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PERTUZUMAB
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Cardiac Electrophysiology
- The effect of pertuzumab with an initial dose of 840 mg followed by a maintenance dose of 420 mg every three weeks on QTc interval was evaluated in a subgroup of 20 patients with HER2-positive breast cancer in CLEOPATRA. No large changes in the mean QT interval (i.e., greater than 20 ms) from placebo based on Fridericia correction method were detected in the trial. A small increase in the mean QTc interval (i.e., less than 10 ms) cannot be excluded because of the limitations of the trial design.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
10980
38370607
Odds Ratio = 0.146
Drug Property Information
ATC Code(s):
- L01XC13 - pertuzumab
- L01XC - Monoclonal antibodies
- L01X - OTHER ANTINEOPLASTIC AGENTS
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
- L01XY02 - pertuzumab
- L01XY - Combinations of antineoplastic agents
- L01X - OTHER ANTINEOPLASTIC AGENTS
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:Pertuzumab
Active Ingredient UNII:K16AIQ8CTM
Drugbank ID:DB06366
PubChem Compound:N/ADIR Classification
CAS Number:
Dosage Form(s):injection, solution, concentrate
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure: 
SMILE Code:
Reference
1: Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial.
[Goel Shom,Pernas Sonia,Tan-Wasielewski Zhenying,Barry William T,Bardia Aditya,Rees Rebecca,Andrews Chelsea,Tahara Rie Kawabori,Trippa Lorenzo,Mayer Erica L,Winer Eric P,Spring Laura M,Tolaney Sara M]Clin Breast Cancer,2019 Dec;19(6):399-404. PMID: 31235441
2: Exposure-response analysis of pertuzumab in HER2-positive metastatic breast cancer: absence of effect on QTc prolongation and other ECG parameters.
[Garg Amit,Li Jing,Clark Emma,Knott Adam,Carrothers Timothy J,Marier Jean-François,Cortés Javier,Brewster Michael,Visich Jennifer,Lum Bert]Cancer Chemother Pharmacol,2013 Nov;72(5):1133-41. PMID: 23999693
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