Ask Away. FAQs.

AUBAGIO is a once-daily pill used to treat relapsing forms of multiple sclerosis (MS).

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 brain 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, if you are a woman of childbearing potential

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.

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.

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 hair 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 clincial 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.

Your healthcare provider will:

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

Work with your healthcare provider to schedule these appointments.

The following instructions are for the 28-day supply of AUBAGIO:

• The AUBAGIO blister pack is contained in an outer box. To open the box, use your thumb to depress the perforated tab at the top
• Pull back the top of the box and remove the blister pack
• To remove your daily AUBAGIO pill, use your thumb to push down from the top and tear through the individual blister

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.

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.

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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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