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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 > Understanding liver test results

Understanding liver test results


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Your liver filters your blood and metabolizes (breaks down) any medication you take. Sometimes, when drugs are metabolized, it can lead to elevated levels of liver enzymes.

Liver enzymes are proteins normally found in your liver, but elevated levels can indicate damage. There are many types of liver enzymes, but alanine aminotransferase (ALT) is the enzyme doctors look at most closely in people taking AUBAGIO® (teriflunomide). Tests showing an elevated ALT levels may indicate you are experiencing a potentially serious side effect of the drug, which is why patients taking AUBAGIO need regular blood tests during their first six months of therapy. The results of your tests will be assessed by your physician to make sure that the amount of ALT liver enzymes in your body is within an acceptable range.

What is normal?

The following graphic can give you a better understanding of where average ranges lie when it comes to monitoring ALT. As you can see from the chart below, the reference values are different for male and female. Reference values can also vary depending on age and ethnicity. Normal value ranges may vary slightly among different laboratories as well.1

However, these values are just a general guide; it's important to discuss your lab results with your healthcare provider—especially if you have questions or concerns.

Fischbach, Frances Talaska, and Marshall Barnett Dunning. A Manual Of Laboratory And Diagnostic Tests. 7th ed. Philadelphia Williams & Wilkins, 2003. Print

Abnormal liver test results?

If your labs indicate you may have elevated ALT levels, you need to talk with your doctor right away to determine the best course of action. In clinical trials studying AUBAGIO, a small percentage of users saw an increase in the ALT levels. Of those people, some discontinued their usage of AUBAGIO.2 Visit this page to review the data collected during these studies. If you have questions about AUBAGIO and liver function but aren’t sure who to ask, please contact MS One to One (1-855-676-6326) A nurse is available 24 hours a day to answer any questions you have.

Additional resources

You can learn more about setting up your liver tests by reading the Preparing for Liver Tests guide or download this handy lab test tracking sheet, which can help you record the dates, times, and results of all your labs.

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.

Reference

1. Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005;172(3):367–379. doi:10.1503/cmaj.1040752

2. Comi G, Freedman M, Kappos L et al. Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions. Multiple Sclerosis and Related Disorders. 2016;5:97-104. doi:10.1016/j.msard.2015.11.006.