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deutetrabenazine; tetrabenazine D6 (Austedo)

Indications: - treatment of Huntington's chorea (FDA-approved April 2017) Contraindications: - suicidal ideation - hepatic impairment - concurrent administration of: MAOI, reserpine, tetrabenazine Dosage: - start 6 mg PO QD - max: 24 mg PO BID - in poor CYP2D6 metabolizers 18 mg PO BID - BID dosing >= 12 mg QD - administer with food - swallow tablets whole; do not chew, crush, or break Tabs: 6 mg, 9 mg, 12 mg Adverse effects: - common (> 8%) - somnolence, diarrhea, xerostomia, fatigue Drug interactions: - strong CYP2D6 inhibitors - alcohol or sedative may increase somnolence, sedation Mechanism of action: - inhibits vesicular monoamine 2 transporter (VMAT2)

General

neurologic agent heterocyclic compound, 3 rings ether amine ketone

Database Correlations

PUBCHEM correlations

References

  1. Fiore K FDA Okays First Tardive Dyskinesia Drug - VMAT2 inhibitor diminished abnormal involuntary movements in pivotal trial. MedPage Today. April 11, 2017 https://www.medpagetoday.com/Neurology/GeneralNeurology/64513 - Brooks M FDA Clears Deutetrabenazine (Austedo) for Huntington's Chorea. Medscape - Apr 04, 2017 http://www.medscape.com/viewarticle/8781621 - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  2. Huntington Study Group, Frank S, Testa CM, Stamler D et al Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):40-50. PMID: 27380342 Free Article
  3. Highlights of Prescribing Information Austedo (deutetrabenazine) https://www.austedo.com/pi