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.SELECT IMPORTANT SAFETY INFORMATION
Do not take AUBAGIO if you have severe liver problems, are pregnant or of childbearing potential and are not using effective birth control, have had an allergic reaction to AUBAGIO or leflunomide, or are taking a medicine called leflunomide for rheumatoid arthritis.
The great tennis player, Billie Jean King, famously said, “champions adjust.” And while that motto certainly worked for her, those are words anyone with relapsing MS can live by. Because, with relapsing MS, you can always count on the fact that things change. Making adjustments is part of the journey.
For instance, you and your healthcare provider (HCP) may believe it’s time for you to begin your first treatment. At the start of your journey, you might consider injections, infusions, and oral options.1 When you are considering a disease-modifying therapy (DMT), it is also important to think about whether you will take your treatment as prescribed.2 How will it fit in your current lifestyle? Will the form of your DMT help you to not miss doses? These are all questions that may influence your decision when it comes to selecting a relapsing MS treatment with your HCP.
If you are currently on treatment, you will want to consider some factors: if you’ve had a relapse, new lesions, or have seen signs of disability progression while on that treatment. Each is a sign you may need to talk to your HCP about changing your therapy.2 It’s never too early to prioritize slowing disability progression.3 Regularly revisiting your treatment plan with your HCP and adjusting your treatment goals is important to ensure your treatment is keeping up with your needs throughout your journey.1
When you discuss your treatment options with your HCP, it’s also wise to talk about safety.2 What is the history of the DMTs you and your HCP are considering? When weighing your options, what clinical data is available for you to review?
All relapsing MS treatments are different, and each comes with its own set of possible side effects.1 Anyone starting treatment for the first time should think about which side effects are deal-breakers for them. If you’re considering a treatment change, you may already have experience with some of these side effects. Take note of them.2 Could you possibly leave an unpleasant side effect behind? Be sure to tell your HCP about your needs and discuss your treatment goals frequently.
Do your best to look at your treatment with a critical eye.1 Then adjust so that your needs stay front and center. Reexamining your relapsing MS with your HCP is how you will maximize your options. The bottom line is, anyone can champion their needs, so speak up. Just be sure when the situation calls for it that you’re willing and ready to adapt to what is available to you.
Visit aubagio.com for more information and helpful
*Healthcare providers measure disability progression using a test
called the Expanded Disability Status Scale, or EDSS.8 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).9
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.
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.
1. Pardo G, Jones DE. The sequence of disease-modifying therapies in relapsing multiple sclerosis: safety and immunologic considerations. J Neurol. 2017;264(12):2351‐2374. 2. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018;90(17):777‐788. 3. Ford CC, Morrow SA. CMSC Practical Guidelines for the Selection of Disease Modifying Therapies in MS. CMSC. https://cmscscholar.org/cmsc-practicalguidelines- for-the-selection-of-disease-modifying-therapies-in-ms/. Published February 29, 2020. Accessed May 12, 2020. 4. O’Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293‐1303. 5. AUBAGIO [prescribing information]. Cambridge, MA: Genzyme Corporation; February 2020. 6. Long-term safety and efficacy of teriflunomide: Nine-year follow-up of the randomized TEMSO study. Neurology. 2016;87(14):1524. 7. Coyle PK, Khatri B, Edwards KR, et al. Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017;17:107‐115. 8. Expanded Disability Status Scale (EDSS). MS Trust. https://www.mstrust.org.uk/a-z/expanded-disability-statusscale- edss. Published January 2020. Accessed May 12, 2020. 9. Healy BC, Engler D, Glanz B, Musallam A, Chitnis T. Assessment of definitions of sustained disease progression in relapsing-remitting multiple sclerosis. Mult Scler Int. 2013;2013:189624.
Last Updated: 06/20.
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