Human Hepatitis B Immunoglobulin (HBIG) is a sterile, concentrated solution of immunoglobulins, predominantly IgG, containing high levels of antibodies against Hepatitis B surface antigen (anti-HBs). It is prepared from pooled human plasma from donors screened for high anti-HBs titers. It provides immediate, passive immunity against Hepatitis B virus (HBV) infection. In the Indian context, it is a critical component of post-exposure prophylaxis (PEP) for healthcare workers and others exposed to HBV, and for prevention of perinatal transmission from HBsAg-positive mothers to newborns.
Adult: Post-exposure Prophylaxis: 200 IU to 400 IU (0.04 to 0.07 mL/kg) intramuscularly as a single dose, administered as soon as possible (preferably within 24 hours, not exceeding 7 days). For sexual exposure: 200 IU IM single dose.
Note: For intramuscular use only. Administer by deep intramuscular injection into the anterolateral aspect of the thigh (infants) or deltoid muscle (adults). Do NOT administer intravenously. Use a separate sterile syringe and needle for each patient. The vial should be at room temperature before use. Do not mix with other medications. Inspect for particulate matter and discoloration before use.
Human Hepatitis B Immunoglobulin provides passive immunity by delivering high-titer antibodies against the Hepatitis B surface antigen (anti-HBs). These antibodies bind to circulating HBsAg, forming immune complexes that are cleared by the reticuloendothelial system. This neutralizes free viral particles, preventing them from attaching to and entering hepatocytes, thereby aborting the establishment of infection.
Pregnancy: Pregnancy Category C (US FDA). No well-controlled studies in pregnant women. Use only if clearly needed, such as for post-exposure prophylaxis in a pregnant healthcare worker. Benefits generally outweigh risks. It does not contain live virus.
Driving: Unlikely to affect ability to drive or use machines. However, patients should be advised about potential side effects like dizziness or malaise.
| Live Attenuated Vaccines (e.g., MMR, Varicella, Yellow Fever) | HBIG may interfere with the immune response to live viral vaccines. Vaccination should be deferred for at least 3 months after HBIG administration, or HBIG should be given at least 2 weeks after the vaccine. | Major |
| Other Immunoglobulin Preparations | Concurrent use may increase the risk of systemic adverse reactions. | Moderate |