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roxane laboratories, inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide - unii:8n3dw7272p) - tablet - 25 mg - cyclophosphamide tablets, although effective alone in susceptible malignancies, are more frequently used concurrently or sequentially with other antineoplastic drugs. the following malignancies are often susceptible to cyclophosphamide treatment: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin’s disease, lyphocytic 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 in children (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 tablets are useful in carefully selected cases of biopsy proven “minimal c

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physicians total care, inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide - unii:8n3dw7272p) - cyclophosphamide 25 mg - cyclophosphamide tablets usp, 25 mg and 50 mg, although effective alone in susceptible malignancies, are more frequently used concurrently or sequentially with other antineoplastic drugs. the following malignancies are often susceptible to cyclophosphamide treatment: - 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 in children (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 tablets usp, 25 mg and 50 mg are useful in carefully s

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hikma pharmaceuticals usa inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide anhydrous 25 mg - cyclophosphamide capsules are indicated for the treatment of: cyclophosphamide capsules, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. cyclophosphamide capsules are indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. limitations of use: the safety and effectiveness of cyclophosphamide capsules for the treatment of nephrotic syndrome in adults or other renal disease has not been established. cyclophosphamide capsules are contraindicated in patients with: risk summary based on its mechanism of action and published reports of effects in pregnant patients or animals, cyclophosphamide capsules 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 feta

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sandoz inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide anhydrous 500 mg in 25 ml - cyclophosphamide is indicated for the treatment of: - 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.    cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately

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ani pharmaceuticals, inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide anhydrous 50 mg - cyclophosphamide capsules are indicated for the treatment of: cyclophosphamide capsules, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. cyclophosphamide capsules are indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. limitations of use: the safety and effectiveness of cyclophosphamide capsules for the treatment of nephrotic syndrome in adults or other renal disease has not been established. cyclophosphamide capsules are contraindicated in patients with: risk summary based on its mechanism of action and published reports of effects in pregnant patients or animals, cyclophosphamide capsules 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

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baxter healthcare corporation - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide anhydrous 500 mg in 25 ml - cyclophosphamide is indicated for the treatment of: cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. limitations of use: the safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. pregnancy category d risk summary cyclophosphamide can cause fetal harm when administered to a pregnant woman based on its mechanism of action and published reports of effects in pregnant patients or animals. exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn. cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monke

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attix pharmaceuticals inc - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide 1 kg in 1 kg

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sti pharma llc - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide is indicated for the treatment of: - 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. cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. limitations of use:  the safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. - 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)] . pregnancy category d cyclophosphamide can cause fetal harm when administered to a pregnant woman based on its mechanism of action and published reports of effects in pregnant patients or animals. exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn. cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monkeys. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. 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. 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. 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 nursing infants from cyclophosphamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 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. pregnancy should be avoided during treatment with cyclophosphamide because of the risk of fetal harm [see use in specific populations ( 8.1)]. female patients of reproductive potential should use highly effective contraception during and for up to 1 year after completion of treatment. male patients who are sexually active with female partners who are or may become pregnant should use a condom during and for at least 4 months after treatment. 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)] . men treated with cyclophosphamide may develop oligospermia or azoospermia which are normally associated with increased gonadotropin but normal testosterone secretion. 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)] .

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northstar rxllc - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide for injection is indicated for the treatment of: - 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 for injection 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 for injection, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. cyclophosphamide for injection is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. limitations of use: the safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. - 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. 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)]. pregnancy category d risk summary cyclophosphamide can cause fetal harm when administered to a pregnant woman based on its mechanism of action and published reports of effects in pregnant patients or animals. exposure to cyclophosphamide during pregnancy may cause fetal malformations, miscarriage, fetal growth retardation, and toxic effects in the newborn. cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monkeys. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. 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. 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 nursing infants from cyclophosphamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 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. contraception pregnancy should be avoided during treatment with cyclophosphamide because of the risk of fetal harm [see use in specific populations (8.1)]. female patients of reproductive potential should use highly effective contraception during and for up to 1 year after completion of treatment. male patients who are sexually active with female partners who are or may become pregnant should use a condom during and for at least 4 months after treatment. 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. 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)].

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

ingenus pharmaceuticals, llc - cyclophosphamide anhydrous (unii: 6uxw23996m) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide is indicated for the treatment of: - 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 metaboli