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Sanofi

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.

For U.S. residents only.

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AUBAGIO & You > Common MS Symptoms > Visible and Physical Symptoms

Visible and Physical Symptoms

Sometimes it is easy for others to see that you are having challenges with your relapsing MS. These symptoms can be frightening, especially when you are in the early stages of diagnosis and you don’t understand what is happening to you. Although the symptoms below are not a comprehensive list they are some of the most visible symptoms to the people around you.

Vision Problems

Blurred vision, poor contrast or color vision, and pain during eye movement are often the first symptoms of MS for many people. Vision problems in MS often result from optic neuritis (inflammation of the optic nerve), nystagmus (uncontrolled eye movements), or diplopia (double vision). Symptoms of optic neuritis include blurring or graying of vision, blindness in one eye, or a dark spot (called a scotoma) in the center of the visual field. The uncontrolled eye movements of nystagmus may be mild and only happen when looking to the side, or they may be severe and impair vision. Double vision may occur more when your eyes are fatigued or overworked, such as after extended periods of reading or computer work.

Walking Difficulties

Difficulty walking is a very common mobility problem for people with MS that can lead to falls and injuries. Several aspects of the disease can contribute to problems with walking and gait. Muscle weakness can lead to toes dragging (called foot drop), raising the heel on the stronger leg to make it easier to swing the weaker leg through (called vaulting), or compensatory hip hike, trunk lean or swinging of the leg out to the side during walking.¹ Other factors that can interfere with walking properly include muscle tightness or spasticity, balance problems leading to swaying gait (called ataxia), severe numbness of the feet, and fatigue.

Spasticity

Spastic muscles are one of the common symptoms of MS. Mild spasticity may feel like muscle tightness, whereas severe spasticity can produce painful, uncontrollable spasms of the legs and arms, most commonly the legs.² Two common types of spasticity in MS affect the hips and knees. Spasticity of the hamstrings, located on the back of the upper leg, and hip flexor muscles, located at the top front of the upper thigh, can cause hips and knees to be bent and difficult to straighten. Spasticity of the quadriceps and adductor muscles, which are located on the front and inside of the upper leg, can cause the hips and knees to be straight and the legs very close together or crossed at the ankles.³ Spasticity in the leg muscles can contribute to problems with walking and balance.

Bladder Problems

Bladder problems, such as spastic (or overactive) bladder, are very common in people with MS and can limit socializing with friends, family, and community. In this situation, the bladder is unable to hold the normal amount of urine or does not empty completely, causing some of the following symptoms:

Frequent and/or urgent urination
Hesitancy starting urination
Frequent nighttime urination
Inability to hold in urine (called incontinence)
Inability to empty the bladder completely²

Bowel Problems

Constipation, loss of bowel control, and diarrhea are common concerns among people with MS that can limit socializing with friends, family, and community. Bowel dysfunction can cause much discomfort and embarrassment, and can worsen other MS symptoms such as spasticity or bladder dysfunction.⁴

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

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. De Milto L. Defeating Drop Foot. Momentum. 2017;(Fall 2016). Available at: http://www.momentummagazineonline.com/defeating-foot-drop/.
Accessed May 2, 2017.

2. Joy J, Johnston R. Multiple Sclerosis. 1st ed. Washington: National Academies Press; 2001.

3. Controlling Spasticity In MS. 1st ed. National Multiple Sclerosis Society; 2017. Available at: https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Controlling-Spasticity.pdf
Accessed May 2, 2017.

4. Bowel Problems: The Basic Facts, Multiple Sclerosis. National Multiple Sclerosis Society; 2009. Available at: http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Bowel-Problems.pdf.
Accessed May 2, 2017.