Given the current situation, we understand that people may experience worry and even fear about how their disease and treatment may impact their personal risk. Sanofi Genzyme is committed to patient safety and to transparent communication. We are taking COVID-19 seriously, and we are committed to updating the communities we serve with relevant information related to our medicines to help inform health decisions.
As COVID-19 has emerged only recently, there are no available data regarding the impact of the virus on our current therapies. At this time, if you have general questions about our therapies, you should consult the current U.S Prescribing Information (USPI).
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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 (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 (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.
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.
• How many people had no relapses during the studies (Relapse-Free)
• How often people in the studies had relapses (Relapse Rate)
on AUBAGIO 14 mg vs 46% on placebo.
54% of people were relapse-free on AUBAGIO 7 mg vs 46% with placebo.
with both AUBAGIO 14 mg and 7 mg vs placebo.
on AUBAGIO 14 mg vs 47% on placebo.
58% were relapse-free on AUBAGIO 7 mg vs 47% with placebo.
with AUBAGIO 14 mg and 22% reduction with 7 mg vs placebo.
on AUBAGIO 14 mg vs 62% on placebo.
71% were relapse-free on AUBAGIO 7 mg vs 62% with placebo.
After Clinical Trial 1 ended, people who remained on AUBAGIO 14 mg during the extension study had
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.
People taking AUBAGIO had
with AUBAGIO 14 mg vs 39% with placebo.
57% fewer new lesions with
AUBAGIO 7 mg vs placebo.
For people taking AUBAGIO
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
with AUBAGIO 14 mg vs placebo.
33% reduction in total lesion volume
with AUBAGIO 7 mg vs 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.
In Clinical Trial 1 and Clinical Trial 2, AUBAGIO 14 mg was shown to keep more people free from disability progression.
with AUBAGIO 14 mg vs 73% with placebo.
78% were free of disability progression with
AUBAGIO 7 mg vs 73% with placebo.
with AUBAGIO 14 mg vs 80% with placebo.
79% remained free of disability progression with AUBAGIO 7 mg vs 80% with placebo.
After Clinical Trial 1 ended, of the people who remained
on AUBAGIO 14 mg during the extension study:
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 sign up to ATTEND A FREE LIVE EVENT for the opportunity to hear firsthand from someone taking AUBAGIO and expert healthcare providers.
*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.
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.
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.
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:
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