Methotrexate Sodium Solution for injection

What is this medicine?

METHOTREXATE (METH oh TREX ate) is a chemotherapy drug. This medicine affects cells that are rapidly growing, such as cancer cells and cells in your mouth and stomach. It is used to treat many cancers and other medical conditions. It is used for leukemias, lymphomas, breast cancer, lung cancer, head and neck cancers, and other cancers. This medicine also works on the immune system and is commonly used to treat psoriasis and rheumatoid arthritis.

How should I use this medicine?

This drug is given as an injection into a muscle or into a vein. It may also be given into the spinal fluid. It is administered in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

• breathing problems, like a dry cough

• changes in vision

• confusion, not alert

• diarrhea

• mouth or throat sores or ulcers

• problems with balance, talking, walking

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• trouble passing urine or change in the amount of urine

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in skin color

• eye irritation

• hair loss

• headache

• loss of appetite

• nausea

• stomach upset

What may interact with this medicine?

• antibiotics and other medicines for infections

• aspirin and aspirin-like medicines including bismuth subsalicylate (Pepto-Bismol)

• cisplatin

• dapsone

• folic acid in supplements or vitamins

• mercaptopurine

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• pemetrexed

• phenylbutazone

• phenytoin

• probenecid

• pyrimethamine

• theophylline

• trimetrexate

• vaccines

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• if you frequently drink alcohol containing drinks

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• immune system problems

• kidney disease

• liver disease

• low blood counts, like platelets, red bloods, or white blood cells

• lung disease

• recent or ongoing radiation therapy

• an unusual or allergic reaction to methotrexate, benzyl alcohol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor for checks on your progress. You will need to have regular blood checks during your treatment to monitor your blood, liver function, and kidney function.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea.

To protect your kidneys, drink water or other fluids as directed while you are taking this medicine.

Do not drink alcohol-containing drinks while taking this medicine. Both alcohol and the medicine may cause damage to your liver.

Men and women must use effective birth control while they are taking this medicine. Do not become pregnant while taking this medicine. Women must continue using effective birth control for 1 full menstrual cycle after stopping this medicine. Tell your doctor right away if you think that you or your partner might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine. Men must continue effective birth control for 3 months after stopping this medicine.