Arava affects the immune system and reduces swelling and inflammation in the body.

Arava is used to treat the symptoms of rheumatoid arthritis.

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

Do not use Arava if you are pregnant, and stop taking this medicine if you think you might be pregnant. Use birth control to prevent pregnancy while you are taking Arava, and until you complete a "drug elimination" procedure.

Arava can cause severe or fatal liver damage. Tell your doctor if you have a history of liver disease or if you also use other medicines such as: pain or arthritis medicine (including aspirin, Tylenol, and Advil/Motrin), medicines to treat tuberculosis or other infections, seizure medication, hormonal birth control or hormone replacement therapy, chemotherapy, cholesterol-lowering medicine, heart medication, or blood pressure medicine.

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

Before taking this medicine

You should not use Arava if you are allergic to leflunomide or teriflunomide, or if:

• 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.

Do not use Arava if you are pregnant or may become pregnant. Avoid getting pregnant until after you stop taking Arava and undergo a "drug elimination" procedure to help rid your body of this medicine. Stop taking Arava and call your doctor right away if you miss a period or think you might be pregnant.

To make sure this medicine 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).

Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking Arava, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

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 Arava.

It is not known whether leflunomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Before you start treatment with Arava, 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.

Arava 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 Arava 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 Arava based on the results of these tests.

After you stop taking this medicine, 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 Arava.

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.

Usual Adult Dose for Rheumatoid Arthritis:

Loading dose: 100 mg orally once a day for 3 days
Maintenance: 20 mg orally once a day (If not well tolerated, the dose may be decreased to 10 mg orally once a day)

Comment:
-Hematology parameters and liver enzymes should be monitored.

Use:
For the treatment of active rheumatoid arthritis (RA):
-To reduce signs and symptoms
-To inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
-To improve physical function

You should not use Arava if you are allergic to leflunomide or teriflunomide, or if:

• 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.

Do not use Arava if you are pregnant or may become pregnant. Avoid getting pregnant until after you stop taking Arava and undergo a "drug elimination" procedure to help rid your body of this medicine. Stop taking Arava and call your doctor right away if you miss a period or think you might be pregnant.

To make sure this medicine 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).

Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking Arava, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

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 Arava.

It is not known whether leflunomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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.

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

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

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 Arava, 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.

Get emergency medical help if you have signs of an allergic reaction to Arava: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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 Arava 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.

Arava 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); a 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.