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Indication and Important Safety Information Prescribing Information Medication Guide

AUBAGIO® (teriflunomide) 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.

Do not take AUBAGIO if you have severe liver problems, are pregnant or of childbearing potential and not using effective birth control, have had an allergic reaction to AUBAGIO or leflunomide, or are taking a medicine called leflunomide for rheumatoid arthritis. View IMPORTANT SAFETY INFORMATION.

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AUBAGIO & You > Preparing for liver tests

Preparing for liver tests

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People new to taking AUBAGIO need to have liver tests monthly during their first six months of treatment. This it to ensure the treatment isn’t interfering with normal liver function. AUBAGIO may cause serious liver problems, so having these tests done—and discussing the results with a healthcare provider—is important.

These liver tests (also known as labs) let your care team know if your liver is functioning properly or help identify any liver function irregularities that may occur during the first six months of treatment.

  • Your first lab will be scheduled right around the time you and your doctor decide AUBAGIO may be right for you. The results from this test give your care team a baseline understanding of how your liver is functioning.
  • Follow up tests will be performed monthly during your first six months on treatment to look for any changes in function.

What you need to know

Liver tests are performed via blood draw, and usually only take a few minutes. Typically, your healthcare provider will schedule your labs for you. It might help to book all six months of testing during your first lab appointment.

Here are a few things to keep in mind before you start labs.

Know your schedule and plan accordingly

Once the tests are booked, there are helpful tips that can help you remember your lab schedule. You can set reminders in your phone, update your calendar app, or give the dates to friends and family and ask them to help remind you. Or, you can download this checklist if you prefer a physical reminder to help you keep track. How you choose to keep track of your labs is up to you; what really matters is that you do remember. Missed appointments can always be rescheduled, but that could interfere with your care providers getting the appropriate information at the appropriate time.

Lab test tracking sheet

Keeping track of all those appointment dates, times, and results can be tricky, espcially considering you’re planning these activities months in advance.

To help make the process more manageable, use a tool like this downloadable checklist.

You can track:

  • The date and time of your appointment
  • Location of testing site
  • Follow up discussions with your doctor
Download

Know what’s happening before your lab

It’s a good idea to talk to your doctor about what to expect before your first test. Here’s some questions to help guide your conversation. (If you like, you can download and print these questions and bring them with you to you next doctor’s visit.)

Questions to ask your doctor

  1. Where is the lab where my test will be done located?
  2. Do I need to fast before my test? If so, for how long?
  3. How will I get my results?
  4. How will I know if there are any issues with my liver?
  5. What do I do if I miss or can’t make it to one of my scheduled labs?
Download

Know the data on AUBAGIO and liver function

In clinical studies of AUBAGIO, the following number of people taking AUBAGIO reported experiencing elevated liver enzymes:1

  • 150 out of 1,002 people (or, 15%) of those on AUBAGIO 14 mg
  • 36 out of 1,045 people (or, 13%) of those on AUAGIO 7 mg.

Of these patients who reported experiencing elevated liver enzymes, 26 people (or 2.6%) taking AUBAGIO 14 mg discontinued use of AUBAGIO. For those taking AUBAGIO 7 mg, 34 people (or 3.3%) discontinued use.1

Still have questions about liver enzyme tests or how AUBAGIO may affect liver function?

Learn more about abnormal liver test results and the most common side effects of AUBAGIO. You can also contact MS One to One for more information at 1-855-676-6326.

IMPORTANT SAFETY INFORMATION

Do not take AUBAGIO if you have severe liver problems. AUBAGIO may cause serious liver problems, including liver failure that can be life-threatening and may require a liver transplant. View More

INDICATION

AUBAGIO® (teriflunomide) 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.

IMPORTANT SAFETY INFORMATION

DO NOT TAKE AUBAGIO IF YOU:
  • Have severe liver problems. AUBAGIO may cause serious liver problems, including liver failure that can be life-threatening and may require a liver transplant. Your risk may be higher if you already have liver problems or take other medicines that affect your liver. Your healthcare provider should do blood tests to check your liver within 6 months before you start AUBAGIO and monthly for 6 months after starting AUBAGIO. Tell your healthcare provider right away if you develop any of these symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of your skin or whites of your eyes, or dark urine.
  • Are pregnant. AUBAGIO may harm an unborn baby. You should have a pregnancy test before starting AUBAGIO. After stopping AUBAGIO, continue to use effective birth control until you have made sure your blood levels of AUBAGIO are lowered. If you become pregnant while taking AUBAGIO or within 2 years after stopping, tell your healthcare provider right away and enroll in the AUBAGIO Pregnancy Registry at 1-800-745-4447, option 2.

  • Are of childbearing potential and not using effective birth control.

    It is not known if AUBAGIO passes into breast milk. Your healthcare provider can help you decide if you should take AUBAGIO or breastfeed — you should not do both at the same time.

    If you are a man whose partner plans to become pregnant, you should stop taking AUBAGIO and talk with your healthcare provider about reducing the levels of AUBAGIO in your blood. If your partner does not plan to become pregnant, use effective birth control while taking AUBAGIO.

  • Have had an allergic reaction to AUBAGIO or a medicine called leflunomide.
  • Take a medicine called leflunomide for rheumatoid arthritis.

AUBAGIO may stay in your blood for up to 2 years after you stop taking it. Your healthcare provider can prescribe a medicine that can remove AUBAGIO from your blood quickly.

Before taking AUBAGIO, talk with your healthcare provider if you have: liver or kidney problems; a fever or infection, or if you are unable to fight infections; numbness or tingling in your hands or feet that is different from your MS symptoms; diabetes; serious skin problems when taking other medicines; breathing problems; or high blood pressure. Your healthcare provider will check your blood cell count and TB test before you start AUBAGIO. Talk with your healthcare provider if you take or are planning to take other medicines (especially medicines for treating cancer or controlling your immune system), over-the-counter medicines, vitamins or herbal supplements.

AUBAGIO may cause serious side effects. Tell your doctor if you have any of the following:

  • decreases in white blood cell count — this may cause you to have more infections. Symptoms include fever, tiredness, body aches, chills, nausea, or vomiting. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.
  • allergic reactions such as difficulty breathing, itching, or swelling on any part of your body including lips, eyes, throat, or tongue. Stop taking AUBAGIO and call your doctor right away.
  • serious skin reactions that may lead to death. Stop taking AUBAGIO if you have rash or redness and peeling, mouth sores or blisters.
  • other allergic reactions that may affect different parts of the body. If you have a fever or rash in combination with severe muscle pain, swollen lymph glands, swelling of your face, unusual bruising or bleeding, weakness or tiredness, or yellowing of your skin or the whites of your eyes, stop taking AUBAGIO and call your doctor right away.
  • numbness or tingling in your hands or feet that is different from your MS symptoms
  • high blood pressure
  • breathing problems (new or worsening) — these may be serious and lead to death

The most common side effects when taking AUBAGIO include: headache; diarrhea; nausea; hair thinning or loss; and abnormal liver test results. These are not all the side effects of AUBAGIO. Tell your healthcare provider about any side effect that bothers you.

Consult your healthcare provider if you have questions about your health or any medications you may be taking, including AUBAGIO.

Please click here for full Prescribing Information, including boxed WARNING and Medication Guide.

Reference

1. Comi G, Freedman M, Kappos L et al. Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions. Multiple Sclerosis and Related Disorders. 2016;5:97-104. doi:10.1016/j.msard.2015.11.006.