Siltuximab

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.

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation	2025/05/25	NCT06990711	Phase 1	Not yet recruiting	Washington University School of Medicine
A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant	2024/11/08	NCT06679829	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center
Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients with Advanced Cancer, CIRES Trial	2024/06/24	NCT06470971	Phase 2	Recruiting	Yuanquan Yang
Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab	2024/06/07	NCT06447376	Phase 1	Recruiting	Taylor Brooks
Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM	2024/04/08	NCT06352866	Phase 2	Withdrawn	Jack Khouri, MD
Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM	2023/01/26	NCT05697510	Phase 1	Recruiting	Nantes University Hospital
Screening Trial for Pain Relief in Schwannomatosis (STARFISH)	2023/01/13	NCT05684692	Phase 2	Recruiting	Massachusetts General Hospital
Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma	2022/12/27	NCT05665725	Phase 1	Completed	Timothy Voorhees
Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)	2022/04/07	NCT05316116	Early Phase 1	Active, not recruiting	H. Lee Moffitt Cancer Center and Research Institute
Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy	2021/07/23	NCT04975555	Phase 2	Recruiting	University of Alabama at Birmingham

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sylvant	EUSA Pharma (UK) Ltd	73090-420	INTRAVENOUS	100 mg in 1 1	2/21/2024
Sylvant	EUSA Pharma (UK) Ltd	73090-421	INTRAVENOUS	400 mg in 1 1	2/21/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Sylvant	Recordati Netherlands B.V.,Recordati Netherlands B.V.,Beechavenue 54,1119PW Schiphol-Rijk,NETHERLANDS	Authorised	5/22/2014

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SYLVANT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL	Cilag AG	SIN14762P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100mg/vial	3/23/2015
SYLVANT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 400MG/VIAL	Cilag AG	SIN14763P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	400mg/vial	3/23/2015

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SYLVANT siltuximab (rmc) 400mg powder for injection vial	229997	Recordati Rare Diseases Australia Pty Ltd	Medicine	A	8/31/2015
SYLVANT siltuximab (rmc) 100mg powder for injection vial	229996	Recordati Rare Diseases Australia Pty Ltd	Medicine	A	8/31/2015

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SYLVANT	recordati rare diseases canada inc	02435128	Powder For Solution - Intravenous	100 MG / VIAL	3/3/2015
SYLVANT	recordati rare diseases canada inc	02435136	Powder For Solution - Intravenous	400 MG / VIAL	3/3/2015

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SYLVANT 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION	Recordati Netherlands B.V.	114928001	POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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