Hepatitis B immunoglobulin


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Prophylaxis of hepatitis B recurrence after liver transplantation
Adult: Initially, 20,000 IU peri-operatively, then 20,000 IU once daily from day 1-7 post-surgery, then once every 2 weeks starting day 14, then once every month starting on month 4 post-surgery. All doses are given via IV infusion. Adjust the dose to reach anti-HBs level of 500 IU/L within the 1st week post-transplant. Alternatively, 10,000 IU peri-operatively, then 2,000-10,000 IU daily for 7 days, then as necessary to maintain antibody levels >100-150 IU/L in HBV-DNA negative patients and above 500 IU/L in HBV-DNA positive patients. There are variabilities in the contents of hepatitis B immunoglobulin between manufacturers as well as the immunisation program among countries. Refer to individual product and local guidelines.

Parenteral
Passive immunisation against hepatitis B infection
Adult: ≥500 IU (according to the intensity of exposure) as a single dose given via IM inj or IV infusion within 24-72 hours (up to 1 week) after exposure. Alternatively, 12-20 IU/kg or 0.06 mL/kg via IM inj within 24 hours of exposure (e.g. mucosal, ocular, needlestick) or within 14 days of sexual exposure. There are variabilities in the contents of hepatitis B immunoglobulin between manufacturers as well as the immunisation program among countries. Refer to individual product and local guidelines.
Child: Perinatal exposure in newborn infants whose mothers are carriers of hepatitis B surface antigen or HBsAg-positive: 30-100 IU/kg via IV infusion or IM inj (depending on product used), preferably within 12-24 hours of birth. Alternatively, 100 IU via IM inj at birth. Postexposure prophylaxis: <5 years 200 IU; 5-9 years 300 IU as a single dose; >10 years Same as adult dose. There are variabilities in the contents of hepatitis B immunoglobulin between manufacturers as well as the immunisation program among countries. Refer to individual product and local guidelines.

Subcutaneous
Prophylaxis of hepatitis B recurrence after liver transplantation
Adult: 500-1,000 IU (up to 1,500 IU in some cases) once weekly or once every 2 weeks depending on anti-HBs level. Adequate anti-HBs serum levels should be stabilised with an IV hepatitis B immunoglobulin to levels ≥300-500 IU/L before initiation of SC dose to ensure adequate anti-HBs coverage during the transition from IV to SC. Maintain antibody levels >100 IU/L in HBsAg and HBV-DNA negative patients. There are variabilities in the contents of hepatitis B immunoglobulin between manufacturers as well as the immunisation program among countries. Refer to individual product and local guidelines.
Renal Impairment
Passive immunisation against hepatitis B infection: Haemodialysis patients: 8-12 IU/kg (Max 500 IU) via IV infusion every 2 months until seroconversion following vaccination.
Chống chỉ định
Hypersensitivity to human immunoglobulins.
Thận trọng
Patient with IgA deficiency, impaired cardiac output, prolonged immobilisation, known or suspected hyperviscosity, thrombocytopenia or coagulation disorder, history of atherosclerosis or cardiovascular and/or thrombotic risk factors. Children. Pregnancy and lactation. Not indicated for the treatment of active hepatitis B infection.
Phản ứng phụ
Significant: Anaphylaxis/hypersensitivity reactions, infusion-related reactions, transmissible infections, thrombotic events.
Gastrointestinal disorders: Nausea, upper abdominal pain.
General disorders and administration site conditions: Malaise, injection site reactions (e.g. pain, tenderness, urticaria, haematoma and erythema).
Musculoskeletal and connective tissue disorders: Myalgia.
Nervous system disorders: Headache.
Vascular disorders: Hypotension.
IM/IV/Parenteral: C
MonitoringParameters
Monitor serum anti-HBs level at least every 2-4 weeks for 6 months; serum HBsAg, LFT, and infusion-related adverse events (liver transplant).
Tương tác
May diminish the therapeutic effect of live vaccines (e.g. measles, rubella and varicella vaccines).
Lab Interference
May falsely elevate glucose level when using glucose-containing devices and test strips which utilises dehydrogenase pyrroloquinolinequinone base methods. May interfere with some serological tests for red cell antibodies (e.g. direct Coombs’ test, direct antiglobulin test).
Tác dụng
Description: Hepatitis B immunoglobulins (HBIG) contains immunoglobulin G (IgG) specific to hepatitis B surface antigen (HBsAg). It is prepared by plasma, preselected for high titer anti-HBs.
Duration: Postexposure prophylaxis: 3-6 months.
Pharmacokinetics:
Absorption: Slowly absorbed after IM administration. Time to peak plasma concentration: 2-10 days (IM).
Distribution: Volume of distribution: 7-15 L.
Excretion: Half-life: 17-25 days.
Bảo quản
Store between 2-8°C. Do not freeze. Protect from light.
Phân loại ATC
J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
References
Anon. Hepatitis B Immune Globulin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/04/2020.

Buckingham R (ed). Hepatitis B Immunoglobulins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2020.

Hepagam B Injection Solution (Aptevo BioTherapeutics LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/04/2020.

Hepatect CP (Biotest Pharma GmbH). MHRA. https://products.mhra.gov.uk/. Accessed 24/04/2020.

Human Hepatitis B Immunoglobulin, 100 IU/mL Sterile Solution (Bio Products Laboratory Limited). MHRA. https://products.mhra.gov.uk/. Accessed 24/04/2020.

Hyperhep B S/D Injection (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/04/2020.

Igantibe 200 IU/mL (Instituto Grifols, S.A.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 01/04/2020.

Joint Formulary Committee. Hepatitis B Immunoglobulin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2020.

Pharmaco (N.Z.) Ltd. HyperHEP B data sheet 26 March 2018. Medsafe. http://www.medsafe.govt.nz/. Accessed 01/04/2020.

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