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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use - AUSTEDO safely and effectively. See full prescribing information for - AUSTEDO. AUSTEDO™ (deutetrabenazine ...
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
See full prescribing information for complete boxed warning.
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Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease ( 5.2)
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Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of AUSTEDO ( 5.2)
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Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior ( 5.2)
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Inform patients, caregivers and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician ( 5.2)
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Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.2)
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AUSTEDO is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression ( 4, 5.2)
INDICATIONS AND USAGE
AUSTEDO is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease (1)
DOSAGE AND ADMINISTRATION
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The starting dose is 6 mg once daily. 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) ( 2.1)
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Administer total daily dosages of 12 mg or above in two divided doses ( 2.1)
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Administer with food ( 2.1)
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Swallow tablets whole; do not chew, crush, or break ( 2.1)
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If switching patients from tetrabenazine, discontinue tetrabenazine and initiate AUSTEDO the following day. See full prescribing information for recommended conversion table ( 2.2)
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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
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Suicidal, or untreated/inadequately treated depression ( 4, 5.2)
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Hepatic impairment ( 4, 8.6, 12.3)
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Taking MAOIs, reserpine, or tetrabenazine (XENAZINE ®) ( 4, 7.2, 7.3, 7.7)
WARNINGS AND PRECAUTIONS
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Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs ( 5.3, 7.4)
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Akathisia, agitation, restlessness, and parkinsonism: Reduce dose or discontinue if this occurs ( 5.4, 5.5)
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Sedation/somnolence: May impair the patient’s ability to drive or operate complex machinery ( 5.6)
ADVERSE REACTIONS
Most common adverse reactions (>8% of AUSTEDO-treated patients and greater than placebo) were: somnolence, diarrhea, dry mouth, and fatigue (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
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Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of AUSTEDO is 36 mg per day (18 mg twice daily) ( 2.3, 7.1)
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Alcohol or other sedating drugs: May have additive sedation and somnolence ( 7.5)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 4/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
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