What is AUBAGIO What is AUBAGIO

Why AUBAGIO

AUBAGIO is proven to be effective

Results from a 108-week clinical trial

AUBAGIO® (teriflunomide) was studied in a 108-week clinical trial of more than 1,000 patients. In this trial, AUBAGIO 14 mg demonstrated a significant positive effect vs. placebo on 3 key measures of MS disease activity—relapses, disability progression, and MRI brain lesions.

AUBAGIO 7 mg demonstrated a significant positive effect vs. placebo on 2 of 3 key measures of MS disease activity—relapses and MRI brain lesions.

AUBAGIO 14 mg slows disability progression vs. placebo

Slowing of sustained disability progression

In a clinical trial, patients taking AUBAGIO 14 mg were 30% less likely to have sustained disability progression vs. those on placebo. AUBAGIO 7 mg did not demonstrate a statistically significant effect on sustained disability progression.

Sustained disability progression is a measure of disability progression over time. This means walking and other basic activities may become more difficult. As noted, AUBAGIO 14 mg has been shown to slow disability progression.


8 out of 10 patients

8 out of 10 patients with MS did not experience sustained disability progression at week 108 with AUBAGIO 14 mg.

  • 17.3%, 18.6%, and 23.7% of patients experienced sustained disability progression at week 108 with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively (AUBAGIO 7 mg did not achieve statistical significance).

AUBAGIO reduces relapses

Reduction of relapses

In a clinical trial, patients taking AUBAGIO 14 mg or 7 mg showed a 31% reduction in MS relapses vs. those on placebo.


61% of patients had zero relapses over the course of the clinical trial with AUBAGIO 14 mg.

60.6%, 57.8%, and 49.3% of patients remained relapse-free at week 108 with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively.

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.

Fewer new, active brain lesions with AUBAGIO

Fewer new lesions on MRI

In a clinical trial, AUBAGIO 14 mg reduced the number of new, active brain lesions on MRI by 80% vs. placebo. AUBAGIO 7 mg reduced the number of new, active brain lesions by 57% vs. placebo.

64% of patients were free of new, active brain lesions at week 108 in a Phase III clinical trial with AUBAGIO 14 mg.

*Gd-enhancing T1 lesions

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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. VIEW FULL IMPORTANT SAFETY INFORMATION
    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.
  • If you take a medicine called leflunomide.
  • If you are pregnant or are of childbearing potential and not using effective birth control. 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.

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 body 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 white 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; kidney problems; high potassium levels in your blood; serious skin problems; breathing problems (new or worsening); and high blood pressure.

The most common side effects when taking AUBAGIO include: abnormal liver test results; hair thinning or loss; diarrhea; flu; upset stomach; and burning or prickling feeling in your skin. 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