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FLUDARABINE PHOSPHATE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- In a randomized, uncontrolled, open-label, parallel study, patients with B-cell CLL were administered a single dose of oral fludarabine phosphate 40 mg/m2 (n = 42) or intravenous fludarabine phosphate 25 mg/m2 (n=14). The maximum increase in the baseline-corrected mean change in QTcI (individual-corrected QT interval) following treatment with oral fludarabine phosphate was less than 10 milliseconds.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
17127
38364460
Odds Ratio = 0.093
Drug Property Information
ATC Code(s):
- L01BB05 - fludarabine phosphate
- L01BB - Purine analogues
- L01B - ANTIMETABOLITES
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:FLUDARABINE PHOSPHATE
Active Ingredient UNII:1X9VK9O1SC
Drugbank ID:DB01073
PubChem Compound:657237
CTD ID:C024352
PharmGKB:PA449655
CAS Number:21679-14-1
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
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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