valbenazine (Ingrezza)
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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
Dosage adjustment in renal failure
- none
- not recommended in patients with severe renal failure
Pharmacokinetics
Adverse effects
* 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)
More general terms
References
- ↑ 1.0 1.1 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 - ↑ 2.0 2.1 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. - ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/ 28320223
- ↑ 4.0 4.1 4.2 Janeczko LL Long-term Valbenazine Appears Safe for Patients With Tardive Dyskinesia Medscape - Dec 01, 2017. https://www.medscape.com/viewarticle/889460
- ↑ INGREZZA <TM> (valbenazine) capsules, for oral use Prescribing Information http://www.ingrezza.com/pdf/prescribing_information.pdf
- ↑ Medscape: valbenazine (Rx) https://reference.medscape.com/drug/ingrezza-valbenazine-1000122