Why AUBAGIO Why AUBAGIO

Why AUBAGIO

AUBAGIO is proven
to
be effective.

In clinical trials, AUBAGIO® (teriflunomide) was shown to be effective, again and again

AUBAGIO is a prescription medication for the treatment of relapsing forms of MS. AUBAGIO is available in 2 strengths, 7 mg and 14 mg, but the more commonly prescribed strength is 14 mg. Your healthcare provider will decide which one is right for you.

AUBAGIO has been studied in 3 Phase III clinical trials with more than 2,800 patients. AUBAGIO 14 mg was shown to be effective vs placebo in 3 key measures of disease activity—relapses, brain lesions, and disability progression—in clinical trials.

AUBAGIO 7 mg was shown to be effective vs placebo in 2 of those 3 key measures—relapses and brain lesions—in clinical trials. Keep reading to learn the details of the clinical trials.

Reduced Risk
of Relapses
Fewer New, Active
Brain Lesions
Reduced Risk of
Disability Progression

TEMSO—PHASE III CLINICAL TRIAL #1

AUBAGIO 14 mg—shown to be effective.

Reduced the risk of relapse.

Patients taking AUBAGIO 7 mg showed a 31% reduction in relapse rate vs placebo.

Shown to help keep more
patients relapse-free.

54% of patients remained relapse-free with AUBAGIO 7 mg vs 46% with placebo over 108 weeks.

1,088 patients were studied in the clinical trial called TEMSO. AUBAGIO 14 mg was shown to be effective vs placebo in 3 key measures of disease activity—relapses, brain lesions, and disability progression—in this clinical trial. AUBAGIO 7 mg was shown to be effective vs placebo in 2 of those 3 key measures—relapses and brain lesions—in this clinical trial.

TOWER—PHASE III CLINICAL TRIAL #2

AUBAGIO 14 mg reduced the risk of relapse.

Reduced the risk of relapse.

Patients taking AUBAGIO 7 mg showed a 22% reduction in relapse rate vs placebo.

Shown to help keep more
patients relapse-free.

58% of patients remained relapse-free with AUBAGIO 7 mg vs 47% with placebo over 108 weeks.

1,165 patients were studied in the clinical trial called TOWER. In this trial 2 key measures of MS disease activity were studied. AUBAGIO 14 mg was shown to be effective in both key measures of MS disease activity—relapses and disability progression. Patients taking AUBAGIO 7 mg experienced improvement in relapses vs placebo.

TOPIC—PHASE III CLINICAL TRIAL #3

AUBAGIO 14 mg helped keep patients relapse-free.

Shown to help keep patients relapse-free.

71% of patients with a first clinical event remained relapse-free with AUBAGIO 7 mg vs 62% with placebo.

614 patients were studied in the clinical trial called TOPIC. Genzyme conducted a trial to measure how AUBAGIO would work in patients recently diagnosed with relapsing MS who had 2 or more lesions on MRI and who had their first symptoms within 90 days before the trial.

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.

* Gd-enhancing T1 lesions

Average lesions per scan

Sustained disability progression is a measure of disability progression over time. This means walking and other basic activities may become more difficult.

TEMSO—PHASE III CLINICAL TRIAL #1

AUBAGIO impacted MRI activity.

Free from new, active brain lesions.*

51% of patients were free from new, active brain lesions with AUBAGIO 7 mg vs 39% with placebo.

Fewer new, active brain lesions.*

57% relative risk reduction with AUBAGIO 7 mg vs placebo.

1,088 patients were studied in the clinical trial called TEMSO. AUBAGIO 14 mg was shown to be effective vs placebo in 3 key measures of disease activity—relapses, brain lesions, and disability progression—in this clinical trial. AUBAGIO 7 mg was shown to be effective vs placebo in 2 of those 3 key measures—relapses and brain lesions—in this clinical trial.

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.

* Gd-enhancing T1 lesions

Average lesions per scan

Sustained disability progression is a measure of disability progression over time. This means walking and other basic activities may become more difficult.

TEMSO—PHASE III CLINICAL TRIAL #1

AUBAGIO 14 mg was shown to impact disability progression.

Shown to help keep patients free from disability progression.

AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression vs placebo.

The estimated proportion of patients with sustained disability progression at week 108 was 20.2%, 21.7%, and 27.3% with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively.

Reduced risk of disability progression.

AUBAGIO 14 mg significantly reduced the risk of sustained disability progression.

AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression vs placebo.

1,088 patients were studied in the clinical trial called TEMSO. AUBAGIO 14 mg was shown to be effective vs placebo in 3 key measures of disease activity—relapses, brain lesions, and disability progression—in this clinical trial. AUBAGIO 7 mg was shown to be effective vs placebo in 2 of those 3 key measures—relapses and brain lesions—in this clinical trial.

TOWER—PHASE III CLINICAL TRIAL #2

AUBAGIO 14 mg was proven to be effective again to have an impact on disability progression.

Shown to help keep patients free from disability progression.

AUBAGIO 7 mg did not achieve a statistically significant reduction of sustained disability progression vs placebo.

The estimated proportion of patients with sustained disability progression at week 108 was 15.8%, 21.1%, and 19.7% with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively.

Reduced risk of disability progression.

AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression vs placebo.

1,165 patients were studied in the clinical trial called TOWER. In this trial 2 key measures of MS disease activity were studied. AUBAGIO 14 mg was shown to be effective in both key measures of MS disease activity—relapses and disability progression. Patients taking AUBAGIO 7 mg experienced improvement in relapses vs placebo.

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.

* Gd-enhancing T1 lesions

Average lesions per scan

Sustained disability progression is a measure of disability progression over time. This means walking and other basic activities may become more difficult.

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INDICATION

AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS).

IMPORTANT SAFETY INFORMATION

DO NOT TAKE AUBAGIO IF YOU:

  • Have severe liver problems. AUBAGIO may cause serious liver problems, which can be life-threatening. Your risk may be higher if you 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.
  • Take a medicine called leflunomide for rheumatoid arthritis.
  • 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.

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), vaccines, vitamins or herbal supplements.

AUBAGIO may cause serious side effects, including: reduced white blood cell count — this may cause you to have more infections; numbness or tingling in your hands or feet that is different from your MS symptoms; serious skin problems; breathing problems (new or worsening); and high blood pressure.

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.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

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, View More