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Chỉ định và Liều dùng
Intravenous
Generalised pustular psoriasis Adult: For the treatment of flares: 900 mg as a single dose. If flare symptoms persist, may give an additional dose of 900 mg 1 week after the initial dose. Doses are given via IV infusion through an IV line containing a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2 micron over 90 minutes.
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Hướng dẫn pha thuốc
Withdraw and discard 15 mL from a 100 mL NaCl 0.9% solution infusion bag. Slowly add 15 mL of spesolimab (2 vials containing 450 mg of spesolimab per 7.5 mL) to the 100 mL infusion bag. Mix gently.
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Chống chỉ định
Hypersensitivity. Clinically significant active infections (e.g. active TB).
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Thận trọng
Patient with a chronic infection or a history of recurrent infection. Avoid concurrent administration of live vaccines during treatment and for at least 16 weeks following therapy.
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Tác dụng không mong muốn
Significant: Infection, hypersensitivity reaction (e.g. anaphylaxis, drug reaction with eosinophilia and systemic symptoms).
General disorders and administration site conditions: Inj site reaction (bruising, haematoma), fatigue. Skin and subcutaneous tissue disorders: Pruritus. |
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Chỉ số theo dõi
Screen for TB infection (latent TB) before treatment initiation. Monitor for infusion-related reactions (e.g. haematoma, bruising). Assess for signs and symptoms of infection or hypersensitivity/anaphylaxis during and after administration.
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Tác dụng
Description:
Mechanism of Action: Spesolimab is a humanised immunoglobulin G1 monoclonal antibody. It prevents interleukin-36 (IL-36) signalling by binding to the IL-36 receptor, thereby preventing the subsequent activation of IL-36 receptor by its ligands (IL-36 α, β, and γ) and downstream activation of pro-inflammatory pathways. Pharmacokinetics: Excretion: Terminal elimination half-life: 25.5 days. |
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Bảo quản
Intact vial: Store between 2-8°C. Do not freeze. Protect from light. Vials may be stored at up to 30°C for 24 hours, if necessary. Diluted solution: May be stored between 2-8°C for up to 24 hours. Protect from light.
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Phân loại MIMS
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Phân loại ATC
L04AC22 - spesolimab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
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Tài liệu tham khảo
Brayfield A, Cadart C (eds). Spesolimab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/09/2024. Joint Formulary Committee. Spesolimab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/09/2024. Spesolimab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 12/09/2024. Spevigo 450 mg Concentrate for Solution for Infusion (Boehringer Ingelheim International GmbH). MHRA. https://products.mhra.gov.uk. Accessed 12/09/2024. Spevigo Concentrate for Solution for Infusion 450 mg/7.5 mL (Boehringer Ingelheim [Hong Kong] Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 12/09/2024. Spevigo Injection (Boehringer Ingelheim Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/09/2024.
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