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BREXPIPRAZOLE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- At a dose 3 times the MRHD for the treatment of schizophrenia and 4 times the MRHD for adjunctive therapy to antidepressants for the treatment of MDD, REXULTI does not prolong the QTc interval to any clinically relevant extent.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
12
24080
Other ADRs
15231
38366356
Odds Ratio = 1.256
Drug Property Information
ATC Code(s):
- N05AX16 - brexpiprazole
- N05AX1 -
- N05AX - Other antipsychotics
- N05A - ANTIPSYCHOTICS
- N05 - PSYCHOLEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:brexpiprazole
Active Ingredient UNII:2J3YBM1K8C
Drugbank ID:DB09128
PubChem Compound:11978813
CTD ID:C000591922
PharmGKB:PA166160053
CAS Number:913611-97-9
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 3.0 mg/day N05AX16
Chemical Structure: 
SMILE Code:
O=C1NC2=CC(OCCCCN3CCN(CC3)C3=C4C=CSC4=CC=C3)=CC=C2C=C1
O=C1NC2=CC(OCCCCN3CCN(CC3)C3=C4C=CSC4=CC=C3)=CC=C2C=C1
Reference
1: Effects of Antipsychotics on Arrhythmogenic Parameters in Schizophrenia Patients: Beyond Corrected QT Interval.
[Okayasu Hiroaki,Shinozaki Takahiro,Takano Yumiko,Sugawara Norio,Fujii Kumiko,Yasui-Furukori Norio,Ozeki Yuji,Shimoda Kazutaka]Neuropsychiatr Dis Treat,2021 Jan 27;17:239-249. PMID: 33542628
2: [Brexpiprazole for treatment of schizophrenia: a critical literature study].
[Spoelstra S K,Baas C A J,Knegtering H]Tijdschr Psychiatr,2021;63(1):48-55. PMID: 33537974
3: Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis.
[Huhn Maximilian,Nikolakopoulou Adriani,Schneider-Thoma Johannes,Krause Marc,Samara Myrto,Peter Natalie,Arndt Thomas,Bäckers Lio,Rothe Philipp,Cipriani Andrea,Davis John,Salanti Georgia,Leucht Stefan]Lancet,2019 Sep 14;394(10202):939-951. PMID: 31303314
4: Effects of atypical antipsychotic drugs on QT interval in patients with mental disorders.
[Aronow Wilbert S,Shamliyan Tatyana A]Ann Transl Med,2018 Apr;6(8):147. PMID: 29862236
5: A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia.
[Forbes Andy,Hobart Mary,Ouyang John,Shi Lily,Pfister Stephanie,Hakala Mika]Int J Neuropsychopharmacol,2018 May 1;21(5):433-441. PMID: 29415258
6: Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia.
[Kane John M,Skuban Aleksandar,Hobart Mary,Ouyang John,Weiller Emmanuelle,Weiss Catherine,Correll Christoph U]Schizophr Res,2016 Jul;174(1-3):93-98. PMID: 27188270
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