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SILTUXIMAB
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 SYLVANT (15 mg/kg every 3 weeks for 4 cycles) on the QTc interval was evaluated in an open label, single arm study in 30 patients with Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma. No large changes in the mean QTc interval (i.e., > 20 ms) were detected in the study.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587
Odds Ratio = N/A
Drug Property Information
ATC Code(s):
- L04AC11 - siltuximab
- L04AC - Interleukin inhibitors
- L04A - IMMUNOSUPPRESSANTS
- L04 - IMMUNOSUPPRESSANTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:Siltuximab
Active Ingredient UNII:T4H8FMA7IM
Drugbank ID:DB09036
PubChem Compound:N/ADIR Classification
CAS Number:
Dosage Form(s):injection, powder, for solution
Route(s) Of Administrator:intravenous
Daily Dose:
- 37.0 mg/day L04AC11
Chemical Structure: 
SMILE Code:
Reference
1: Evaluation of the QTc prolongation potential of a monoclonal antibody, siltuximab, in patients with monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or low-volume multiple myeloma.
[Thomas Sheeba K,Suvorov Alexander,Noens Lucien,Rukavitsin Oleg,Fay Joseph,Wu Ka Lung,Zimmerman Todd M,van de Velde Helgi,Bandekar Rajesh,Puchalski Thomas A,Qi Ming,Uhlar Clarissa,Samoylova Olga S]Cancer Chemother Pharmacol,2014 Jan;73(1):35-42. PMID: 24149943
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