Arava contains leflunomide USP, which is a pyrimidine synthesis inhibitor. It is available as film-coated tablets for oral administration in strengths of 10 mg and 20 mg. Key inactive ingredients include colloidal silicon dioxide, lactose monohydrate, and magnesium stearate.

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

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.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture and light. Keep the container tightly closed. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Dry cough, shortness of breath or trouble breathing -Increase in blood pressure -Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell -Redness, blistering, peeling, or loosening of the skin, including inside the mouth -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Pain, tingling, or numbness in the hands or feet -Unusual bruising or bleeding Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Back pain -Diarrhea -Hair loss -Headache -Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Cancer -Diabetes -High blood pressure -Immune system problems -Infection -Kidney disease -Liver disease -Low blood cell levels (white cells, red cells, and platelets) -Lung or breathing disease, such as asthma or COPD -Recent or upcoming vaccine -Skin conditions -Tingling of the fingers or toes, or other nerve disorder -An unusual or allergic reaction to leflunomide, other medications, food, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Teriflunomide This medication may also interact with the following: -Alosetron -Caffeine -Cefaclor -Certain medications for diabetes, such as nateglinide, repaglinide, rosiglitazone, pioglitazone -Certain medications for high cholesterol, such as atorvastatin, pravastatin, rosuvastatin, simvastatin -Charcoal -Cholestyramine -Ciprofloxacin -Duloxetine -Estrogen and progestin hormones -Furosemide -Ketoprofen -Live virus vaccines -Medications that increase your risk for infection -Methotrexate -Mitoxantrone -Paclitaxel -Penicillin -Theophylline -Tizanidine -Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medication. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms. You should not receive certain vaccines during your treatment and for a certain time after your treatment with this medication ends. Talk to your care team for more information. This medication may stay in your body for up to 2 years after your last dose. Tell your care team about any unusual side effects or symptoms. A medication can be given to help lower your blood levels of this medication more quickly. Talk to your care team if you may be pregnant. This medication can cause serious birth defects if taken during pregnancy and for a while after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for a while after the last dose. Your care team can help you find the option that works for you. Do not breastfeed while taking this medication.

What are the most serious risks of this medication?

This medication may cause serious birth defects if taken during pregnancy. Do not take this medication if you are pregnant. This medicine can cause serious, life-threatening liver damage.