A new treatment

is now available for
chorea associated with
Huntington's disease

Now Available

For chorea associated
with Huntington's disease

To learn more,
talk to your doctor or

visit Austedo.com

Important Safety Information

Important Safety Information

  • AUSTEDO™ belongs to a class of drugs that can cause serious side effects, including:
    • depression
    • suicidal thoughts
  • You should not start taking AUSTEDO™ if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts
  • Pay close attention to any changes, especially unusual changes, in mood, behaviors, thoughts or feelings, or worsening depression
  • Do not take AUSTEDO™ if you have liver problems or are taking monoamine oxidase inhibitors (MAOIs), reserpine or tetrabenazine. Ask your doctor or pharmacist if you are not sure. At least 20 days should pass after stopping reserpine before starting AUSTEDO™. If you are switching from tetrabenazine to AUSTEDO, take your first dose of AUSTEDO on the day after your last dose of tetrabenazine
  • Tell your doctor if you are pregnant or plan to become pregnant, breast-feeding, have breast cancer or a history of breast cancer
  • Tell your doctor about all the medicines you take. Do not start any new medicines while taking AUSTEDO™ without talking to your doctor first
  • Take AUSTEDO™ exactly as prescribed by your doctor. The need for therapy should be evaluated on an ongoing basis with your doctor. The dose of AUSTEDO™ should be adjusted slowly over several weeks for a dose that is appropriate for you. Tell your doctor if you stop taking AUSTEDO® for more than 7 days. Do not take another dose until you talk to your doctor. If your doctor thinks you need to take more than 36 mg of AUSTEDO™ each day, you will need to have a blood test to see if a higher dose is right for you
  • Neuroleptic Malignant Syndrome (NMS) is a potentially fatal side effect reported with AUSTEDO™. Call your doctor right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating. AUSTEDO™ should be stopped immediately if NMS is diagnosed
  • AUSTEDO™ can also cause other serious side effects, including parkinsonism (slight shaking, body stiffness, trouble moving, or keeping your balance), restlessness (akathisia), and trouble swallowing. Trouble swallowing may increase the risk of pneumonia
  • The risk of side effects, such as parkinsonism, NMS, and restlessness (akathisia), may be increased when using AUSTEDO™ with other drugs (e.g., dopamine antagonists or neuroleptics)
  • Sleepiness is a common side effect of AUSTEDO™; do not drive or operate dangerous machinery until you know how AUSTEDO® affects you. Alcohol and other drugs may increase sleepiness caused by AUSTEDO™
  • Some side effects, such as sleepiness, parkinsonism, agitation, and restlessness (akathisia) may be dose-dependent. If side effects don’t stop or lessen, your doctor should consider lowing the dose or stopping your AUSTEDO™. The most commonly reported side effect in studies with AUSTEDO™ was sleepiness

Indication

AUSTEDO™ is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease.

AUSTEDO™ is a trademark of Auspex Pharmaceuticals, Inc., a member of the Teva Group.

© 2016 Teva Neuroscience, Inc.

AUS-40105