ONE PILL, ONCE A DAY GET TO KNOW AUBAGIO Patient Portrayal Ask your doctor if AUBAGIO may be right for you. INDICATION AUBAGIO (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS). IMPORTANT SAFETY INFORMATION 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. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide.
TABLE OF CONTENTS ABOUT AUBAGIO ONE SMALL PILL, ONCE A DAY WHO IS AUBAGIO FOR? CLINICAL RESULTS CLINICAL TRIALS RELAPSES DISABILITY PROGRESSION LESIONS GETTING STARTED TODAY IS A NEW BEGINNING FIRST THINGS FIRST GET SUPPORT THAT S TRULY PERSONAL FINANCIAL ASSISTANCE SUPPORT IS JUST A PHONE CALL AWAY HELPFUL RESOURCES IMPORTANT SAFETY INFORMATION LEARN MORE AUBAGIO IN THE BODY ABOUT POTENTIAL SIDE EFFECTS 3 QUESTIONS COVER A LOT CHECK OUT A LIVE EVENT $0 CO-PAY PROGRAM
QUIETS RELAPSES The majority of patients taking AUBAGIO did not experience a relapse during clinical studies. QUIETS DISABILITY PROGRESSION 80% of patients taking AUBAGIO 14 mg experienced no disability progression. QUIETS NEW LESIONS AUBAGIO 14 mg cut the risk of new lesions by 80%. Patient Portrayal * AUBAGIO (teriflunomide) is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and discontinuation rates due to common adverse events were 3.3% in the pooled clinical trials. 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 point (lasting at least 12 weeks). 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. 14 mg only. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. ABOUT AUBAGIO
ONE SMALL PILL, ONCE A DAY TAKE IT ANYTIME, WITH OR WITHOUT FOOD Taking AUBAGIO (teriflunomide) is one way you may be able to help put your relapsing MS in the background. 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. 4 Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. ABOUT AUBAGIO
medication used to weigh on me. Now I take one pill in the morning and then I don t think about it. Darin Taking On AUBAGIO 14 mg Individual experiences may vary AUBAGIO (TERIFLUNOMIDE) IS AN OPTION FOR PEOPLE LIVING WITH RELAPSING MS WHO ARE: Newly diagnosed or have never used treatment Changing therapies because of side effects from current MS medication Switching Switching therapies therapies due due to to disease activity Dissatisfied with their current treatment 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), vitamins or herbal supplements. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. ABOUT AUBAGIO
CLINICAL RESULTS Patient Portrayal 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. Tell your doctor if you have any side effect that bothers you or does not go away. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. IN 3 CLINICAL TRIALS, AUBAGIO WAS PROVEN EFFECTIVE CLINICAL RESULTS CLINICAL RESULTS CLINICAL RESULTS
PROVEN IN 3 CLINICAL TRIALS AUBAGIO (teriflunomide) WAS STUDIED In 3 CLINICAL TRIALS With more than 2,800 PATIENTS For up to 108 WEEKS In doses of 14 mg & 7 mg AUBAGIO 14 mg was shown to be effective vs. placebo in 3 key measures: relapses, disability progression and brain lesions. AUBAGIO 7 mg was shown to be effective vs. placebo in 2 of the 3 key measures relapses and brain lesions. 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. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. CLINICAL RESULTS
1ST CLINICAL T R I A L* TEMSO 1,088 PATIENTS who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial 2ND CLINICAL T R I A L* TOWER 1,165 PATIENTS who had at least 1 relapse during 1 year prior to trial, or 2 relapses during 2 years prior to trial 3RD CLINICAL T R I A L* TOPIC 614 PATIENTS who had their 1st clinical event within 3 months prior to trial, and 2 or more lesions characteristic of relapsing MS *The clinical trials were each given a name. Trial 1 was called TEMSO; Trial 2 was called TOWER; and Trial 3 was called TOPIC. 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. Patient Portrayal Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. CLINICAL RESULTS
AUBAGIO QUIETS RELAPSES * In all 3 clinical trials, AUBAGIO kept more patients relapse-free vs. placebo. CLINICAL TRIAL 1 on AUBAGIO 14 mg vs. 46% with placebo. 54% remained relapse-free on AUBAGIO 7 mg vs. 46% with placebo. Patient Portrayal 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. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. *AUBAGIO is effective against annualized relapse rates. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and discontinuation rates due to common adverse events were 3.3% in the pooled clinical trials. CLINICAL RESULTS
