Leflunomide, Oral

What are other names for this medicine?

Type of medicine: antirheumatic

Generic and brand names: leflunomide, oral; Arava

What is this medicine used for?

This medicine is taken by mouth to treat rheumatoid arthritis in adults. It helps to lessen its symptoms and reduce damage to the joints. It may be used for other conditions as determined by your health care provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have:

• an allergy to any medicine
• an immune system disorder caused by other medicines, a bone marrow disorder, or AIDS
• a bleeding disorder
• an infection
• breathing problems or lung disease
• kidney or liver disease

Females of childbearing age: This medicine has been reported to cause birth defects. Read the information that comes in the medicine package. You must meet certain conditions and sign a consent form. Use 2 forms of birth control to avoid pregnancy. You must not get pregnant while you are using this medicine and for several weeks after your treatment ends. This is very important whether you are a man or a woman. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: If you wish to father a child, stop taking this medicine. Use 2 forms of birth control to prevent pregnancy. You must not father a child while you are using this medicine and for several weeks after your treatment ends. To reduce the risk of harm to the baby, you should take another medicine to eliminate this drug from your blood and tissues.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval, even if you start to feel better. When your healthcare provider tells you to stop, you may need to take another medicine to help eliminate this medicine from your blood. Follow your healthcare provider's directions exactly.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: yellowing of the skin or eyes, severe and sudden stomach pain, diarrhea, vomiting.

What should I watch out for?

WARNING: Do not take this medicine if you are pregnant because it will seriously harm the baby. You will need to take a pregnancy test to be sure that you are not pregnant before taking this medicine. You must use a reliable method of birth control while taking this medicine. After you stop taking this medicine, do not become pregnant until you have completed a drug elimination procedure. Talk to your healthcare provider about this. After you start taking this medicine, if you have any sign of pregnancy such as a late period, stop taking this medicine and contact your healthcare provider right away. Do not breast-feed a baby while you are taking this medicine.

You need to have regular blood tests while taking this medicine. Keep all appointments for these tests.

Do not drink alcohol while taking this medicine. Alcohol can increase your risk of serious side effects.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Yellowish eyes or skin, dark colored urine, unusual bruising or bleeding, unexplained tiredness, pale skin, fever, cough or shortness of breath, abdominal pain, sores on the skin or in the mouth, severe nausea or vomiting.

Other: Hair loss, diarrhea, heartburn, weight loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• acetaminophen (Tylenol)
• alcohol
• antifungal medicines such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• auranofin (gold compound)
• carbamazepine (Tegretol)
• charcoal
• cholestyramine (LoCHOLEST, LoCHOLEST Light, Prevalite, Questran, Questran Light)
• cyclophosphamide (Cytoxan)
• disulfiram (Antabuse)
• haloperidol (Haldol)
• hydantoins such as phenytoin (Dilantin), mephenytoin (Mesantoin), and ethotoin (Peganone)
• live virus vaccines
• immunosuppressants such as azathioprine (Imuran), cyclosporine (Sandimmune, Gengraf, Neoral), sirolimus (Rapamune), and tacrolimus (Prograf, Protopic)
• medicines to treat TB such as rifampin (Rifadin, Rimactane) and rifapentine (Priftin)
• methotrexate (Rheumatrex, Trexall)
• steroids such as cortisone (Cortone), hydrocortisone (Cortef, Hydrocortone, A-HydroCort, Solu-Cortef), prednisolone (Delta-Cortef, Hydeltrasol), methylprednisolone (Medrol, A-Methapred, Depo-Medrol), prednisone (Meticorten), triamcinolone (Aristocort), and dexamethasone (Hexadrol, Dexone)
• tolbutamide
• warfarin (Coumadin)

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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