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ALEMTUZUMAB


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 effect of multiple doses of alemtuzumab (12 mg/day for 5 days) on the QTc interval was evaluated in a single-arm study in 53 patients without malignancy. No large changes in the mean QTc interval (i.e., >20 ms) were detected in the study. A mean increase in heart rate of 22 to 26 beats/min was observed for at least 2 hours following the initial infusion of alemtuzumab. This increase in heart rate was not observed with subsequent doses.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
11
24081
Other ADRs
61431
38320156

Odds Ratio = 0.285

Drug Property Information



ATC Code(s):
  • L04AA34 - alemtuzumab
    • L04AA - Selective immunosuppressants
    • L04A - IMMUNOSUPPRESSANTS
    • L04 - IMMUNOSUPPRESSANTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:ALEMTUZUMAB
Active Ingredient UNII:3A189DH42V
Drugbank ID:DB00087
PubChem Compound:N/ADIR Classification
CTD ID:
PharmGKB:
CAS Number:
Dosage Form(s):injection
Route(s) Of Administrator:intravenous
Daily Dose:
  • 0.13 mg/day L04AA34
Chemical Structure:
SMILE Code:

Reference

N/A

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