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AUBAGIO is a once-daily pill used to treat relapsing forms of multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Your healthcare provider will run certain tests before you start treatment. Once on AUBAGIO, your healthcare provider will monitor your liver enzyme levels monthly for the first 6 months.

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You and your healthcare provider will decide if AUBAGIO is right for you. AUBAGIO is an option for people with relapsing MS who are:

• Newly diagnosed or have never used treatment
• Switching therapy due to disease activity
• Changing therapy because of side effects from current relapsing MS treatment
• Dissatisfied with current treatment

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.

While we don’t fully understand how AUBAGIO works in relapsing MS, we do know that it works differently from other relapsing MS medicines. AUBAGIO is believed to block the enzyme needed for immune cells to keep multiplying at an overactive rate.

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In clinical trials, AUBAGIO 14 mg was proven to be effective vs. placebo in reducing relapses, slowing disability progression, and decreasing the number of new lesions. AUBAGIO 7 mg was shown to be effective vs. placebo in reducing relapses and new lesions.

To learn more about the efficacy data for AUBAGIO, CLICK HERE.

Your healthcare provider will need to run a few tests within 6 months before you can begin AUBAGIO:

• Perform blood tests to check your liver
• Obtain a complete blood count
• Perform a TB (tuberculosis) skin test or blood test for Mycobacterium tuberculosis infection
• Check your blood pressure
• Perform a pregnancy test prior to starting AUBAGIO, if you are a woman of childbearing potential

Your healthcare provider will:

1. 1. Monitor your liver enzyme levels monthly for the first 6 months
2. 2. Check your blood pressure periodically after starting treatment

Work with your healthcare provider to schedule these appointments.

No, but it should be stored at room temperature from 68°F to 77°F (20°C to 25°C). Make sure to keep AUBAGIO out of the reach of children.

If you miss a pill, you should follow your set schedule and take your next pill as normal. There is no need to double up a dose to make up for a missed dose. It is important to take your medication as prescribed in order to get the full benefit of AUBAGIO. If you have concerns about missing a dose(s), please talk to your healthcare provider.

In addition to the risk of liver problems, including liver failure that can be life-threatening and may require a liver transplant, and the risk of harm to an unborn baby, other possible serious side effects include:

• Decreases in white blood cell count – this may cause you to have more infections
• Certain vaccinations should be avoided during treatment with AUBAGIO and for at least 6 months after discontinuation
• Allergic reactions
• Serious skin reactions that may lead to death
• Other allergic reactions that may affect different parts of the body such as your liver, kidneys, heart, or blood cells
• Numbness or tingling in your hands or feet that is different from your MS symptoms
• High blood pressure
• Breathing problems (new or worsening) – that 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.

Flushing was not a common side effect reported in AUBAGIO clinical trials. However, not every individual reacts the same to medicine. Tell your healthcare provider about any side effect that you experience.

Not every individual reacts the same to medicine. In our clinical trials, up to 14% of patients on AUBAGIO had diarrhea versus 8% of patients on placebo. Most cases of diarrhea were mild to moderate and not persistent. Tell your healthcare provider about any side effect that you experience.

Hair thinning or loss was a side effect of AUBAGIO reported in clinical trials. 87% of patients on AUBAGIO 14 mg and 90% of patients on AUBAGIO 7 mg did not report experiencing hair thinning or hair loss. 13% of patients on AUBAGIO 14 mg and 10% of patients on AUBAGIO 7 mg did report experiencing hair thinning or hair loss. In clinical trials, about 1 in 20 people taking placebo (5% of 997 patients) reported experiencing hair thinning or hair loss. In most cases, hair thinning or hair loss was mild to moderate, had a median time to onset of 99 days, and improved in the majority of patients without corrective therapy while patients remained in the clinical trials. Tell your healthcare provider about any side effect that you experience.

AUBAGIO is a once-daily pill with infection rates similar to placebo.

AUBAGIO may cause decreases in your white blood cell count. When you have a low white blood cell count you may have more frequent infections. Infection rates were similar with AUBAGIO vs. placebo in clinical trials. One death due to Klebsiella pneumoniae sepsis occurred in a patient taking AUBAGIO 14 mg for 1.7 years. In clinical trials with AUBAGIO, cytomegalovirus hepatitis reactivation and cases of TB (tuberculosis) have been observed. AUBAGIO has no PML in its Prescribing Information.

Do not take AUBAGIO if you are pregnant. AUBAGIO may harm an unborn baby. Always talk to your healthcare provider about all your medications if you are pregnant.

If you become pregnant while taking AUBAGIO or within 2 years after you stop taking it, tell your healthcare provider right away. There is a process called accelerated elimination to help you remove AUBAGIO from your blood if needed. Without using accelerated elimination, AUBAGIO may stay in your blood for up to 2 years after you stop using it. In addition, you can enroll in the AUBAGIO Pregnancy Registry by calling 1-800-745-4447, then press option 2. The purpose of the registry is to collect information about your health and your baby’s health.

Women who are pregnant or not using effective birth control should not take AUBAGIO because it’s possible that AUBAGIO may harm your unborn baby.

