Deutetrabenazine (US brand name Austedo®) is a vesicular monoamine transporter 2 (VMAT2) inhibitor.
Here is basic information about this medication. Other articles on this website with more advanced information and tips related to this medication are linked to under Related Pages below.
– Treatment of chorea associated with Huntington’s disease
– Treatment of tardive dyskinesia in adults
How to dose deutetrabenazine (Austedo®) for tardive dyskinesia
Before getting to the dosing, here are a few things to know that are relevant to the dosing;
– Deutetrabenazine has to be given in two doses per day. This is because the half-life of deutetrabenazine and its metabolites is relatively short, about 9 hours.
– It should be given with food. The reason for this is that while food does not change the overall amount of deutetrabenazine reaching the bloodstream (represented by the “area under the curve”, if you know what that means), it decreases the peak plasma concentration by half. The peak plasma concentration of medications generally correlates with side effects.
– As of October 2021, deutetrabenazine is available in 6 mg, 9 mg, and 12 mg strengths.
The starting dose is 6 mg twice daily.
Titrating the dose
– Then, at one-week intervals, the daily dose can be increased by 6 mg/day depending on the benefit and any side effects.
The recommended dose range is 12 mg/day (6 mg twice daily) to 48 mg/day (24 mg twice daily).
But, in persons who are CYP2D6 poor metabolizers, the maximum recommended dose of deutetrabenazine is 18 mg twice daily (instead of 24 mg twice daily).
Similarly, in persons who are also taking a medication that is a strong CYP2D6 inhibitor, the maximum recommended dose of deutetrabenazine is 18 mg twice daily. Strong CYP2D6 inhibitors include (alphabetically):
– Cinacalcet (used to reduce serum calcium, for example, in patients with chronic renal disease who are on dialysis)
In persons who are at risk for QT prolongation, if the daily dose of deutetrabenazine needs to be increased above 24 mg/day, an ECG should be done before and after increasing the dose.
Dosage forms and strengths
Tablets: 6 mg, 9 mg, 12 mg
The Prescribing Information states that patients should swallow whole tablets without chewing, crushing, or breaking tablets.
Potential side effects
Please see THIS PAGE for a handout listing both the common and less common side effects of this medication along with the percentages of patients who report them.
Important! Please refer to the full Prescribing Information (see link below) before prescribing this medication.
Caroff SN, Aggarwal S, Yonan C. Treatment of tardive dyskinesia with tetrabenazine or valbenazine: a systematic review. J Comp Eff Res. 2018 Feb;7(2):135-148. doi: 10.2217/cer-2017-0065. Epub 2017 Oct 2. PMID: 28965423.
Citrome L. Deutetrabenazine for tardive dyskinesia: A systematic review of the efficacy and safety profile for this newly approved novel medication-What is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int J Clin Pract. 2017 Nov;71(11). doi: 10.1111/ijcp.13030. Epub 2017 Oct 12. Review. PubMed PMID: 29024264.
Short-term clinical trials
Anderson KE, Stamler D, Davis MD, Factor SA, Hauser RA, Isojärvi J, Jarskog LF, Jimenez-Shahed J, Kumar R, McEvoy JP, Ochudlo S, Ondo WG, Fernandez HH. 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 Aug;4(8):595-604. doi: 10.1016/S2215-0366(17)30236-5. Epub 2017 Jun 28. PubMed PMID: 28668671.
Fernandez HH, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Meltzer HY, Woods SW, Bega D, LeDoux MS, Shprecher DR, Davis C, Davis MD, Stamler D, Anderson KE. Randomized controlled trial of deutetrabenazine for tardive dyskinesia: The ARM-TD study. Neurology. 2017 May 23;88(21):2003-2010. doi: 10.1212/WNL.0000000000003960. Epub 2017 Apr 26. PubMed PMID: 28446646; PubMed Central PMCID: PMC5440239.
Fernandez HH, Stamler D, Davis MD, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Woods SW, Bega D, LeDoux MS, Shprecher DR, Anderson KE. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1317-1323. doi: 10.1136/jnnp-2018-319918. Epub 2019 Jul 10. PubMed PMID: 31296586.
Longer-term clinical trials
Chaijale N, Bona J, Barkay H, Wilhelm A, Gordon MF. Deutetrabenazine Reduces Severe Tardive Dyskinesia Movements in a 3-year Open-Label Extension Trial. CNS Spectr. 2021 Apr;26(2):156. doi: 10.1017/S1092852920002497. PMID: 34127115.
Fernandez HH, Stamler D, Davis MD, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Woods SW, Bega D, LeDoux MS, Shprecher DR, Anderson KE. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1317-1323. doi: 10.1136/jnnp-2018-319918. Epub 2019 Jul 10. PMID: 31296586; PMCID: PMC6902058.
Hauser RA, Barkay H, Fernandez HH, Factor SA, Jimenez-Shahed J, Gross N, Marinelli L, Wilhelm A, Gordon MF, Savola JM, Anderson KE. Long-Term Deutetrabenazine Treatment Is Associated With Continued Improvement in Tardive Dyskinesia in the Completed 3-Year Open-Label Extension Study. CNS Spectr. 2021 Apr;26(2):162. doi: 10.1017/S1092852920002606. PMID: 34127136.
Knebel H, Alexander J, Wilhelm A, Loupe P, Schneider F, Gordon MF. On crushing of deutetrabenazine tablets. Am J Health Syst Pharm. 2021 Aug 30;78(17):1551-1552. doi: 10.1093/ajhp/zxab130. PMID: 33821933; PMCID: PMC8404741.
Schneider F, Stamler D, Bradbury MJ, Loupe PS, Gordon MF, Rabinovich-Guilatt L. The effect of potent CYP2D6 inhibition on the pharmacokinetics and safety of deutetrabenazine in healthy volunteers. Eur J Clin Pharmacol. 2021 Sep 1. doi: 10.1007/s00228-021-03202-0. Epub ahead of print. PMID: 34491372.
Wietholter JP, Sizemore J, Piechowski K. Crushing deutetrabenazine for treatment of tardive dyskinesia in a patient with severe orofacial symptoms: A case report. Am J Health Syst Pharm. 2020 Sep 4;77(18):1477-1481. doi: 10.1093/ajhp/zxaa205. PMID: 32761113.
Wietholter JP, Sizemore J, Piechowski K. Crushing of deutetrabenazine tablets limited to individual case. Am J Health Syst Pharm. 2021 Aug 30;78(17):1552-1553. doi: 10.1093/ajhp/zxab128. PMID: 33765151.
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