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OFATUMUMAB


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 ARZERRA on the QTc interval was evaluated in a pooled analysis of 3 open-label studies in patients with CLL (N = 85). Patients received ARZERRA 300 mg on Day 1 followed by either 1,000 mg or 2,000 mg for subsequent doses. No large changes in the mean QTc interval (i.e., >20 milliseconds) were detected in the pooled analysis.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
3
24089
Other ADRs
6285
38375302

Odds Ratio = 0.761

Drug Property Information



ATC Code(s):
  • L01XC10 - ofatumumab
    • L01XC1 -
    • L01XC - Monoclonal antibodies
    • L01X - OTHER ANTINEOPLASTIC AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:OFATUMUMAB
Active Ingredient UNII:M95KG522R0
Drugbank ID:DB06650
PubChem Compound:N/ADIR Classification
CTD ID:
PharmGKB:
CAS Number:
Dosage Form(s):injection, solution
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure:
SMILE Code:

Reference

N/A

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