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

fresenius kabi usa, llc - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 25 mg in 1 ml - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated for use in maintenance therapy in combination with other chemotherapeutic agents.   methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin’s lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor. methotrexate is indicated in the symptomatic control of se

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

fresenius kabi usa, llc - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 1 g - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents.  methotrexate is also indicated in the treatment of meningeal leukemia. methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types.  methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin’s lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resectio

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

sandoz inc - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 25 mg in 1 ml - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. methotrexate is also indicated in the treatment of meningeal leukemia. methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin's lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection

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

rebel distributors corp - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 2.5 mg - methotrexate tablets are indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides, (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin’s lymphomas.  methotrexate tablets are indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation . it is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses. methotrexate tablets are indicated in the management of selected adults with severe

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

mylan institutional inc. - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 2.5 mg - methotrexate tablets are indicated for the: - treatment of adults and pediatric patients with acute lymphoblastic leukemia (all) as part of a combination chemotherapy maintenance regimen. - treatment of adults with mycosis fungoides (cutaneous t-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. - treatment of adults with relapsed or refractory non-hodgkin lymphomas as part of a metronomic combination chemotherapy regimen. methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pjia). methotrexate tablets are indicated for the treatment of adults with severe psoriasis. methotrexate tablets are contraindicated in: - pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see warnings and precautions (5.1), and use in specific populations (8.1, 8.3)] . - patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see warnings and precautions (5.2)] . methotrexate tablets are contraindicated in pregnant women with non-neoplastic diseases [see contraindications (4)]. based on published reports and its mechanism of action [see clinical pharmacology (12.1)], methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman. there are no animal data that meet current standards for nonclinical developmental toxicity studies. advise pregnant women with neoplastic diseases of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. published data from case reports, literature reviews, and observational studies report that methotrexate exposure during pregnancy is associated with an increased risk of embryo-fetal toxicity and fetal death. methotrexate exposure during the first trimester of pregnancy is associated with an increased incidence of spontaneous abortions and multiple adverse developmental outcomes, including skull anomalies, facial dysmorphism, central nervous system abnormalities, limb abnormalities, and sometimes cardiac anomalies and intellectual impairment. adverse outcomes associated with exposure during second and third trimesters of pregnancy include intrauterine growth restriction and functional abnormalities. because methotrexate is widely distributed and persists in the body for a prolonged period, there is a potential risk to the fetus from preconception methotrexate exposure. a prospective multicenter study evaluated pregnancy outcomes in women taking methotrexate less than or equal to 30 mg/week after conception. the rate of spontaneous abortion and miscarriage in pregnant women exposed to methotrexate was 42% (95% confidence interval [95% ci] 29, 59), which was higher than in unexposed patients with autoimmune disease (22%; 95% ci: 17, 30) and unexposed patients with nonautoimmune disease (17%; 95% ci: 13, 23). of the live births, the rate of major birth defects in pregnant women exposed to methotrexate after conception was higher than in unexposed patients with autoimmune disease (adjusted odds ratio (or) 1.8 [95% ci: 0.6, 6]) and unexposed patients with non-autoimmune disease (adjusted or 3.1 [95% ci: 1, 10]) (2.9%). major birth defects associated with pregnancies exposed to methotrexate after conception were not always consistent with methotrexate-associated adverse developmental outcomes. limited published literature report the presence of methotrexate in human milk in low amounts, with the highest breast milk to plasma concentration ratio reported to be 0.08:1. there are no data on the effects of methotrexate or its metabolites on the breastfed child or their effects on milk production. because of the potential for serious adverse reactions in a breastfed child, instruct women not to breastfeed during treatment with methotrexate tablets and for 1 week after the final dose. methotrexate can cause malformations and fetal death at doses less than or equal to the recommended clinical doses [see use in specific populations (8.1)]. verify the pregnancy status of females of reproductive potential prior to initiating methotrexate tablets [see contraindications (4), use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment with methotrexate tablets and for 6 months after the final dose. methotrexate can cause chromosomal damage to sperm cells. advise males with female partners of reproductive potential to use effective contraception during treatment with methotrexate tablets and for 3 months after the final dose. based on published reports of female infertility after methotrexate, advise females of reproductive potential that methotrexate can cause impairment of fertility and menstrual dysfunction during treatment with methotrexate tablets and after the final dose. it is not known if the infertility may be reversed in all affected females. based on published reports of male infertility after methotrexate, advise males that methotrexate can cause oligospermia or infertility during treatment with methotrexate tablets and after the final dose. it is not known if the infertility may be reversed in all affected males. the safety and effectiveness of methotrexate tablets in pediatric patients have been established for the treatment of all as part of the combination chemotherapy maintenance regimen and the treatment of pjia [see indications and usage (1), dosage and administration (2)]. no new safety signals have been observed in pediatric patients in clinical studies [see adverse reactions (6.1)]. the safety and effectiveness of methotrexate tablets have not been established in pediatric patients for the other indications [see indications and usage (1)]. clinical studies of methotrexate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. methotrexate elimination is reduced in patients with renal impairment [see clinical pharmacology (12.3)]. patients with renal impairment are at increased risk for methotrexate adverse reactions. closely monitor patients with renal impairment [creatinine clearance (clcr) less than 90 ml/min, cockcroft-gault] for adverse reactions. reduce the dosage or discontinue methotrexate tablets as appropriate [see warnings and precautions (5.8)]. the pharmacokinetics and safety of methotrexate in patients with hepatic impairment is unknown. patients with hepatic impairment may be at increased risk for methotrexate adverse reactions based on the elimination characteristics of methotrexate [see clinical pharmacology (12.3)]. closely monitor patients with hepatic impairment for adverse reactions. reduce the dosage or discontinue methotrexate tablets as appropriate [see warnings and precautions (5.5)] .

