European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - antineoplastic agents - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

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

dr reddys laboratories australia pty ltd - carmustine, quantity: 100 mg - injection, diluent for - excipient ingredients: ethanol absolute - carmustine-juno is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1. malignant glioma 2. multiple myeloma - in combination with prednisone. 3. hodgkin?s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4. non-hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

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

accord healthcare pty ltd - carmustine, quantity: 100 mg - diluent, not applicable - excipient ingredients: ethanol absolute - carmustine accord is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:,1. malignant glioma,2. multiple myeloma - in combination with prednisone.,3. hodgkin?s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.,4. non-hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

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

southern cross pharma pty ltd - carmustine, quantity: 100 mg - injection, powder for - excipient ingredients: - carmustine lupin is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:,1. malignant glioma,2. multiple myeloma - in combination with prednisone.,3. hodgkin?s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.,4. non-hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

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

ingenus pharmaceuticals, llc - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1) ] and findings in animals [see data] . limited available data with carmustine for injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotoxic in rats and rab

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

navinta llc - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection, usp is indicated as palliative therapy as a single agent or in established combination therapy in the following: -   brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. -   multiple myeloma in combination with prednisone. -   relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. -   relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection, usp is contraindicated in patients with previous hypersensitivity to carmustine for injection, usp or its components. risk summary carmustine for injection, usp can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1) ] and findings in animals [see data] . limited available data with carmustine for injection, usp use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotoxic in rats and rabbits and teratogenic in rats (thoracoabdominal closure, neural tube, and eye defects and malformations of the skeletal system of the fetus) when given in doses lower than the maximum cumulative human dose based on body surface area. consider the benefits and risks of carmustine for injection, usp for the mother and possible risks to the fetus when prescribing carmustine for injection, usp to a pregnant woman. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data intraperitoneal (ip) administration of carmustine to pregnant rats 14 days prior to mating and during the period of organogenesis at cumulative doses ≥ 26 mg/kg (158 mg/ m2 ), approximately 0.1 times the maximum cumulative human dose of 1400 mg/m2 , resulted in pre-implantation loss, increased resorptions (including completely resorbed litters), and reduced the number of live births in the presence of maternal toxicity. carmustine administered ip to pregnant rats during the period of organogenesis at cumulative doses ≥ 4 mg/kg (24 mg/m2 ), approximately 0.02 times the maximum cumulative human dose based on a mg/m2 basis, resulted in reduced fetal weight and various malformations, which included thoracoabdominal closure defects, neural tube defects, and eye defects, including microphthalmia/anophthalmia, and skeletal anomalies in the skull, sternebra, vertebrae and ribs, and reduced skeletal ossification) in the presence of maternal toxicity. embryo-fetal death was observed at cumulative doses ≥ 8 mg/kg (48 mg/m2 ), approximately 0.03 times the maximum cumulative human dose on a mg/ m2 basis. intravenous (iv) administration of carmustine to rats at a cumulative dose of 50 mg/kg (300 mg/ m2 ), approximately 0.2 times the maximum cumulative human dose on a mg/m2 basis, during the last quarter of pregnancy resulted in the death of offspring within 4 months. carmustine administered iv to rabbits during the period of organogenesis resulted in spontaneous abortions in mothers and growth defects in the fetus, mainly at cumulative doses ≥ 13 mg/kg (156 mg/ m2 ), approximately 0.1 times the maximum cumulative human dose on a mg/ m2 basis. risk summary there is no information regarding the presence of carmustine in human milk, the effects on the breastfed infant, or the effects on milk production. because many drugs are excreted in human milk and because of the potential for serious adverse events (e.g., carcinogenicity and myelosuppression) in nursing infants, nursing should be discontinued while taking carmustine for injection, usp. contraception advise female patients to avoid pregnancy during treatment with carmustine for injection, usp because of the risk of fetal harm [see use in specific populations (8.1) ]. advise female patients of reproductive potential to use highly effective contraception during and for up to six months after completion of treatment. advise males with female sexual partners of reproductive potential to use effective contraception during carmustine for injection, usp treatment and for at least three months after the final dose of carmustine for injection, usp [see nonclinical toxicology (13.1) ]. infertility based on nonclinical findings, male fertility may be compromised by treatment with carmustine for injection, usp [see nonclinical toxicology (13.1)]. safety and effectiveness in children have not been established. delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in a long-term study of patients who received carmustine for injection, usp in childhood and early adolescence (1-16 years). eight out of the 17 patients (47%) who survived childhood brain tumors, including all the 5 patients initially treated at less than 5 years of age, died of pulmonary fibrosis. [see adverse reactions (6.1)]. clinical studies of carmustine for injection, usp did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from 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 dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. carmustine for injection, usp and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

