Leflunomide Treatment Report

Precautions

Instructions

Side Effects

Interactions

You should not use this medication if you are allergic to leflunomide, 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:

• liver disease or a history of 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.

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.

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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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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:

• 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.

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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);
• cancer medications;
• 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).

Leflunomide can be harmful to the liver, and this effect is increased when leflunomide is used together with other medicines that can harm the liver. Tell your doctor if you are also using:

• 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), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), and others;
• an antibiotic such as dapsone, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);
• cholesterol medications such as niacin (Advicor), atorvastatin (Lipitor), simvastatin (Zocor), 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 (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others; or
• seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene).

This list is not complete and there may be other drugs that can interact with leflunomide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Arava and leflunomide

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