Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Methotrexate Injection Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate 25mg/mL; soln for IV, IM, intra-arterial, or intrathecal administration after dilution; preservative-free.
Pharmacological Class
Folic acid antagonist.
See Also
How Supplied
Soln (2mL, 4mL, 8mL, 10mL)—10 (single-use vials); pwd (1 gram)—1 (single-use vial)
Manufacturer
Methotrexate Injection Indications
Indications
Non-metastatic osteosarcoma in patients who have undergone surgical resection or amputation for the primary tumor (high-dose therapy with leucovorin rescue).
Methotrexate Injection Dosage and Administration
Adult
Initially 12g/m2 IV infusion over 4 hours; may be increased to 15g/m2; see literature for leucovorin rescue dosing with high-dose methotrexate.
Children
See literature.
Methotrexate Injection Contraindications
Contraindications
Pregnancy (Cat. X). Nursing mothers.
Methotrexate Injection Boxed Warnings
Not Applicable
Methotrexate Injection Warnings/Precautions
Warnings/Precautions
Be fully familiar with this drug's toxicity before use. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Hepatic or renal impairment. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Infection. Dehydration. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Elderly (use low doses and monitor closely). Debilitated.
Methotrexate Injection Pharmacokinetics
See Literature
Methotrexate Injection Interactions
Interactions
Avoid live virus vaccines. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, chloramphenicol, non-absorbable broad spectrum antibiotics. May be antagonized by folic acid. May potentiate theophylline, mercaptopurine. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).
Methotrexate Injection Adverse Reactions
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, GI upset, malaise, fatigue, chills, fever, dizziness, infection, myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, seizures (esp in children); interstitial pneumonitis, tumor lysis syndrome, skin reactions (may be fatal; eg, toxic epidermal necrolysis, Stevens-Johnson syndrome).
Methotrexate Injection Clinical Trials
See Literature
Methotrexate Injection Note
Not Applicable
Methotrexate Injection Patient Counseling
See Literature
Methotrexate Injection Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate 25mg/mL; soln for IV, IM, intra-arterial, or intrathecal administration after dilution; preservative-free.
Pharmacological Class
Folic acid antagonist.
See Also
How Supplied
Tabs—30; IV soln, pwd—contact supplier
Manufacturer
Methotrexate Injection Indications
Indications
Breast cancer.
Methotrexate Injection Dosage and Administration
Adult
See full labeling.
Children
Not established.
Methotrexate Injection Contraindications
Contraindications
Pregnancy (Cat.X). Nursing mothers.
Methotrexate Injection Boxed Warnings
Boxed Warning
Should be used only by experienced physicians. Patients should be informed of the risks involved and be under a physician's care throughout therapy. Severe toxic reactions. Deaths have been reported. See full labeling.
Methotrexate Injection Warnings/Precautions
Warnings/Precautions
Be fully familiar with this drug's toxicity before use. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Hepatic or renal impairment. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Infection. Dehydration. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Elderly (use low doses and monitor closely). Debilitated.
Methotrexate Injection Pharmacokinetics
See Literature
Methotrexate Injection Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, chloramphenicol, non-absorbable broad spectrum antibiotics. May be antagonized by folic acid. May potentiate theophylline, mercaptopurine. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).
Methotrexate Injection Adverse Reactions
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, GI upset, malaise, fatigue, chills, fever, dizziness, infection, myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, seizures (esp in children); interstitial pneumonitis, tumor lysis syndrome, skin reactions (may be fatal; eg, toxic epidermal necrolysis, Stevens-Johnson syndrome).
Methotrexate Injection Clinical Trials
See Literature
Methotrexate Injection Note
Not Applicable
Methotrexate Injection Patient Counseling
See Literature
Methotrexate Injection Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate 25mg/mL; soln for IV, IM, intra-arterial, or intrathecal administration after dilution; preservative-free.
Pharmacological Class
Folic acid antagonist.
See Also
How Supplied
Tabs—30; IV soln, pwd—contact supplier
Manufacturer
Methotrexate Injection Indications
Indications
Gestational choriocarcinoma. Chorioadenoma destruens. Hydatidiform mole.
