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Description

Methotrexate belongs to the group of medicines known as antimetabolites. It is used to treat cancer of the breast, head and neck, lung, blood, bone, and lymph, and tumors in the uterus. It may also be used to treat other kinds of cancer, as determined by your doctor.

Methotrexate blocks an enzyme needed by the cell to live. This interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by methotrexate, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with methotrexate, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Methotrexate is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, methotrexate is used in certain patients with the following medical conditions:

• Acute nonlymphocytic leukemia (a type of cancer of the blood and lymph system)
• Cancer in the membranes that cover and protect the brain and spinal cord (the meninges)
• Cancer of the bladder
• Cancer of the brain (lymphoma)
• Cancer of the cervix
• Cancer of colon and rectum
• Cancer of the esophagus
• Cancer of the ovaries
• Cancer of the pancreas
• Cancer of the penis
• Cancers of the soft tissues of the body, including the muscles, connective tissues (tendons), vessels that carry blood or lymph, or fat
• Cancer of the stomach
• Hodgkin's lymphoma (a cancer of the lymph system, a part of the body's immune system)

This product is available in the following dosage forms:

• Tablet
• Solution
• Powder for Solution
• Injectable

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Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Newborns and other infants may be more sensitive to the effects of methotrexate. However, in other children it is not expected to cause different side effects or problems than it does in adults.

Geriatric

Side effects may be more likely to occur in the elderly, who are usually more sensitive to the effects of methotrexate.

Pregnancy

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of)—Increased risk of unwanted effects on the liver

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Colitis

• Disease of the immune system

• Gout (history of) or
• Kidney stones (or history of)—Methotrexate may increase levels of a chemical called uric acid in the body, which can cause gout or kidney stones

• Infection—Methotrexate can reduce immunity to infection

• Intestine blockage or
• Kidney disease or
• Liver disease—Effects may be increased because of slower removal of methotrexate from the body

• Mouth sores or inflammation or
• Stomach ulcer—May be worsened

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Proper Use

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Methotrexate is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

While you are using methotrexate, your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug to pass from the body, and will prevent kidney problems and keep your kidneys working well.

Methotrexate commonly causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of methotrexate, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not drink alcohol while using this medicine. Alcohol can increase the chance of liver problems.

Some patients who take methotrexate may become more sensitive to sunlight than they are normally. When you first begin taking methotrexate, avoid too much sun and do not use a sunlamp until you see how you react to the sun, especially if you tend to burn easily. In case of a severe burn, check with your doctor.

Do not take medicine for inflammation or pain (aspirin or other salicylates, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, naproxen, phenylbutazone, piroxicam, sulindac, suprofen, tolmetin) without first checking with your doctor. These medicines may increase the effects of methotrexate, which could be harmful.

While you are being treated with methotrexate, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Methotrexate may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Methotrexate can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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Side Effects

Along with their needed effects, medicines like methotrexate can sometimes cause unwanted effects such as blood problems, kidney problems, stomach or liver problems, loss of hair, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• Blood in urine or stools
• Bloody vomit
• Diarrhea
• Joint pain
• Reddening of skin
• Stomach pain
• Swelling of feet or lower legs

• Blurred vision
• Confusion
• Convulsions (seizures)
• Cough
• Pinpoint red spots on skin
• Shortness of breath
• Unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur:

• Sores in mouth and on lips

• Back pain
• Cough or hoarseness accompanied by fever or chills
• Dark urine
• Dizziness
• Drowsiness
• Fever or chills
• Headache
• Lower back or side pain accompanied by fever or chills
• Painful or difficult urination accompanied by fever or chills
• Unusual tiredness or weakness
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Loss of appetite
• Nausea or vomiting

• Acne
• Boils
• Pale skin
• Skin rash or itching

This medicine may cause a temporary loss of hair in some people. After treatment with methotrexate has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Back pain
• Blurred vision
• Confusion
• Convulsions (seizures)
• Dizziness
• Drowsiness
• Fever
• Headache
• Unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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