Methotrexate

February 20, 2008

From a silent sister:METHOTREXATE (WYETH)

IMPORTANT NOTE:

This is a summary and does not contain all possible information about

this product. For complete information about this product or your

specific health needs, ask your health care professional. Always seek

the advice of your health care professional if you have any questions

about this product or your medical condition. This information is not

intended as individual medical advice and does not substitute for the

knowledge and judgment of your health care professional. This

information does not contain any assurances that this product is safe,

effective, or appropriate for you.METHOTREXATE - ORAL: (meth-oh-TREX-ate)COMMON BRAND NAME(S): RheumatrexWARNING:

Methotrexate has rarely caused serious (sometimes fatal) side effects.

Therefore, this medication should be used only to treat cancer or

severe diseases caused by an overactive immune system (e.g., psoriasis,

rheumatoid arthritis). Methotrexate has caused birth defects and death

in unborn babies. Women must avoid becoming pregnant while taking this

medication. Pregnant women who have psoriasis or rheumatoid arthritis

must not use methotrexate. (See also Precautions) If you have kidney

problems or excess body water (ascites, pleural effusion), you must be

closely monitored and your dose may be adjusted or stopped by your

doctor. Methotrexate (usually at high dosages) has rarely caused severe

(sometimes fatal) bone marrow suppression (decreasing your body's

ability to fight infections) and stomach/intestinal disease (e.g.,

bleeding) when used at the same time as non-steroidal anti-inflammatory

drugs (NSAIDs such as indomethacin, ketoprofen). Therefore, NSAIDs

should not be used with high-dose methotrexate. Caution is advised if

you also take aspirin. NSAIDs/aspirin may be used with low-dose

methotrexate such as for the treatment of rheumatoid arthritis if

directed by your doctor. If you are using low-dose aspirin (81-325 mg

per day) for heart attack or stroke prevention, continue to take it

unless directed otherwise. Consult your doctor regarding safe use of

these drugs (e.g., close monitoring by your doctor, maintaining stable

doses of NSAIDs). In rare instances, this drug may also cause liver

problems when it is used for long periods of time. If you are using

methotrexate long-term, a liver biopsy is usually recommended.

Methotrexate use has rarely resulted in serious (sometimes fatal) lung

problems, lung infections (Pneumocystis carinii pneumonia), skin

reactions, diarrhea and mouth sores (ulcerative stomatitis). (See also

Side Effects.) Lumps (tumors/abnormal growths) may very infrequently

appear during methotrexate use. If this occurs, the drug must be

stopped and treatment may be needed. Consult your doctor immediately if

new lumps/growths occur. When used to treat tumors, methotrexate

sometimes causes side effects due to the rapid destruction of cancer

cells (tumor lysis syndrome). Tell your doctor immediately if you

experience symptoms such as irregular heartbeat or muscle weakness.

Although rare, this medication when used with radiation treatment may

increase the risk of tissue and bone damage. Discuss the risks and

benefits of your treatment plan with your doctor.USES:

Methotrexate is used to treat certain types of cancer or to control

severe psoriasis or rheumatoid arthritis. This medication works by

interfering with cell growth and by suppressing the immune system.

Early treatment of rheumatoid arthritis with more aggressive therapy

such as methotrexate helps to reduce further joint damage and to

preserve joint function.OTHER USES:

This section contains uses of this drug that are not listed in the

approved professional labeling for the drug but that may be prescribed

by your health care professional. Use this drug for a condition that is

listed in this section only if it has been so prescribed by your health

care professional. This medication has also been used to treat other

disorders such as lupus and psoriatic arthritis.HOW TO USE:

This is a potent medication. The dose and how often you take this drug

is based on your medical condition and response to therapy. There are

many different dosing schedules for this medicine (especially for

cancer treatment). Therefore, it is very important that you follow your

doctor's instructions carefully. Take it by mouth exactly as directed.

For managing psoriasis or rheumatoid arthritis, take this medication

exactly as directed, usually once a week. It may take up to several

months of continued use before the full benefit of this drug takes

effect. Do not increase your dose or take this medication more often

without your doctor's approval. Your condition will not improve any

faster and the risk of serious side effects may be increased. Unless

your doctor instructs you otherwise, drink plenty of fluids while

taking this medication. This helps your kidneys to remove the drug from

your body and minimize some of the side effects. This medication may

come with a Patient Information Leaflet. Read it carefully. Ask your

doctor or pharmacist any questions that you may have about this

medicine.METHOTREXATE (WYETH) SIDE EFFECTS:

See also Warning section. Nausea, vomiting, stomach pain, drowsiness or

dizziness may occur. If any of these effects persist or worsen, notify

your doctor or pharmacist promptly. Remember that your doctor has

prescribed this medication because he or she has judged that the

benefit to you is greater than the risk of side effects. Many people

using this medication do not have serious side effects. Tell your

doctor immediately if any of these serious side effects occur: mouth

sores, diarrhea, fever, fatigue, persistent sore throat, unusual

bleeding or bruising, black stools, skin rash, enlarged glands/lymph

nodes, dark urine, bone pain, unusual pain and discoloration of the

skin. Tell your doctor immediately if any of these unlikely but serious

side effects occur: yellowing eyes/skin, change in the amount of urine,

chest pain, dry cough, trouble breathing, calf pain/swelling, vision

changes, irregular heartbeat, muscle weakness, mental/mood changes,

seizures. Temporary hair loss may occur. Normal hair growth should

return after treatment has ended. A serious allergic reaction to this

drug is unlikely, but seek immediate medical attention if it occurs.

