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FDA Alerts
Experience of Supervising Clinician
Administer only under supervision of qualified clinicians experienced in use of antimetabolite therapy.
Serious Toxic Reactions (Sometimes Fatal) Possible
Deaths reported with use in treatment of malignancy, psoriasis, and rheumatoid arthritis.
Use only for treatment of life-threatening neoplastic diseases or severe, recalcitrant, disabling psoriasis or rheumatoid arthritis in patients who have not responded adequately to other forms of therapy.
Closely monitor patients for bone marrow, hepatic, pulmonary, or renal toxicities. (See Major Toxicities under Cautions.)
Inform patients of risks involved with therapy and importance of remaining under care of clinician throughout therapy.
High-Dose Regimens
Use of high-dose regimens recommended for treatment of osteosarcoma requires meticulous care. (See High-Dose Methotrexate Therapy with Leucovorin Rescue and also Osteosarcoma, under Dosage and Administration.)
Use of high-dose regimens for other neoplastic diseases is investigational; therapeutic advantage not established.
Formulations or Diluents Containing Preservatives
Do not use formulations or diluents containing preservatives for intrathecal administration or high-dose therapy.
Fetal/Neonatal Morbidity and Mortality
Fetal death and/or congenital anomalies reported. Not recommended for use in women of childbearing potential unless potential benefit clearly outweighs risks; do not use in pregnant women with psoriasis or rheumatoid arthritis. (See Contraindications and also Fetal/Neonatal Morbidity and Mortality, under Cautions.)
Reduced Elimination
Elimination reduced in patients with renal impairment, ascites, or pleural effusions. Carefully monitor for toxicity in such patients; dosage reduction or discontinuance may be required.
Concomitant Therapy with NSAIAs
Unexpectedly severe, sometimes fatal, myelosuppression, aplastic anemia, and GI toxicity reported with concomitant use of methotrexate (usually at high dosages) and some NSAIAs. (See Specific Drugs under Interactions.)
Hepatotoxicity
Possible hepatotoxicity, fibrosis, and cirrhosis, generally only after prolonged use. (See Hepatic Effects under Cautions.)
Acute liver enzyme elevations frequently observed; usually transient and asymptomatic and do not appear predictive of subsequent hepatic disease.
Liver biopsy after sustained use often shows histologic changes. Fibrosis and cirrhosis may not be preceded by symptoms or abnormal liver function tests in patients with psoriasis; periodic liver biopsies usually recommended in such patients undergoing long-term therapy.
Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in patients with rheumatoid arthritis.
Pulmonary Toxicity
Potentially dangerous pulmonary lesions, not always reversible, may occur acutely at any time during therapy and have been reported at dosages as low as 7.5 mg weekly. Pulmonary symptoms (especially dry, nonproductive cough) may require therapy interruption and careful evaluation.
GI Toxicity
Diarrhea and ulcerative stomatitis require interruption of therapy; otherwise, hemorrhagic enteritis and death from intestinal perforation may occur.
Malignant Lymphomas
Malignant lymphomas (e.g., non-Hodgkin’s lymphoma) may occur in patients receiving low-dose oral therapy; such lymphomas may regress following methotrexate discontinuance and may not require cytotoxic therapy. If the lymphoma does not regress following discontinuance, institute appropriate therapy.
Tumor Lysis Syndrome
May induce tumor lysis syndrome in patients with rapidly growing tumors; appropriate pharmacologic and supportive treatment may prevent or alleviate syndrome.
Dermatologic Reactions
Severe, occasionally fatal skin reactions reported following single or multiple doses; reactions occurred within days of oral, IM, IV, or intrathecal administration. Recovery reported with discontinuance of therapy. (See Dermatologic and Sensitivity Reactions under Cautions.)
This drug is given as an injection into a muscle or into a vein. It may also be given into the spinal fluid. It is administered in a hospital or clinic by a specially trained health care professional.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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