Demonstrated safety and tolerability profile for both indications

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Demonstrated safety and tolerability profile in a diverse tardive dyskinesia (TD) patient population with AUSTEDO (deutetrabenazine) tablets

Rates of discontinuation and dose reduction due to adverse events1-3:

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

Adverse Reactions Reported in ≥2% of Patients Treated With AUSTEDO in Placebo-Controlled Tardive Dyskinesia Studies2,3

Adverse Reaction AUSTEDO (n=279) Placebo (n=131)
Headache 5% 8%
Somnolence 4% 7%

4% of patients taking AUSTEDO experienced somnolence vs 7% with placebo

4% of patients taking AUSTEDO experienced somnolence vs 7% with placebo

Diarrhea 4% 4%
Nasopharyngitis 4% 2%
Fatigue 4% 5%
Insomnia 4% 1%
Anxiety 4% 5%
Upper respiratory tract infection 3% 4%
Dry mouth 3% 5%
Nausea 2% 7%
Weight increased 2% 3%
Urinary tract infection 2% 2%
Depression/
dysthymic disorder
2% 1%

2% of patients taking AUSTEDO experienced depression/dysthymic disorder vs 1% with placebo

2% of patients taking AUSTEDO experienced depression/dysthymic disorder vs 1% with placebo

Akathisia/agitation/
restlessness
2% 1%
Arthralgia 2% 1%

No label recommended dose adjustment with AUSTEDO for patients with renal impairment.

AUSTEDO is primarily renally eliminated. No clinical studies have been conducted to assess the effect of renal impairment on the pharmacokinetics of AUSTEDO.3

AUSTEDO has no contraindications or dose reductions for concomitant use with strong CYP3A4 inducers or inhibitors.3

In the placebo-controlled TD studies, symptom improvement was achieved while psychiatric scale scores generally remained stable2,3

ARM-TD: C-SSRS assessments at any visit during the 12-week randomized trial1,2

Patients Taking AUSTEDO (n=58) Patients Taking Placebo (n=59)
Suicidal ideation 0 (0.0%) 3 (5.2%)
Suicidal behavior 0 (0.0%) 1 (1.7%)

ARM-TD: HADS for depression or anxiety—no worsening was detected at Week 12.

AIM-TD: C-SSRS assessments at any visit during the 12-week randomized trial1,2

Patients Taking AUSTEDO (n=221) Patients Taking Placebo (n=72)
Suicidal ideation 7 (3.2%) 2 (2.8%)
Suicidal behavior 1 (0.5%) 0 (0.0%)

AIM-TD: HADS for depression or anxiety—no worsening was detected at Week 12.

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References: 1. 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. Published online June 28, 2017. doi: 10.1016/S2215-0366(17)30236-5 2. Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 3. AUSTEDO® (deutetrabenazine) tablets current Prescribing Information Parsippany, NJ. Teva Neuroscience, Inc.