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Indication and Important Safety Information Prescribing Information Medication Guide

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 & You > AUBAGIO Resources > FAQs

AUBAGIO FAQs


MS One to One® Nurses assist people who take AUBAGIO for their relapsing MS by providing them with knowledge and advice, as well as practical and emotional support.

In their conversations with people taking AUBAGIO, there are certain topics that come up frequently. Here are answers to the questions they hear most often. These are here as a guide, but remember that if you have any concerns about your health or treatment, contact your healthcare provider. He or she can best answer your questions or concerns about your health.

I’m worried about paying for my AUBAGIO. What should I do?

There are ways to access (or continue accessing) AUBAGIO, even if you’re facing financial challenges, or are experiencing a change in insurance. Your dedicated MS One to One nurse will help you navigate your insurance, including benefits verification and helping to secure financial assistance for eligible patients. Here are some typical types of insurance people use to help with the cost of treatment.

Commercial Insurance

Sold individually or as part of a group plan offered by an employer, this type of insurance typically covers medical and pharmacy expenses. Learn more about commercial insurance, and about the different ways MS One to One can help you navigate your insurance plan, and/or help you find ways to offset some of the remaining costs.

AUBAGIO Co-Pay Program

The AUBAGIO Co-Pay Program offers assistance for those with commercial insurance. It assists with co-pays and co-insurance for the cost of your AUBAGIO prescription*—regardless of financial status. (Other medical costs are not covered.) Learn more about the Co-Pay Program.

*Out-of-pocket costs related to medical 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 at any time without notice. The maximum annual patient benefit under the AUBAGIO Co-Pay Program is $18,000. Copay amounts after applying copay assistance may depend on the patient’s insurance plan and may vary. The AUBAGIO Co-Pay Program is intended to help patients afford AUBAGIO. Patients may have insurance plans that attempt to dilute the impact of the assistance available under the AUBAGIO Co-Pay Program.  In those situations, the AUBAGIO Co-Pay Program may change its terms.

Medicare Part D

Medicare Part D is an optional prescription drug plan that people with Medicare insurance can purchase to cover the cost of prescription drugs. Read more about the program, and learn about the different ways MS One to One can help you navigate your Medicare Part D coverage plan.

Medicaid

Medicaid provides health coverage for low income people and select others. It’s federally mandated, but each state administers the program differently. Learn more about Medicaid, including how you can get more information about your state’s Medicaid program.

Patient Assistance Program (PAP)

If you find yourself without insurance and you meet certain eligibility requirements, you may qualify for the Patient Assistance Program, which can help offset the cost of your AUBAGIO. Learn more about this program and review its eligibility requirements.

Foundations

There are charitable groups that provide funding to patients who are unable to pay for medication or are having trouble paying for medication. See a list of foundations you can contact to find out if you qualify for their funding.

Can I still work with my MS?

Some people continue to work long after receiving an MS diagnosis, while others find it challenging. Everyone’s situation is different, but there are things you can consider when asking if staying on the job is the right decision for you. Read more about work and MS.

I’m concerned about AUBAGIO’s potential side effects.
What do I need to know?

It's important to understand side effects of medication you're taking. AUBAGIO is no exception. The most common side effects of AUBAGIO are:

  • Headaches
  • Diarrhea
  • Nausea
  • Hair thinning and loss
  • Abnormal liver tests
These are not all of the side effects.

There are also possible serious side effects of AUBAGIO, including risk of liver problems and potential harm to an unborn baby. If you experience any of the following side effects while taking AUBAGIO, speak with your healthcare provider right away.

Other possible 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

Not every individual reacts the same to medicine. Talk to your healthcare provider about any concerns that you have regarding side effects. You can also call the MS One to One Nurses at 1‑855‑676‑6326.

Learn about possible side effects of AUBAGIO.

I’m worried that AUBAGIO could lead to hair thinning or
loss. What should I know?

It’s normal to be concerned about possible hair thinning or loss. Hair thinning associated with AUBAGIO is similar to hair thinning that can come with childbirth, stress, or an iron deficiency.1,2 It’s usually temporary and may occur around three months after beginning treatment.3

Most people who reported hair thinning or loss did not stop taking AUBAGIO as a result.

If you do experience hair thinning, there are things you can do minimize its appearance.

  • Use hair-volumizing shampoo, conditioner, and other hair-volumizing products.
  • Use a broad-tooth hairbrush that easily slips through hair so it’s less likely to break hair or pull it out.
  • Talk to your hair stylist about styles or colors that offer depth or dimension and may create the appearance of fuller hair.

THE SCIENCE BEHIND

Hair thinning or loss

A quick, quirky animated video to help you understand the science of hair thinning.

Watch Now

4

I’m experiencing something… unpleasant. Is it a side effect of
AUBAGIO, a symptom of my MS, or something else entirely?

Side effects are the unintended “effects” of a medication that have been identified and recorded during the clinical trial process and real-world patient experience. Symptoms, on the other hand, are related to a specific disease or condition. (For example, dizziness is a symptom of relapsing MS.) Though very different, side effects and symptoms can be mistaken for each other. If you have questions about your health, or any medication your taking—including AUBAGIO—please consult your healthcare provider.

I have questions about my liver test results. What should I do?

