Aubagio Side Effects – New FDA Approved

September 14th, 2012 by Paul Jude

The U.S. Food and Drug Administration (FDA) has approved Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). Aubagio has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.

Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). .

Aubagio is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS). Aubagio can decrease the number of MS flare-ups (relapses). Aubagio does not cure MS, but it can help slow down the physical problems that MS causes.

It is not known if Aubagio is safe and effective in children.

Before you take Aubagio, tell your doctor if you:

  • have liver or kidney problems
  • have a fever or infection, or you are unable to fight infections
  • have numbness or tingling in your hands or feet that is different from your MS symptoms
  • have diabetes
  • have had serious skin problems when taking other medicines
  • have breathing problems
  • have high blood pressure
  • are breastfeeding or plan to breastfeed. It is not known if Aubagio passes into your breast milk. You and your doctor should decide if you will take Aubagio or breastfeed. You should not do both at the same time.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using Aubagio and other medicines may affect each other causing serious side effects. Aubagio may affect the way other medicines work, and other medicines may affect how Aubagio works.

Especially tell your doctor if you take medicines that could raise your chance of getting infections, including medicines used to treat cancer or to control your immune system.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

Aubagio may cause serious side effects, including:

  • See What is the most important information I should know about Aubagio?
  • decreases in your white blood cell count. Your white blood cell counts should be checked before you start taking Aubagio. When you have a low white blood cell count you:
    • may have more frequent infections. You should have a skin test for TB (Tuberculosis) before you start taking Aubagio.
      Tell your doctor if you have any of these symptoms of an infection:

      • fever
      • tiredness
      • body aches
      • chills
      • nausea
      • vomiting
    • should not receive certain vaccinations during your treatment with Aubagio and for 6 months after your treatment with Aubagio ends.
  • numbness or tingling in your hands or feet that is different from your MS symptoms. You have a greater chance of getting peripheral neuropathy if you:
    • are over 60 years of age
    • take certain medicines that affect your nervous system
    • have diabetes

    Tell your doctor if you have numbness or tingling in your hands or feet that is different from your MS.

  • kidney problems. Tell your doctor if you have pain in your side (flank pain).
  • high potassium levels in your blood. Tell your doctor if you have nausea that does not go away or a racing heartbeat.
  • serious skin problems. Tell your doctor if you have any skin problems such as redness and peeling.
  • new or worsening breathing problems. Tell your doctor if you have shortness of breathor coughing with or without fever.
  • high blood pressure. Your doctor should check your blood pressure before you start taking Aubagio and while you are taking Aubagio.

The most common side effects of Aubagio include:

  • increases in the results of blood tests to check your liver
  • hair thinning or loss (alopecia)
  • diarrhea
  • flu
  • nausea
  • burning or prickling feeling in your skin (paraesthesia)

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

These are not all the possible side effects of Aubagio. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.