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

mylan pharmaceuticals inc. - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 2.5 mg - methotrexate tablets are indicated for the: methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pjia). methotrexate tablets are indicated for the treatment of adults with severe psoriasis. methotrexate tablets are contraindicated in: methotrexate tablets are contraindicated in pregnant women with non-neoplastic diseases [see contraindications (4)]. based on published reports and its mechanism of action [see clinical pharmacology (12.1)], methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman. there are no animal data that meet current standards for nonclinical developmental toxicity studies. advise pregnant women with neoplastic diseases of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. published data from case reports, literature reviews, and observational studies report that methotrexate exposure during pregnancy is associated with an increased risk of embryo-fetal toxicity and fetal death. methotrexate exposure during the first trimester of pregnancy is associated with an increased incidence of spontaneous abortions and multiple adverse developmental outcomes, including skull anomalies, facial dysmorphism, central nervous system abnormalities, limb abnormalities, and sometimes cardiac anomalies and intellectual impairment. adverse outcomes associated with exposure during second and third trimesters of pregnancy include intrauterine growth restriction and functional abnormalities. because methotrexate is widely distributed and persists in the body for a prolonged period, there is a potential risk to the fetus from preconception methotrexate exposure. a prospective multicenter study evaluated pregnancy outcomes in women taking methotrexate less than or equal to 30 mg/week after conception. the rate of spontaneous abortion and miscarriage in pregnant women exposed to methotrexate was 42% (95% confidence interval [95% ci] 29, 59), which was higher than in unexposed patients with autoimmune disease (22%; 95% ci: 17, 30) and unexposed patients with nonautoimmune disease (17%; 95% ci: 13, 23). of the live births, the rate of major birth defects in pregnant women exposed to methotrexate after conception was higher than in unexposed patients with autoimmune disease (adjusted odds ratio (or) 1.8 [95% ci: 0.6, 6]) and unexposed patients with non-autoimmune disease (adjusted or 3.1 [95% ci: 1, 10]) (2.9%). major birth defects associated with pregnancies exposed to methotrexate after conception were not always consistent with methotrexate-associated adverse developmental outcomes. limited published literature report the presence of methotrexate in human milk in low amounts, with the highest breast milk to plasma concentration ratio reported to be 0.08:1. there are no data on the effects of methotrexate or its metabolites on the breastfed child or their effects on milk production. because of the potential for serious adverse reactions in a breastfed child, instruct women not to breastfeed during treatment with methotrexate tablets and for 1 week after the final dose. methotrexate can cause malformations and fetal death at doses less than or equal to the recommended clinical doses [see use in specific populations (8.1)]. verify the pregnancy status of females of reproductive potential prior to initiating methotrexate tablets [see contraindications (4), use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment with methotrexate tablets and for 6 months after the final dose. methotrexate can cause chromosomal damage to sperm cells. advise males with female partners of reproductive potential to use effective contraception during treatment with methotrexate tablets and for 3 months after the final dose. based on published reports of female infertility after methotrexate, advise females of reproductive potential that methotrexate can cause impairment of fertility and menstrual dysfunction during treatment with methotrexate tablets and after the final dose. it is not known if the infertility may be reversed in all affected females. based on published reports of male infertility after methotrexate, advise males that methotrexate can cause oligospermia or infertility during treatment with methotrexate tablets and after the final dose. it is not known if the infertility may be reversed in all affected males. the safety and effectiveness of methotrexate tablets in pediatric patients have been established for the treatment of all as part of the combination chemotherapy maintenance regimen and the treatment of pjia [see indications and usage (1), dosage and administration (2)]. no new safety signals have been observed in pediatric patients in clinical studies [see adverse reactions (6.1)]. the safety and effectiveness of methotrexate tablets have not been established in pediatric patients for the other indications [see indications and usage (1)]. clinical studies of methotrexate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. methotrexate elimination is reduced in patients with renal impairment [see clinical pharmacology (12.3)]. patients with renal impairment are at increased risk for methotrexate adverse reactions. closely monitor patients with renal impairment [creatinine clearance (clcr) less than 90 ml/min, cockcroft-gault] for adverse reactions. reduce the dosage or discontinue methotrexate tablets as appropriate [see warnings and precautions (5.8)]. the pharmacokinetics and safety of methotrexate in patients with hepatic impairment is unknown. patients with hepatic impairment may be at increased risk for methotrexate adverse reactions based on the elimination characteristics of methotrexate [see clinical pharmacology (12.3)]. closely monitor patients with hepatic impairment for adverse reactions. reduce the dosage or discontinue methotrexate tablets as appropriate [see warnings and precautions (5.5)] .

