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SaveGeneric Name: methotrexate
FDA Alerts-
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Experience of Supervising Clinician
- Administer only under supervision of qualified clinicians experienced in use of antimetabolite therapy.
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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.
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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.
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Formulations or Diluents Containing Preservatives
- Do not use formulations or diluents containing preservatives for intrathecal administration or high-dose therapy.
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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.)
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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.
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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.)
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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.
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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.
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GI Toxicity
- Diarrhea and ulcerative stomatitis require interruption of therapy; otherwise, hemorrhagic enteritis and death from intestinal perforation may occur.
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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.
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Tumor Lysis Syndrome
- May induce tumor lysis syndrome in patients with rapidly growing tumors; appropriate pharmacologic and supportive treatment may prevent or alleviate syndrome.
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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.)
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Opportunistic Infections
- Potentially fatal opportunistic infections, especially Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia.
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Concomitant Radiotherapy
- Possible increased risk of soft tissue necrosis and osteonecrosis in patients receiving methotrexate concomitantly with radiotherapy.
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- Interactions
Many drugs can interact with methotrexate injection. Below is just a partial list. Tell your doctor if you are using:
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any other cancer medications, especially cisplatin (Platinol);
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phenytoin (Dilantin);
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diabetes medication you take by mouth;
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retinol, tretinoin (Retin-A), isotretinoin (Accutane);
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theophylline (Elixophyllin, Slo-Bid, Theobid, Theo-Dur);
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vitamin or mineral supplements containing folic acid;
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an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others;
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salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others;
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a sulfa drug such as Azulfidine, Bactrim, or Septra;
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an antibiotic such as chloramphenicol (Chloromycetin), tetracycline, penicillin, ampicillin (Principen), amoxicillin (Amoxil, Trimox), or an antibiotic given by injection;
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medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
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medicines used to prevent organ transplant rejection, such as azathioprine (Imuran), sirolimus (Rapamune) or tacrolimus (Prograf); or
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antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir).
This list is not complete and there may be other drugs that can interact with methotrexate injection. 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.
Get emergency medical help if you have any of these
Call your doctor at once if you have a serious side effect such as:
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diarrhea, vomiting, white patches or sores inside your mouth or on your lips;
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weight loss, night sweats, swollen glands;
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fever, chills, flu symptoms, cough with yellow or green mucus;
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dry cough without mucus;
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stabbing chest pain, feeling short of breath;
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pale skin, easy bruising or bleeding;
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sudden numbness or weakness on one side of the body, confusion, neck stiffness, headache, back pain, seizure (convulsions);
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black, bloody, or tarry stools;
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urinating less than usual or not at all;
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dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;
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fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
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the first sign of any skin rash, no matter how mild.
Less serious side effects may include:
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nausea, vomiting, upset stomach;
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dizziness; or
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tired feeling.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
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