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

Trexall is also used to treat severe psoriasis and rheumatoid arthritis in adults.

Trexall is also used to treat active polyarticular-course juvenile rheumatoid arthritis in children.

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

Trexall may also be used for purposes not listed in this medication guide.

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

Do not use Trexall 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 Trexall EVERY DAY. Some people have died after incorrectly taking this medicine every day. You must use the correct dose for your condition.

Trexall 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.

YOU MAY NOT NEED TO TAKE Trexall 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 Trexall every day.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Trexall 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 Trexall.

Store Trexall 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 Trexall 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.

Trexall 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.

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. Trexall may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. However, this medicine is sometimes used to treat cancer during pregnancy.

Trexall can harm an unborn baby if the mother or the father is using Trexall.

• 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 Trexall 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 Trexall.

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 Trexall 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 Trexall.

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.

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

Do not receive a "live" vaccine while using Trexall, 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.

Trexall 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 (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).

Trexall 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 side effects of Trexall 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 affect Trexall. 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.