For More information, please visit https://www.austedo.com
For: Huntington Disease, Tardive Dyskinesia
Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease and the treatment of tardive dyskinesia. These highlights do not include all the information needed to use AUSTEDO safely and effectively. See full prescribing information for AUSTEDO.
AUSTEDO� (deutetrabenazine) tablets, for oral use
Initial U.S. Approval: 2017
WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON'S DISEASE SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease (5.1)
Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of AUSTEDO (5.1)
Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior (5.1)
Inform patients, caregivers, and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician (5.1)
Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation (5.1)
AUSTEDO is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression (4, 5.1)
RECENT MAJOR CHANGES
Boxed Warning
08/2017
Indications and Usage (1)
08/2017
Dosage and Administration (2.1)
08/2017
Contraindications (4)
08/2017
Warnings and Precautions (5.1, 5.2, 5.3, 5.5, 5.7)
08/2017
INDICATIONS AND USAGE
AUSTEDO is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of:
Chorea associated with Huntington's disease (1)
Tardive dyskinesia in adults (1)
DOSAGE AND ADMINISTRATION
Initial Dose
Recommended Dose
Maximum Dose
Chorea associated with Huntington's disease
6 mg/day
6 mg� 48 mg/day
48 mg/day
Tardive dyskinesia
12 mg/day
12 mg� 48 mg/day
48 mg/day
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 (24 mg twice daily) (2.1)
Administer total daily dosages of 12 mg or above in two divided doses (2.1)
For patients at risk for QT prolongation, assess the QT interval before and after increasing the total dosage above 24 mg per day (2.1)
Administer with food (2.1)
Swallow tablets whole; do not chew, crush, or break (2.1)
If switching patients from tetrabenazine, discontinue tetrabenazine and initiate AUSTEDO the following day. See full prescribing information for recommended conversion table (2.2)
Maximum recommended dosage of AUSTEDO in poor CYP2D6 metabolizers is 36 mg per day (i.e., 18 mg twice daily) (2.4, 8.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 6 mg, 9 mg, and 12 mg (3)
CONTRAINDICATIONS
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 (XENAZINE�), or valbenazine (4, 7.3, 7.4, 7.7)
WARNINGS AND PRECAUTIONS
QT Prolongation: May cause an increase in QT interval. 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)
ADVERSE REACTIONS
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)
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of AUSTEDO is 36 mg per day (18 mg twice daily) (2.3, 7.1)
Alcohol or other sedating drugs: May have additive sedation and somnolence (7.6)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
