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Chỉ định và Liều dùng
Subcutaneous
Prophylaxis of haemorrhage in haemophilia A Adult: In patients with or without factor VIII inhibitors: Initially, 3 mg/kg once weekly for the 1st 4 weeks. Maintenance: Either 1.5 mg/kg once weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks.
Child: Same as adult dose. |
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Chống chỉ định
Hypersensitivity.
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Thận trọng
Patient with risk factors for thrombotic microangiopathy. Discontinue treatment (including prophylactic use) with bypassing agents the day prior to initiation of emicizumab. Children. Pregnancy and lactation.
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Tác dụng không mong muốn
Significant: Thrombotic microangiopathy, thromboembolism, antibody formation.
Gastrointestinal disorders: Diarrhoea. General disorders and administration site conditions: Inj site reactions (e.g. erythema, pain, pruritus, haematoma), pyrexia. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia. Nervous system disorders: Headache. Skin and subcutaneous tissue disorders: Skin necrosis. Vascular disorders: Thrombophlebitis superficial, cavernous sinus thrombosis. |
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Thông tin tư vấn bệnh nhân
Women of childbearing potential must use effective birth control methods during therapy and for at least 6 months after stopping the treatment.
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Chỉ số theo dõi
Monitor coagulation parameters using single factor assays utilising chromogenic or immune-based methods. Assess for thrombotic microangiopathy and thrombotic events in patients receiving activated prothrombin complex concentrate (aPCC).
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Tương tác
Increased risk of thrombotic microangiopathy and thromboembolism with aPCC.
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Ảnh hưởng đến kết quả xét nghiệm
May affect the results of intrinsic pathway clotting-based laboratory tests, including activated clotting time, aPTT, Bethesda assays (clotting-based) for FVIII inhibitor titres, one-stage aPTT-based single-factor assays, and aPTT-based activated protein C resistance.
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Tác dụng
Description:
Mechanism of Action: Emicizumab, a humanised monoclonal modified IgG4 antibody with a bispecific antibody structure, links activated factor IX and factor X to restore the function of missing activated factor VIII, which is necessary for effective haemostasis. Pharmacokinetics: Absorption: Bioavailability: 80.4-93.1%. Distribution: Volume of distribution: 10.4 L. Excretion: Elimination half-life: 26.9 ± 9.1 days. |
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Bảo quản
Store between 2-8°C. Do not freeze. Do not shake. Protect from light. Unopened vials may also be stored below 30°C for up to 7 days.
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Phân loại MIMS
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Phân loại ATC
B02BX06 - emicizumab ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
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Tài liệu tham khảo
Anon. Emicizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/11/2022. Buckingham R (ed). Emicizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/11/2022. Hemlibra 150 mg/mL Solution for Injection (Roche Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 07/11/2022. Hemlibra 30 mg/mL, 150 mg/mL Solution for Injection (Roche [Malaysia] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/11/2022. Hemlibra Injection, Solution (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/11/2022. Joint Formulary Committee. Emicizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/11/2022. Roche Products (New Zealand) Limited. Hemlibra 30 mg/1 mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/1 mL Solution for Injection data sheet 1 February 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 08/11/2022.
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