Methotrexate Injection Dosage and Administration
Adult
See literature. Tablet form is often preferred when low doses are being administered. Choriocarcinoma and similar trophoblastic diseases: 15–30mg orally or by IM inj daily for 5 days; usually repeated 3–5 times as required with a rest period of ≥1 week between courses.
Children
Not applicable.
Methotrexate Injection Contraindications
Contraindications
Pregnancy (Cat.X). Nursing mothers.
Methotrexate Injection Boxed Warnings
Boxed Warning
Should be used only by experienced physicians. Patients should be informed of the risks involved and be under a physician's care throughout therapy. Severe toxic reactions. Deaths have been reported. See full labeling.
Methotrexate Injection Warnings/Precautions
Warnings/Precautions
Be fully familiar with this drug's toxicity before use. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Hepatic or renal impairment. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Infection. Dehydration. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Elderly (use low doses and monitor closely). Debilitated.
Methotrexate Injection Pharmacokinetics
See Literature
Methotrexate Injection Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, chloramphenicol, non-absorbable broad spectrum antibiotics. May be antagonized by folic acid. May potentiate theophylline, mercaptopurine. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).
Methotrexate Injection Adverse Reactions
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, GI upset, malaise, fatigue, chills, fever, dizziness, infection, myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, seizures (esp in children); interstitial pneumonitis, tumor lysis syndrome, skin reactions (may be fatal; eg, toxic epidermal necrolysis, Stevens-Johnson syndrome).
Methotrexate Injection Clinical Trials
See Literature
Methotrexate Injection Note
Not Applicable
Methotrexate Injection Patient Counseling
See Literature
Methotrexate Injection Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate 25mg/mL; soln for IV, IM, intra-arterial, or intrathecal administration after dilution; preservative-free.
Pharmacological Class
Folic acid antagonist.
See Also
How Supplied
Tabs—30; IV soln, pwd—contact supplier
Manufacturer
Methotrexate Injection Indications
Indications
Epidermoid cancers of the head and neck.
Methotrexate Injection Dosage and Administration
Adult
See full labeling.
Children
Not established.
Methotrexate Injection Contraindications
Contraindications
Pregnancy (Cat.X). Nursing mothers.
Methotrexate Injection Boxed Warnings
Boxed Warning
Should be used only by experienced physicians. Patients should be informed of the risks involved and be under a physician's care throughout therapy. Severe toxic reactions. Deaths have been reported. See full labeling.
Methotrexate Injection Warnings/Precautions
Warnings/Precautions
Be fully familiar with this drug's toxicity before use. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Hepatic or renal impairment. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Infection. Dehydration. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Elderly (use low doses and monitor closely). Debilitated.
Methotrexate Injection Pharmacokinetics
See Literature
Methotrexate Injection Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, chloramphenicol, non-absorbable broad spectrum antibiotics. May be antagonized by folic acid. May potentiate theophylline, mercaptopurine. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).
Methotrexate Injection Adverse Reactions
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, GI upset, malaise, fatigue, chills, fever, dizziness, infection, myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, seizures (esp in children); interstitial pneumonitis, tumor lysis syndrome, skin reactions (may be fatal; eg, toxic epidermal necrolysis, Stevens-Johnson syndrome).
Methotrexate Injection Clinical Trials
See Literature
Methotrexate Injection Note
Not Applicable
Methotrexate Injection Patient Counseling
See Literature
Methotrexate Injection Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate 25mg/mL; soln for IV, IM, intra-arterial, or intrathecal administration after dilution; preservative-free.
Pharmacological Class
Folic acid antagonist.
See Also
How Supplied
Tabs—30; IV soln, pwd—contact supplier
Manufacturer
Methotrexate Injection Indications
Indications
Prophylaxis and treatment of meningeal leukemia. Advanced mycosis fungoids (cutaneous T cell lymphoma). Advanced non-Hodgkin's lymphomas.
