Dosage/Direction for Use
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. Renal impairment: Haemodialysis patients: 8-12 IU/kg (Max 500 IU) via IV infusion every 2 months until seroconversion following vaccination. 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. 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. |
Contraindications
Hypersensitivity to human immunoglobulins.
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Special Precautions
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. Monitoring Parameters Monitor serum anti-HBs level at least every 2-4 weeks for 6 months; serum HBsAg, LFT, and infusion-related adverse events (liver transplant).
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Adverse Reactions
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.
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Drug Interactions
May diminish the therapeutic effect of live vaccines (e.g. measles, rubella and varicella vaccines).
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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).
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Action
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. 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. |
Storage
Intravenous: Store between 2-8°C. Do not freeze. Protect from light. Parenteral: Store between 2-8°C. Do not freeze. Protect from light. Subcutaneous: Store between 2-8°C. Do not freeze. Protect from light.
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CIMS Class
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