Varicella-Zoster immunoglobulin


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intramuscular
Passive immunisation against varicella infections
Adult: In individuals who are at high risk of severe varicella infection and complications and have no antibodies to varicella-zoster virus (VZV) and who have significant exposure to varicella or herpes zoster: >40 kg: 625 IU, administer as a single inj as soon as possible (ideally within 96 hours) and within 10 days following exposure to VZV. Divide dose and inject in ≥2 sites, depending on patient size (Max: 3 mL per inj site). Alternatively, ≥15 IU/kg or 1,000 mg given as soon as possible (ideally within 3 days) and within 10 days following exposure; if >5 mL is required, administer in divided doses at different sites. A 2nd full dose may be given if an additional exposure to varicella occurs >3 weeks after the initial dose. Dosage recommendations may vary among countries or individual products (refer to specific product guideline).
Child: Dosing based on weight: ≤2 kg: 62.5 IU; 2.1-10 kg: 125 IU; 10.1-20 kg: 250 IU; 20.1-30 kg: 375 IU; 30.1-40 kg: 500 IU; >40 kg: 625 IU. Administer as a single inj as soon as possible (ideally within 96 hours) and within 10 days following exposure to VZV. Divide dose and inject in ≥2 sites, depending on patient size (Max: 3 mL per inj site). Alternative dosing recommendations: ≥15 IU/kg given as soon as possible (ideally within 3 days) and within 10 days following exposure. Dosing based on age: 0-5 years 250 mg; 6-10 years 500 mg; 11-14 years 750 mg; ≥15 years 1,000 mg. Dose to be given as soon as possible (ideally within 3 days) and within 10 days following exposure; if >2 mL is required, administer in divided doses at different sites. A 2nd full dose may be given if an additional exposure to varicella occurs >3 weeks after the initial dose. Dosage recommendations may vary among countries or individual products (refer to specific product guideline).
Chống chỉ định
Hypersensitivity to human immunoglobulins, particularly in IgA-deficient patients with antibodies against IgA.
Thận trọng
Patient with severe thrombocytopenia or any coagulation disorders, history of atherosclerosis, multiple CV risk factors, impaired cardiac output, prolonged periods of immobilisation, known or suspected hyperviscosity disorders. Children. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Arterial and venous thromboembolic events (e.g. MI, DVT, stroke, pulmonary embolism), severe hypersensitivity reactions (including anaphylactic shock).
Cardiac disorders: Tachycardia.
Gastrointestinal disorders: Nausea, vomiting.
General disorders and administration site conditions: Chills, fatigue, fever, malaise, local reactions at inj sites (e.g. pain, swelling, soreness, redness, induration, local heat, itching, bruising, rash).
Musculoskeletal and connective tissue disorders: Arthralgia, moderate low back pain.
Nervous system disorders: Headache, dizziness.
Skin and subcutaneous tissue disorders: Pruritus, rash (including erythematous or vesicular rash), urticaria.
Vascular disorders: Hypotension.
Chỉ số theo dõi
Assess blood viscosity in patients at risk for hyperviscosity at baseline. Observe for signs and symptoms of varicella infection for 28 days after administration.
Tương tác
May impair the efficacy of live attenuated vaccines (e.g. measles, mumps, rubella, varicella).
Ảnh hưởng đến kết quả xét nghiệm
May interfere with some serological tests for red cell antibodies (e.g. direct Coombs' test).
Tác dụng
Description:
Mechanism of Action: Varicella-Zoster immunoglobulin is used for passive immunisation against varicella. It has been used successfully to prevent the spread of varicella in high-risk individuals and has been shown to prevent the infection in susceptible contacts of an index case.
Duration: ≥6 weeks.
Pharmacokinetics:
Absorption: Bioavailability: 100%. Time to peak plasma concentration: 4.5 ± 2.8 days.
Metabolism: Metabolised in the reticuloendothelial system.
Excretion: Elimination half-life: 26.2 ± 4.6 days (may vary from patient to patient).
Bảo quản
Store between 2-8°C. Do not freeze. Protect from light.
Phân loại MIMS
Vaccin, kháng huyết thanh & thuốc miễn dịch
Phân loại ATC
J06BB03 - varicella/zoster immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Tài liệu tham khảo
Anon. Varicella-Zoster Immune Globulin (Human). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/10/2021.

Buckingham R (ed). Varicella-Zoster Immunoglobulins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/10/2021.

CSL Behring Australia Pty Ltd. Zoster Immunoglobulin-VF 200 IU, Solution for Intramuscular Injection data sheet 13 April 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 13/10/2021.

Human Varicella-Zoster Immunoglobulin 100 IU/mL Solution for Injection (Bio Products Laboratory Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 13/10/2021.

Joint Formulary Committee. Varicella-Zoster Immunoglobulin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/10/2021.

Varizig Liquid (Cangene BioPharma). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/10/2021.

Varizig Lyophilized Powder for Solution for Injection (Cangene Corporation). U.S. FDA. https://www.fda.gov. Accessed 13/10/2021.

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