Siltuximab


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Multicentric Castleman’s disease
Adult: In patients who are HIV-negative and human herpesvirus-8 (HHV-8) negative: 11 mg/kg given via infusion over 1 hour once every 3 weeks until treatment failure. Consider delaying doses if absolute neutrophil count (ANC) is <1,000 cells/mm3, platelet count <75,000 cells/mm3 before the 1st dose or <50,000 cells/mm3 before any subsequent doses, and Hb ≥17 g/dL. Dose reduction is not recommended.
Hướng dẫn pha thuốc
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 of 20 mg/mL. Gently swirl to mix; do not shake. To prepare the solution for infusion, further dilute the reconstituted solution with 250 mL of dextrose 5% in water (D5W) within 2 hours. Slowly add the reconstituted solution to the 250 mL D5W infusion bag and gently invert to mix.
Chống chỉ định
Severe infections (until resolved). Concomitant use with live vaccines.
Thận trọng
Patient with chronic infections, history of recurrent infection, or underlying conditions predisposing to infection; at risk of gastrointestinal perforation (e.g. diverticulitis, ulcers). Not indicated for use in HIV-positive and HHV-8 positive patients. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Hypersensitivity, anaphylactic reactions, cytokine-release syndrome, infusion-related reaction, mask signs and symptoms of infection and acute inflammation (e.g. C-reactive protein elevation, fever), serious infection (e.g. pneumonia, sepsis), gastrointestinal perforation, increased risk of malignancy, transient or intermittent increase in hepatic transaminases or other LFTs, including bilirubin; elevated lipid, cholesterol, and Hb levels.
Blood and lymphatic system disorders: Neutropenia, thrombocytopenia.
Gastrointestinal disorders: Nausea, abdominal pain, vomiting, constipation, diarrhoea, GERD, mouth ulceration.
General disorders and administration site conditions: General or localised oedema.
Immune system disorders: Antibody development.
Investigations: Increased weight.
Metabolism and nutrition disorders: Hypertriglyceridaemia, hypercholesterolaemia, hyperuricaemia.
Musculoskeletal and connective tissue disorders: Pain in extremity, arthralgia.
Nervous system disorders: Headache, dizziness.
Renal and urinary disorders: Renal impairment, UTI.
Respiratory, thoracic and mediastinal disorders: Upper and lower respiratory tract infection, oropharyngeal pain, nasopharyngitis.
Skin and subcutaneous tissue disorders: Rash, pruritus, psoriasis, eczema, skin hyperpigmentation, xeroderma.
Vascular disorders: Hypotension, hypertension.
Thông tin tư vấn bệnh nhân
Women of childbearing potential must use proven birth control methods during therapy and for 3 months after stopping the treatment.
Chỉ số theo dõi
Obtain CBC with differential prior to each dose for the 1st 12 months and every 3 dosing cycles thereafter, or as necessary. Monitor for signs or symptoms of anaphylaxis, infusion-related or cytokine release reactions, gastrointestinal perforation, and infection.
Tương tác
May increase the metabolism of CYP450 substrates (e.g. warfarin, theophylline, ciclosporin). May decrease the effects of CYP3A4 substrates (e.g. oral contraceptives, atorvastatin, lovastatin).
Potentially Fatal: May enhance the adverse effects of live vaccines.
Tác dụng
Description: Siltuximab is a recombinant chimeric human-murine monoclonal antibody that binds with high affinity and specificity to interleukin-6 (IL-6). It prevents the binding of human IL-6 to both soluble and membrane-bound IL-6 receptors. The overproduction of IL-6 may result in systemic manifestations of multicentric Castleman’s disease (MCD) by induction of C-reactive protein synthesis. Lowering the serum IL-6 levels may improve these systemic symptoms.
Pharmacokinetics:
Distribution: Volume of distribution: 4.5 L.
Excretion: Elimination half-life: Approx 21 days (range: 14.2-29.7 days).
Bảo quản
Intact vial: Store between 2-8°C. Do not freeze. Protect from light. Reconstituted and diluted solutions are stable for 8 hours between 15-25°C.
Phân loại MIMS
Thuốc ức chế miễn dịch
Phân loại ATC
L04AC11 - siltuximab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Tài liệu tham khảo
Anon. Siltuximab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/10/2022.

Anon. Siltuximab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/10/2022.

Buckingham R (ed). Siltuximab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/10/2022.

Joint Formulary Committee. Siltuximab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/10/2022.

Link Pharmaceuticals Ltd. Sylvant 100 mg and 400 mg Powder for Infusion Concentrate data sheet 4 February 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 06/10/2022.

Sylvant 100 mg and 400 mg Powder for Concentrate for Solution for Infusion (Link Healthcare Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/10/2022.

Sylvant 100 mg Powder for Concentrate for Solution for Infusion (EUSA Pharma [UK] Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 06/10/2022.

Sylvant Injection, Powder for Solution (EUSA Pharma [UK] Ltd). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/10/2022.

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