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Generic Name: methotrexate

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An antirheumatic - treats Trophoblastic Disease, Psoriasis, Lymphoma, Mycosis Fungoides, Acute Lymph... more

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.)

Opportunistic Infections

Potentially fatal opportunistic infections, especially Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia.

Concomitant Radiotherapy

Possible increased risk of soft tissue necrosis and osteonecrosis in patients receiving methotrexate concomitantly with radiotherapy.

Media Gallery

images

Methotrexate Sodium
54 323 2.5 mg	b 572 2.5 mg	M 14 2.5 mg
Trexall
b / 928 7 1/2 7.5 mg	b / 945 15 15 mg	b / 927 5 5 mg	b / 929 10 10 mg

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(meth oh TREX ate)

What is the most important information I should know about methotrexate?

Methotrexate can cause serious or life-threatening side effects on your liver, lungs, kidneys, and bone marrow (immune system). Do not take this medication in larger amounts, or take it for longer than prescribed. Follow the directions on your prescription label. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you have liver disease (especially if caused by alcoholism), a blood cell or bone marrow disorder, or if you are breast-feeding a baby. This medication can cause birth defects in an unborn baby. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you are pregnant. Use an effective form of birth control, whether you are a man or a woman. Tell your doctor if you or your sexual partner become pregnant during treatment.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

There are many other medicines that can interact with methotrexate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What is methotrexate?

Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat certain types of cancer of the breast, skin, head and neck, or lung. Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis.

Methotrexate is usually given after other medications have been tried without successful treatment of symptoms.

Methotrexate may also be used for other purposes not listed in this medication guide.

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