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.)
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. If used for arthritis or psoriasis, the drug is only given once a week.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth. Swallow it with a full glass of water. Follow the directions on the prescription label. Do not take your medicine more often than directed. Finish the full course prescribed by your doctor or health care professional. Do not stop taking except on your doctor's advice.
If you take methotrexate for rheumatoid arthritis or psoriasis, the dose is given only once a week. Do not take more frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
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?
If you miss a dose, talk with your doctor or health care professional. Do not take double or extra doses. If you vomit after taking a dose, call your doctor or health care professional for advice.
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.
What should I watch for while using this medicine?
Visit your doctor or health care professional for checks on your progress. You will need to have regular blood checks. You will also need a chest X-ray before starting the medicine.
If you take the medicine for rheumatoid arthritis or psoriasis, you may not see an improvement in your condition for several weeks.
Do not drink alcohol-containing drinks while taking this medicine. Both alcohol and the medicine may cause damage to your liver.
This medicine may increase your risk of getting an infection. Stay away from people who are sick.
To protect your kidneys, drink water or other fluids as directed while you are taking this medicine.
Both men and women must use effective birth control. Use 2 reliable forms of birth control together. Do not become pregnant while taking this medicine. Women should continue to use birth control until after their first normal menstrual cycle after stopping the medicine. Call your doctor right away if you think 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 should continue to use birth control for at least 3 months after stopping the medicine.
If you are going to have surgery or dental work, tell your health care professional that you are taking this medicine.
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.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
symptoms of infection like fever or chills, cough, sore throat, pain or difficulty passing urine
unusually weak or tired, fainting spells
vomiting
yellow coloring of skin or eyes
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
dizziness
drowsiness
loss of appetite
nausea
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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