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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 > It takes a village! Adherence isn't a solo act

It takes a village! Adherence isn't a solo act

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Has anyone (like a doctor or loved one) ever made it sound like taking medication as prescribed is something that’s easy to do? Maybe someone has told you to “just do it” as a way to motivate you over a particular hurdle?

The reality is that taking medication as prescribed (also known as adherence) isn’t easy. In fact, it’s a complex behavior that can be influenced by lots of personal factors.1

In this article, we will shine a light on some things that can affect adherence. Hopefully it can help inform you so you can understand the importance of taking medication as prescribed, navigate challenges if you encounter them, and enlist support to help you stay with the treatment plan you and your doctor chose for you.

Adherence is important

Your healthcare provider has likely spent time with you discussing the benefits and risks of taking AUBAGIO to treat your relapsing MS. He or she may have discussed how AUBAGIO was proven effective in treating relapsing MS. This was the result of extensive clinical study in patients who took AUBAGIO once daily.

And while each person’s experience with a medication is different, the one thing you can count on is that if you don’t take a treatment, it won’t work. This is why adherence is important. It’s the link between treatment and outcomes.1

Let’s review some factors that can affect adherence.

Working together for your health

Doctor knows best. Have you ever heard this phrase? While some people might want clear directives from their doctor, most people prefer a collaborative approach.2 Your collaboration shouldn’t stop at choosing which treatment to take; it should also include working together with your care team to create a plan that supports you for taking it as prescribed. When you are starting a new treatment such as AUBAGIO, it’s a good time to have an open and candid dialogue with your healthcare team. Here are things you’ll want to consider.

Do you understand why you are taking medication?

Adherence is more than taking medication as prescribed, it’s also about a personal acceptance of the treatment plan. If you aren’t entirely sure why your doctor has prescribed you medication, or you forget over time, ask your doctor to review the plan. Be sure to ask questions if you don’t understand. It can also help to reflect back to your doctor (in your own words) why you think you are taking the medication. Putting it into your own words may help reinforce your personal understanding of why it’s important to take the treatment as prescribed.

Do you understand how to take it?
A doctor’s visit can be overwhelming. It’s easy to forget what was discussed. If you have any questions about how to take medication, you can call your doctor’s office, your pharmacist, or in the case of AUBAGIO, your dedicated MS One to One Nurse at 1‑855‑676‑6326. AUBAGIO should be taken once daily as prescribed, and it can be taken with or without food.

You can also review information if you miss a dose.

Do you need support for remembering to take your medication?
AUBAGIO can be taken once a day at any time, day or night. It’s best to get on a consistent schedule so that you take it around the same time each day. If you want support in establishing a routine, talk to your healthcare provider and your loved ones. AUBAGIO Ambassadors also have some tips and tricks that they share.

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Are you concerned about side effects?
When you start a new medication, your doctor will discuss possible benefits and risks, including side effects. When it comes to taking AUBAGIO, there are possible common and serious side effects you should know about. If you have concerns about possible side effects, discuss them with your doctor.

It’s important to be candid. For example, are you concerned about possible hair thinning or loss with AUBAGIO? Maybe you worry secretly that you will lose your hair. If you don’t discuss your concerns with your doctor, that fear can linger, and you may be wary of taking AUBAGIO as prescribed.1

Talking to your doctor can help you be more informed about what you might expect. For example, in the case of hair thinning or loss with AUBAGIO, it’s usually temporary; and it’s typically extra shedding of hair similar to what women experience after childbirth.3,4 Having a candid conversation with your doctor can help you feel more informed, which can support good medication adherence.1

Are you concerned about cost?
It’s not uncommon for a patient to avoid talking about financial concerns with their doctor; but being able to afford medication is a critical factor in good adherence. You should feel comfortable discussing financial concerns with your healthcare team. If you experience any changes in insurance or have other financial concerns with affording AUBAGIO, you can also call your dedicated nurse at MS One to One at 1‑855‑676‑6326.

Are you skipping doses here or there?
It can be hard to adjust to a new medication routine, and there can be many reasons why you may miss a dose. If you find that you are missing doses routinely, tell your doctor. You shouldn’t feel judged or shamed. Your doctor is there to help you problem-solve challenges and support you in taking medication as prescribed.

It takes a village

There are many personal reasons why adherence can be complex. It’s easy to say “just do it” when it comes to taking medication for a chronic illness, but that approach isn’t particularly helpful. What is helpful is understanding some of the factors that can influence adherence and recognizing that you can enlist support from your healthcare team, MS One to One, and your loved ones to help you stay motivated to take medication as prescribed.

Getting your questions answered, finding support when you need it, and developing a medication adherence plan with your extended care team can help you feel more supported and empowered in your own care.

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. Brown, M, and Bussell, J. Medication Adherence: WHO Cares? Mayo Clin Proc. April 2011;86(4):304-314.

2. Kavookjian, J. Motivational Interviewing. Science and Practice of Pharmacology. Pharmacotheraphy Self-Assessment Program (PSAP) VII.

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. Mounsey A, Reed S. Diagnosing and treating hair loss. Am Fam Physician. 2009;80(4):356-362.