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FAM-TRASTUZUMAB DERUXTECAN-NXKI


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • The administration of multiple doses of ENHERTU (6.4 mg/kg every 3 weeks, which is 1.2 times the recommended dosage) did not show large mean effect (i.e. >20 ms) on the QTc interval in an open label, single-arm study in 51 patients with HER2-expressing metastatic breast cancer.

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):
  • L01XC41 - fam-trastuzumab deruxtecan-nxki
    • L01XC - Monoclonal antibodies
    • L01X - OTHER ANTINEOPLASTIC AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:Trastuzumab Deruxtecan
Active Ingredient UNII:5384HK7574
Drugbank ID:DB14962
PubChem Compound:N/ADIR Classification
CTD ID:
PharmGKB:
CAS Number:
Dosage Form(s):injection, powder, lyophilized, for solution
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure:
SMILE Code:

Reference

N/A

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