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BREXPIPRAZOLE


DIR Classification


Classification:Most-DIR concern
Severity Score:4

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
Rhabdomyolysis
3
42909
Other ADRs
2615
14114664

Odds Ratio = 0.378

Drug Property Information



ATC Code(s):
  • N05AX16 - brexpiprazole
    • N05AX - Other antipsychotics
    • N05A - ANTIPSYCHOTICS
    • N05 - PSYCHOLEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:brexpiprazole
Active Ingredient UNII:2J3YBM1K8C
Drugbank ID:DB09128
PubChem Compound:11978813
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:
C1CN(CCN1CCCCOC2=CC3=C(C=C2)C=CC(=O)N3)C4=C5C=CSC5=CC=C4

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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