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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Watch the moment i knewaubagio has proven results
AUBAGIO was effective in treating relapsing MS in 3 important ways:
Reduces
relapses
Slows disability
progression*†
Decreases
new lesions
*Doctors measure disability progression using a test called the Expanded Disability Status Scale, or EDSS. Your first score—or 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 1 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.
Aubagio has been well studied
-
In 3 clinical trials
-
With more than 2,800 people
-
For up to 108 weeks
-
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.
1,088 PEOPLE
who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial
1,165 PEOPLE
who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial
614 PEOPLE
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.
Free of
relapses
In all 3 clinical trials, AUBAGIO kept more people 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
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
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
on AUBAGIO 14 mg vs. 62% with placebo.
71% remained relapse-free on AUBAGIO 7 mg vs. 62% with placebo.
In 2 clinical trials with people diagnosed with relapsing MS, AUBAGIO was proven to reduce relapse vs. placebo.
Clinical Trial 1
31%Reduction
In relapse rate
on AUBAGIO 14 mg and 7 mg vs. placebo.
Clinical Trial 2
36%Reduction
in relapse rate
on AUBAGIO 14 mg vs. placebo.
22% reduction in relapse rate on AUBAGIO 7 mg vs. placebo.
REDUCED RELAPSES
OVER TIME
People experienced about 1 relapse every 6 years on AUBAGIO 14 mg in the extension study of clinical trial 1.
This extension study followed participants who stayed on AUBAGIO 5.5 years after the original study ended.
- An extension study follows participants after the original clinical trial has ended and looks at their long-term experience with the medication
- Everybody in the extension study took AUBAGIO. Participants who were given a placebo (a pill that does not contain medicine) in the original clinical trial were switched to AUBAGIO
- The people who stayed in the extension study came in for follow-ups, so researchers could learn more about the long-term safety and effectiveness of AUBAGIO
Slowed
disability
progression
AUBAGIO 14 mg was shown to help keep people 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
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
with AUBAGIO 14 mg vs. 80% with placebo.
79% remained free of disability progression with AUBAGIO 7 mg vs. 80% with placebo.
MAJORITY OF PEOPLE REMAINED free of
disability
progression
for up to
7.5 years
61% showed no disability progression on AUBAGIO 14 mg for up to 7.5 years.
If you’re concerned about disability progression, take a look at this study. The results may be meaningful to you. The study found that the majority of participants showed no disability progression for up to 7.5 years—the treatment was AUBAGIO.
Think about what you were doing 2 years ago, and what you can do today. Is your current treatment meeting your needs? Visit Exploring Treatment to learn more.
- This extension study of Clinical Trial 1 followed participants who stayed on AUBAGIO—and those who changed from placebo to AUBAGIO—to examine long-term experience with AUBAGIO
- The graph above shows results for people who took AUBAGIO during both the clinical trial and the extension study
- Among people who started with placebo and then changed to AUBAGIO, 59% taking the 14 mg pill and 54% taking the 7 mg pill remained free of disability progression for up to 7.5 years
FEWER
NEW LESIONS§
One clinical trial looked at brain lesions as a key measure of disease activity.
Patients taking AUBAGIO had a reduced risk of new brain lesions vs. placebo.
Clinical Trial 1
80%Fewer
New
Lesions||
Lesions||
with AUBAGIO 14 mg vs. placebo.
57% fewer new lesions with AUBAGIO 7 mg vs. placebo.
§AUBAGIO is effective against MRI lesion activity.
∥Average contrast-enhancing lesions per scan.
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, 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 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.
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