If you are concerned about relapses, ask your healthcare provider if once-daily AUBAGIO may be right for you. CLINICAL TRIAL 2 CLINICAL TRIAL 3 on AUBAGIO 14 mg vs. 47% with placebo. 58% remained relapse-free on AUBAGIO 7 mg vs. 47% with placebo. on AUBAGIO 14 mg vs. 62% with placebo. 71% remained relapse-free on AUBAGIO 7 mg vs. 62% with placebo. 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), vitamins or herbal supplements. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. CLINICAL RESULTS
AUBAGIO QUIETS DISABILITY PROGRESSION * AUBAGIO 14 mg was shown to help keep patients free of disability progression. Patient Portrayal *AUBAGIO is effective against sustained disability progression (14 mg only). Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and discontinuation rates due to common adverse events were 3.3% in the pooled clinical trials. 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 point (lasting at least 12 weeks). 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. Tell your doctor if you have any side effect that bothers you or does not go away. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. CLINICAL RESULTS
Disability progression was looked at in 2 of the clinical trials. In both of those trials, AUBAGIO 14 mg was shown to help keep more people free from disability progression. AUBAGIO 7 mg did not achieve a statistically significant reduction in risk of sustained disability progression. CLINICAL TRIAL 1 CLINICAL TRIAL 2 80 % HAD NO DISABILITY PROGRESSION with AUBAGIO 14 mg vs. 73% with placebo. 78% remained free of disability progression with AUBAGIO 7 mg vs. 73% with placebo. 84 % HAD NO DISABILITY PROGRESSION with AUBAGIO 14 mg vs. 80% with placebo. 79% remained free of disability progression with AUBAGIO 7 mg vs. 80% with placebo. 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. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. CLINICAL RESULTS
AUBAGIO QUIETS NEW LESIONS * One clinical trial looked at brain lesions as a key measure of disease activity. Patients taking AUBAGIO experienced less risk of new brain lesions vs. placebo. CLINICAL TRIAL 1 % FEWER NEW LESIONS with AUBAGIO 14 mg vs. placebo. 57% fewer new lesions with AUBAGIO 7 mg vs. placebo. Average lesions per scan *AUBAGIO is effective against MRI activity. Overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo, and discontinuation rates due to common adverse events were 3.3% in the pooled clinical trials. 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. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. CLINICAL RESULTS
LEARN MORE WHAT YOU NEED TO KNOW TO HELP YOU DECIDE IF AUBAGIO IS RIGHT FOR YOU Patient Portrayal Patient Portrayal 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. Please see see Important Safety Safety Information Information on on pages pages 2830 and and 2931 and and accompanying accompanying full full Prescribing Prescribing Information, Information, including boxed including WARNING boxed WARNING and Medication and Medication Guide, enclosed. Guide. LEARN MORE
AUBAGIO IN THE BODY MS is thought to occur when immune cells become overactive and begin to attack the central nervous system, specifically targeting the outer covering of nerves known as the myelin sheath. While we don t know exactly 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. When you have MS, certain immune cells in your body become overactive and multiply. AUBAGIO blocks an enzyme called DHODH that these overactive cells need to keep multiplying at their overactive rate. Taken daily, AUBAGIO reduces the number of overactive immune cells thought to cause MS flare-ups, while still allowing normal immune cell activity to occur. For illustrative purposes only. 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), vitamins or herbal supplements. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. Patient Portrayal LEARN MORE
