Deutetrabenazine

Deutetrabenazine is indicated in adults patients for the treatment of tardive dyskinesia and for chorea associated with Huntington's disease

The precise mechanism by which  (deutetrabenazine) exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine [HTBZ] and β-HTBZ) of deutetrabenazine, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.

Patients not presently receiving Tetrabenazine:
Titrate up at weekly intervals by 6 mg per day to a tolerated dose that reduces chorea, up to a maximum recommended daily dosage of 48 mg (24 mg twice daily). Administer total daily dosages of 12 mg or above in two divided doses and administer with foods.
Patients receiving Tetrabenazine: If switching patients from tetrabenazine, discontinue tetrabenazine and initiate deutetrabenazine the following day.
After patients are switched to deutetrabenazine, the dose may be adjusted at weekly intervals.
Patients with Hepatic & Renal Impairment: No clinical studies have been conducted to assess the effect of renal & hepatic impairment on the pharmacokinetics of deutetrabenazine.
Patients with poor CYP2D6 metabolizers: Maximum recommended dosage of deutetrabenazine in poor CYP2D6 metabolizers is 36 mg per day (i.e., 18 mg twice daily)

Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of deutetrabenazine is 36 mg per day (18 mg twice daily) and alcohol or other sedating drugs- may have additive sedation and somnolence.

Patients may experience Neuroleptic Malignant Syndrome (discontinue deutetrabenazine if this occurs), Akathisia, agitation, restlessness, and Parkinsonism (reduce the daily dose of deutetrabenazine or discontinue if this occurs) and Sedation/somnolence.

Huntington's disease: Somnolence, diarrhea, dry mouth, fatigue, urinary tract infection, insomnia, anxiety, constipation, contusion.

Tardive dyskinesia: Nasopharyngitis, insomnia, somnolence, fatigue, depression/dysthymic disorder, anxiety, diarrhea, dry mouth, akathisia/agitation/restlessness.

Pregnancy: There are no adequate data on the developmental risk associated with the use of deutetrabenazine in pregnant women.
Lactation: There are no data on the presence of deutetrabenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.
Use in Children: Safety & effectiveness of deutetrabenzine in infants & children have not been established.

The following adverse reactions occurred with overdosing: acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.