Siltuximab

Therapeutic Siltuximab antibody from the original Sylvant® commercial drug.

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Siltuximab KCI42014
IL-6
Monoclonal Antibody
Sylvant®
20 mg/mL
–
2 mg
-80°C
2023.02
229,00 €
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Sylvant® / Siltuximab Reference Product

Drug nameSylvant®
INNSiltuximab
API typeSiltuximab is a chimeric (human-murine) immunoglobulin G1κ (IgG1κ) monoclonal antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology.
Pharmacotherapeutic group
Immunosuppressants, interleukin inhibitors
ATC code
L04AC11
Target of antibody
IL-6
General functionSiltuximab 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.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6. Siltuximab prevents the binding of human IL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of the hexameric signalling complex with gp130 on the cell surface. Interleukin-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T-cells and B-cells, lymphocytes, monocytes and fibroblasts, as well as malignant cells. IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion, initiation of hepatic acute-phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. Overproduction of IL-6, in chronic inflammatory diseases and malignancies, has been linked to anaemia and cachexia and has been hypothesised to play a central role in driving plasma cell proliferation and systemic manifestations in patients with CD.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)In vitro, siltuximab dose-dependently inhibited the growth of an IL-6-dependent murine plasmacytoma cell line in response to human IL-6. In cultures of human hepatoma cells, IL-6-stimulated production of the acute-phase protein serum amyloid A was dose-dependently inhibited by siltuximab. Similarly, in cultures of human Burkitt’s B-lymphoma cells, the production of immunoglobulin M protein in response to IL-6 was dose-dependently inhibited by siltuximab.
Original license holder
EUSA Pharma (Netherlands) B.V.
Beechavenue 54
1119PW Schiphol-Rijk
Netherlands
Marketing authorisation numbers
EU/1/14/928/001
Marketing authorisation holder
EUSA Pharma (Netherlands) B.V.
Beechavenue 54
1119PW Schiphol-Rijk
Netherlands
Name of the manufacturer of the biological active substance
Janssen Biotech Inc.
200 Great Valley Parkway
Malvern
Pennsylvania
19355
United States

Janssen Sciences Ireland UC
Barnahely
Ringaskiddy
Co. Cork
Ireland

Janssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands
Name and address of the manufacturer(s) responsible for batch releaseJanssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
The Netherlands
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
Histidine
Histidine hydrochloride monohydrate
Polysorbate 80
Sucrose