ABOUT POTENTIAL SIDE EFFECTS POSSIBLE SERIOUS SIDE EFFECTS It s important to know the serious risks of any medication you take. And when it comes to AUBAGIO (teriflunomide), it s no different. If you experience any of the following side effects while taking AUBAGIO, speak with your healthcare provider right away. In addition to the risk of liver problems and the risk of harm to an unborn baby, other serious side effects include: 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) High blood pressure Certain vaccinations should be avoided during treatment with AUBAGIO and for at least 6 months after discontinuation MOST COMMON SIDE EFFECTS Here are some of the most common side effects reported in the clinical trials. These are not all the side effects. SIDE EFFECTS Headache Abnormal liver test results Diarrhea Hair thinning or loss Nausea AUBAGIO 14 mg (n=1002) 7 mg (n=1045) 16% 15% 14% 13% 11% 18% 13% 13% 10% 8% Tell your doctor if you have any side effect that bothers you or does not go away. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. PLACEBO (n=997) 15% 9% 8% 5% 7% n=number of people in trial LEARN MORE
SEE HOW MANY PEOPLE STOPPED TAKING AUBAGIO DUE TO COMMON SIDE EFFECTS, IN CLINICAL TRIALS DISCONTINUATION RATES DUE TO COMMON SIDE EFFECTS SIDE EFFECTS AUBAGIO 14 mg (n=1002) 7 mg (n=1045) PLACEBO (n=997) Diarrhea 0.4% 0.5% 0.1% Nausea 0.3% 0.1% 0% Hair thinning or loss 1.3% 0.2% 0.1% Abnormal liver test results 2.6% 3.3% 2.3% Headache 0% 0% 0.3% n=number of people in trial Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. LEARN MORE
3 QUESTIONS COVER A LOT Start the conversation about relapsing MS treatment and AUBAGIO (teriflunomide) with your healthcare provider. Just ask: 1 How well do current relapsing MS medications work? 2 What should I know about the side effects of each option? 3 Which treatment is right for me? ASK IF AUBAGIO IS RIGHT FOR YOU Patient Portrayal 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. Tell your doctor if you have any side effect that bothers you or does not go away. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. LEARN MORE
CHECK OUT A LIVE EVENT The maker of AUBAGIO (teriflunomide) hosts free special events all across the country for people living with relapsing MS and their care partners. You ll hear from an MS expert and others living with relapsing MS. Whether you re on AUBAGIO or considering it, please join us. Signing up for an event is an easy way to learn about relapsing MS. Simply go to aubagioevents.com to find an event near you. 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. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. LEARN MORE
$0 CO-PAY PROGRAM To learn more about how eligible patients with commercial insurance can become part of the $0 Co-Pay Program* and about other ways that may help pay for AUBAGIO (teriflunomide), click here. *Out-of-pocket costs related to medical appointments, evaluations, testing, or other related services are not covered by the AUBAGIO Co-Pay Program. Patient Portrayal Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. LEARN MORE
GETTING STARTED WHAT YOU NEED TO KNOW TO BEGIN ONCE-DAILY AUBAGIO 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. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. G E T T I N G S TA R T E D Patient Portrayal
TODAY IS A NEW BEGINNING You re about to start AUBAGIO (teriflunomide). This brochure will walk you through the basics of beginning AUBAGIO, including details about: Tests you ll need 24-hour personalized support Financial assistance G E T T I N G S TA R T E D Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide.
First things first Before you start on AUBAGIO (teriflunomide), your healthcare provider will need to run a few tests within 6 months before beginning treatment. Your healthcare provider will check for the following, but these are often done together: Perform blood tests to check your liver Perform a TB (tuberculosis) skin test or blood test for mycobacterium tuberculosis infection Perform a pregnancy test, if you are a woman of childbearing potential Obtain a complete blood count Check your blood pressure G E T T I N G S TA R T E D Patient Portrayal Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide.
GET SUPPORT THAT S TRULY PERSONAL Once you begin taking AUBAGIO (teriflunomide), you ll have access to the following MS One to One offerings: Your own dedicated Nurse, who will get to know you and is available Monday Friday, 8:30 AM to 8:00 PM ET which means you won t have to start over with your story each time you call Your Nurse s direct extension, so you can reach out with questions or concerns, or simply talk Assistance navigating your insurance, including benefits verification and financial assistance for eligible patients. Help connecting with financial assistance programs that have a specialty pharmacy Visit aubagio.com to learn more. Patient Portrayal G E T T I N G S TA R T E D Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide.
