What is AUBAGIO What is AUBAGIO

What is AUBAGIO

A once-daily pill used
to treat relapsing forms

of multiple sclerosis (RMS).

Get to know AUBAGIO

AUBAGIO is a once-daily pill used to treat relapsing forms of MS that has been shown to quiet MS. AUBAGIO® (teriflunomide) is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. 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, and treatment discontinuation rates due to common adverse events were ≤3.3% in the pooled clinical trials.

This pill can be taken any time of day, any place, with or without food. It does not need to be taken at exactly the same time each day. AUBAGIO is available in two strengths, 7 mg and 14 mg, and the more commonly prescribed strength is 14 mg. Your healthcare provider will decide which one is right for you.

Important things to know about AUBAGIO

1. AUBAGIO IS EFFECTIVE

 

AUBAGIO 14 mg was shown to be effective vs placebo in 3 key measures of disease activity—relapses, brain lesions, and disability progression*—in clinical trials.

AUBAGIO 7 mg was shown to be effective in 2 of those 3 key measures—relapses and brain lesions—in clinical trials.

2. AUBAGIO IS ONE PILL, ONCE A DAY

Your healthcare provider will run certain tests before you start treatment. Once on AUBAGIO, your healthcare provider will monitor your liver enzyme levels monthly for the first 6 months.

*Doctors measure disability progression using a test called the Expanded Disability Status Scale, or EDSS. Your first score — or your "baseline" — will determine how your disability is gauged moving forward. If your baseline score is ≤ 5.5, you're considered to have sustained disability progression if that score goes up by one point (lasting at least 12 weeks). If your baseline score is > 5.5 you're considered to have sustained disability progression if that score goes up by at least 0.5 points (lasting at least 12 weeks).

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; allergic reactions, including serious skin problems; breathing problems (new or worsening); and high blood pressure. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.

Tell your doctor if you have any side effect that bothers you or does not go away.

The most common side effects when taking AUBAGIO include: headache; diarrhea; nausea; hair thinning or loss; and abnormal liver test results.

With AUBAGIO, your healthcare provider will run tests within 6 months before you start treatment: perform blood tests to check your liver; obtain a complete blood count; perform a TB (tuberculosis) skin test or blood test for mycobacterium tuberculosis infection; check your blood pressure; and perform a pregnancy test, if you are a woman of childbearing potential.

After starting treatment, your healthcare provider will monitor your liver enzyme levels monthly for the first 6 months, and check your blood pressure periodically.

“AUBAGIO is a pill — I don't have to think about my medication once I take it in the morning.”

Individual experiences may vary.
Hear from Darin
- Darin
Diagnosed: 1997See Darin's full story

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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.
  • 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), 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; allergic reactions, including serious skin problems; breathing problems (new or worsening); and high blood pressure. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.

Tell your doctor if you have any side effect that bothers you or does not go away.

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