Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat leukemia and certain types of cancer of the breast, skin, head and neck, lung, or uterus.

Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis in adults. It is also used to treat active polyarticular-course juvenile rheumatoid arthritis in children.

Methotrexate is sometimes given when other medicines have not been effective.

Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. Methotrexate is sometimes used to treat cancer during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

Do not use this medicine to treat psoriasis or rheumatoid arthritis if you have low blood cell counts, a weak immune system, alcoholism or chronic liver disease, or if you are breastfeeding.

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. Some people have died after incorrectly taking methotrexate every day. You must use the correct dose for your condition.

Methotrexate can cause serious or fatal side effects. Tell your doctor if you have diarrhea, mouth sores, cough, shortness of breath, upper stomach pain, dark urine, numbness or tingling, muscle weakness, confusion, seizure, or skin rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use methotrexate if you are allergic to it. You may not be able to take this medicine if you have:

• alcoholism, cirrhosis, or chronic liver disease;

• low blood cell counts;

• a weak immune system or bone marrow disorder; or

• if you are pregnant or breastfeeding.

Methotrexate is sometimes used to treat cancer in people who have a condition listed above. Your doctor will decide if this treatment is right for you.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver problems, especially fluid in your stomach (ascites);

• kidney disease;

• lung problems, especially fluid in the lungs (pleural effusion);

• radiation treatments; or

• a stomach ulcer or ulcerative colitis.

Tell your doctor if you are pregnant or plan to become pregnant. Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. However, methotrexate is sometimes used to treat cancer during pregnancy.

Methotrexate can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using methotrexate and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using methotrexate.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because methotrexate may harm the baby if a pregnancy does occur.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Do not give this medicine to a child without the advice of a doctor.

Methotrexate comes as a tablet to take by mouth. Your doctor will tell you how often you should take methotrexate. The schedule depends on the condition you have and on how your body responds to the medication.

Your doctor may tell you to take methotrexate on a rotating schedule that alternates several days when you take methotrexate with several days or weeks when you do not take the medication. Follow these directions carefully and ask your doctor or pharmacist if you do not know when to take your medication.

If you are taking methotrexate to treat psoriasis or rheumatoid arthritis, your doctor may tell you to take the medication once a week. Pay close attention to your doctor's directions. Some people who mistakenly took methotrexate once daily instead of once weekly experienced very severe side effects or died.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take methotrexate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking methotrexate to treat psoriasis or rheumatoid arthritis, your doctor may start you on a low dose of the medication and gradually increase your dose. Follow these directions carefully.

If you are taking methotrexate to treat rheumatoid arthritis, it may take 3 to 6 weeks for your symptoms to begin to improve, and 12 weeks or longer for you to feel the full benefit of methotrexate. Continue to take methotrexate even if you feel well. Do not stop taking methotrexate without talking to your doctor.

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. This medicine is sometimes taken only once per week, or 2 to 4 times per week. Some conditions are treated daily for just a few days followed by a rest period of 1 week or longer before taking the medicine again.

You must use the correct dose. Some people have died after incorrectly taking methotrexate every day.

Take methotrexate exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Methotrexate can be toxic to your organs, and may lower your blood cell counts. You will need frequent medical tests, and you may need an occasional liver biopsy or chest X-ray. Your cancer treatments may be delayed based on the results.

If you need to be sedated for dental work, tell your dentist you currently use methotrexate.

Store methotrexate at room temperature away from moisture, heat, and light.

You may store Xatmep in a refrigerator or at room temperature. Avoid freezing or high heat. Throw away any unused Xatmep after 60 days if kept at room temperature.

You should not use methotrexate if you are allergic to it. You may not be able to take this medicine if you have:

• alcoholism, cirrhosis, or chronic liver disease;

• low blood cell counts;

• a weak immune system or bone marrow disorder; or

• if you are pregnant or breastfeeding.

Methotrexate is sometimes used to treat cancer in people who have a condition listed above. Your doctor will decide if this treatment is right for you.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver problems, especially fluid in your stomach (ascites);

• kidney disease;

• lung problems, especially fluid in the lungs (pleural effusion);

• radiation treatments; or

• a stomach ulcer or ulcerative colitis.

Tell your doctor if you are pregnant or plan to become pregnant. Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. However, methotrexate is sometimes used to treat cancer during pregnancy.

Methotrexate can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using methotrexate and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using methotrexate.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because methotrexate may harm the baby if a pregnancy does occur.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Do not give this medicine to a child without the advice of a doctor.

Call your doctor for instructions if you miss a dose of methotrexate.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methotrexate can be fatal.

Overdose symptoms may include bruising or unusual bleeding, mouth sores, vomiting, little or no urination, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. It may increase your risk of liver damage.

Do not receive a "live" vaccine while using methotrexate, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Methotrexate could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to methotrexate: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

• sudden chest pain, wheezing, dry cough, cough with mucus, chest pain, feeling short of breath;

• fever, chills, swollen lymph glands, night sweats, weight loss;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• vomiting, diarrhea, blood in your urine or stools;

• skin changes such as redness, warmth, swelling, or oozing;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• kidney problems - little or no urination, swelling in your feet or ankles;

• liver problems - swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• nerve problems - confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or

• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common methotrexate side effects may include:

• fever, chills, tiredness, not feeling well;

• low blood cell counts;

• mouth sores;

• nausea, stomach pain;

• abnormal liver function tests;

• hair loss;

• burning skin lesions; or

• being more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• an antibiotic or sulfa drug;

• folic acid;

• mercaptopurine;

• theophylline;

• NSAIDs> (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

• stomach acid reducers - esomeprazole, lansoprazole, omeprazole, pantoprazole, Nexium, Prilosec, Protonix, and others.

Many drugs can interact with methotrexate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.