Methotrexate (meth-oh-TREX-ate)

Treats cancer, including bone, lung, breast, head, neck, or blood cancer (including acute lymphoblastic leukemia), mycosis fungoides, or non-Hodgkin lymphoma. Also treats rheumatoid arthritis, psoriasis (a skin disease), lupus, multiple sclerosis, and polyarticular juvenile idiopathic arthritis.

Brand Name(s):

Jylamvo, Trexall, Xatmep

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Do not take this medicine everyday to treat conditions other than cancer.
• Oral liquid: Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Tablet: Swallow whole. Do not crush, break, or chew it. Do not take the tablet if you cannot swallow it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you use this medicine only once a week and you miss a dose or forget to use your medicine, skip the missed dose and use your medicine as soon as possible. Return to your regular schedule the following week. Do not use extra medicine to make up for a missed dose.
• You may store this medicine in the refrigerator or at room temperature. If stored at room temperature, throw it away after 60 days. Do not freeze or expose this medicine to high temperatures.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how methotrexate works. Tell your doctor if you are using any of the following:
  • Acitretin, azathioprine, carbamazepine, cisplatin, clozapine, cyclosporine, foscarnet, phenytoin, pimecrolimus, probenecid, sulfasalazine, tacrolimus, theophylline
  • Antifolate medicine (including dapsone, pemetrexed, pyrimethamine, sulfonamides)
  • Blood thinner (including warfarin)
  • Diabetes medicine (including sulfonylureas)
  • Medicine to treat an infection (including penicillin, sulfamethoxazole, trimethoprim/sulfamethoxazole, neomycin, tetracyclines)
  • NSAIDs or pain medicine (including aspirin, diclofenac, ibuprofen, naproxen)
  • Other cancer medicines, including radiation treatment
  • Retinoid medicine
  • Salicylates
  • Steroid medicine
  • Stomach medicine (including esomeprazole, omeprazole, pantoprazole)
  • Vitamin supplements containing folic acid
• Do not take this medicine with foods that are rich in milk.
• Do not drink alcohol while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Female patients should use an effective form of birth control during treatment and for at least 3 or 6 months after the last dose. Male patients who have female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed during treatment and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, blood or bone marrow problems (including anemia), diabetes, a weak immune system, any type of infection, stomach or bowel problem (including ulcers), lung or breathing problem, or a history of alcohol abuse.
• This medicine may cause the following problems:
  • Serious infections, which may be life-threatening
  • Kidney problems
  • Stomach or bowel problems, including ulcer or perforation
  • Liver problems
  • Lung or breathing problems, including acute or chronic interstitial pneumonitis
  • Serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, or erythema multiforme
  • Increased risk of other cancers, including blood or skin cancer
  • Nerve problems
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, lower back or side pain
• Chest pain, trouble breathing, blue lips or fingers
• Dark urine or pale stools, nausea, vomiting, diarrhea, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Rapid weight gain, swelling in your leg, ankles, or feet
• Seizures, confusion, tingling or numbness in your hands, feet, or lips, trouble seeing, headache
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088