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What is leflunomide?
Leflunomide affects the immune system and reduces swelling and inflammation in the body. Leflunomide is used to treat the symptoms of rheumatoid arthritis. Leflunomide also helps reduce joint damage and improves physical functioning. Leflunomide may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

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What are the possible side effects of leflunomide?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using leflunomide and call your doctor at once if you have any of these serious side effects:

• fever, chills, body aches, flu symptoms;

• white patches or sores inside your mouth or on your lips;

• chest pain;

• cough, trouble breathing (you may also have a fever);

• pain or burning when you urinate;

• pale skin, easy bruising or bleeding, unusual weakness;

• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

• weakness;

• nausea, stomach pain, diarrhea, loss of appetite;

• weight loss;

• headache, dizziness;

• numbness or tingling;

• sore throat, runny or stuffy nose; or

• mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take leflunomide?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Leflunomide can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

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What is the most important information I should know about leflunomide?
This medication can cause birth defects. Do not use if you are pregnant. Your doctor may want you to have a pregnancy test to make sure you are not pregnant before you start taking leflunomide. Stop taking leflunomide and tell your doctor right away if you become pregnant during treatment. You will need to receive medications to help your body eliminate the drug quickly and reduce the risk of harm to your unborn baby. Use effective birth control while you are taking leflunomide, whether you are a man or a woman. After your treatment ends, continue using birth control until you have received the drug elimination medications.

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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, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

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What other drugs will affect leflunomide?
Before taking leflunomide, tell your doctor if you are taking cholestyramine (Questran, Prevalite, LoCHOLEST) or rifampin (Rifadin, Rimactane). Also tell your doctor if you are using medications that can weaken your immune system, such as: methotrexate (Rheumatrex); cyclosporine (Neoral, Sandimmune, Gengraf); sirolimus (Rapamune), tacrolimus (Prograf); basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone); mycophenolate mofetil (CellCept); or azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel).

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Leflunomide has been assigned to category X by the FDA. Animal studies have revealed signs of teratogenicity and embryolethality. There are no controlled data in human pregnancy. Women of childbearing potential must not be started on leflunomide until pregnancy is excluded and it has been established that they are using reliable contraception. Use of leflunomide is considered contraindicated in women who are or may become pregnant, or prior to the completion of the drug elimination procedure after treatment. Before starting treatment with leflunomide, the patient should be cautioned of the potential for serious risk to a fetus. There are no data that suggest leflunomide is associated with an increased risk of male-mediated fetal toxicity. Animal studies to evaluate this risk have not been conducted. However, to minimize any possible risk, the manufacturer recommends that men wishing to father a child should consider discontinuing use of leflunomide and take cholestyramine 8 grams, 3 times a day for 11 days.

The manufacturer states that women of childbearing potential must be advised that if there is any delay in the onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing. If the results are positive, the physician and patient must discuss the risk to the pregnancy. Rapidly lowering the blood level of the active metabolite (by instituting the drug elimination procedure below), at the first delay of menses may decrease the risk to the fetus. Following discontinuation of leflunomide, all women of childbearing potential should undergo the following drug elimination procedure (below): 1) Administer cholestyramine 8 grams, 3 times daily for 11 days. (The 11 days only need to be consecutive when there is a need (such as pregnancy) to lower the cholesterol levels rapidly.) 2) Verify plasma levels less than 0.02 mg/L by 2 separate tests at least 14 days apart. If plasma levels are higher than 0.02 mg/L, additional cholestyramine treatment should be considered. Human plasma levels less than 0.02 mg/L are expected to have minimal risk based on available animal data. Without the drug elimination procedure, it may take up to 2 years to reach plasma M1 metabolite levels less than 0.02 mg/L due to individual variation in drug clearance.

There are no data on the excretion of leflunomide into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Leflunomide is not recommended for use by nursing mothers.

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Who should NOT use this medication?

• Known hypersensitivity to leflunomide or any ingredient in the formulation.
• Do not initiate leflunomide in pregnant women or women of childbearing potential unless the possibility of pregnancy has been excluded and an effective method of contraception has been started. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include diarrhea, abdominal pain, blood problems, and liver problems.

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What should I discuss with my healthcare provider before taking leflunomide?
You should not use this medication if you are allergic to leflunomide, or if you are pregnant or may become pregnant. Before taking leflunomide, tell your doctor if you are allergic to any drugs, or if you have: liver disease or a history of hepatitis; any type of infection; a weak immune system or a bone marrow disorder; or if you are using any drugs that weaken your immune system (such as cancer medicine or steroids). If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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