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TRASTUZUMAB


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 effects of trastuzumab on electrocardiographic (ECG) endpoints, including QTc interval duration, were evaluated in patients with HER2 positive solid tumors. Trastuzumab had no clinically relevant effect on the QTc interval duration and there was no apparent relationship between serum trastuzumab concentrations and change in QTcF interval duration in patients with HER2 positive solid tumors.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
30
24062
Other ADRs
71758
38309829

Odds Ratio = 0.666

Drug Property Information



ATC Code(s):
  • L01XC03 - trastuzumab
    • L01XC0 -
    • L01XC - Monoclonal antibodies
    • L01X - OTHER ANTINEOPLASTIC AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
  • L01XY02 - trastuzumab
    • L01XY - Combinations of antineoplastic agents
    • L01X - OTHER ANTINEOPLASTIC AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
  • L01XC41 - trastuzumab
    • L01XC - Monoclonal antibodies
    • L01X - OTHER ANTINEOPLASTIC AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
  • L01XC14 - trastuzumab
    • L01XC - Monoclonal antibodies
    • L01X - OTHER ANTINEOPLASTIC AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:TRASTUZUMAB
Active Ingredient UNII:P188ANX8CK
Drugbank ID:DB00072
PubChem Compound:N/ADIR Classification
CTD ID:
PharmGKB:
CAS Number:
Dosage Form(s):injection, powder, lyophilized, for solution; kit
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure:
SMILE Code:

Reference

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[Stortecky Stefan,Suter Thomas M]
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