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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.

For U.S. residents only.

AUBAGIO & You > Symptoms or side effects?

Symptoms or side effects?


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When you have MS, it can be difficult to know the difference between MS symptoms and medication side effects—particularly when you are new to taking a medication such as AUBAGIO.

For people who have relapsing MS, medication side effects can be confused with MS symptoms.

  • Side effects are unintended events or reaction to a medication.
  • MS symptoms are related to how MS affects nerve fibers in the central nervous system. When the fibers that carry messages to and from the brain are damaged, symptoms may occur. 1

It can help to review common MS symptoms, potential serious and common side effects of AUBAGIO and questions you can answer to help inform your healthcare provider about what you are experiencing.

Common symptoms of MS

MS symptoms are variable and unpredictable. No two people have exactly the same symptoms, and a person’s symptoms can change or fluctuate over time.

During an MS relapse (also called an exacerbation or flare-up), you might experience new symptoms, or a worsening of existing symptoms. When you recover from a relapse, some symptoms may go away while others can linger.2

Sometimes, other factors can make symptoms worse. It could be from heat exposure, stress, or an infection or sickness.2 Typically, when these factors are resolved (for example, when you cool down), the symptoms should improve.

Common symptoms seen in MS include:3

  • Bladder and bowel problems
  • Cognitive changes
  • Depression
  • Dizziness and vertigo
  • Emotional changes
  • Fatigue
  • Numbness or tingling
  • Pain
  • Sexual problems
  • Spasticity
  • Vision problems
  • Walking difficulties
  • Weakness

You can review more detailed information about common MS symptoms here.

Less common symptoms can include speech problems, problems with swallowing, hearing loss, seizures, tremors, and breathing problems.1

Talk to your healthcare provider if you are experiencing new symptoms or existing symptoms are worsening. Your healthcare provider can also help you develop a treatment plan to manage certain symptoms.

Looking for a way to track your symptoms? Download the symptom tracker guide from Common Threads.

Side effects & AUBAGIO

It’s important to know the risks of any medication you take. And when it comes to AUBAGIO, it’s no different.

Possible serious side effects

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
  • 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

Review the list of possible serious side effects with AUBAGIO.

Common side effects with AUBAGIO

Here are some of the most common side effects reported in AUBAGIO clinical trials. Please note, that these are not all of them. Talk to your healthcare provider about any concerns that you have regarding possible side effects.

  • Headache
  • Diarrhea
  • Nausea
  • Hair thinning or loss
  • Abnormal liver test results

Review the list of possible common side effects with AUBAGIO.

Not every person reacts the same way to medication. If you have concerns about side effects, please talk to your healthcare provider. You can also call the MS One to One Nurses at 1‑855‑676‑6326.

What to do about symptoms and side effects

Always let your medical team know about any new side effects or symptoms you are experiencing.

Your healthcare team may have practical tips that can help with side effects. They may want to evaluate you if you have a new symptom.

To help provide information about what you are experiencing, here are some things you can note:

  • When did you start to feel the symptom or side effect?
  • What are you experiencing?
  • Be as specific as you can. For instance, if you are experiencing headaches, note when you experience them, where you feel the ache, and what the level of pain is. Let your healthcare provider know if you’ve taken over-the-counter pain relievers for the headache and whether you found relief. You can also provide context, such as poor sleep or increased stress that may be contributing to how you feel.
  • Have you have been ill, or had any type of infection or fever? When did the illness start? Are you being treated for the illness with any medication, such as antibiotics?
  • What medications are you taking, including any medication changes or over-the-counter medications or supplements?

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. Definition of MS. National MS Society. https://www.nationalmssociety.org/What-is-MS/Definition-of-MS. Accessed on 4/26/19

2. Managing Relapses. Multiple Sclerosis Trust. March 2019. https://www.mstrust.org.uk/about-ms/ms-symptoms/managing-relapses accessed on 4/25/19.

3. MS Symptoms. National MS Society. https://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms#section-0 accessed on 4/26/19