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GENERIC NAME: LEFLUNOMIDE - ORAL (leh-FLEW-no-mide)

BRAND NAME(S): Arava

Warning | Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage | Medical Alert

WARNING: Pregnancy must be excluded before the start of treatment with leflunomide. This drug must not be used during pregnancy, nor by women of childbearing age who are not using reliable birth control (contraception). Unless female leflunomide users go through a certain process to eliminate this drug from their body, pregnancy must be avoided for 2 years after this drug has been stopped.

USES: This medication is used to treat arthritis (rheumatoid type). It works by suppressing your immune system, since rheumatoid arthritis is caused by damage from an overactive immune system.

HOW TO USE: This drug is taken by mouth, generally once daily. Follow directions carefully, as it is generally recommended to start with a special higher dose for the first 3 days, then decrease to the regular dose thereafter. Dosing is based on your medical conditions, response to therapy, and liver function test results. After treatment is stopped, cholestyramine may be given as directed, generally three times daily for 11 days. This procedure is used if you require a rapid removal of the drug from your system. Without the procedure the drug may persist for 2 years. Consult your doctor or pharmacist to learn whether you are a candidate for cholestyramine treatment (such as a couple planning to have children).

SIDE EFFECTS: Nausea, diarrhea, flu-like symptoms, mild dizziness, headache may occur. If these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of the following unlikely but serious side effects occur: hair loss, chest pain, back pain, mouth sores, muscle cramping, numbness/tingling sensations. Tell your doctor immediately if any of the following highly unlikely but very serious side effects occur: unusual lumps (lymph gland enlargement). Leflunomide has rarely caused serious (possibly fatal) infections and blood disorders due to suppressing the bone marrow and immune system. Tell your doctor immediately if signs of infection (such as fever), extreme weakness/fatigue, or easy bruising/bleeding develop. Leflunomide may need to be stopped. The elimination procedure using cholestyramine or charcoal may be required (see How to Use section). Consult your doctor or pharmacist for more details. Leflunomide has rarely caused serious (possibly fatal) liver disease, especially in people with other risks for liver disease. Tell your doctor immediately if persistent nausea or vomiting, stomach/abdominal pain, dark urine, or yellowing eyes/skin develop. Leflunomide may need to be stopped. The elimination procedure using cholestyramine or charcoal may be required (see How to Use section). Consult your doctor or pharmacist for more details. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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