Some people on AUBAGIO have reported experiencing elevated liver enzymes, specifically alanine aminotransferase (ALT). Elevated ALTs can indicate serious liver problems, which is why people taking AUBAGIO need regular blood tests to check the liver during their first six months of therapy. Have you have received the results of a lab test and want to know how to interpret it? Read more about liver testing and understanding the tests’ results. However, it’s important to note that those values cited are just a general guide; you should discuss your lab results with your healthcare provider, especially if you have questions or concerns.

I feel like my family doesn’t understand what I’m going
through and it’s creating friction. What can I do?

This is not an uncommon issue for people living with MS. Studies show the condition can often have a significant impact on families, and can lead to stress and tension within the family unit.4 When dealing with these family challenges, some people find it helpful to talk their problems through with a supportive, third-party person who has experience with chronic illness and its effect.

MS One to One can also offer support. Reach out to them at any time with your questions, concerns, or to simply talk about what’s on your mind: 1-855-676-6326.

What do I need to know about AUBAGIO and family planning?

When it comes to MS and pregnancy, there are some important choices you may need to make. If you’re thinking about starting or expanding your family, you should speak with your healthcare provider.5,6 Planning a family is possible when you work with your healthcare team to decide which treatment is best for you.5,6

Having multiple sclerosis does not directly affect your ability to father a child,6 become pregnant,7 or carry a baby to term.7 But, AUBAGIO may cause harm to an unborn baby.1 Therefore, a woman should not take AUBAGIO if she is pregnant, or of childbearing age and not using effective birth control. AUBAGIO is detected in human semen,1 so men capable of fathering children and taking AUBAGIO should use effective birth control at all times.

If you are taking AUBAGIO and plan on becoming pregnant, there are a few steps to take.

Women taking AUBAGIO
  • Speak with your primary care physician, OB-GYN, and neurologist about what your family planning goals are for the next few years.1,5,6
  • Consult with your healthcare provider about the accelerated elimination process for AUBAGIO, which can remove AUBAGIO from your blood quickly. (The process takes about 11 days.)1
Men taking AUBAGIO
  • Speak with your primary care physician and your neurologist about what your family planning goals are for the next few years.1,6
  • Advise your partner to let her OB-GYN know that you are taking or considering taking AUBAGIO.1
  • Consult with your healthcare provider about the accelerated elimination process for AUBAGIO, which can remove AUBAGIO from your blood quickly. (The process takes 11 days.)1

If you become pregnant while taking AUBAGIO—or within two years of taking it— tell your healthcare provider right away. You may also want to enroll in the AUBAGIO Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. The number to join is: 1-800-745-4447

MS One to One
MS One to One logo

Is a change in employment status disrupting your medication coverage for AUBAGIO?

MS One to One is here for you. Our team can help you navigate any disruptions to coverage you may be facing.

Call today 1‑855‑676‑6326

Unsure about insurance?

We can help. Learn more about your coverage options by selecting the insurance type that best applies to you:

Commercial Insurance Medicare Part D Medicaid I don't have insurance

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

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.

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. Your risk may be higher if you already have liver problems or 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), over-the-counter medicines, vitamins or herbal supplements.

AUBAGIO may cause serious side effects. Tell your doctor if you have any of the following:

  • decreases in white blood cell count — this may cause you to have more infections. Symptoms include fever, tiredness, body aches, chills, nausea, or vomiting. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.
  • allergic reactions such as difficulty breathing, itching, or swelling on any part of your body including lips, eyes, throat, or tongue. Stop taking AUBAGIO and call your doctor right away.
  • serious skin reactions that may lead to death. Stop taking AUBAGIO if you have rash or redness and peeling, mouth sores or blisters.
  • other allergic reactions that may affect different parts of the body. If you have a fever or rash in combination with severe muscle pain, swollen lymph glands, swelling of your face, unusual bruising or bleeding, weakness or tiredness, or yellowing of your skin or the whites of your eyes, stop taking AUBAGIO and call your doctor right away.
  • numbness or tingling in your hands or feet that is different from your MS symptoms
  • high blood pressure
  • breathing problems (new or worsening) — these 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.

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.

References

1. AUBAGIO (teriflunomide) [package insert]. Cambridge, MA: Genzyme Corporation.

2. Mounsey AL, Reed SW. Diagnosing and treating hair loss. Am Fam Physician. 2009;80(4):356-362,373-374.

3. Hendin Travis, Okai, A, et al. Real-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical Practice? Neurol Ther (2018) 7; 341-347.

4. Uccelli M. The impact of multiple sclerosis on family members: a review of the literature. Neurodegener Dis Manag. 2014;4(2):177-185. doi:10.2217/nmt.14.6

5. Bove R, Alwan S, Friedman JM, et al. Management of multiple sclerosis during pregnancy and the reproductive years. Obstet Gynecol. 2014;124(6):1157-1168. doi:10.1097/AOG.0000000000000541.

6. US Department of Veterans Affairs Multiple Sclerosis Centers of Excellence. Overview of Multiple Sclerosis for Veterans. Washington, DC: United States Department of Veterans Affairs; 2017. Veterans Affairs publication IB 10-977.

7. Coyle PK. Management of women with multiple sclerosis through pregnancy and after childbirth. Ther Adv Neurol Disord. 2016;9(3):198-210. doi:10.1177/1756285616631897.

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MAT-US-2002680-v4.0-11/2021 Last Updated: November 2021

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