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

zydus pharmaceuticals usa inc. - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection, usp is indicated as palliative therapy as a single agent or in established combination therapy in the following: -     brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. -     multiple myeloma in combination with prednisone. -     relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. -     relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection, usp is contraindicated in patients with previous hypersensitivity to carmustine for injection, usp or its components. risk summary carmustine for injection, usp can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animals [see data ]. limited available data with carmustine for injection, usp use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotoxic in rats and rabbits and teratogenic in rats (thoracoabdominal closure, neural tube, and eye defects and malformations of the skeletal system of the fetus) when given in doses lower than the maximum cumulative human dose based on body surface area. consider the benefits and risks of carmustine for injection, usp for the mother and possible risks to the fetus when prescribing carmustine for injection, usp to a pregnant woman. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data intraperitoneal (ip) administration of carmustine to pregnant rats 14 days prior to mating and during the period of organogenesis at cumulative doses ≥ 26 mg/kg (158 mg/ m2 ), approximately 0.1 times the maximum cumulative human dose of 1400 mg/m2 , resulted in pre-implantation loss, increased resorptions (including completely resorbed litters), and reduced the number of live births in the presence of maternal toxicity. carmustine administered ip to pregnant rats during the period of organogenesis at cumulative doses ≥ 4 mg/kg (24 mg/m2 ), approximately 0.02 times the maximum cumulative human dose based on a mg/m2 basis, resulted in reduced fetal weight and various malformations, which included thoracoabdominal closure defects, neural tube defects, and eye defects, including microphthalmia/anophthalmia, and skeletal anomalies in the skull, sternebra, vertebrae and ribs, and reduced skeletal ossification) in the presence of maternal toxicity. embryo-fetal death was observed at cumulative doses ≥ 8 mg/kg (48 mg/m2 ), approximately 0.03 times the maximum cumulative human dose on a mg/ m2 basis. intravenous (iv) administration of carmustine to rats at a cumulative dose of 50 mg/kg (300 mg/ m2 ), approximately 0.2 times the maximum cumulative human dose on a mg/m2 basis, during the last quarter of pregnancy resulted in the death of offspring within 4 months. carmustine administered iv to rabbits during the period of organogenesis resulted in spontaneous abortions in mothers and growth defects in the fetus, mainly at cumulative doses ≥ 13 mg/kg (156 mg/ m2 ), approximately 0.1 times the maximum cumulative human dose on a mg/ m2 basis. risk summary there is no information regarding the presence of carmustine in human milk, the effects on the breastfed infant, or the effects on milk production. because many drugs are excreted in human milk and because of the potential for serious adverse events (e.g., carcinogenicity and myelosuppression) in nursing infants, nursing should be discontinued while taking carmustine for injection, usp. contraception advise female patients to avoid pregnancy during treatment with carmustine for injection, usp because of the risk of fetal harm [see use in specific populations (8.1)] . advise female patients of reproductive potential to use highly effective contraception during and for up to six months after completion of treatment. advise males with female sexual partners of reproductive potential to use effective contraception during carmustine for injection, usp treatment and for at least three months after the final dose of carmustine for injection, usp [see nonclinical toxicology (13.1)]. infertility based on nonclinical findings, male fertility may be compromised by treatment with carmustine for injection, usp [see nonclinical toxicology (13.1)]. safety and effectiveness in children have not been established. delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in a long-term study of patients who received carmustine for injection, usp in childhood and early adolescence (1-16 years). eight out of the 17 patients (47%) who survived childhood brain tumors, including all the 5 patients initially treated at less than 5 years of age, died of pulmonary fibrosis. [see adverse reactions (6.1)]. clinical studies of carmustine for injection, usp did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from 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 dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. carmustine for injection, usp and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection, usp is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1) ] and findings in animals [see data] . limited available data with carmustine for injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotoxic in rats an

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection, usp is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [see clinical pharmacology (12.1) ] and findings in animals [see data] . limited available data with carmustine for injection use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmustine was embryotoxic in rats an

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

accord healthcare inc. - carmustine (unii: u68wg3173y) (carmustine - unii:u68wg3173y) - carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - multiple myeloma in combination with prednisone. - relapsed or refractory hodgkin's lymphoma in combination with other approved drugs. - relapsed or refractory non-hodgkin's lymphomas in combination with other approved drugs. carmustine for injection is contraindicated in patients with previous hypersensitivity to carmustine for injection or its components. risk summary carmustine for injection can cause fetal harm when administered to a pregnant woman based on the mechanism of action [ see clinical pharmacology (12.1) ] and findings in animals [see data] . limited available data with carmustine use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. carmusti