"Siltuximab"

National dose banding table ' siltuximab NHS England » National dose banding table – siltuximab Skip to main content Cookies on the NHS England websiteWe’ve put some small files called cookies on your device to make our site work. We’d also like to use analytics cookies. These send information about how our site is used to a service called Google Analytics. We use this information to improve our Page updated: 19 July 2024 Topic: Cancer, Medicine, Pharmacy, Specialised commissioning Publication type: Guidance The national dose banding tables are to be used by hospital trust pharmacy teams to ensure a standard approach to dose banding of chemotherapy across all hospital trusts. Document National dose banding table - siltuximab * PDF * 638 KB * 1 pages * Terms and conditions * Privacy

Clinical commissioning policy: siltuximab for idiopathic multicentric Castleman disease (adults) Skip to main contentCookies on the NHS England websiteWe’ve put some small files called cookies on your device to make our site work.We’d also like to use analytics cookies. These send information about how our site is used to a service called Google Analytics. We use this information to improve our site.Let us know if this is OK. We’ll use a cookie to save your choice. You can read more about our cookies before you choose. Change my preferences I'm OK with analytics cookiesHome News Publications Statistics Blogs Events Contact usSearch SearchAbout us Our work Commissioning Get involved CoronavirusClinical commissioning policy: siltuximab for idiopathic multicentric Castleman disease (adults

Siltuximab is associated with improved progression-free survival in idiopathic multicentric Castleman disease. Idiopathic multicentric Castleman disease (iMCD) is a rare heterogeneous disorder involving multicentric lymphadenopathy, systemic inflammation, and cytokine-driven organ dysfunction. Despite the approval of siltuximab, a monoclonal antibody against interleukin-6, for the treatment of iMCD, it is not known how long patients should receive siltuximab before determining whether the treatment is beneficial and should be continued. We performed post hoc analyses of the phase 2 randomized double-blind placebo-controlled trial of siltuximab for the treatment of patients with iMCD to determine the sequence of normalization of laboratory, clinical, and lymph node responses in patients who

Sylvant (siltuximab) - To treat patients with multicentric Castleman?s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes) SYLVANT (siltuximab) * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDASYLVANT (siltuximab) * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print SYLVANT (siltuximab)Company: Janssen

Sylvant - siltuximab 20 March 2014 EMA/CHMP/258608/2014 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report SYLVANT International non-proprietary name: SILTUXIMAB Procedure No.: EMEA/H/C/003708/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail info@ema.europa.eu Website www.ema.europa.eu Product information Name of the medicinal product: SYLVANT Applicant: Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIUM Active substance: SILTUXIMAB International Nonproprietary Name/Common Name: SILTUXIMAB

Newly diagnosed and previously treated multicentric Castleman disease respond equally to siltuximab.

[Siltuximab: assessment according to section 35a (paragraph 1, sentence 10) Social Code Book V (dossier assessment)] Siltuximab – Bewertung gemass Section 35a Abs. 1 Satz 10 SGB V [Siltuximab: assessment according to section 35a (paragraph 1, sentence 10) Social Code Book V (dossier assessment )] ..

Siltuximab An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM and EffectsSummary of Use during LactationNo information is available on the clinical use of siltuximab during breastfeeding. Because siltuximab is a large protein molecule with a molecular weight of about 145,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data

Long-term safety of siltuximab in patients with idiopathic multicentric Castleman disease: a prespecified, open-label, extension analysis of two trials. Siltuximab is recommended by international consensus as a first-line treatment for idiopathic multicentric Castleman disease on the basis of durable efficacy and safety data. This study was done to assess the long-term safety and activity of siltuximab over up to 6 years of treatment. This study is a prespecified open-label extension analysis of a phase 1 trial (NCT00412321) and a phase 2 trial (NCT01024036), done at 26 hospitals worldwide. Patients in both studies were at least 18 years old with histologically confirmed, symptomatic Castleman disease. This extension study enrolled 60 patients who completed the previous trials without disease

Sylvant - siltuximab CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125496Orig1s000 MEDICAL REVIEW(S) Page 1 Secondary (Team Leader) Review Date February 12, 2014 From Albert Deisseroth, MD, PhD Subject Secondary Review NDA Number BLA 125496 Applicant Janssen Biotech, Inc. Date of Submission August 30, 2013 PDUFA Goal Date April 29, 2014 Established Name/Proprietary Name Siltuximab/Sylvant Dosage Regimen 11mg/kg every 3 weeks Applicant’s Proposed Indication Treatment of Multicentric Castleman’s Disease in patients who are immunodeficiency virus negative (HIV) and human herpes virus-8 (HHV-8) Recommended: Approval Material Reviewed/Consulted Reviewer/Author Medical Officer Review Patricia Dinndorf, MD Pharmacology/Toxicology Pedro L. Del Valle

Randomized, Double-blind, Placebo-controlled, Multicenter Study of Siltuximab in High-risk Smoldering Multiple Myeloma. IL6 is important for the growth and survival of myeloma cells. This study evaluated blocking IL6 with siltuximab to delay the transition from high-risk smoldering multiple myeloma (SMM) to multiple myeloma. In a randomized, double-blind, placebo-controlled, multicenter study , 85 patients with high-risk SMM were randomized to 15 mg/kg siltuximab (43 patients) or placebo (42 patients). The primary endpoint was 1-year progression-free survival (PFS) rate, based on IMWG CRAB criteria. Secondary endpoints included progressive disease indicator rate, PFS, and safety. Median age was 62 years (range: 21-84); 57% were male and 87% had a baseline Eastern Cooperative Oncology

