AUSTEDO: Demonstrated safety and tolerability profile in a diverse tardive dyskinesia (TD) patient population1-4

Safety profile of AUSTEDO was demonstrated in patients with1-4:

  • Comorbid conditions including cardiovascular disorders, metabolism/nutritional disorders (including diabetes, and lipid disorders)
  • Concomitant medication use at baseline, including antidepressants, atypical antipsychotics, typical or combination antipsychotics

See patient characteristics from the studies.

Adverse Reactions Reported in ≥2% of Patients Treated With AUSTEDO in TD Studies1,4

Adverse reactions reported in ≥2% of patients treated with AUSTEDO in placebo-controlled tardive dyskinesia studies. Adverse reactions reported in ≥2% of patients treated with AUSTEDO in placebo-controlled tardive dyskinesia studies.

  • Discontinuation due to adverse reactions occurred in up to 4% of patients taking AUSTEDO vs 3% of patients taking placebo2,3
  • Dose reduction due to adverse reactions was required in 4% of patients taking AUSTEDO vs 2% of patients taking placebo2,3

Some adverse events were not reported once patients reached their maintenance dose4:

  • Dry mouth, nausea, hypertension (AIM-TD)

  • Somnolence and dry mouth (ARM-TD)

AUSTEDO has no label-recommended dose adjustment for patients with renal impairment1

  • AUSTEDO is primarily renally eliminated. No clinical studies have been conducted to assess the effect of renal impairment on the pharmacokinetics of AUSTEDO

AUSTEDO is the only VMAT2 inhibitor indicated for TD with no recommendations against concomitant use with strong CYP3A4/5 inducers or inhibitors.1

VMAT2, vesicular monoamine transporter 2.

REFERENCES: 1. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information. Parsippany, NJ, Teva Neuroscience, Inc. 2. Fernandez HH, Factor SA, Hauser RA, et al. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010. 3. Anderson KE, Stamler D, Davis MD, et al. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017;4(8):595-604. 4. Data on file. North Wales, PA: Teva Neuroscience, Inc.