Hepatitis B Immune gloubulin

Indications
 Intramuscular
Passive immunisation against hepatitis B infection
Adult: 500 IU given as a single dose, given preferably within 48 hr of exposure and not >1 wk after exposure. Contents of hepatitis B immunoglobulin may vary between countries and between manufacturers (see lit). Caution should be taken in interpreting dosage recommendations which are not given in terms of IU.
Child: <5 yr: 200 IU; 5-9 yr: 300 IU; >10 yr: 500 IU. To be given as a single dose, preferably within 48 hr of exposure and not >1 wk after exposure. For newborns (whose mothers are persistent carriers of hepatitis B surface antigen (HbsAg) or mothers who are HBsAg-positive as a result of recent infection): 200 IU at birth or within 24 hr after birth. Contents of hepatitis B immunoglobulin may vary between countries and between manufacturers. Caution should be taken in interpreting dosage recommendations which are not given in terms of IU.
Intravenous
Prophylaxis of hepatitis B recurrence after liver transplantation
Adult: Given in doses of 20,000 IU/dose: Initially, 1 dose with liver transplant. In the 1st wk post-operation: 1 dose daily for 7 days (day 1-7); from wk 2-12 post-operation (starting from day 14): 1 dose every 2 wk; from 4th mth onwards: 1 dose mthly. Adjust dose to reach anti-HBs levels of 500 IU/L within the 1st wk post-transplantation. For patients with surgical bleeding, abdominal fluid drainage >500 ml or those undergoing plasmapheresis, 10,000 IU should be given every 6 hr until target anti-HBs levels are reached. Contents of hepatitis B immunoglobulin may vary between countries and between manufacturers (See Lit). Caution should be taken in interpreting dosage recommendations which are not given in terms of IU.
Contraindications
 Hypersensitivity; severe allergy to gamma globulin or anti-immunoglobulin therapies. IM inj in patients with thrombocytopenia or coagulation disorders.
Warnings / Precautions
 Patients with thrombocytopenia or coagulation disorders. May contain certain infectious agents that could transmit disease. Hepatitis B immunoglobulins may be administered at the same time (but at a different site) or up to 1 mth before hepatitis B vaccination without compromising the active immune response. Human hepatitis B immunoglobulin should not be administered via IV inj. May cause drowsiness. Monitor for infusion-related adverse events. Pregnancy and lactation.
Adverse Reactions
 Fainting, headache, lightheadedness, malaise, angioedema, bruising, urticaria, nausea, vomiting, increased AST and alkaline phosphatase. Ache, pain, erythema, and/or tenderness at inj site. Anaphylaxis, cold/flu-like syndrome, arthralgia, joint stiffness and myalgia.
Drug Interactions
 May interfere with immune response when used with live vaccines; live vaccines should be given only 3 mth after admin of immunoglobulin.
See Below for More hepatitis b immunoglobulin Drug Interactions
Lab Interactions
 Products containing maltose may cause in falsely-elevated blood glucose readings.
Mechanism of Actions
 Hepatitis B immunoglobulins contain specific neutralising antibodies (mainly IgG) that provide passive immunisation for individuals exposed to the hepatitis B virus. It is used for post-exposure prophylaxis in persons who are not vaccinated, or whose prior vaccination regimen is incomplete or when the antibody level is <10 IU/ml. It may also be used in haemodialysis patients and receptors of certain blood products who are unable to develop adequate immune protection.
Duration: Postexposure prophylaxis: 3-6 mth.
Absorption: Slow absorption via IM inj.
Distribution: Volume of distribution: 7-15 L.
Excretion: Average half-life ranges from 17-25 days.
Storage Conditions
 Intramuscular: Store at 2-8°C. Intravenous: Store at 2-8°C.
Storage
 Intramuscular: Store at 2-8°C. Intravenous: Store at 2-8°C.
Available As
  • Hepatitis B Immune gloubulin 100 iu
  • Hepatitis B Immune gloubulin 20 mg
  • Hepatitis B Immune gloubulin 200 iu

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