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

hospira, inc. - methotrexate sodium (unii: 3ig1e710zn) (methotrexate - unii:yl5fz2y5u1) - methotrexate 25 mg in 1 ml - methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. in acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. methotrexate is also indicated in the treatment of meningeal leukemia. methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin's lymphomas. methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection

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

accord healthcare pty ltd - methotrexate, quantity: 100 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections - antineoplastic chemotherapy - methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. methotrexate may be used in combination with other chemotherapeutic agents for the palliative treatment of acute leukaemias, particularly acute lymphoblastic leukaemia. it may also be used in the treatment of burkitt's lymphoma, advanced stages (iii and iv, peters' staging system) of lymphosarcoma, especially in children, and in advanced cases of mycosis fungoides. high dose therapy - in high-dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic carcinoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy. psoriasis chemotherapy (see warning box) - methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic consultation.

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

accord healthcare pty ltd - methotrexate, quantity: 25 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide - antineoplastic chemotherapy - methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. methotrexate may be used in combination with other chemotherapeutic agents for the palliative treatment of acute leukaemias, particularly acute lymphoblastic leukaemia. it may also be used in the treatment of burkitt's lymphoma, advanced stages (iii and iv, peters' staging system) of lymphosarcoma, especially in children, and in advanced cases of mycosis fungoides. high dose therapy - in high-dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic carcinoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy. psoriasis chemotherapy (see warning box) - methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic consultation.

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

sandoz pty ltd - methotrexate, quantity: 5000 mg - injection, concentrated - excipient ingredients: sodium hydroxide; water for injections - antineoplastic chemotherapy:,methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer and the palliation of acute and subacute lymphocytic leukaemia (greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias). methotrexate is now most commonly used for the maintenance of drug induced remissions.,high dose therapy:,in high dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic sarcoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy.,psoriasis chemotherapy (see warnings box and section 4.4 special warnings and precautions for use).:,methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use,