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Leflunomide

Pronunciation

Generic Name: leflunomide (le-FLOO-noe-mide)
Brand Name: Arava

Leflunomide may cause fetal harm (eg, birth defects) or fetal death. Do not take leflunomide if you are pregnant or if you may become pregnant and are not using an effective form of birth control. You must make sure you are not pregnant before you start leflunomide. Do not become pregnant while you take leflunomide or for as long as any medicine remains in your body after you stop treatment. Leflunomide may stay in the body for 2 years or longer after you stop it. Women who may become pregnant must use effective birth control while they take leflunomide and for as long as any medicine remains in the body.

After you stop leflunomide, your doctor may prescribe other medicines to help remove leflunomide from your body more quickly. Blood tests may also be performed to check if any medicine remains in the body. Talk with your doctor for more information and if you have questions about effective birth control.

Serious and sometimes fatal liver problems have been reported with leflunomide. Your doctor will monitor your liver function while you use leflunomide to check for liver problems. Do not take leflunomide if you have liver problems or if you have abnormal liver function tests before taking leflunomide. Ask your doctor if you are taking other medicines that may harm the liver. Contact your doctor right away if you develop symptoms of liver problems, such as dark urine, pale stools, yellowing of the skin or eyes, stomach pain, severe or persistent nausea or loss of appetite, or unusual tiredness.


Leflunomide is used for:

Treating rheumatoid arthritis by reducing signs and symptoms, improving physical function, and preventing 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, planning to become pregnant, or breast-feeding
  • you may become pregnant and are not using effective birth control
  • you have bone marrow problems; a severely weakened immune system; or a severe, uncontrolled infection
  • you have liver problems (eg, hepatic insufficiency or failure), abnormal liver function tests prior to taking leflunomide, or a history of hepatitis B or C infection

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

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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 pregnant, planning to become pregnant, or 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, an infection, a history of an infection that keeps coming back, or you have recently received a vaccination
  • if you have a history of lung problems, tuberculosis (TB) or a positive TB test, high blood pressure, blood or bone marrow problems, diabetes, liver problems, abnormal liver function tests, or if you drink alcoholic beverages
  • if you have or have a history of kidney problems or you are on dialysis
  • if you take or have recently taken methotrexate, another medicine to treat rheumatoid arthritis, or another medicine that may suppress your immune system
  • if you are taking medicine to treat or prevent malaria

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

  • Methotrexate because the risk of liver problems, blood problems, or infection may be increased
  • Rifampin because it may increase the risk of leflunomide's side effects
  • Anticoagulants (eg, warfarin) because the risk of its side effects, including bleeding, may be increased by leflunomide
  • Medicines that may suppress the immune system because the risk of infection or unusual bruising or bleeding may be increased. Ask your doctor if you are unsure if any of your medicines may suppress the immune system
  • Medicines that may cause nerve problems, because the risk of a certain nerve side effect (burning, numbness, or tingling sensation) may be increased. Ask your doctor if you are unsure if any of you medicines may cause nerve problems
  • Cholestyramine because it may decrease leflunomide's effectiveness
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

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.

  • Take leflunomide by mouth 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:

  • Leflunomide may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use leflunomide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Drinking alcohol while you are taking leflunomide may increase the risk of liver problems. Talk with your doctor before drinking alcohol while taking leflunomide.
  • Leflunomide may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Leflunomide may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking leflunomide. Talk with your doctor before you receive any vaccine.
  • The safety of leflunomide in patients with inactive TB has not been confirmed. You may need to have a TB skin test before you start leflunomide to determine if you have TB infection. Discuss any questions or concerns with your doctor.
  • Serious and sometimes fatal liver problems have been reported with leflunomide. Contact your doctor right away if you develop symptoms such as dark urine, pale stools, yellowing of the skin or eyes, stomach pain, severe or persistent nausea or loss of appetite, or unusual tiredness.
  • A serious and sometimes fatal lung problem (interstitial lung disease) has been reported with leflunomide. Contact your doctor right away if you develop new or worsening breathing problems, such as cough or shortness of breath (with or without fever).
  • Serious and sometimes fatal skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been rarely reported with leflunomide. Contact your doctor right away if you develop a rash; red, swollen, blistered, or peeling skin; or blisters on the inside of the eyes, nose, or mouth.
  • Lab tests, including liver function, blood pressure, and complete blood cell counts, may be performed to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use leflunomide with caution in the ELDERLY; they may be more likely to develop burning, numbness, or tingling.
  • Leflunomide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Leflunomide may remain in the body for 2 years or longer after you stop taking it. Your doctor may prescribe medicine to help remove leflunomide from your body more quickly after you finish treatment (drug elimination procedure). Talk with your doctor for more information.
  • The risk of harm or death to a fetus fathered by a man using leflunomide is not known. Men who take leflunomide should talk with their doctor about the need to use a condom when having sex with a woman who may become pregnant. If you wish to father a child, talk with your doctor. You may need to stop leflunomide and complete the drug elimination procedure to remove it from your blood before you father a child.
  • If you are able to become pregnant, you must not start leflunomide unless it has been confirmed that you are not pregnant. You will need to use an effective form of birth control while you take leflunomide and for as long as leflunomide remains in your body. If you plan to become pregnant, talk with your doctor about stopping leflunomide and completing the drug elimination procedure before you become pregnant. Talk with your doctor for more information or if you have questions about effective birth control.
  • PREGNANCY and BREAST-FEEDING: Do not use leflunomide if you are pregnant. It may cause birth defects or fetal death. You must have a negative pregnancy test before you start treatment with leflunomide. Do not become pregnant while you are taking it. Contact your doctor at once if your period does not occur when expected or if you suspect that you are pregnant. It is not known if leflunomide is found 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; diarrhea; dizziness; hair loss; headache; indigestion; muscle aches; nausea; runny nose; 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); blisters on the inside of the eyes, nose, or mouth; burning, numbness, or tingling; chest pain; fast or irregular heartbeat; muscle cramps, including leg cramps; new or worsening breathing problems (eg, cough or shortness of breath, with or without fever); red, swollen, blistered, or peeling skin; severe or persistent vomiting; symptoms of high blood pressure (eg, severe or persistent headache or dizziness, vision changes); symptoms of infection (eg, fever, chills, sore throat, cough, increased or painful urination); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes, stomach pain, severe or persistent nausea or loss of appetite); unusual or easy bruising or bleeding; unusual tiredness; unusually pale skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of leflunomide:

Store leflunomide 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take leflunomide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about leflunomide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to leflunomide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using leflunomide.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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