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

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

AUBAGIO® (teriflunomide) 14 mg tablet image

Patient Portrayal

Results = Confidence. Clinical Data.

AUBAGIO was studied

  • AUBAGIO® was studied in 3 clinical trials: TEMSO, TOWER, & TOPIC In 3 clinical trials
  • AUBAGIO® was studied with more than 2800 patients With more than 2,800 patients
  • AUBAGIO® was studied for up to 108 weeks For up to 108 weeks
  • AUBAGIO® was studied in both the 14 mg % 7 mg doses In doses of 14 mg & 7 mg

AUBAGIO® (teriflunomide) 14 mg was shown to be effective vs. placebo in 3 key measures: relapses, disability progression, and brain lesions. AUBAGIO 7 mg was shown to be effective vs. placebo in 2 of the 3 key measures — relapses and brain lesions.

1st Clinical Trial: TEMSO

1,088 PATIENTS

who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial
2nd Clinical Trial: TOWER

1,165 PATIENTS

who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial
3rd Clinical Trial: TOPIC

614 PATIENTS

who had their 1st clinical event within 3 months prior to trial, and 2 or more lesions characteristic of relapsing MS

*The clinical trials were each given a name. Trial 1 was called TEMSO; Trial 2 was called TOWER; and Trial 3 was called TOPIC.

Aubagio quietsMS in three ways.*

AUBAGIO® quiets relapses

Quiets Relapses

AUBAGIO® slows disability progression

Quiets
Disability Progression

AUBAGIO® lessens new lesions

Quiets
New Lesions

*AUBAGIO is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.

Doctors measure disability progression using a test called the Expanded Disability Status Scale, or EDSS. Your first scoreor your “baseline”will determine how your disability is gauged moving forward. If your baseline score is ≤5.5, you’re considered to have sustained disability progression if that score goes up by one point (lasting at least 12 weeks). If your baseline score is >5.5, you’re considered to have sustained disability progression if that score goes up by at least 0.5 point (lasting at least 12 weeks).

14 mg only.

Ask your doctor if AUBAGIO is right for you.

Free of relapses.

In all 3 clinical trials, AUBAGIO kept more patients relapse-free vs. placebo.

If you are concerned about relapses, ask your healthcare provider if once-daily AUBAGIO may be right for you.

Clinical Trial 1
57%Remained
Relapse-Free
57% remained relapse free in clinical trial #1

on AUBAGIO 14 mg vs. 46% with placebo.

54% remained relapse-free on AUBAGIO 7 mg vs. 46% with placebo.

31% reduction in relapse rate with both AUBAGIO 14 mg and 7 mg vs. placebo.

Clinical Trial 2
57%Remained
Relapse-Free
57% remained relapse free in clinical trial #2

on AUBAGIO 14 mg vs. 47% with placebo.

58% remained relapse-free on AUBAGIO 7 mg vs. 47% with placebo.

36% reduction in relapse rate with AUBAGIO 14 mg and 22% reduction with 7 mg vs. placebo.

Clinical Trial 3
72%Remained
Relapse-Free
72% remained relapse free in clinical trial #3

on AUBAGIO 14 mg vs. 62% with placebo.

71% remained relapse-free on AUBAGIO 7 mg vs. 62% with placebo.

Slowed disability progression.

AUBAGIO 14 mg was shown to help keep patients free of disability progression.

Disability progression was looked at in 2 of the clinical trials. In both of those trials, AUBAGIO 14 mg was shown to help keep more people free from disability progression.

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

Clinical Trial 1
80%had no
Disability
Progression
80% had no disability progression in clinical trial #1

with AUBAGIO 14 mg vs. 73% with placebo.

78% remained free of disability progression with AUBAGIO 7 mg vs. 73% with placebo.

Clinical Trial 2
84%had no
Disability
Progression
84% had no disability progression in clinical trial #2

with AUBAGIO 14 mg vs. 80% with placebo.

79% remained free of disability progression with AUBAGIO 7 mg vs. 80% with placebo.


Lessened new lesions.

One clinical trial looked at brain lesions as a key measure of disease activity.

Patients taking AUBAGIO experienced less risk of new brain lesions vs. placebo.

§AUBAGIO is effective against MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.

Clinical Trial 1
80%Fewer
New Lesions
80% fewer lesions in clinical trial #1

with AUBAGIO 14 mg vs. placebo.

57% fewer new lesions with AUBAGIO 7 mg vs. placebo.


Average lesions per scan


Check Out
Aubagio Events

Find AUBAGIO® MS Events

Get facts and answers about
relapsing MS, AUBAGIO,
and more.

save my seat

Contact an
MS ONE to ONE®
Nurse

MS One to One® Nurse Support

Get support, even if you're
not taking AUBAGIO.  

Learn more

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; allergic reactions, including serious skin problems; breathing problems (new or worsening); and high blood pressure. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.

The most common side effects when taking AUBAGIO include: headache; diarrhea; nausea; hair thinning or loss; and abnormal liver test results.

With AUBAGIO, your healthcare provider will run tests within 6 months before you start treatment:

perform blood tests to check your liver; obtain a complete blood count; perform a TB (tuberculosis) skin test or blood test for mycobacterium tuberculosis infection; check your blood pressure; and perform a pregnancy test, if you are a woman of childbearing potential.

After you start treatment, your healthcare provider will monitor your liver enzyme levels monthly for the first 6 months, and check your blood pressure periodically.

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.
  • 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), 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; allergic reactions, including serious skin problems; breathing problems (new or worsening); and high blood pressure. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.

Tell your doctor if you have any side effect that bothers you or does not go away.

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, which can be life-threatening. Your risk may be higher if you take other medicines that affect your liver. View More