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Methotrexate Sodium Solution for injection

This medicine affects cells that are rapidly growing, such as cancer cells and cells in your mouth a... more

Generic Name: methotrexate  |  Brand Name: Methotrexate Sodium, Preservative Free

Brand Names: Trexall, Rheumatrex Dose Pack, Methotrexate Sodium, Preservative Free, Methotrexate LPF Sodium

There is an FDA Alert for this drug. Click here to view it.

    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 see 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 see 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.

What is this medicine?

METHOTREXATE (METH oh TREX ate) is a chemotherapy drug. This medicine affects cells that are rapidly growing, such as cancer cells and cells in your mouth and stomach. It is used to treat many cancers and other medical conditions. It is used for leukemias, lymphomas, breast cancer, lung cancer, head and neck cancers, and other cancers. This medicine also works on the immune system and is commonly used to treat psoriasis and rheumatoid arthritis.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • if you frequently drink alcohol containing drinks
  • infection (especially a virus infection such as chickenpox, cold sores, or herpes)
  • immune system problems
  • kidney disease
  • liver disease
  • low blood counts, like platelets, red bloods, or white blood cells
  • lung disease
  • recent or ongoing radiation therapy
  • an unusual or allergic reaction to methotrexate, benzyl alcohol, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

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.

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.

What may interact with this medicine?

  • antibiotics and other medicines for infections
  • aspirin and aspirin-like medicines including bismuth subsalicylate (Pepto-Bismol)
  • cisplatin
  • dapsone
  • folic acid in supplements or vitamins
  • mercaptopurine
  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
  • pemetrexed
  • phenylbutazone
  • phenytoin
  • probenecid
  • pyrimethamine
  • theophylline
  • trimetrexate
  • vaccines

What should I watch for while using this medicine?

Visit your doctor for checks on your progress. You will need to have regular blood checks during your treatment to monitor your blood, liver function, and kidney function.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea.

To protect your kidneys, drink water or other fluids as directed while you are taking this medicine.

Do not drink alcohol-containing drinks while taking this medicine. Both alcohol and the medicine may cause damage to your liver.

Men and women must use effective birth control while they are taking this medicine. Do not become pregnant while taking this medicine. Women must continue using effective birth control for 1 full menstrual cycle after stopping this medicine. Tell your doctor right away if you think that you or your partner might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine. Men must continue effective birth control for 3 months after stopping this medicine.


Last Updated: June 25, 2009
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