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Generic Name: teriflunomide (TER-i-FLOO-noe-mide)
Brand Name: Aubagio

Aubagio may cause major birth defects or fetal death if used during pregnancy. Do not take Aubagio if you are pregnant. Do not take it if you may become pregnant and are not using an effective form of birth control. You must make sure you are not pregnant before you start Aubagio. Do not become pregnant while you take Aubagio or for as long as any medicine remains in your body after you stop treatment. Aubagio may stay in the body for as long as 2 years after you stop it. Women who may become pregnant must use effective birth control while they take Aubagio and for as long as any medicine remains in the body.

Serious and sometimes fatal liver problems have been reported with a similar medicine (leflunomide). This effect may also occur with Aubagio. The risk of this effect may be greater if you already have liver problems or if you take other medicine that may harm the liver. Ask your doctor if you are unsure if any of your other medicines may harm the liver. Your doctor will monitor your liver function while you use Aubagio. Do not take Aubagio if you have severe liver problems or if you have abnormal liver function tests before taking Aubagio. Contact your doctor right away if you develop symptoms of liver problems, such as dark urine, pale stools, yellowing of the skin or eyes, stomach pain, severe or persistent nausea or loss of appetite, or unusual tiredness.


Aubagio is used for:

Treating certain forms of multiple sclerosis (MS). It may also be used for other conditions as determined by your doctor.

Aubagio is a pyrimidine synthesis inhibitor. Exactly how Aubagio works to treat MS is not known.

Do NOT use Aubagio if:

  • you are allergic to any ingredient in Aubagio or to leflunomide
  • you are pregnant, are planning to become pregnant, or are breast-feeding
  • you may become pregnant and are not using effective birth control
  • you have bone marrow problems; a severely weakened immune system; or a severe, uncontrolled infection
  • you have severe liver problems or you have abnormal liver function tests prior to taking Aubagio
  • you are taking leflunomide

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Aubagio:

Some medical conditions may interact with Aubagio. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a weakened immune system, a fever or an infection, a history of an infection that keeps coming back, or you have recently received or are scheduled to receive a vaccination
  • if you have a history of lung or breathing problems, tuberculosis (TB) or a positive TB test, high blood pressure, blood or bone marrow problems, diabetes, liver problems, or abnormal liver function tests, or if you drink alcoholic beverages
  • if you have unusual numbness or tingling in your hands or feet that is different from your MS symptoms, or if you have had serious skin problems from taking other medicine
  • if you have or have had a history of kidney problems or you are on dialysis
  • if you take or have recently taken other medicine for MS, medicine to treat cancer, or any other medicine that may suppress your immune system
  • if you take cholestyramine

Some MEDICINES MAY INTERACT with Aubagio. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Leflunomide because it may increase the risk of Aubagio's side effects
  • Oral contraceptives (birth control pills), paclitaxel, pioglitazone, repaglinide, or rosiglitazone because the risk of their side effects may be increased by Aubagio
  • Alosetron, anticoagulants (eg, warfarin), duloxetine, theophylline, or tizanidine because their effectiveness may be decreased by Aubagio
  • Methotrexate because the risk of liver problems, blood problems, or infection may be increased
  • Rifampin because it may increase the risk of Aubagio's side effects
  • Anticoagulants (eg, warfarin) because the risk of its side effects, including bleeding, may be increased by Aubagio
  • Medicines that may suppress the immune system because the risk of infection or unusual bruising or bleeding may be increased. Ask your doctor if you are unsure if any of your medicines may suppress the immune system
  • Medicines that may cause nerve problems, because the risk of a certain nerve side effect (burning, numbness, or tingling sensation) may be increased. Ask your doctor if you are unsure if any of you medicines may cause nerve problems
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aubagio may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aubagio:

Use Aubagio as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Aubagio comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aubagio refilled.
  • Take Aubagio by mouth with or without food.
  • If you miss a dose of Aubagio, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aubagio.