Predictors of response to anti-IL6 monoclonal antibody therapy (siltuximab) in idiopathic multicentric Castleman disease: secondary analyses of phase II clinical trial data. Siltuximab is the only US Food and Drug Administration-approved treatment for idiopathic multicentric Castleman disease (iMCD), a rare haematological disorder associated with substantial morbidity and mortality. Although siltuximab induces a response in a significant proportion of iMCD patients via interleukin 6 (IL6) neutralization, it is not universally effective. To develop a predictive model of response, we performed an in-depth analysis of 38 baseline laboratory parameters in iMCD patients from the phase II siltuximab trial who met criteria for treatment response or treatment failure. Univariate analyses identified

Impact of siltuximab on patient-related outcomes in multicentric Castleman’s disease Multicentric Castleman's disease (MCD) is a rare, widespread lymphoproliferative disorder and a life-threatening disease involving hyperactivity of the immune system, excessive proinflammatory cytokine release, immune cell proliferation, and organ system dysfunction. Interleukin-6 (IL-6) is a cytokine that plays a key role in the pathogenesis of MCD, as it is involved in the synthesis of acute-phase reactants and aids in the induction of B-cell proliferation. Siltuximab is an anti-IL-6 chimeric monoclonal antibody that acts as a novel treatment modality to bind to IL-6 with high affinity, thus neutralizing the cytokine bioactivity and inhibiting B-cell proliferation. Clinical trials with siltuximab have

Successful treatment of disseminated Rosai-Dorfman disease with siltuximab

An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Siltuximab for Patients with Castleman's Disease Treated in Italy in a Real-life Context The study is a pilot, observational, retrospective, and (italian) multicenter study. The study will involve the collection of patient data from medical records for patients with Multicentric Castelman Disease Relapsed/Refractory who received treatment with at least one dose of siltuximab, as part of standard of care in a real-life context, from July 2016 till April 2022 in 31selected italian centres. The aim of the present study is to provide useful information about use, effectiveness, and safety profile of siltuximab given to relapsed or refractory (R/R) MCD in a real-life context since approval as more

JAK1 Genomic Alteration Associated With Exceptional Response to Siltuximab in Cutaneous Castleman Disease. Castleman disease (CD) is an ultrarare, interleukin-6 (IL-6)-driven lymphoproliferative disorder whose underlying molecular alterations are unknown. Siltuximab (anti-IL-6 antibody) is approved for treatment of this disease. To our knowledge, genomic sequencing of CD has not been reported . To investigate and identify molecular aberration(s) that help explain the exceptional response to siltuximab in a patient with cutaneous CD. This case study examines data from comprehensive genomic profiling (using targeted next-generation sequencing) of tissue from a patient with cutaneous CD who demonstrated an exceptional response to siltuximab treated at a National Cancer Institute-designated Comprehensive

Hematologic Safety of Siltuximab in in patients with hematologic disorders PROSPEROInternational prospective register of systematic reviews Print | PDFHematologic Safety of Siltuximab in in patients with hematologic disordersLi Wang, Haiyang Zhang, Yuanyuan Wang, Han Qu, Guorong FanTo enable PROSPERO to focus on COVID-19 submissions, this registration record has undergone basic automated checks for eligibility and is published exactly as submitted. PROSPERO has never provided peer review, and usual checking by the PROSPERO team does not endorse content. Therefore, automatically published records should be treated as any other PROSPERO registration. Further detail is provided here.CitationLi Wang, Haiyang Zhang, Yuanyuan Wang, Han Qu, Guorong Fan. Hematologic Safety of Siltuximab in in patients

Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial This phase II trial studies how well giving siltuximab during the reintroduction (rechallenge) of immune checkpoint inhibitor (ICI) therapy works in preventing severe immune-related adverse events (irAEs) in patients with cancer . Siltuximab is a monoclonal antibody that binds to receptors for a protein called interleukin-6 (IL-6). This may help lower the body's immune response and reduce inflammation. Giving siltuximab during ICI rechallenge may help prevent severe irAEs in patients with advanced cancer. PRIMARY OBJECTIVE: I. To determine whether siltuximab prophylaxis reduces rates of de novo or recurrent severe irAE within 24

Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab The goal of this clinical trial is to is to determine the safety, feasibility and efficacy of siltuximab prophylaxis of cytokine release syndrome and neurotoxicity occurring after epcoritamab subcutaneous administration for participants with large b-cell lymphoma (DLBCL) or follicular lymphoma (FL ). Participants will receive siltuximab, prior to the infusion of epcoritamab. Epcoritamab is administered in 28 day cycles for one year. After this infusion, the physician will continue to watch participants for side effects and follow the condition for a minimum of 60 days. Siltuximab is a monoclonal antibody that blocks interleukin-6 (IL-6) from binding to its receptor, preventing it from acting. IL-6

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration