What are leflunomide tablets?

LEFLUNOMIDE (Arava®) is a medication that reduces inflammation and swelling due to rheumatoid arthritis. The response of the immune system may contribute to rheumatoid arthritis. Leflunomide affects this system and is able to slow down the progression of the disease, especially in the affected joints. Leflunomide helps to treat all stages of adult rheumatoid arthritis. Leflunomide can be used with some of the other medications that are used to treat the inflammation and pain of this condition (for example, aspirin, other salicylates, or nonsteroidal anti-inflammatory drugs like ibuprofen).

What should I tell my health care provider before I take this medicine?

They need to know if you have, or have ever had, any of these conditions:

• an alcohol problem
• anemia or other blood disorders
• cancer or cancer treatments (radiation therapy)
• an immune deficiency (natural or due to cancer, cancer chemotherapy, infection with the HIV virus or AIDS, radiation, or steroid therapy)
• fever or infection
• high blood pressure
• kidney disease
• liver disease
• lung disease or breathing problems
• an unusual or allergic reaction to leflunomide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take leflunomide tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. You can take leflunomide with food or milk. Take your doses at the same time every day. Do not take your medicine more often than directed. Continue to take your medicine even if you feel better. Do not stop taking your medicine unless your prescriber or health care professional tells you to discontinue taking it.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with leflunomide?

• some anti-inflammatory medicines
• azathioprine
• charcoal
• cholestyramine
• cyclosporine
• doxercalciferol
• fosphenytoin
• isoniazid
• itraconazole
• ketoconazole
• methotrexate
• phenytoin
• ramelteon
• rifampin
• some vaccines
• sulfasalazine
• tacrine
• troglitazone, and some other medicines for diabetes
• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from receiving leflunomide?

Side effects you should report to your prescriber or health care professional as soon as possible:

• dark yellow or brown urine
• diarrhea, especially if severe or does not stop
• difficulty breathing or shortness of breath
• dizziness
• fever or chills, cough or sore throat
• increases in blood pressure, especially if you are being treated for high blood pressure
• numbness, pain, or tingling in an arm, hand, leg, or foot
• pain in the stomach or abdomen
• skin rash or hives
• ulcers of the mouth or difficulty or pain on swallowing
• unusual bleeding or bruising, pinpoint red spots on the skin, nose bleeds or bleeding gums
• unusual tiredness or weakness
• vomiting
• yellowing of eyes or skin

Side effects that do usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• change in the taste of foods or drinks
• changes in the appearance of the fingernails or toenails
• hair loss (reversible)
• headache
• itching of the skin
• loss of appetite
• nausea, indigestion, or vomiting
• weight loss
• worsening of joint pain

What should I watch for while taking leflunomide?

Visit your prescriber or health care professional for checks on your progress. A few side effects occur commonly with leflunomide. They include diarrhea, abdominal pain or nausea, rash, changes in hair texture or growth. In some persons, liver function can be altered. Sometimes the side effects can be more serious. Your prescriber or health care professional will be observing you closely and will monitor blood tests related to your medicine. You will need to have regular tests to see if your liver is working properly. The side effects of leflunomide can continue after you finish your treatment; report side effects promptly.

If you are a woman who has the potential to become pregnant, it is important that you discuss birth control options with your prescriber or health care professional prior to taking leflunomide. You must not be pregnant and must be using a reliable form of birth control to prevent pregnancy. Leflunomide has the potential to harm an unborn baby. If you think that you might be pregnant at any time during your treatment with leflunomide, you should see your health care provider at once.

While you are taking medications for rheumatoid arthritis you might be more susceptible to infection. Try to avoid people with colds, flu, and bronchitis. Do not have any vaccinations without your doctor’s approval.

Call your health care professional for advice if you get a fever, chills or sore throat, do not treat yourself.

If you are going to have surgery tell your doctor or dentist that you are taking leflunomide.

Alcoholic drinks can make you more dizzy and increase possible damage to your liver. Avoid alcoholic drinks while taking leflunomide.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.