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IXABEPILONE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Effect of Ixabepilone on QT/QTc Interval
- The QT prolongation potential of ixabepilone was assessed as part of an uncontrolled, open-label, single-dose study in advanced cancer patients. Fourteen patients received a single dose of IXEMPRA 40 mg/m 2 intravenously over 3 hours and serial ECGs were collected over 24 hours. The maximum mean AQTcF was observed 1 hour after the end of infusion and was 8 ms (upper 95% Cl: 12 ms). No patients had a QTcF interval >450 ms or AQTcF >30 ms after IXEMPRA administration. However, small increases in QTc interval with the use of ixabepilone cannot be excluded due to study design limitations.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
4
24088
Other ADRs
3336
38378251
Odds Ratio = 1.911
Drug Property Information
ATC Code(s):
- L01DC04 - ixabepilone
- L01DC0 -
- L01DC - Other cytotoxic antibiotics
- L01D - CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:IXABEPILONE
Active Ingredient UNII:K27005NP0A
Drugbank ID:DB04845
PubChem Compound:6445540
CTD ID:C430592
PharmGKB:PA165958343
CAS Number:219989-84-1
Dosage Form(s):kit
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure: 
SMILE Code:
[H][C@]12C[C@H](NC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](C)[C@@H](O)[C@@H](C)CCC[C@@]1(C)O2)C(\C)=C\C1=CSC(C)=N1
[H][C@]12C[C@H](NC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](C)[C@@H](O)[C@@H](C)CCC[C@@]1(C)O2)C(\C)=C\C1=CSC(C)=N1
Reference
N/A
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The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.
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