When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to methotrexate, or if you are pregnant or breastfeeding.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin, into a muscle, or into a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to. This medicine should only be given once a week.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
• If you store this medicine at home, keep it at room temperature, away from heat and direct light.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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:
  
  • Azathioprine, hydroxychloroquine, mercaptopurine, phenylbutazone, phenytoin, probenecid, theophylline, or a retinoid
  • Medicine to treat an infection, an NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen), steroid medicines, sulfa drugs, stomach medicine (such as esomeprazole, lansoprazole, omeprazole, pantoprazole), or vitamin supplements that contain folic acid
• 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. Men should continue birth control for at least 3 months after the last dose. Women should continue birth control for at least 1 menstrual period after the last dose.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Tell your doctor if you have kidney disease, liver disease, bone marrow problems (such as anemia), diabetes, a weak immune system, any type of infection, stomach ulcers, or a history of alcohol abuse.
• This medicine may cause the following problems:
  
  • Stomach ulcer or perforation
  • Liver or lung damage
  • Serious skin reactions
  • Higher risk of lymphoma (cancer of the lymph system)
  • Tumor lysis syndrome (high levels of electrolytes or minerals in your blood)
• This medicine may make you dizzy or tired. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• 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 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. You may also need chest x-rays.
• 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, or blue lips or fingers
• Dark urine or pale stools, nausea, vomiting, diarrhea, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, dry cough, sore throat, and body aches
• Seizures, confusion, tingling or numbness in your hands, feet, or lips, trouble seeing, headache
• Unusual bleeding, bruising, or weakness

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

• Mild diarrhea, nausea, vomiting, stomach pain
• 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