Symptoms of a serious allergic reaction include: rash, itching,

swelling, severe dizziness, trouble breathing. If you notice other

effects not listed above, contact your doctor or pharmacist.METHOTREXATE (WYETH) PRECAUTIONS:

Before taking methotrexate, tell your doctor or pharmacist if you are

allergic to it; or if you have any other allergies. This medication

should not be used if you have certain medical conditions. Before using

this medicine, consult your doctor or pharmacist if you have: liver

disease, severe kidney disease, severe lung disease (e.g., pulmonary

fibrosis), alcohol use, suppressed immune system, blood cell/bone

marrow disorders. Before using this medication, tell your doctor or

pharmacist your medical history, especially of: stomach/intestinal

diseases (e.g., peptic ulcer, ulcerative colitis), kidney disease, any

active infection (including chickenpox or recent exposure to it), folic

acid deficiency. This drug may make you dizzy or drowsy; use caution

engaging in activities requiring alertness such as driving or using

machinery. Avoid alcoholic beverages. This medication may make you more

sensitive to the sun. Avoid prolonged sun exposure, tanning booths or

sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not have immunizations/vaccinations without the consent of your

doctor and avoid contact with people who have recently received oral

polio vaccine. Use caution with sharp objects like safety razors or

nail cutters and avoid activities such as contact sports to lower the

chance of getting cut, bruised, or injured. Wash your hands well to

prevent the spread of infections. Methotrexate must not be used during

pregnancy. It may cause harm to an unborn baby. If you become pregnant

or think you may be pregnant, inform your doctor immediately. Pregnancy

must be avoided, therefore males and females must use reliable form(s)

of birth control during and for at least 3 months following the end of

methotrexate treatment. Methotrexate passes into breast milk. Due to

the risk to the infant, do not breast-feed while using this medication.METHOTREXATE (WYETH) DRUG INTERACTIONS:

Your doctor or pharmacist may already be aware of any possible drug

interactions and may be monitoring you for them. Do not start, stop, or

change the dosage of any medicine before checking with them first. See

also Warnings about non-steroidal anti-inflammatory drugs (NSAIDs) and

aspirin use. This drug should not be used with the following

medications because very serious interactions may occur: acitretin,

asparaginase, live vaccines, pyrimethamine. If you are currently using

any of these medications, tell your doctor or pharmacist before

starting methotrexate. Before using this medication, tell your doctor

or pharmacist of all prescription and nonprescription products you may

use, especially of: other cancer treatments potentially toxic to the

kidney (e.g., cisplatin), digoxin, leflunomide, other drugs potentially

toxic to the liver (e.g., azathioprine, sulfasalazine, retinoids such

as isotretinoin), penicillins, phenytoin, probenecid, procarbazine,

sulfa medications, theophylline. Certain antibiotics (e.g.,

chloramphenicol, sulfa, tetracyclines) may interfere with methotrexate

blood tests (increase methotrexate blood levels due to protein-binding

displacement). Make sure laboratory personnel and your doctors know you

are using any of these types of antibiotics.OVERDOSE:

If overdose is suspected, contact your local poison control center or

emergency room immediately. US residents can call the US national

poison hotline at 1-800-222-1222. Canadian residents should call their

local poison control center directly. Symptoms of overdose may include

severe nausea and vomiting, and bloody stools.NOTES:

Do not share this medication with others. Laboratory and/or medical

tests (e.g., CBC, liver and kidney function tests) should be performed

periodically to monitor your progress or check for side effects.

Consult your doctor for more details.MISSED DOSE:

It is important to use each dose at the scheduled time. If you miss a

dose, contact your doctor or pharmacist immediately to establish a new

dosing schedule. Do not double the dose to catch up.STORAGE:

Store this medication at room temperature between 59-86 degrees F

(15-30 degrees C) away from light and moisture. Do not store in the

bathroom. Keep all medicines away from children and pets. Properly

discard this product when it is expired or no longer needed. Consult

your pharmacist or local waste disposal company for more details about

how to safely discard your product.MEDICAL ALERT:

Your condition can cause complications in a medical emergency. For

enrollment information call MedicAlert at 1-800-854-1166 (USA), or

February 20, 2008