If you become pregnant while taking AUBAGIO, tell your healthcare provider right away. A process called accelerated elimination helps remove AUBAGIO from your blood if needed. It is recommended that you continue using birth control until the level of AUBAGIO is lower in your blood than 0.02 mg/L.

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.

The financial assistance programs for those with primary commercial insurance are:

• AUBAGIO Co-Pay Program*
• One Start^®

The financial assistance program for individuals without insurance and who meet other eligibility requirements:

• Patient Assistance Program (PAP)

You can get help figuring out coverage from an MS One to One^® Nurse.

*Out-of-pocket costs related to medication appointments, evaluations, testing, or other related services are not covered by the AUBAGIO Co-Pay Program. The AUBAGIO Co-Pay Program is not available for prescriptions purchased under Medicare, Medicaid, TRICARE, or other federal- and state-funded programs. Sanofi Genzyme reserves the right to amend or terminate the program.

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MS One to One is a support program aimed at empowering anyone living with relapsing multiple sclerosis. The program is available to anyone affected by MS—people living with MS, their care partners, and their healthcare providers. Nurses are always available, 24/7, by phone to assist you and answer any questions you may have.

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Common Threads is a supportive community for people taking AUBAGIO and their friends and family. Common Threads provides 24/7 access to information about AUBAGIO and living well with relapsing MS. Members have access to tools, tips, and stories featuring people taking AUBAGIO. To learn more, visit COMMON THREADS.

Sanofi Genzyme sponsors free local events with topics focusing on the disease, living with MS, and once-daily AUBAGIO for relapsing MS.

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MS stands for multiple sclerosis. It is a disease that damages nerves in your brain and your spinal column, which can disrupt the flow of information within the brain and between the brain and body.

Nobody knows what causes MS. It is not an inherited disease, but people with a family history of MS may be slightly more likely to develop it. This is also true for people who live farther from the equator. The risk of getting MS is about 1 in 1,000.

Relapsing MS is the most common type of MS and is characterized by clearly defined attacks, called relapses, exacerbations, or flare-ups, and are followed by periods of partial or complete recovery or remission.

The symptoms of MS vary from person to person. They can also be different from one relapse to the next. The most common symptoms include:

• Unexplained periods of fatigue
• Vision problems
• Muscle spasms or stiffness
• Weak muscles
• Bowel and bladder problems
• Trouble with balance and coordination
• Problems with learning, memory, or processing information
• Numbness or “pins and needles” sensations

A relapse is the appearance of new symptoms or the worsening of old symptoms. To be considered a relapse, the flare-up must last 24 hours or longer and it must be separated from a previous attack by at least 30 days and followed by a period of complete or partial recovery.

A relapse is an MS attack lasting more than 24 hours where you either have new symptoms or old symptoms get worse. A relapse may be mild or severe (possibly requiring a hospital stay) and may occur at any time. All relapses are a sign of disease activity, which means MS is doing more damage to your nerves.

It depends on how much nerve damage is done and whether or not your body can repair the pathway or find a new one. After a relapse, some people go back to how they were before the attack. Others can end up with ongoing symptoms. That’s why it’s so important to work closely with your healthcare providers and find a treatment that meets your needs.

A primary goal of treating MS should be to keep you from having MS symptoms. Relapsing MS treatments are known as disease-modifying treatments. A disease-modifying treatment that works for you should prevent relapses, prevent new lesions, and slow the progression of disability.

You should start treating MS as soon as possible after you are diagnosed. Research has shown that this is the best way to slow MS progression. You may also need treatments to help relieve your MS symptoms, but these should be taken in addition to your relapsing MS treatment, also known as disease-modifying treatment.

A primary goal of treating MS should be to keep you from having those symptoms in the first place. An MS disease-modifying treatment that works for you should prevent relapses, prevent new lesions, and slow the progression of disability.

Ask yourself the following questions about your current treatment:

• Am I uncomfortable with the safety record?
• Have I had a relapse?
• Have I had new lesions?
• Have I noticed a change in my abilities?
• Are my side effects unmanageable?
• Am I no longer taking it as prescribed?

If you answered yes to any of these questions, then it may be time to consider a change and talk to your healthcare provider about a different treatment for relapsing MS.

There is no cure for MS. But there are treatments, known as disease-modifying treatments (or DMTs), that are shown to:

• Reduce the risk of relapses
• Decrease the number of new lesions
• Slow the progression of disability

MRI stands for magnetic resonance imaging. By using powerful magnets and radio waves, it creates pictures of things inside your body without using x-rays. MRIs are one of the most sensitive, non-invasive ways of seeing in tissue. An MRI can be used to help diagnose relapsing MS and to monitor disease activity.

A lesion is an area of swollen, irritated, or damaged nerves.

The loss of abilities that comes from nerve damage caused by MS. This damage builds up, eventually leading to long-term disability.

A healthy lifestyle is important for everybody, but research shows that eating right, moderate exercise, and not smoking, can help with relapsing MS symptoms by improving cardiovascular fitness, bettering bladder and bowel function, increasing energy, and elevating mood.