AUBAGIO contains teriflunomide, an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme. The drug is available as film-coated tablets for oral administration in 7 mg and 14 mg strengths. Key inactive ingredients include colloidal silicon dioxide, corn starch, and lactose monohydrate, among others. The 14 mg tablet coating includes ingredients like FD&C Blue#2 Aluminium Lake, while the 7 mg tablet coating includes iron oxide yellow.

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. 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). 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 or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing -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 -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 -Rash, fever, and swollen lymph nodes -Redness, blistering, peeling, or loosening of the skin, including inside the mouth -Unusual bruising or bleeding Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Hair loss -Headache -Joint pain -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: -Diabetes -Have a fever or infection -High blood pressure -Immune system problems -Kidney disease -Liver disease -Low blood cell counts, such as low white cells, platelets, red cell counts -Lung or breathing disease, such as asthma -Recently received or scheduled to receive a vaccine -Receiving treatment for cancer -Skin conditions or sensitivity -Tingling of the fingers or toes, or other nerve disorder -Tuberculosis -An unusual or allergic reaction to teriflunomide, other medications, food, dyes, or preservatives -If you or your partner are pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Leflunomide 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 while 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. 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. You should not receive some vaccines during your treatment and for 6 months after the last dose. Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for some time after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for some time after the last dose. Your care team can help you find the option that works for you. If your partner can get pregnant, use a condom during sex while taking this medication and for some time after the last dose. 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.