Side Effects Side Effects

Side
Effects

Important things to
know about AUBAGIO.

Let's talk about AUBAGIO side effects

When taking any medication, it's important to understand how it might affect your body, and AUBAGIO is no different. This section details the side effects reported in clinical trials. Scroll down to see all sections, or click a link below to go directly to that section:

Possible serious side effects of AUBAGIO

The most common side effects of AUBAGIO

Learn more about discontinuation rates while on AUBAGIO

The facts about possible hair thinning or hair loss and AUBAGIO

Information for women of childbearing potential

Possible serious side effects of AUBAGIO

It's important to know the serious risks of any medication you take. And when it comes to AUBAGIO, it's no different. If you experience any of the following side effects while taking AUBAGIO, call 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—this may cause you to have more infections
  • Numbness or tingling in your hands and feet that is different from your MS symptoms
  • Serious skin problems
  • Breathing problems (new or worsening)
  • High blood pressure

The most common side effects of AUBAGIO

AUBAGIO was associated with some side effects, and below is a graph of the most common side effects seen in clinical trials. Of course, not every individual reacts the same to medicine. So your healthcare provider is a great person to discuss your concerns about side effects with you. You can also call the MS One to One® Nurses at 1‑855‑MSOne2One (1‑855‑676‑6326).

THE MOST COMMON SIDE EFFECTS OF AUBAGIO

  • Most cases of hair thinning or hair loss were mild to moderate, had a median time to onset of 99 days, and improved without corrective therapy while patients remained in the clinical trials
  • Most cases of nausea and diarrhea were mild to moderate and not persistent

AUBAGIO quiets relapsing MS quietly*

*AUBAGIO (teriflunomide) is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Common side effects with AUBAGIO led to treatment discontinuation rates ≤3.3% in clinical trials.

The overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo.

Discontinuation rates from common side effects

DISCONTINUATION RATES FROM COMMON SIDE EFFECTS

Discontinuation rates from common side effects

The facts about possible hair thinning or hair loss and AUBAGIO

Hair thinning or hair loss was a side effect of AUBAGIO reported in clinical trials. 87% of patients on AUBAGIO 14 mg did not report hair thinning or hair loss. In most cases, hair thinning or hair loss was mild to moderate, had a median time to onset of 99 days, and improved without corrective therapy while patients remained in the clinical trials.

“I did experience a little hair loss and noticed extra hair in the shower and in my brush, but it stopped for me after 6 months.”

Individual experiences may vary.
Hear from Jessica Hear from Jessica
- Jessica B.
Diagnosed: 2007

Information for women of childbearing potential

Women who are pregnant or not using effective birth control should not take AUBAGIO because it’s possible that AUBAGIO may harm your unborn baby. If you’re not pregnant and are using effective birth control, you can take AUBAGIO. Always talk to your healthcare provider about all your medications if you are planning to become pregnant.

If you become pregnant while taking AUBAGIO, tell your healthcare provider right away. A process called accelerated elimination helps remove AUBAGIO from your blood if needed. It is recommended that you continue using birth control until the level of AUBAGIO is lower than 0.02 mg/L in your blood.

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 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. The purpose of this registry is to collect information about your health and your baby's health.

Men considering or taking AUBAGIO should also talk to their healthcare provider about family planning.

“My doctor said there is an accelerated elimination process that can help clear AUBAGIO from my system if we decide to have another child.”

Individual experiences may vary.
Hear from TeriHear from Teri
- Teri E.
Diagnosed: 1999See Teri's full story

Talk to your healthcare provider Talk to your healthcare provider about AUBAGIO

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Get facts and answers about relapsing MS, AUBAGIO, and more.

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® Nurse

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INDICATION

AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS).

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.
  • Take a medicine called leflunomide for rheumatoid arthritis.
  • 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.

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), vaccines, 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; serious skin problems; breathing problems (new or worsening); and high blood pressure.

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.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

Please click here for full Prescribing Information, including boxed WARNING and Medication Guide.

IMPORTANT SAFETY INFORMATION
Do not take AUBAGIO if you have severe liver problems. AUBAGIO may cause serious liver problems, View More