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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.

For U.S. residents only.

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AUBAGIO & You > Develop a treatment routine that works for you

Develop a treatment routine that works for you

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When it comes to taking AUBAGIO once daily, you will want to develop a routine that works for you.

Starting a new treatment can be exciting—and a little overwhelming. When you start taking AUBAGIO for relapsing MS, you will want to stay with the once-daily dosing regimen as your doctor prescribed. One way to develop a new medication routine—take it one step at a time!

Create a daily routine—one step a time

Here are some tips to help you remember to take AUBAGIO each day.

  • Take AUBAGIO with activities that are part of your everyday routine. AUBAGIO can be taken with or without food. This means you can take AUBAGIO as soon as you wake each morning. Or perhaps you want to take it with your first cup of coffee. Mornings not for you? Take it with dinner or as you brush your teeth at night. Using a routine daily activity as the prompt to remind you to take AUBAGIO can really help establish a routine.
  • Keep your medication visible where you will remember to take it. If you want to start taking AUBAGIO with your first cup of coffee, leave the medication next to your coffee maker. Or, if you want to take it as you go to bed, leave it on your nightstand. Keeping your medication visible can help you remember to take it. Just remember to keep medicines out of reach of children.
  • Set a daily reminder. Today, there are all sorts of reminder alerts you can set on a digital clock, smartphone or through an app. Sometimes just getting that daily alert can be just the prompt you need to remember to take your medication.
  • Rely on a buddy. Family and friends want to be involved in their loved one’s care. If you need that little extra support, maybe you ask a loved one to remind you to take medication. Just be sure they are reliable and have a consistent method to remind you to take medication, such as a daily text or phone call.
  • Create a medication calendar. Many people like the feeling of accomplishment by checking something off their list each day. Create a monthly calendar and leave a spot each day for you to check off that you’ve taken your medication.
  • Use the AUBAGIO medication tracker band as a visual signal that you’ve taken your daily dose of AUBAGIO.

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What happens if…?

Developing a new medication routine takes some getting used to. Here’s some information that will be helpful:

  • Miss a dose of AUBAGIO? Learn what to do if you forget to take a dose.
  • Need help navigating insurance or can no longer afford your medication? Call your dedicated MS One to One Nurse at 1‑855‑676‑6326.
  • Want tips or tricks to help remember to take your medication? See what some Ambassadors do to remember to take their medication.

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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.