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SONIDEGIB


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 of 800 mg once daily, sonidegib does not prolong the QTc interval.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
825
38380762

Odds Ratio = 0.0

Drug Property Information



ATC Code(s):
  • L01XJ02 - sonidegib
    • L01XJ -
    • L01X - OTHER ANTINEOPLASTIC AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:SONIDEGIB PHOSPHATE
Active Ingredient UNII:W421AI34UW
Drugbank ID:DB09143
PubChem Compound:24775005
CTD ID: C561435
PharmGKB:
CAS Number:956697-53-3
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure:
SMILE Code:
[H][C@]1(C)CN(C[C@@]([H])(C)O1)C1=CC=C(NC(=O)C2=CC=CC(=C2C)C2=CC=C(OC(F)(F)F)C=C2)C=N1

Reference

1: Exposure-QT analysis for sonidegib (LDE225), an oral inhibitor of the hedgehog signaling pathway, for measures of the QT prolongation potential in healthy subjects and in patients with advanced solid tumors.

[Quinlan Michelle,Zhou Jocelyn,Hurh Eunju,Sellami Dalila]
Eur J Clin Pharmacol,2016 Dec;72(12):1427-1432. PMID: 27663457

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