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.)
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.
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.
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.
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:
low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
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?
This drug is given in a hospital or clinic and will not be stored at home.
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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