient data from clinical studies of cyclophosphamide available for patients 65 years of age and older to determine whether they respond differently than 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 functioning, and of concomitant disease or other drug therapy. in patients with severe renal impairment, decreased renal excretion may result in increased plasma levels of cyclophosphamide and its metabolites. this may result in increased toxicity [see clinical pharmacology (12.3)] . monitor patients with severe renal impairment (crcl =10 ml/min to 24 ml/min) for signs and symptoms of toxicity. cyclophosphamide and its metabolites are dialyzable although there are probably quantitative differences depending upon the dialysis system being used. in patients requiring dialysis, use of a consistent interval between cyclophosphamide administration and dialysis should be considered. patients with severe hepatic impairment have reduced conversion of cyclophosphamide to the active 4­-hydroxyl metabolite, potentially reducing efficacy [see clinical pharmacology (12.3)] . the alcohol content of cyclophosphamide injection should be taken into account when given to patients with hepatic impairment [see warnings and precautions (5.7) ].

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - cyclophosphamide monohydrate - coated tablet - 50 milligram(s) - nitrogen mustard analogues; cyclophosphamide

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - cyclophosphamide monohydrate 534,5 mg - eq. cyclophosphamide 500 mg - powder for solution for injection/infusion - 500 mg - cyclophosphamide monohydrate 534.5 mg - cyclophosphamide