Methotrexate Injection Dosage and Administration
Adult
See literature. Tablet form is often preferred when low doses are being administered. Leukemia: Induction: 3.3mg/m2 + prednisone, given daily; maintenance: give twice weekly either orally or by IM inj for a total weekly dose of 30mg/m2; or 2.5mg/kg IV every 14 days. Meningeal leukemia (treatment): 12mg/m2 intrathecally (max 15mg) at intervals of 2–5 days; see literature for prophylaxis treatment. Burkitt's tumor (stage I–II): 10–25mg per day orally for 4–8 days. Lymphosarcomas (stage III): 0.625–2.5mg/kg daily. Mycosis fungoides (cutaneous T cell lymphoma): 5–50mg once weekly.
Children
See literature.
Methotrexate Injection Contraindications
Contraindications
Pregnancy (Cat.X). Nursing mothers.
Methotrexate Injection Boxed Warnings
Boxed Warning
Should be used only by experienced physicians. Patients should be informed of the risks involved and be under a physician's care throughout therapy. Severe toxic reactions. Deaths have been reported. See full labeling.
Methotrexate Injection Warnings/Precautions
Warnings/Precautions
Be fully familiar with this drug's toxicity before use. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Hepatic or renal impairment. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Infection. Dehydration. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Elderly (use low doses and monitor closely). Debilitated.
Methotrexate Injection Pharmacokinetics
See Literature
Methotrexate Injection Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, chloramphenicol, non-absorbable broad spectrum antibiotics. May be antagonized by folic acid. May potentiate theophylline, mercaptopurine. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).
Methotrexate Injection Adverse Reactions
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, GI upset, malaise, fatigue, chills, fever, dizziness, infection, myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, seizures (esp in children); interstitial pneumonitis, tumor lysis syndrome, skin reactions (may be fatal; eg, toxic epidermal necrolysis, Stevens-Johnson syndrome).
Methotrexate Injection Clinical Trials
See Literature
Methotrexate Injection Note
Not Applicable
Methotrexate Injection Patient Counseling
See Literature
Methotrexate Injection Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate 25mg/mL; soln for IV, IM, intra-arterial, or intrathecal administration after dilution; preservative-free.
Pharmacological Class
Folic acid antagonist.
See Also
How Supplied
Tabs—30; IV soln, pwd—contact supplier
Manufacturer
Methotrexate Injection Indications
Indications
Lung cancer (squamous cell and small cell types).
Methotrexate Injection Dosage and Administration
Adult
See full labeling.
Children
Not established.
Methotrexate Injection Contraindications
Contraindications
Pregnancy (Cat.X). Nursing mothers.
Methotrexate Injection Boxed Warnings
Boxed Warning
Should be used only by experienced physicians. Patients should be informed of the risks involved and be under a physician's care throughout therapy. Severe toxic reactions. Deaths have been reported. See full labeling.
Methotrexate Injection Warnings/Precautions
Warnings/Precautions
Be fully familiar with this drug's toxicity before use. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Hepatic or renal impairment. Obesity. Diabetes. Peptic ulcer. Ulcerative colitis. Infection. Dehydration. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Elderly (use low doses and monitor closely). Debilitated.
Methotrexate Injection Pharmacokinetics
See Literature
Methotrexate Injection Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, phenytoin, sulfonylureas, sulfonamides, probenecid, folic acid antagonists. May be potentiated by penicillins (monitor), tetracyclines, chloramphenicol, non-absorbable broad spectrum antibiotics. May be antagonized by folic acid. May potentiate theophylline, mercaptopurine. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Caution with other hepatotoxic drugs (eg, azathioprine, retinoids, sulfasalazine) and nephrotoxic agents (eg, cisplatin).
Methotrexate Injection Adverse Reactions
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, GI upset, malaise, fatigue, chills, fever, dizziness, infection, myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, seizures (esp in children); interstitial pneumonitis, tumor lysis syndrome, skin reactions (may be fatal; eg, toxic epidermal necrolysis, Stevens-Johnson syndrome).
Methotrexate Injection Clinical Trials
See Literature
Methotrexate Injection Note
Not Applicable
Methotrexate Injection Patient Counseling
See Literature
