Updated lem isi

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.

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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A ONCE-DAILY
PILL WITH A
WELL-ESTABLISHED
HISTORY

What does that mean to you?

It means AUBAGIO has 15+ years of ongoing clinical studies and real-world patient experience. This may give you peace of mind as
you and your doctor consider whether AUBAGIO could help put your relapsing MS in the background.

Scroll below to see the possible side effects of AUBAGIO.

Clinical trials meet real-world experience.

Over 15 years of ongoing clinical studies and real-world patient experience – FDA approval of AUBAGIO in 2012.

POSSIBLE SIDE EFFECTS AND You

Since each MS treatment works differently, they all have different side effects. It is important to review the possible side effects of any medication you take.

As with other medicines, AUBAGIO is processed by the liver. Your healthcare provider will test your liver enzymes before going on AUBAGIO and for the first 6 months on AUBAGIO to make sure you are tolerating treatment. Most people who had elevated liver enzymes during clinical trials returned to normal over time.

POSSIBLE SIDE EFFECTS AND You

Since each MS treatment works differently, they all have different side effects. It is important to review the possible side effects of any medication you take.

As with other medicines, AUBAGIO is processed by the liver. Your healthcare provider will test your liver enzymes before going on AUBAGIO and for the first 6 months on AUBAGIO to make sure you are tolerating treatment. Most people who had elevated liver enzymes during clinical trials returned to normal over time.

POSSIBLE SERIOUS
SIDE EFFECTS OF AUBAGIO

If you experience any of the following side effects while taking AUBAGIO, speak with your healthcare provider right away.

In addition to the risk of liver problems, including liver failure that can be life-threatening and may require a liver transplant, and the risk of harm to an unborn baby, other possible serious side effects include:

  • Decreases in white blood cell count – this may cause you to have more infections
  • Certain vaccinations should be avoided during treatment with AUBAGIO and for at least 6 months after discontinuation
  • Allergic reactions
  • Serious skin reactions that may lead to death
  • Other allergic reactions that may affect different parts of the body such as your liver, kidneys, heart, or blood cells
  • Numbness or tingling in your hands or feet that is different from your MS symptoms
  • High blood pressure
  • Breathing problems (new or worsening) – that may be serious and lead to death

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COMMON SIDE
EFFECTS OF
AUBAGIO

These were the most common side effects of AUBAGIO in clinical trials.

Of course, everyone reacts differently to treatment. And not everyone experiences side effects with AUBAGIO. Talk to your healthcare provider if you’re concerned about potential side effects. You can also speak with one of our MS One to One® Nurses at 1‑855‑676‑6326.

If side effects are important to you when choosing a relapsing MS treatment visit Exploring Treatment for some questions you may want to ask yourself.

SIDE EFFECTS AUBAGIO PLACEBO
14 mg
(1002 people)
7 mg
(1045 people)
(997 people)
Headache 16% 18% 15%
Abnormal liver
test results
15% 13% 9%
Diarrhea 14% 13% 8%
Hair thinning
or loss
13% 10% 5%
Nausea 11% 8% 7%

Of course, everyone reacts differently to treatment. And not everyone experiences side effects with AUBAGIO. Talk to your healthcare provider if you’re concerned about potential side effects. You can also speak with one of our MS One to One® Nurses at 1-855-676-6326.

If side effects are important to you when choosing a relapsing MS treatment visit Exploring Treatment for some questions you may want to ask yourself.

PEOPLE WHO STOPPED TAKING AUBAGIO DUE TO COMMON SIDE EFFECTS

SIDE EFFECTS AUBAGIO PLACEBO
14 mg
(1002 people)
7 mg
(1045 people)
(997 people)
Diarrhea 0.4% =
4 people
0.5% =
5 people
0.1% =
1 person
Nausea 0.3% =
3 people
0.1% =
1 person
0% =
0 people
Hair thinning
or loss
1.3% =
13 people
0.2% =
2 people
0.1% =
1 person
Abnormal liver
test results
2.6% =
26 people
3.3% =
34 people
2.3% =
23 people
Headache 0% =
0 people
0% =
0 people
0.3% =
3 people

POSSIBLE HAIR THINNING OR
LOSS – IT’S USUALLY TEMPORARY

I experienced hair thinning. It lasted a few months, visible in the tub after I
showered. It grew back soon thereafter.”

– Heather On AUBAGIO 14 mg
Individual experiences may vary.

Watch Heathers video where she shares her experience with hair loss during her relapsing MS treatment.


It’s normal to be concerned about possible hair thinning or loss. Hair thinning associated with AUBAGIO is like the hair thinning that may happen with childbirth, stress, or iron deficiency.

DOSAGE OUTCOME PERCENTAGE
AUBAGIO 14 mg REPORTED HAIR LOSS 13%
DID NOT REPORT HAIR LOSS 87%
AUBAGIO 7 mg REPORTED HAIR LOSS 10%
DID NOT REPORT HAIR LOSS 90%
PLACEBO REPORTED HAIR LOSS 5%
DID NOT REPORT HAIR LOSS 95%

To learn more, WATCH THE SCIENCE BEHIND HAIR THINNING

It’s normal to be concerned about possible hair thinning or loss. Hair thinning associated with AUBAGIO is like the hair thinning that may happen with childbirth, stress, or iron deficiency.

Most people who reported hair thinning or loss in clinical trials did not stop taking AUBAGIO as a result.

  • Less than 1% of people stopped taking AUBAGIO due to hair thinning or loss, while 99% continued taking it
  • Hair thinning is usually temporary and may occur around 3 months after starting treatment

To learn more, WATCH THE SCIENCE BEHIND HAIR THINNING

ABOUT AUBAGIO
AND PREGNANCY

If you’re not pregnant and are using effective birth control, you can take AUBAGIO. Always talk to your healthcare provider about all your medications if you are planning to become pregnant.

If you stop taking AUBAGIO, it stays in your system for an average of 8 months although it may remain for up to 2 years.

Talk to your doctor about the 11 day accelerated elimination procedure if you become pregnant or plan to become pregnant.

If you become pregnant, plan to become pregnant, or if your doctor decides to discontinue AUBAGIO for any reason, there’s an 11-day accelerated elimination procedure. At the end of 11 days, the accelerated process has been shown to decrease AUBAGIO in your blood by more than 98%. Talk to your healthcare provider to learn more.

Patient Portrayal

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
  • 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 with or without a rash; other symptoms you may have include fever, severe muscle pain, swollen lymph glands, swelling of your face, unusual bruising or bleeding, weakness or tiredness, yellowing of your skin or the white of your eyes
  • 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.

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