Important safety information:

  • Aubagio may cause blurred vision. This effect may be worse if you take it with alcohol or certain medicines. Use Aubagio with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not stop taking Aubagio without checking with your doctor.
  • Drinking alcohol while you are taking Aubagio may increase the risk of liver problems. Talk with your doctor before drinking alcohol while taking Aubagio.
  • Aubagio may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Aubagio may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Aubagio and for at least 6 months after you stop treatment. Talk with your doctor before you receive any vaccine.
  • The safety of Aubagio in patients with inactive TB has not been confirmed. You may need to have a TB skin test before you start Aubagio to determine if you have TB infection. Discuss any questions or concerns with your doctor.
  • A serious and sometimes fatal lung problem (interstitial lung disease) has been reported with a similar medicine (leflunomide). Contact your doctor right away if you develop new or worsening breathing problems, such as cough or shortness of breath (with or without fever).
  • Serious and sometimes fatal skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been rarely reported with a similar medicine (leflunomide). Contact your doctor right away if you develop a rash; red, swollen, blistered, or peeling skin; or blisters on the inside of the nose or mouth.
  • Lab tests, including liver function, blood pressure, and complete blood cell counts, may be performed while you use Aubagio. These tests may be used to monitor your condition or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Aubagio with caution in the ELDERLY; they may be more likely to develop burning, numbness, or tingling.
  • Aubagio should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Aubagio may remain in the body for as long as 2 years after you stop taking it. Your doctor may prescribe medicine to help remove Aubagio from your body more quickly after you finish treatment (drug elimination procedure). Talk with your doctor for more information.
  • The risk of harm or death to a fetus fathered by a man using Aubagio is not known. Men who take Aubagio should talk with their doctor about the need to use a condom when having sex with a woman who may become pregnant. If you wish to father a child, talk with your doctor. You may need to stop Aubagio and complete the drug elimination procedure to remove it from your blood before you father a child.
  • If you are able to become pregnant, you must not start Aubagio unless it has been confirmed that you are not pregnant. You will need to use an effective form of birth control while you take Aubagio and for as long as Aubagio remains in your body. If you plan to become pregnant, talk with your doctor about stopping Aubagio and completing the drug elimination procedure before you become pregnant. Talk with your doctor for more information or if you have questions about effective birth control.
  • PREGNANCY and BREAST-FEEDING: Do not use Aubagio if you are pregnant. It may cause major birth defects or fetal death. You must have a negative pregnancy test before you start treatment with Aubagio. Do not become pregnant while you are taking it or for as long as it is in your body. Contact your doctor at once if your period does not occur when expected or if you suspect that you are pregnant. It is not known if Aubagio is found in breast milk. Do not breast-feed while taking Aubagio.

Possible side effects of Aubagio:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; flu-like symptoms; hair loss; headache; muscle aches; nausea; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; blisters on the inside of the nose or mouth; blurred vision; chest pain; fast or irregular heartbeat; muscle cramps, including leg cramps; new or worsening breathing problems (eg, cough or shortness of breath, with or without fever); new or unusual burning, numbness, or tingling; red, swollen, blistered, or peeling skin; symptoms of high blood pressure (eg, severe or persistent headache or dizziness, vision changes); symptoms of infection (eg, fever; chills; sore throat; cough; increased or painful urination; warm, red, swollen, or painful skin); symptoms of kidney problems (eg, decreased urination, lower back or side pain); symptoms of liver problems (eg, dark urine; pale stools; yellowing of the skin or eyes; stomach pain; severe or persistent nausea, vomiting, or loss of appetite); unusual or easy bruising or bleeding; unusual tiredness or weakness; unusually pale skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Aubagio:

Store Aubagio at room temperature at between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in bathroom. Keep Aubagio out of the reach of children and away from pets.

General information:

  • If you have any questions about Aubagio, please talk with your doctor, pharmacist, or other health care provider.
  • Aubagio is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Aubagio or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aubagio. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aubagio. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Aubagio.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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