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leflunomide

Pronunciation

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

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.

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

Leflunomide can harm an unborn baby or cause birth defects. Do not use leflunomide 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.

Slideshow: Drug Treatment for Rheumatoid Arthritis - What Are Your Options?

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.

Before taking leflunomide, tell your doctor if you have a history of liver disease or hepatitis, kidney disease, any type of infection, a history of tuberculosis, a blood cell disorder such as anemia or low platelets, a bone marrow disorder, or if you are using any drugs that weaken your immune system (such as cancer medicine or steroids).

Leflunomide can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with leflunomide, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

After you stop taking leflunomide, you may need to be treated with other medications to help your body eliminate leflunomide quickly. Without receiving this drug elimination procedure, leflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.

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

You should not use this medication if you are allergic to leflunomide, if you have liver disease, or if you are pregnant or may become pregnant.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take this medication:

  • a history of liver disease or hepatitis;

  • kidney disease;

  • any type of infection;

  • a history of tuberculosis;

  • a blood cell disorder (such as anemia, easy bruising or bleeding);

  • a weak immune system or bone marrow disorder; or

  • if you are using any drugs that weaken your immune system (such as cancer medicine or steroids).

FDA pregnancy category X. This medication can cause birth defects. Do not use leflunomide 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 if you miss a period, and tell your doctor right away if you become pregnant during treatment. If you become pregnant while taking leflunomide, you will need to receive medications to help your body eliminate the drug quickly. This will reduce the risk of harm to your unborn baby. You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking leflunomide.

Use effective birth control while you are taking leflunomide. After your treatment ends, continue using birth control until you have received the drug elimination medications.

If a man fathers a child during or after leflunomide treatment, the baby may have birth defects. Use a condom to prevent pregnancy while you are taking leflunomide. After your treatment ends, continue using condoms until you have received the medications to help your body eliminate leflunomide.

It is not known whether leflunomide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take leflunomide?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Before you start taking leflunomide, you may need a skin test to make sure you do not have tuberculosis.

Your doctor may occasionally change your dose to make sure you get the best results.

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 often. Your liver function may also need to be tested. Visit your doctor regularly.

After you stop taking leflunomide, you may need to be treated with other medications to help your body eliminate leflunomide quickly. Without receiving this drug elimination procedure, leflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.

Rheumatoid arthritis is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include diarrhea, stomach pain, easy bruising or bleeding, dark urine, or jaundice (yellowing of the skin or eyes).

What should I avoid while taking leflunomide?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using leflunomide, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Leflunomide side effects

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;

  • chest pain, dry cough, wheezing, feeling short of breath (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:

  • mild stomach pain, diarrhea, loss of appetite;

  • weight loss;

  • headache, dizziness;

  • back pain;

  • numbness or tingling;

  • runny or stuffy nose, cold symptoms; or

  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Leflunomide dosing information

Usual Adult Dose for Rheumatoid Arthritis:

Loading dose: 100 mg once daily for 3 days.

Maintenance: 10 to 20 mg daily.

Study (n=263)
100 mg per day for 2 days, followed by 10 mg leflunomide daily in combination with methotrexate (10 to 15 mg/week or 15 to 20 mg/week), and folate 1 mg/day.

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, Trexall);

  • cancer medications;

  • cyclosporine (Neoral, Sandimmune, Gengraf);

  • sirolimus (Rapamune), tacrolimus (Prograf);

  • basiliximab (Simulect), muromonab-CD3 (Orthoclone);

  • mycophenolate mofetil (CellCept); or

  • azathioprine (Imuran), etanercept (Enbrel).

Leflunomide can harm your liver. This effect is increased when you also use other medicines harmful to the liver, such as:

  • acetaminophen (Tylenol);

  • tuberculosis medications;

  • birth control pills or hormone replacement therapy;

  • other arthritis medications such as auranofin (Ridaura) or aurothioglucose (Solganol);

  • an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;

  • an antibiotic such as dapsone or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);

  • an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);

  • cholesterol medications such as niacin (Advicor, Niaspan, Niacor, Slo-Niacin, and others), atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin), and others;

  • HIV/AIDS medications such as abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Combivir, Epivir), nevirapine (Viramune), tenofovir (Viread), or zidovudine (Retrovir);

  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

  • seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene).

This list is not complete and other drugs may interact with leflunomide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about leflunomide.
  • 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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 7.01. Revision Date: 2011-08-12, 4:53:14 PM.

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