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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aubagio’s effectiveness.
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their relapsing MS in the background
AUBAGIO 14 mg is a once-daily pill effective at treating the 2 sides of relapsing MS
Reduced
Inflammation
- Reduced relapses
- Decreased the number of new lesions
Slowed
disability
progression*
AUBAGIO was studied in three Phase III trials
-
In 3 clinical trials
-
With more than 2800 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, brain lesions, and disability progression. AUBAGIO 7 mg was shown to be effective vs placebo in 2 of the 3 key measures—relapses and brain lesions.
Clinical Trial 1 †
1088 PEOPLE
who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial
Clinical Trial 2 †
1165 PEOPLE
who had their 1st relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial
Clinical Trial 3 †
614 PEOPLE
who had their 1st clinical event within 3 months prior to trial, and 2 or more lesions characteristic of relapsing MSAUBAGIO (teriflunomide) 14 mg was shown to be effective vs placebo in 3 key measures: relapses, brain lesions, and disability progression. AUBAGIO 7 mg was shown to be effective vs placebo in 2 of the 3 key measures—relapses and brain lesions.
AUBAGIO SIGNIFICANTLY CUT RELAPSES
Relapses are new or worsening symptoms, or the return of old symptoms, that last 24 hours or more. A relapse can last days, weeks, or months, and it can be mild or severe. But a relapse is always a sign your MS is active.
AUBAGIO Clinical Trials looked at relapses 2 ways:
• How many people had no relapses during the studies (Relapse-Free)
• How often people in the studies had relapses (Relapse Rate)
Clinical Trial 1 †
57%
of people were
relapse-free
relapse-free
on AUBAGIO 14 mg vs 46% on placebo.
54% of people were relapse-free on AUBAGIO 7 mg vs 46% with placebo.
31%
reduction in
relapse rate
relapse rate
with both AUBAGIO 14 mg and 7 mg vs placebo.
Clinical Trial 2 †
57%
of people were
relapse-free
relapse-free
on AUBAGIO 14 mg vs 47% on placebo.
58% were relapse-free on AUBAGIO 7 mg vs 47% with placebo.
36%
reduction in
relapse rate
relapse rate
with AUBAGIO 14 mg and 22% reduction with 7 mg vs placebo.
Clinical Trial 3 †
72%
of people were
relapse-free
relapse-free
on AUBAGIO 14 mg vs 62% on placebo.
71% were relapse-free on AUBAGIO 7 mg vs 62% with placebo.
AUBAGIO REDUCED RELAPSES OVER TIME
After Clinical Trial 1 ended, people who remained on AUBAGIO 14 mg during the extension study had
About
1 Relapse
over 6 Years
- The extension study followed people taking AUBAGIO for 5.5 years beyond the original study, for a total of 7.5 years
- Original clinical study: about 1 relapse over 2 years for people taking placebo
- 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
AUBAGIO DECREASED THE NUMBER
OF NEW LESIONS AND REDUCED
LESION VOLUME
The appearance of new or enlarging lesions on your MRI are signs that your MS is active and causing damage to your central nervous system.
Clinical Trial 1 †
Clinical Trial 1 looked at brain lesions as a measure of MS activity. This study looked at lesions 3 ways:
- The number of new lesions (areas of active inflammation) people had
- How many people had no new lesions
- The total area (or volume) of all lesions (including both new and old lesions)
Clinical Trial 1 demonstrated that:
People taking AUBAGIO had
80%
Fewer New
Lesions‡
Lesions‡
with AUBAGIO 14 mg vs 39% with placebo.
57% fewer new lesions with
AUBAGIO 7 mg vs placebo.
For people taking AUBAGIO
64%
were free of
new Lesions‡
new Lesions‡
with AUBAGIO 14 mg vs 39% with placebo.
51% were free from new lesions with
AUBAGIO 7 mg vs 39% with placebo.
People had a
69%
reduction in
total Lesion
volume§
total Lesion
volume§
with AUBAGIO 14 mg vs placebo.
33% reduction in total lesion volume
with AUBAGIO 7 mg vs placebo.
Discovering new lesions was just one reason they switched to AUBAGIO, WATCH VIDEO
AUBAGIO 14 mg SIGNIFICANTLY SLOWED DISABILITY PROGRESSION
You want to be able to do what you enjoy for as long as possible.
In clinical trials, disability progression was measured using the Expanded Disability Status Scale, or EDSS. The EDSS rates the severity of disability a person has from 0 to 10.* But in everyday life, disability can show itself in small changes in your abilities and the things you do to overcome them. For example: taking the elevator instead of the stairs; parking closer to the supermarket; preferring lighter pots and pans for cooking.
AUBAGIO slowed disability progression in 2 clinical trials.
In Clinical Trial 1 and Clinical Trial 2, AUBAGIO 14 mg was shown to keep more people free from disability progression.
For people taking AUBAGIO:
Clinical Trial 1 †
80%
Had no
disability
Progression
disability
Progression
with AUBAGIO 14 mg vs 73% with placebo.
78% were free of disability progression with
AUBAGIO 7 mg vs 73% with placebo.
Clinical Trial 2 †
84%
Had no
disability
Progression
disability
Progression
with AUBAGIO 14 mg vs 80% with placebo.
79% remained free of disability progression with AUBAGIO 7 mg vs 80% with placebo.
AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression.
AUBAGIO 14 mg SLOWED DISABILITY PROGRESSION over time
After Clinical Trial 1 ended, of the people who remained
on AUBAGIO 14 mg during the extension study:
61%
Had no disability
Progression for
up to 7.5 Years
Progression for
up to 7.5 Years
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 find out. You can also register to watch a FREE ON DEMAND VIDEO for the opportunity to hear firsthand from someone taking AUBAGIO and expert healthcare providers.
- The 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 results above are for people who took AUBAGIO during both the clinical trial and the extension study
- In the original and extension study of Clinical Trial 1, 61.5% of patients taking AUBAGIO 7 mg remained free from disability progression for up to 7.5 years.
- 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
Shown to be effective against disability progression was just the beginning. To hear people answer the question “Why AUBAGIO?”, WATCH VIDEO
*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 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 points (lasting at least 12 weeks).
†The clinical trials were each given a name. Trial 1 was called TEMSO; Trial 2 was called TOWER; and Trial 3 was called TOPIC.
‡Average Gd-enhanced T1 lesions per scan.
§New and old lesions (T2) plus permanent nerve damage (T1) lesions.
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. Stop taking AUBAGIO and call your doctor right away.
- 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. If you have a fever or rash in combination with severe muscle pain, swollen lymph glands, swelling of your face, unusual bruising or bleeding, weakness or tiredness, or yellowing of your skin or the whites of your eyes, stop taking AUBAGIO and call your doctor right away.
- 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