TETRABENAZINE TAB

Clinical Criteria Summary

Patient is actively suicidal or with untreated or inadequately treated depression.
Congenital long QT interval, or a QTc >450 ms for men or QTc >470 ms for women.
History of cardiac arrhythmias (patients with a history of ventricular arrhythmias), cardiac conduction system disease (LBBB or RBBB) or cardiac device can be considered candidates with cardiology evaluation.
Concurrent use of a monoamine oxidase inhibitor (MAOI).
Current or use of reserpine within the past 20 days.
Concurrent use of another VMAT2 inhibitor.
A history of neuroleptic malignant syndrome (NMS).
Current clinically significant hyperprolactinemia.
Pregnant or breast feeding.
Hepatic impairment.
Patient is receiving a medication known to increase the QTc interval, e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone, antibiotics (e.g., moxifloxacin), Class IA (quinidine, procainamide) or Class III (amiodarone, sotalol) antiarrhythmic medications or any other medications known to prolong the QTc interval.

When the initial prescriber is a resident, fellow or other trainee, an attending psychiatrist or neurologist has verified the diagnosis and need for tetrabenazine.
The patient has a diagnosis of Huntington disease documented in his/her medical record.
The chorea is disabling or painful and interferes with the patient’s functional status, including self-care and ambulation; quality of life; or creates a social stigma sufficient to cause social isolation or embarrassment.
The prescriber has documented the specific movement(s) (e.g., facial, oral extremity, or trunk) in the patient’s medical record along with how the chorea is affecting the patient’s function, quality of life or socialization.

When the initial prescriber is a resident, fellow or other trainee, an attending psychiatrist or neurologist has verified the diagnosis and need for tetrabenazine.
No response or are intolerant to alternative agents (local botulinum toxin injections, anticholinergics, or benzodiazepines).

The patient has a diagnosis of tardive dyskinesia (TD) secondary to a dopaminergic blocking agent, e.g. antipsychotic or metoclopramide.
The patient’s TD interferes with the patient’s functional status, including self-care and ambulation; quality of life; or creates a social stigma sufficient to cause social isolation or embarrassment.
The prescriber has documented the specific movement(s) (e.g., facial, oral extremity, or trunk) in the patient’s medical record along with how TD is affecting the patient’s function, quality of life or socialization.
A recent Abnormal Involuntary Movement Scale (AIMS) score is recorded in the patient’s medical record.
An ECG was performed to confirm a QTc <450 ms for men or QTc <470 ms for women.
When the initial prescriber is a resident, fellow or other trainee, an attending psychiatrist or neurologist has verified the diagnosis and need for tetrabenazine.

Dosage form: Oral tablets (6 mg, 9 mg, 12 mg); non-formulary status
Administer with food; swallow tablets whole (do not crush, chew, or break)
HD dosing: 6 mg once daily; may increase dose weekly based on response and tolerability in increments of 6 mg/day. If total daily dose is ≥12 mg, administer in two divided doses. Maximum recommended dose: 48 mg/day.
TD dosing: 6 mg twice daily; may increase dose weekly based on response and tolerability in increments of 6 mg/day. If total daily dose is ≥12 mg, administer in two divided doses. Maximum recommended dose: 48 mg/day.

HD: Demonstrated reduction in Total Chorea Score compared to placebo (p<0.0001) in a 12-week randomized, double-blind, placebo-controlled study.
TD: Demonstrated reduction in Abnormal Involuntary Movement Scale (AIMS) scores compared to placebo at week 12 in the AIM-TD and ARM-TD trials.

VMAT-2 inhibitor utilized for management of HD chorea and TD.
Indirect evidence suggests better tolerability compared to tetrabenazine, though VA ADERS data does not fully support this finding.
Sequencing of VMAT-2 inhibitors is not warranted based on current evidence and utilization data.