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valbenazine (Ingrezza)

Indications: - treatment of tardive dyskinesia [1,2,4] (FDA-approved April 2017) Contraindications: - congenital long QT syndrome - prolonged QT interval - pregnancy, may cause fetal harm - breastfeeding not recommended Dosage: - start 40 mg PO QD - increase to 80 mg PO QD after 1 week - maintenance dose: 80 mg PO QD - may be take with or without food * reduce dose to 40 mg QD for moderate hepatic insufficiency Tabs: 40 mg, 80 mg Pharmacokinetics: - metabolized by CYP3A4 Dosage adjustment in renal failure: - none - not recommended in patients with severe renal failure Adverse effects: - sleepiness, somnolence - QT prolongation * safe for > 1 year [4]] (industry-sponsored study) Drug interations: - avoid MAO inhibitors in combination - strong CYP3A4 inducers: avoid in combination - strong CYP3A4 inhibitors: reduce valbenazine dosage to 40 mg QD Mechanism of action: - inhibits vesicular monoamine 2 transporter (VMAT2)

General

neurologic agent heterocyclic compound, 3 rings aromatic compound amine ether

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 - FDA News Release. April 11, 2017 FDA approves first drug to treat tardive dyskinesia. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552418.htm - 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. Visk D Valbenazine for Tardive Dyskinesia Tolerated Long-Term - Only 15% of patients discontinued tx over 1 year due to adverse events. MedPage Today. May 28, 2017 https://www.medpagetoday.com/MeetingCoverage/APA/65645 - Josiassen RC, et al Long-term safety and tolerability of valbenazine in subjects with tardive dyskinesia and a diagnosis of schizophrenia or mood disorders. American Psychiatric Association (APA) 2017.
  3. Hauser RA, Factor SA, Marder SR et al KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017 May 1;174(5):476-484. Epub 2017 Mar 21. PMID: 28320223
  4. Janeczko LL Long-term Valbenazine Appears Safe for Patients With Tardive Dyskinesia Medscape - Dec 01, 2017. https://www.medscape.com/viewarticle/889460
  5. INGREZZA (valbenazine) capsules, for oral use Prescribing Information http://www.ingrezza.com/pdf/prescribing_information.pdf