Leflunomide

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Leflunomide


Generic Name: Leflunomide (le-FLOO-noh-mide)
Brand Name: Arava

Leflunomide is not to be used by women who are pregnant or women of childbearing potential who are not using effective birth control methods. Avoid becoming pregnant while taking Leflunomide . Unless women who have taken Leflunomide go through a certain process to remove Leflunomide from their body, pregnancy must be avoided for at least 2 years after use of Leflunomide has stopped.


Leflunomide is used for:

Reducing signs and symptoms of rheumatoid arthritis. It is also used to improve physical function and to prevent the development of structural damage to the joints.

Leflunomide is a pyrimidine synthesis inhibitor. It is thought to work by blocking certain enzymes responsible for abnormal tissue development or growth.

Do NOT use Leflunomide if:

  • you are allergic to any ingredient in Leflunomide
  • you are pregnant or planning to become pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Leflunomide :

Some medical conditions may interact with Leflunomide . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a weakened immune system, blood or bone marrow disorders, an infection, or have recently received a vaccination
  • if you have hepatitis B or C or other liver problems, kidney problems, or drink alcoholic beverages

Some MEDICINES MAY INTERACT with Leflunomide . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Cholestyramine because the effectiveness of Leflunomide may be decreased
  • Methotrexate or rifampin because side effects, including liver toxicity, headache, and muscle pains, may occur
  • Anticoagulants (eg, warfarin) because side effects, including risk of bleeding, may be increased by Leflunomide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Leflunomide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Leflunomide :

Use Leflunomide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Leflunomide may be taken with or without food.
  • It may take 4 weeks or more to notice any improvement while taking Leflunomide .
  • If you miss a dose of Leflunomide , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Leflunomide .

Important safety information:

  • Drinking alcohol while you are taking Leflunomide may increase the risk of liver problems. Talk with your doctor before drinking alcohol while taking Leflunomide .
  • Avoid receiving vaccines while taking Leflunomide .
  • Contact your doctor immediately if you develop a skin rash, small blisters over a large portion of the body, or lesions around the eyes, mouth, or throat.
  • LAB TESTS, including liver function, may be performed to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments.
  • Leflunomide is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
  • Leflunomide may cause birth defects in children of men taking Leflunomide at the time of conception. Discuss the use of reliable birth control methods (eg, condoms) with your doctor or pharmacist while taking Leflunomide . Talk with your health care provider about stopping Leflunomide if you and your female partner are planning for parenthood.
  • PREGNANCY and BREAST-FEEDING: Leflunomide may cause harm to the fetus. Leflunomide must not be used during pregnancy, or by women who are able to become pregnant unless they are using reliable forms of birth control. A negative pregnancy test must be obtained before the start of treatment with Leflunomide . Contact your health care provider at once if your menstrual flow is delayed or if you suspect that you are pregnant. After completing therapy, women of childbearing potential who plan to become pregnant must undergo a procedure to flush any remaining medicine out of the body system. It is unknown if Leflunomide is excreted in breast milk. Do not breast-feed while taking Leflunomide .

Possible side effects of Leflunomide :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; bronchitis; diarrhea; dizziness; dry skin; hair loss; headache; increased cough; indigestion; joint disorder; loss of appetite; muscle aches; nausea; runny nose; sinus infection; upper respiratory tract infection; urinary tract infection; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering or peeling skin; blisters on the inside of eyes, nose, or mouth; chest pain; dark urine; easy bruising/bleeding; feelings of numbness or tingling; fever; infection; muscle cramps, including leg cramps; pale skin; pale stools; sore throat; stomach pain; unusual tiredness; vomiting; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Leflunomide :

Store this medicine at room temperature at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in bathroom. Keep Leflunomide out of the reach of children and away from pets.

General information:

  • If you have any questions about Leflunomide , please talk with your doctor, pharmacist, or other health care provider.
  • Leflunomide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Leflunomide . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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