MedPath

Siltuximab

Generic Name
Siltuximab
Brand Names
Sylvant
Drug Type
Biotech
CAS Number
541502-14-1
Unique Ingredient Identifier
T4H8FMA7IM

Overview

Siltuximab is a chimeric (human-mouse) monoclonal immunoglobulin G1-kappa antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. Siltuximab prevents the binding of IL-6 to soluble and membrane-bound IL-6 receptors by forming high affinity complexes with human interleukin-6 (IL-6). Its use is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. MCD is a rare blood disorder caused by dysregulated IL-6 production, proliferation of lymphocytes, and subsequent enlargement of the lymph nodes. It is administered as a 1 hour intravenous infusion every 3 weeks.

Background

Siltuximab is a chimeric (human-mouse) monoclonal immunoglobulin G1-kappa antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. Siltuximab prevents the binding of IL-6 to soluble and membrane-bound IL-6 receptors by forming high affinity complexes with human interleukin-6 (IL-6). Its use is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. MCD is a rare blood disorder caused by dysregulated IL-6 production, proliferation of lymphocytes, and subsequent enlargement of the lymph nodes. It is administered as a 1 hour intravenous infusion every 3 weeks.

Indication

Siltuximab is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab did not bind to virally produced IL-6 in a nonclinical study and was therefore not studied in patients with MCD who are HIV or HHV-8 positive.

Associated Conditions

  • Castleman Disease

FDA Approved Products

Sylvant
Manufacturer:EUSA Pharma (UK) Ltd
Route:INTRAVENOUS
Strength:400 mg in 1 1
Approved: 2024/02/21
NDC:73090-421
Sylvant
Manufacturer:EUSA Pharma (UK) Ltd
Route:INTRAVENOUS
Strength:100 mg in 1 1
Approved: 2024/02/21
NDC:73090-420

Singapore Approved Products

SYLVANT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
Manufacturer:Cilag AG
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:100mg/vial
Online:Yes
Approved: 2015/03/23
Approval:SIN14762P
SYLVANT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 400MG/VIAL
Manufacturer:Cilag AG
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:400mg/vial
Online:Yes
Approved: 2015/03/23
Approval:SIN14763P

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