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

accord healthcare pty ltd - cyclophosphamide, quantity: 500 mg (equivalent: cyclophosphamide monohydrate, qty mg) - injection, powder for - excipient ingredients: mannitol - the proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy, and continued evaluation of the patient?s general and haematologic status. it is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide.,the clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk.,antineoplastic properties patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone.,the following classification is a guide to the various neoplastic conditions in which benefit may be derived from chemotherapy with cyclophosphamide:,frequently responsive myeloproliferative and lymphoproliferative disorders: malignant lymphomas including hodgkins (stages iii and iv, peter?s staging system*) and non-hodgkins lymphomas; multiple myeloma; leukaemias; mycosis fungoides (advanced disease).,stage i: disease limited to one anatomic region (stage i) or two contiguous anatomic regions (stage i2) on the same side of the diaphragm.,* modified as the international staging classification for hodgkin?s disease in ?report of the committee on the staging of hodgkin?s disease?. cancer res 26:1310, 1966.,stage ii: disease in more than two anatomic regions or two contiguous regions on the same side of the diaphragm.,stage iii: disease on both sides of the diaphragm, but not extending beyond the involvement of lymph nodes, spleen, and/or waldeyer?s ring.,stage iv: involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or in any tissue or organ in addition to lymph nodes, spleen or waldeyer?s ring.,all stages are subclassified as a or b to indicate the absence or presence, respectively, of systemic symptoms.,frequently responsive solid malignancies: neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary, retinoblastoma.,infrequently responsive malignancies: carcinoma of the breast; malignant neoplasms of the lung.,immunosuppressive properties,cyclophosphamide has also been used in the treatment of autoimmune diseases and immunopathies of unspecified type (ie wegener?s granulomatosis) when these diseases have been resistant to conventional first and second line of treatment, and for the prevention of transplant rejection. cyclophosphamide can be recommended for use in treatment of nonmalignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.

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

reach pharmaceuticals pty ltd - cyclophosphamide monohydrate, quantity: 1069 mg (equivalent: cyclophosphamide, qty 1000 mg) - injection, powder for - excipient ingredients: mannitol - the proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy, and continued evaluation of the patient?s general and haematologic status. it is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide.,the clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk.,antineoplastic properties,patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone.,the following classification is a guide to the various neoplastic conditions in which benefit may be derived from chemotherapy with cyclophosphamide:,frequently responsive myeloproliferative and lymphoproliferative disorders:,malignant lymphomas including hodgkins (stages iii and iv, peter?s staging system*) and non- hodgkins lymphomas; multiple myeloma; leukaemias; mycosis fungoides (advanced disease).,stage i: disease limited to one anatomic region (stage i) or two contiguous anatomic regions (stage i2) on the same side of the diaphragm.,stage ii: disease in more than two anatomic regions or two contiguous regions on the same side of the diaphragm.,stage iii: disease on both sides of the diaphragm, but not extending beyond the involvement of lymph nodes, spleen, and/or waldeyer?s ring.,stage iv: involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or in any tissue or organ in addition to lymph nodes, spleen or waldeyer?s ring.,all stages are subclassified as a or b to indicate the absence or presence, respectively, of systemic symptoms.,frequently responsive solid malignancies:,neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary, retinoblastoma.,infrequently responsive malignancies:,carcinoma of the breast; malignant neoplasms of the lung.,immunosuppressive properties,cyclophosphamide has also been used in the treatment of autoimmune diseases and immunopathies of unspecified type (ie wegener?s granulomatosis) when these diseases have been resistant to conventional first and second line of treatment, and for the prevention of transplant rejection. cyclophosphamide can be recommended for use in treatment of nonmalignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.,* modified as the international staging classification for hodgkin?s disease in ?report of the committee on the staging of hodgkin?s disease?. cancer res 26:1310, 1966.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

baxter healthcare ltd - cyclophosphamide monohydrate - oral tablet - 50mg

Canada - English - Health Canada

accord healthcare inc - cyclophosphamide - powder for solution - 500mg - cyclophosphamide 500mg

Canada - English - Health Canada

accord healthcare inc - cyclophosphamide - powder for solution - 1000mg - cyclophosphamide 1000mg

Canada - English - Health Canada

accord healthcare inc - cyclophosphamide - powder for solution - 2000mg - cyclophosphamide 2000mg

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

attix pharmaceuticals - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide anhydrous - unii:6uxw23996m) - cyclophosphamide anhydrous 5 kg in 5 kg

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

amdipharm mercury australia pty ltd - cyclophosphamide monohydrate, quantity: 53.5 mg (equivalent: cyclophosphamide, qty 50 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; iron oxide red; iron oxide black; ethylcellulose - indications as at 18 december 2002 : the proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy and continued evaluation of the patient's general and haematological status. it is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide. the clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk. antineoplastic properties: patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone. the following classification is a guide to the various neoplastic conditions in which benefit may be derived from chemotherapy with cyclophosphamide. (a) frequently responsive myeloproliferative and lymphoproliferative disorders: malignant lymphomas (stages iii and iv, peter's staging system*); multiple myeloma; leukaemias; mycosis fungoides (advanced disease). * modified as the international staging classification for hodgkin's disease in "report of the committee on the staging of hodgkin's disease." cancer res. 26, 1310, 1966. stage i. disease limited to one anatomic region (stage i) or two contiguous anatomic regions (stage i) on the same side of the diaphragm. stage ii. disease in more than two anatomic regions or in two contiguous regions on the same side of the diaphragm. stage iii. disease on both sides of the diaphragm, but not extending beyond the involvement of the lymph nodes, spleen and/or tonsils. stage iv. involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or any tissue or organ in addition to lymph nodes, spleen or tonsils. all stages are sub classified as a or b to indicate the absence or presence respectively of systemic symptoms. (b) frequently responsive solid malignancies: neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary; retinoblastoma. (c) infrequently responsive malignancies: carcinoma of the breast; malignant neoplasm of the lung. immunosuppressive properties: cyclophosphamide has been used in the treatment of autoimmune diseases and immunopathies of unspecified type (i.e. wegener's granulomatosis) when these diseases have been resistant to the conventional first and second line treatment and for the prevention of transplant rejection. cyclophosphamide can be recommended for use in the treatment of non-malignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.

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

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)] .

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

amneal pharmaceuticals llc - 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 syn