Now Available

For the treatment
of chorea
associated with
Huntington's disease

To learn more

IMPORTANT SAFETY INFORMATION

WARNING: DEPRESSION AND SUICIDALITY

  • VMAT2 inhibitors increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease
  • Balance risks of depression and suicidality with the clinical need for control of choreiform movements when considering the use of AUSTEDOTM
  • Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior
  • Inform patients, carepartners, and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician
  • Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation
  • AUSTEDOTM is contraindicated in patients who are actively suicidal, or in patients with untreated or inadequately treated depression
  • AUSTEDOTM is also contraindicated in patients who have impaired hepatic function or are taking monoamine oxidase inhibitors (MAOIs) or reserpine. AUSTEDO™ should not be used in combination with an MAOI, or with in a minimum of 14 days of discontinuing therapy with an MAOI. At least 20 days should elapse after stopping reserpine before starting AUSTEDOTM
  • Prescribers should periodically re-evaluate the need for AUSTEDOTM in their patients by assessing the beneficial effect on chorea and possible adverse effects, including sedation/somnolence and cognitive decline. AUSTEDOTM should be titrated slowly, over several weeks for a dose that is appropriate for each patient
  • Before administering a dose greater than 36 mg, the patient’s CYP2D6 metabolizer status should be determined. Do not exceed 48 mg/day or 36 mg/day dose if AUSTEDOTM is administered with a strong CYP2D6 inhibitor
  • AUSTEDOTM therapy should be retitrated if there is a treatment interruption of more than 7 days
  • A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with VMAT2 inhibitors. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria, rhabdomyolysis, and acute renal failure. The management of NMS should include immediate discontinuation of AUSTEDOTM and other drugs not essential to concurrent therapy
  • VMAT2 inhibitors can cause other serious side effects including: akathisia, restlessness, agitation, parkinsonism, sedation/somnolence, and dysphasia. These side effects may require a dose reduction or discontinuation of AUSTEDOTM. In a double-blind, placebo-controlled trial, akathisia or restlessness was reported by 2.2% of patients treated with AUSTEDOTM or placebo; somnolence was reported by 11.1% of patients treated with AUSTEDOTM and 4.4% of patients on placebo; and there were no reported rates of parkinsonism or dysphasia
  • AUSTEDOTM may induce sedation/somnolence, which may impair the ability to drive or operate dangerous machinery. Alcohol or other sedating drugs can worsen sedation/somnolence
  • The most commonly reported adverse reaction with AUSTEDOTM occurring at >10% and at a rate at ≤2x the placebo rate was somnolence (11% vs 4%, respectively)

Indication

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

Please see full Prescribing Information for AUSTEDOTM.

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

© 2016 Teva Neuroscience, Inc.

AUS-40042