Medications: Austedo^® – deutetrabenazine

AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of:

• Chorea associated with Huntington’s disease (1)
• Tardive dyskinesia (1)

DOSAGE AND ADMINISTRATION

Titrate at weekly intervals by 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg (2.1)

Administer AUSTEDO XR with or without food in once-daily doses (2.1)

Administer AUSTEDO with food and administer total daily dosages of 12 mg or above in two divided doses (2.1)

Swallow tablets whole; do not chew, crush, or break (2.1)

DOSAGE FORMS AND STRENGTHS

Extended-release tablets: 6 mg, 12 mg, 18 mg, 24 mg, 30 mg, 36 mg, 42 mg, and 48 mg (3)

Tablets: 6 mg, 9 mg, and 12 mg (3)

Most common adverse reactions (>8% of AUSTEDO-treated patients with Huntington’s disease and greater than placebo): somnolence, diarrhea, dry mouth, and fatigue (6.1)

Most common adverse reactions (that occurred in 4% of AUSTEDO treated patients with tardive dyskinesia and greater than placebo): nasopharyngitis and insomnia (6.1)

Suicidal, or untreated/inadequately treated depression in patients with Huntington’s disease (4, 5.1)

Hepatic impairment (4, 8.6, 12.3)

Taking reserpine, MAOIs, tetrabenazine, or valbenazine (4, 7.2, 7.3, 7.6)

WARNINGS AND PRECAUTIONS:

QT Prolongation: Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval (5.3)

Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs (5.4)

Akathisia, agitation, restlessness, and parkinsonism: Reduce dose or discontinue if this occurs (5.5, 5.6)

Sedation/somnolence: May impair the patient’s ability to drive or operate complex machinery (5.7)

Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of AUSTEDO XR or AUSTEDO is 36 mg per day (2.3, 7.1)

Alcohol or other sedating drugs: May have additive sedation and somnolence (7.5)

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 tremors. 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. Telephone numbers for certified poison control centers are listed on the American Association of Poison Control Centers website www.aapcc.org.