When I started AUBAGIO (teriflunomide), I got the monthly phone call from MS One to One to remind me to have my routine blood work, and just to check in to see how I was doing. Heather On AUBAGIO 14 mg Individual experiences may vary. 1-855-676-6326 G E T T I N G S TA R T E D Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide.
$0 CO-PAY NOTHING S LOWER The last thing you want to worry about is paying for your medication. That s why the AUBAGIO (teriflunomide) Co-Pay Program offers assistance for those with commercial insurance. It assists with drug-related out-of-pocket expenses including co-pays and co-insurance regardless of your financial status. Once enrolled in the program, you ll have a $0 co-payment.* ADDITIONAL FINANCIAL ASSISTANCE If you do not have insurance or are unable to pay for treatment, the Sanofi Genzyme Patient Assistance Program could be the answer. Another solution: an MS One to One Nurse may be able to direct you to not-for-profit organizations that may be able to provide support. Talk to an MS One to One Nurse for more information and to ask for help from any of these programs. You may also want to check with your local patient advocacy group about other support. *Out-of-pocket costs related to medical appointments, evaluations, testing, or other related services are not covered by the AUBAGIO Co-Pay Program. G E T T I N G S TA R T E D Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide.
Call MS One to One at 1-855-676-6326, or visit aubagio.com to learn more. We re Here to Help G E T T I N G S TA R T E D Patient Portrayal Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide.
HELPFUL RESOURCES American Academy of Neurology (AAN) aan.com 1-800-879-1960 Dedicated to helping people understand neurology and the available treatments for neurological disorders, including MS. Multiple Sclerosis Foundation (MSF) msfocus.org 1-800-225-6495 MSF offers a wide range of free services, including national toll-free support, home care, support groups, assistive technology, and more. National Multiple Sclerosis Society nationalmssociety.org 1-800-344-4867 A 50-state U.S. network that helps people with the challenges of MS. Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. G E T T I N G S TA R T E D MS One to One msonetoone.com 1-855-676-6326 Start a one-on-one conversation with an MS One to One Nurse who understands MS and what you re going through.
MSWorld msworld.org Provides online support, chat, and message boards to more than 150,000 worldwide living with MS. MyMSTeam mymsteam.com A social network for those living with MS. Turn to them for practical advice and insights on managing life with MS. Multiple Sclerosis Association of America (MSAA) mymsaa.org 1-800-532-7667 A national organization dedicated to improving the quality of life for everyone affected by MS. Caregiver Action Network caregiveraction.org 1-202-454-3970 Educates, supports, and empowers people who take care of loved ones who have chronic illnesses or disabilities. G E T T I N G S TA R T E D Please see Important Safety Information on pages 30 and 31 and accompanying full Prescribing Information, including boxed WARNING and Medication Guide. Can Do Multiple Sclerosis mscando.org 1-800-367-3101 Lifestyle empowerment programs for people with MS.
INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION AUBAGIO (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS). IMPORTANT SAFETY INFORMATION DO NOT TAKE AUBAGIO IF YOU: Have severe liver problems. AUBAGIO may cause serious liver problems, which can be life-threatening. Your risk may be higher if you 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. IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION (continued) 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), vitamins or herbal supplements. 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. Tell your doctor if you have any side effect that bothers you or does not go away. 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. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including boxed WARNING and Medication Guide, enclosed. IMPORTANT SAFETY INFORMATION
2017 Genzyme Corporation. All rights reserved. AUBAGIO, MS One to One, Sanofi and Genzyme registered in U.S. Patent and Trademark Office. SAUS.AUBA.17.03.0575. July 2017. Please see Important Safety Information on pages 30 and 31 of this brochure and accompanying full Prescribing Information, including boxed WARNING and Medication Guide, enclosed.