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Therapeutic Siltuximab antibody from the original Sylvant® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
IL-6 |
Monoclonal Antibody |
Sylvant® |
20 mg/mL |
– |
2 mg |
-80°C |
02/2023 |
199,80 € |
| Drug name | Sylvant® |
| INN | Siltuximab |
| API type | Siltuximab 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 function | Siltuximab 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 release | Janssen 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 |
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