In 3 clinical trials
For U.S. Residents Only
CONTINUE TO EXPERIENCE THE RESULTS
YOU’VE SEEN OVER TIME
YOU’VE SEEN OVER TIME
Have confidence knowing branded AUBAGIO 14 mg remains available
and effective at treating the
2 sides of relapsing MS
I. Reduced Inflammation
- Reduced relapses
- Decreased the number of lesions
II. Slowed Disability Progression*
AUBAGIO, a once-daily pill, was studied in three phase III 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†
who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial.
Clinical Trial 2†
who had at least 1 relapse within a year prior to trial or 2 relapses within 2 years prior to trial.
Clinical Trial 3†
who had their 1st clinical event within 3 months prior to trial, and 2 or more lesions characteristic of relapsing MS.
Branded AUBAGIO
14 mg significantly
cut relapses
Relapses are new or worsening symptoms, or the return of old
symptoms, that last 24 hours or more and are not explained by alternate causes such as infection or heat. 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†
of people were
relapse-free
on AUBAGIO 14 mg vs 46% on placebo.
54% of people were relapse-free on AUBAGIO 7 mg vs 46% with placebo.
reduction in
relapse rate
with both AUBAGIO 14 mg and 7 mg vs placebo.
Clinical Trial 2†
of people were
relapse-free
on AUBAGIO 14 mg vs 47% on placebo.
58% were relapse-free on AUBAGIO 7 mg vs 47% with placebo.
reduction in
relapse rate
with AUBAGIO 14 mg and 22% reduction with 7 mg vs placebo.
Clinical Trial 3†
of people were
relapse-free
on AUBAGIO 14 mg vs 62% on placebo.
71% were relapse-free on AUBAGIO 7 mg vs 62% with placebo.
Branded AUBAGIO reduces relapses over time
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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
- 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
- Original clinical study: about 1 relapse over 2 years for people taking placebo
- 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
Branded 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 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)
People taking AUBAGIO had
fewer new
lesions‡
with AUBAGIO 14 mg vs placebo.
57% fewer new lesions with
AUBAGIO 7 mg vs placebo.
For people taking AUBAGIO
were free of
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
reduction in total
lesion volume§
with AUBAGIO 14 mg vs placebo.
33% reduction in total lesion volume
with AUBAGIO 7 mg vs placebo.
Branded AUBAGIO
14 mg significantly slowed disability progression
You want to be able to do what you enjoy for as long as possible.
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†
had no 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†
had no disability progression with AUBAGIO 14 mg vs 80% with placebo.
79% were free of
disability progression
with AUBAGIO 7 mg vs 80% with placebo.
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.
Branded 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.
AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression.
Demonstrated effectiveness for 7.5 years
Branded AUBAGIO 14 mg slowed disability progression over time
- 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
After Clinical Trial 1 ended, of the people who remained on AUBAGIO 14 mg during the extension study:
had no disability progression for up to 7.5 years
had no disability progression for up to 7.5 years
Ways to help keep getting branded AUBAGIO
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Download*Healthcare providers 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 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. 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. View More
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