Drug Profile

Pregnancy Warning

Methotrexate can cause fetal death and malformations when given to pregnant women. Because of the potential for serious adverse effects to the fetus, methotrexate should not be used by pregnant women.

Breast-feeding Warning

Because this drug interfers with essential DNA synthesis in nursing infants, you should not take this drug while nursing.

FDA BLACK BOX WARNING

Methotrexate should be used only by physicians whose knowledge and experience include the use of antimetabolite therapy.

Because of the possibility of serious toxic reactions (which can be fatal):
Methotrexate should be used only in life threatening neoplastic diseases, or in patients with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy.

Deaths have been reported with the use of methotrexate in the treatment of malignancy, psoriasis, and rheumatoid arthritis.

Patients should be closely monitored for bone marrow, liver, lung, and kidney toxicities.

Patients should be informed by their physician of the risks involved and be under a physician’s care throughout therapy.

• Methotrexate has been reported to cause fetal death and/or congenital anomalies. Therefore, it is not recommended for women of childbearing potential unless there is clear medical evidence that benefits can be expected to ourweigh the considered risks. Pregnant women with psoriasis or rheumatoid arthritis should not receive methotrexate.
• Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). [Click here to find a list of NSAIDs.]
• Methotrexate causes hepatotoxicity [liver toxicity], fibrosis and cirrhosis, but generally only after prolonged use.
• Methotrexate-induced lung disease is a potentially dangerous lesion, which may occur acutely at any time during therapy and which has been reported at doses as low as 7.7 mg/week. It is not always fully reversible. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation.
• Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus may not require cytotoxic treatment.
• Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of methotrexate.
• Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may occur with methotrexate therapy.

Dietary Steps to Manage Nausea Induced by Cancer Drugs

Drugs used to treat cancer often cause severe nausea and vomiting, either immediately after the drug is taken or several hours later. You can treat this kind of nausea and vomiting by changing your diet or by taking an antinausea drug. You should always try dietary changes first.

• Eat small, frequent meals so that your stomach is never empty.
• When you get up from sleeping or resting, eat some dry crackers or toast before you start being active.
• Drink carbonated drinks or other clear liquids such as soups and gelatin.
• Eat tart foods such as lemons and pickles.
• Do not eat foods with strong smells.

Do not use if you have or have had:

• pregnancy or are breast-feeding
• bone marrow depression
• severe liver or kidney disease

Tell your doctor if you have or have had:

• allergy to methotrexate
• alcohol dependence
• bone marrow depression
• recent infection
• kidney or liver problems
• colitis
• stomach ulcers
• intestinal obstruction
• cytotoxic drugs or radiation
• chicken pox exposure or infection
• shingles (herpes zoster)
• mouth sores or inflammation

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

• Schedule regular visits with your doctor to check your blood counts, liver function, and progress on the drug.
• Use a doctor who is experienced in antimetabolite drug use.
• Do not use more or less often or in a higher or lower dose than prescribed.
• Check with your doctor before you stop using this drug.
• Do not drink alcohol. It increases your chances of liver damage.
• Avoid salicylate-containing products or NSAIDs.
• Notify your doctor at once if adverse events occur.
• Try to stay out of the sun. Methotrexate makes your skin more sensitive to sunlight.
• Do not get immunizations without your doctor’s approval, and avoid exposure to people who have colds or other infections or who have recently been immunized. Because methotrexate decreases the number of white blood cells, which fight infection, you are more likely to get an infection while you are taking it.
• If you plan to have any surgery, including dental, tell your doctor that you take this drug.

• If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
• Do not share your medication with others.
• Take the drug at the same time(s) each day.
• Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.
• Call your doctor if you miss a dose or vomit shortly after taking the drug.

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

ARAVA, asparaginase, aspirin, azapropazone, BACTRIM, BENEMID, chloramphenicol, cisplatin, COTRIM, DILANTIN, ECOTRIN, EMPIRIN, etretinate, GENUINE BAYER ASPIRIN, ketoprofen, leflunomide, leucovorin, MATULANE, neomycin, NEO-RX, ORUDIS, ORUVAIL, phenytoin, piperacillin, PLATINOL, PROBALAN, probenecid, procarbazine, rofecoxib, SEPTRA, SUMYCIN, TEGISON, tetracycline, trimethoprim/sulfamethoxazole, VIOXX, WELLCOVORIN, ZOSYN.

Call your doctor immediately if you experience:

• black, tarry stools
• stomach pain
• diarrhea
• bloody vomit
• fever, chills, or sore throat
• unusual bleeding or bruising
• lower back or side pain
• sores in mouth or on lips
• blood in urine
• painful or difficult urination
• swelling of feet or lower legs
• joint pain
• cough, shortness of breath
• dark urine
• yellow eyes or skin
• pinpoint red spots on skin
• blurred vision
• convulsions
• dizziness

Call your doctor if these symptoms continue:

• nausea, vomiting, loss of appetite
• hair loss
• skin rash, hives, or itching
• acne or boils
• pale or reddened skin

Ask your doctor which of these tests should be done periodically while you are taking this drug:

• kidney function tests
• monthly liver function tests
• monthly complete blood tests (including hematocrit, platelet count, white blood cell count)
• examination for mouth ulcers