leflunomide

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

Your liver function will need to be tested often, and you may need to stop taking leflunomide based on the results of these tests.

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 may also be used for purposes not listed in this medication guide.

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

• you are pregnant (you will need to have a negative pregnancy test before starting this treatment);
• you have severe liver disease; or
• you are also using teriflunomide.

To make sure leflunomide is safe for you, tell your doctor if you have:

• a history of liver disease or hepatitis (leflunomide can cause severe liver problems);
• a severe or uncontrolled infection;
• kidney disease;
• nerve problems, such as neuropathy caused by diabetes;
• a history of tuberculosis;
• 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).

Ask your doctor if you should use a barrier form of birth control (condom or diaphragm with spermicide). Using hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may increase your risk of liver damage while taking leflunomide.

How should I take leflunomide?

Before you start treatment with leflunomide, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your blood pressure will need to be checked often.

Leflunomide can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your leflunomide treatment may be stopped for a short time based on the results of these tests.

Your liver function will also need to be tested often, and you may need to stop taking leflunomide based on the results of these tests.

After you stop taking leflunomide, you may need to be treated with other medicines to help your body eliminate leflunomide quickly. If you do not undergo this drug elimination procedure, leflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking leflunomide.

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.

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?

Overdose symptoms may include diarrhea, stomach pain, pale skin, 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, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of leflunomide?

• signs of infection --sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing;
• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• numbness, tingling, or burning pain in your hands or feet;
• liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, diarrhea, stomach pain;
• headache;
• abnormal liver function tests;
• thinning hair;
• back pain;
• weakness;
• rash; or
• high blood pressure.

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.

What other drugs will affect leflunomide?

Leflunomide can cause severe or fatal liver damage. This effect is increased when you also use certain other medicines, including:

• acetaminophen (Tylenol), aspirin, gout or arthritis medication (including gold injections); an NSAID (non-steroidal anti-inflammatory drug) --ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;
• an antibiotic, antifungal medicine, or sulfa drug; tuberculosis medicine; antiviral or HIV/AIDS medication; medicine to treat mental illness; seizure medication --carbamazepine, phenytoin, valproic acid, and others;
• birth control pills or hormone replacement therapy; anabolic steroids --methyltestosterone, "performance-enhancing drugs"; cancer medication; or
• cholesterol-lowering medication --Crestor, Lipitor, Vytorin, Zocor, and others; heart or blood pressure medication.

This list is not complete and many other drugs can interact with leflunomide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about leflunomide.