Siltuximab


Concise Prescribing Info
Indications/Uses
Multicentric Castleman’s disease.
Dosage/Direction for Use
Adult : IV In patient who are HIV-negative and human herpesvirus-8 (HHV-8) negative: 11 mg/kg via infusion over 1 hour every 3 weeks until treatment failure.
Dosage Details
Intravenous
Multicentric Castleman’s disease
Adult: In patient who are HIV-negative and human herpesvirus-8 (HHV-8) negative: 11 mg/kg, given via infusion over 1 hour every 3 weeks until treatment failure. Interrupt dosing if absolute neutrophil count (ANC) <1,000 cells/mm3; platelet count <75,000 cells/mm3 before the 1st dose or <50,000 cells/mm3 before succeeding doses; Hb <17 g/100 mL. Dose reduction is not recommended.
Reconstitution
Reconstitute vial labelled as 100 mg and 400 mg with 5.2 mL and 20 mL sterile water for inj respectively, to make a final concentration containing 20 mg/mL. Gently swirl and do not shake. To prepare the solution for infusion, further dilute with 250 mL dextrose 5% in water.
Contraindications
Concomitant use with live viral vaccines.
Special Precautions
Patient with risk for gastrointestinal perforation (e.g. diverticulitis, ulcers), concurrent active severe infection. Pregnancy and lactation. Not indicated for use for HIV and human herpesvirus-8 (HHV-8) positive patients.
Adverse Reactions
Significant: Hypersensitivity/infusion related reactions (e.g. anaphylaxis, cytokine release syndrome), serious infection (e.g. pneumonia, sepsis), lipid and cholesterol elevations, gastrointestinal perforation, increased Hb level.
Blood and lymphatic system disorders: Neutropenia, thrombocytopenia.
Gastrointestinal disorders: Abdominal pain/distention, constipation, diarrhoea, oropharyngeal pain.
General disorders and administration site conditions: Fatigue.
Investigations: Increased weight.
Metabolism and nutrition disorders: Peripheral/localised oedema, hypertriglyceridaemia, hypercholesterolaemia, hyperuricaemia.
Musculoskeletal and connective tissue disorders: Arthralgia, limb pain.
Nervous system disorders: Headache.
Renal and urinary disorders: Renal impairment.
Respiratory, thoracic and mediastinal disorders: Respiratory tract infection, nasopharyngitis.
Skin and subcutaneous tissue disorders: Maculopapular rash, pruritus.
Vascular disorders: Hypertension, hypotension.
IV/Parenteral: C
MonitoringParameters
Monitor CBC with differential prior to each dose for 1 year and every 3 dosing cycles, thereafter, or as needed; anaphylaxis and signs or symptoms of infusion-related, allergic, or cytokine release reactions; gastrointestinal perforation, infection.
Drug Interactions
May decrease serum concentration of CYP3A4 substrate (e.g. warfarin, ciclosporin). May enhance adverse effects of live vaccines. May diminish therapeutic effects of inactivated and live vaccines. May decrease therapeutic effect of oral contraceptives, atorvastatin.
Action
Description: Siltuximab is a chimeric murine/human monoclonal antibody that selectively binds cytokine interleukin-6 (IL-6) and prevents its binding to soluble and membrane-bound receptors. This leads to inhibition of immunoglobulin secretion and hepatic acute phase protein synthesis, thereby lowering IL-6 and C-reactive protein levels.
Pharmacokinetics:
Distribution: Volume of distribution: 4.5 L.
Excretion: Elimination half-life: Approx 21 days.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
ATC Classification
L04AC11 - siltuximab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Disclaimer: This information is independently developed by MIMS based on Siltuximab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Sylvant
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in