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OXALIPLATIN
DIR Classification
Classification:Most-DIQT concern
Severity Score:4.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- QT Interval Prolongation and Ventricular Arrhythmias
- QT prolongation and ventricular arrhythmias, including fatal torsade de pointes, have been reported with oxaliplatin injection [see Adverse Reactions (6.2)].
- Avoid oxaliplatin injection in patients with congenital long QT syndrome. Monitor electrocardiograms (ECG) in patients with congestive heart failure, bradyarrhythmias, and electrolyte abnormalities and in patients taking drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics [see Drug Interactions (7.1)]. Monitor and correct electrolyte abnormalities prior to initiating oxaliplatin injection and periodically during treatment.
- DRUG INTERACTIONS
- Drugs that Prolong the QT Interval
- QT interval prolongation and ventricular arrhythmias can occur with oxaliplatin injection [see Warnings and Precautions (5.7)]. Avoid coadministration of oxaliplatin injection with medicinal products with a known potential to prolong the QT interval.
- ADVERSE REACTIONS
- QT Interval Prolongation and Ventricular Arrhythmias [see Warnings and Precautions (5.7)]
- The following adverse reactions have been identified during postapproval use of oxaliplatin injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Cardiovascular: QT prolongation leading to ventricular arrhythmias, including fatal torsade de pointes; bradyarrhythmia
- PATIENT COUNSELING INFORMATION
- QT Interval Prolongation
- Advise patients that oxaliplatin injection can cause QTc interval prolongation and to inform their physician if they have any symptoms, such as syncope [see Warnings and Precautions (5.7)].
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
32
24060
Other ADRs
72135
38309452
Odds Ratio = 0.707
Drug Property Information
ATC Code(s):
- L01XA03 - oxaliplatin
- L01XA0 -
- L01XA - Platinum compounds
- L01X - OTHER ANTINEOPLASTIC AGENTS
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:oxaliplatin
Active Ingredient UNII:04ZR38536J
Drugbank ID:DB00526
PubChem Compound:6857599
CTD ID:D000077150
PharmGKB:PA131285527
CAS Number:61825-94-3
Dosage Form(s):injection, solution
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure: 
SMILE Code:
[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reference
1: Safety and antitumor activity of arsenic trioxide plus infusional 5-fluorouracil, leucovorin, and irinotecan as second-line chemotherapy for refractory metastatic colorectal cancer: A pilot study from South India.
[Lakshmaiah K C,Chaudhuri Tamojit,Babu Govind K,Lokanatha Dasappa,Jacob Linu Abraham,Suresh Babu M C,Rudresha A H,Lokesh K N,Rajeev L K]Indian J Cancer,Oct-Dec 2017;54(4):631-633. PMID: 30082548
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