Leflunomide (patient information)

IMPORTANT WARNING
Pregnant women and women of childbearing age who are not using a reliable method of birth control should not take leflunomide. Pregnancy must be avoided during treatment and for 2 years after treatment with leflunomide. If your period is late or you miss a period during treatment with leflunomide, call your doctor immediately. Talk to your doctor if you plan to become pregnant after stopping treatment with leflunomide. Your doctor can prescribe a treatment that will decrease the risk of harm to the fetus.

Why this medication is prescribed
Leflunomide is used to treat rheumatoid arthritis. Leflunomide decreases the symptoms of rheumatoid arthritis and slows damage to joints caused by the disease.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How this medication should be used
Leflunomide comes as a tablet to take by mouth. It is usually taken once a day. You will need to take a larger dose for the first 3 days of treatment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take leflunomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Special precautions
Before taking leflunomide:


 * tell your doctor and pharmacist if you are allergic to leflunomide or any other drugs.
 * tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially cholestyramine (Cholybar, Questran), colestipol (Colestid), felbamate (Felbatol), mercaptopurine (Purinethol), rifampin (Rifadin, Rimactane, Rifater), methotrexate (Rheumatrex), tolbutamide (Orinase), troglitazone (Rezulin), and vitamins.
 * tell your doctor if you have or have ever had liver or kidney disease, hepatitis, severe infections, or conditions affecting the bone marrow or the immune system (including human immunodeficiency virus [HIV] and acquired immunodeficiency syndrome [AIDS]).
 * tell your doctor if you are breast-feeding.
 * if you are planning to father a child, you should talk to your doctor about stopping leflunomide prior to conception.
 * you should not receive any vaccinations while taking leflunomide unless you have talked with your doctor.
 * you should know that there is a special treatment for removing leflunomide from your body once you stop taking it. Ask your doctor or pharmacist for more information about this treatment.

What to do if you forget a dose
Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Minor side effects
Leflunomide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:


 * diarrhea
 * hair loss
 * headache
 * dizziness
 * upset stomach
 * vomiting
 * stomach pain
 * loss of appetite
 * weight loss
 * mouth sores
 * runny nose
 * back pain
 * dry or itchy skin
 * muscle pain or weakness
 * flu-like symptoms
 * urinary tract infection

Severe side effects
If you experience any of the following symptoms, call your doctor immediately:


 * rash
 * difficulty breathing
 * chest pain
 * increased heart rate

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication
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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Other information
Keep all appointments with your doctor. Your doctor will order certain laboratory tests to monitor your response to leflunomide.

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

Brand names

 * Arava®