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ZANUBRUTINIB


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 the approved recommended doses (160 mg twice daily or 320 mg once daily), there were no clinically relevant effects on the QTc interval. The effect of BRUKINSA on the QTc interval above the therapeutic exposure has not been evaluated.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587

Odds Ratio = N/A

Drug Property Information



ATC Code(s):
  • L01EL03 - zanubrutinib
    • L01EL -
    • L01E -
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:ZANUBRUTINIB
Active Ingredient UNII:AG9MHG098Z
Drugbank ID:DB15035
PubChem Compound:N/ADIR Classification
CTD ID:C000629551
PharmGKB:
CAS Number:1691249-45-2
Dosage Form(s):capsule, gelatin coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure:
SMILE Code:
NC(=O)C1=C2NCC[C@@H](C3CCN(CC3)C(=O)C=C)N2N=C1C1=CC=C(OC2=CC=CC=C2)C=C1

Reference

1: No QTc Prolongation With Zanubrutinib: Results of Concentration-QTc Analysis From a Thorough QT Study in Healthy Subjects.

[Mu Song,Darpo Borje,Tang Zhiyu,Novotny William,Tawashi Manal,Xue Hongqi,Willett Michael,Lin Leo,Sahasranaman Sri,Ou Ying C]
Clin Transl Sci,2020 Sep;13(5):923-931. PMID: 32144955

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