Description

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

The most common side effects of Deutetrabenazine include: sleepiness (sedation) tiredness diarrhea dry mouth

Pregnancy: There are no adequate data on the developmental risk associated with the use of Deutetrabenazine in pregnant women. Administration of deutetrabenazine to rats during organogenesis produced no clear adverse effect on embryofetal development. However, administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. 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. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Deutetrabenazine and any potential adverse effects on the breastfed infant from Deutetrabenazine or from the underlying maternal condition.

Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of deutetrabenazine Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior Inform patients, caregivers and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation Deutetrabenazine is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression

Overdoses ranging from 100 mg to 1 g have been reported in the literature with tetrabenazine, a closely related VMAT2 inhibitor. The following adverse reactions occurred with overdosing: acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor. Treatment should consist of those general measures employed in the management of overdosage with any central nervous system-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.