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All about: Arava

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Generic Name: leflunomide (oral) (leh FLEW no mide)
Brand Names: Arava

What is leflunomide?

Leflunomide affects the immune system and decreases inflammation.

Leflunomide is used to reduce the signs and symptoms of rheumatoid arthritis, reduce damage to the joints caused by rheumatoid arthritis, and to improve physical function in people with rheumatoid arthritis.

Leflunomide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about leflunomide?

Leflunomide is in the FDA pregnancy category X. There is an increased risk of birth defects and death of the unborn baby while taking leflunomide. Do not take this medication if you are pregnant or could become pregnant during treatment. Notify your doctor immediately if you think you have become pregnant during treatment. Birth control must be used during treatment with leflunomide. Discuss with your doctor the procedure for removing leflunomide from the body following treatment before becoming pregnant. Without the proper drug elimination procedure, it may take up to two years before leflunomide is at sufficiently low levels in the body so as to reduce the risk of harm to an unborn baby. It is not known whether leflunomide imposes an increased risk of fetal harm when taken by a man. Men wishing to father a child while taking leflunomide should discuss their options with their doctor.

What should I discuss with my healthcare provider before taking leflunomide?

Before taking leflunomide, tell your doctor if you have

  • liver disease or a history of hepatitis;
  • a history of significant alcohol use;

  • kidney disease;
  • an immune system disease;

  • recently received a live vaccine;

  • poor bone marrow function; or

  • a current or chronic infection.

You may not be able to take leflunomide, or you may require a dosage adjustment or special monitoring during your treatment if you have any of the conditions listed above.

Leflunomide is in the FDA pregnancy category X. There is an increased risk of birth defects and death of the unborn baby while taking leflunomide. Do not take this medication if you are pregnant or could become pregnant during treatment. Notify your doctor immediately if you think you have become pregnant during treatment. Birth control must be used during treatment with leflunomide. Discuss with your doctor the procedure for removing leflunomide from the body following treatment before becoming pregnant. Without the proper drug elimination procedure, it may take up to two years before leflunomide is at sufficiently low levels in the body so as to reduce the risk of harm to an unborn baby. It is not known whether leflunomide imposes an increased risk of fetal harm when taken by a man. Men wishing to father a child while taking leflunomide should discuss their options with their doctor. It is not known whether leflunomide passes into breast milk. There is a potential for serious side effects in a nursing baby from leflunomide. Do not take leflunomide if you are breast-feeding a baby.

How should I take leflunomide?

Take leflunomide exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Leflunomide can be taken with or without food or milk.

It is important to take leflunomide regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations while taking leflunomide to monitor side effects and progress.

Store leflunomide at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a leflunomide overdose may include diarrhea, abdominal pain, blood problems, and liver problems.

What should I avoid while taking leflunomide?

Discuss with your doctor the use of alcohol while taking leflunomide. Alcohol and leflunomide can both be damaging to the liver.

Leflunomide can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

Leflunomide side effects

If you experience any of the following serious side effects, stop taking leflunomide and seek medical treatment or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  • changes in liver function (may be detected by blood tests or cause symptoms such as yellowing of the skin or eyes; pale colored stools or dark colored urine; unusual fatigue; or abdominal pain);

  • decreased bone marrow function or blood problems (may be detected by blood tests or cause symptoms such as extreme or unusual fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); or

  • skin rash; or

  • sores in the mouth.

Other, less serious side effects may be more likely to occur. Continue to take leflunomide and talk to your doctor if you experience

  • headache;

  • increased blood pressure;

  • muscle aches;

  • nausea;

  • diarrhea; or

  • hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect leflunomide?

Before taking leflunomide, tell your doctor if you are taking any of the following drugs:

  • cholestyramine (Questran, Prevalite, LoCHOLEST);

  • methotrexate (Rheumatrex); or

  • rifampin (Rifadin, Rimactane).

You may not be able to take leflunomide, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with leflunomide. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines , including vitamins, minerals, and herbal products.

Where can I get more information?

  • Your pharmacist has additional information about leflunomide written for health professionals that you may read.

What does my medication look like?

Leflunomide is available with a prescription under the brand name Arava. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Arava 10 mg-white, round, film-coated tablets

  • Arava 20 mg-light-yellow, triangular, film-coated tablets

  • Arava 100 mg-white, round, film-coated tablets

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 4.03. Revision Date: 8/24/04 1:59:57 PM.

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