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AUBAGIO- teriflunomide tablet, film coated


  1. Patient Information
  2. Liver Problems:
  3. Harm To Your Unborn Baby:
  4. For Men Taking Aubagio:
  5. What Is Aubagio?
  6. Do Not Take Aubagio If You:
  7. Before You Take Aubagio, Tell Your Doctor If You:
  8. How Should I Take Aubagio?
  9. Aubagio May Cause Serious Side Effects, Including:
  10. What Are The Ingredients In Aubagio?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

A Medication Guide is required for distribution with AUBAGIO.

Hepatotoxicity

Inform patients that AUBAGIO may increase liver enzymes and that their liver enzymes will be checked before starting AUBAGIO and for at least 6 months while they are taking AUBAGIO. Advise patients that they should contact their physician if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.

Embryofetal Toxicity

  • Advise females of reproductive potential
    • of the potential for fetal harm if AUBAGIO is taken during pregnancy
    • to notify their healthcare provider immediately if a pregnancy occurs or is suspected
    • to use effective contraception during treatment with AUBAGIO and until the teriflunomide plasma concentration is verified to be less than 0.02 mg/L[

Liver Problems: 

AUBAGIO may cause serious liver problems that may lead to death. Your risk of liver problems may be higher if you take other medicines that also affect your liver. Your doctor should do blood tests to check your liver:
  • within 6 months before you start taking AUBAGIO
  • 1 time a month for 6 months after you start taking AUBAGIO
Call your doctor right away if you have any of the following symptoms of liver problems:
  • nausea
  • vomiting
  • stomach pain
  • loss of appetite
  • tiredness
  • your skin or the whites of your eyes turn yellow
  • dark urine

Harm To Your Unborn Baby: 

AUBAGIO may cause harm to your unborn baby. Do not take AUBAGIO if you are pregnant. Do not take AUBAGIO unless you are using effective birth control.
  • If you are a female, you should have a pregnancy test before you start taking AUBAGIO. Use effective birth control during your treatment with AUBAGIO.
  • After stopping AUBAGIO, continue using effective birth control until you have blood tests to make sure your blood levels of AUBAGIO are low enough. If you become pregnant while taking AUBAGIO or within 2 years after you stop taking it, tell your doctor right away.
  • AUBAGIO Pregnancy Registry.If you become pregnant while taking AUBAGIO or during the 2 years after you stop taking AUBAGIO, talk to your doctor about enrolling in the AUBAGIO Pregnancy Registry at 1-800-745-4447, option 2. The purpose of this registry is to collect information about your health and your baby's health.

For Men Taking Aubagio: 

  • If your female partner plans to become pregnant, you should stop taking AUBAGIO and ask your doctor how to quickly lower the levels of AUBAGIO in your blood.
  • If your female partner does not plan to become pregnant, you and your female partner should use effective birth control during your treatment with AUBAGIO. AUBAGIO remains in your blood after you stop taking it, so continue using effective birth control until AUBAGIO blood levels have been checked and they are low enough.

AUBAGIO may stay in your blood for up to 2 years after you stop taking it. Your doctor can prescribe a medicine to help lower your blood levels of AUBAGIO more quickly. Talk to your doctor if you want more information about this.

What Is Aubagio? 

AUBAGIO is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if AUBAGIO is safe and effective in children.

Do Not Take Aubagio If You: 

  • have had an allergic reaction to AUBAGIO or a medicine called leflunomide
  • have severe liver problems
  • are pregnant or are of childbearing age and not using effective birth control
  • take a medicine called leflunomide

Before You Take Aubagio, Tell Your Doctor If You: 

  • have liver or kidney problems
  • have a fever or infection, or you are unable to fight infections
  • have numbness or tingling in your hands or feet that is different from your MS symptoms
  • have diabetes
  • have had serious skin problems when taking other medicines
  • have breathing problems
  • have high blood pressure
  • are breastfeeding or plan to breastfeed. It is not known if AUBAGIO passes into your breast milk. You and your doctor should decide if you will take AUBAGIO or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using AUBAGIO and other medicines may affect each other causing serious side effects. AUBAGIO may affect the way other medicines work, and other medicines may affect how AUBAGIO works.

Especially tell your doctor if you take medicines that could raise your chance of getting infections, including medicines used to treat cancer or to control your immune system.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How Should I Take Aubagio? 

  • Take AUBAGIO exactly as your doctor tells you to take it.
  • Take AUBAGIO 1 time each day.
  • Take AUBAGIO with or without food.

Aubagio May Cause Serious Side Effects, Including: 

    • Store AUBAGIO at room temperature between 68 F to 77 F (20 C to 25 C).
    • Keep AUBAGIO and all medicines out of reach of children.

    General information about the safe and effective use of AUBAGIO.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AUBAGIO for a condition for which it was not prescribed. Do not give AUBAGIO to other people, even if they have the same symptoms you have. It may harm them.

    This Medication Guide summarizes the most important information about AUBAGIO. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about AUBAGIO that is written for healthcare professionals.

    For more information, go to www.aubagio.com or call Genzyme Medical Information Services at 1-800-745-4447, option 2.

What Are The Ingredients In Aubagio? 

Active ingredient: teriflunomide

Inactive ingredients in 7 mg and 14 mg tablets: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake.

In addition, the 7 mg tablets also contain iron oxide yellow.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Genzyme Corporation
Cambridge, MA 02142
A SANOFI COMPANY

Revised: September 2019



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