What are the adverse reactions of Hepatitis B Immunoglobulins (HBIG)?

Adverse Reactions of Hepatitis B Immunoglobulins (HBIG)

Hepatitis B immunoglobulins (HBIG) are generally safe with primarily mild and transient adverse reactions, most commonly including pain at the injection site, fever, and chills. 1

Common Adverse Reactions

HBIG is a human plasma-derived purified immunoglobulin G that contains high titers of antibody to hepatitis B surface antigen. The most frequently reported adverse reactions include:

• Local reactions:

  • Pain at injection site (most common)
  • Swelling at injection site
  • Erythema at injection site

• Systemic reactions:

  • Fever (typically low-grade, >37.7°C)
  • Chills
  • Arthralgias (joint pain)
  • Myalgias (muscle pain)

These side effects are typically mild and self-limiting, resolving without specific intervention 2, 3.

Serious Adverse Reactions

Serious adverse reactions to HBIG are rare but can include:

• Hypersensitivity reactions:

  • Anaphylaxis (extremely rare)
  • Angioedema
  • Urticaria (hives)

• Serum sickness-like reactions:

  • Characterized by fever, rash, arthralgia
  • Typically occurs 1-2 weeks after administration 4

• Hemolysis (rare):

  • More common in patients receiving high doses
  • Particularly in patients with blood group A, B, or AB

Risk Factors for Adverse Reactions

Certain factors may increase the risk of adverse reactions:

• History of allergic reactions to human immunoglobulin products
• IgA deficiency (may increase risk of anaphylactic reactions)
• High-dose or rapid intravenous administration
• Pre-existing renal insufficiency

Clinical Considerations

When administering HBIG, clinicians should:

1. Monitor patients for at least 20 minutes after administration for immediate hypersensitivity reactions
2. Administer slowly when given intravenously to minimize infusion-related reactions
3. Have emergency equipment readily available to manage potential anaphylactic reactions
4. Consider premedication with antipyretics in patients with history of fever following immunoglobulin administration

Specific Indications and Safety Considerations

HBIG is used in several clinical scenarios:

• Postexposure prophylaxis after percutaneous or mucosal exposure to HBV
• Prevention of perinatal HBV transmission
• Prevention of HBV recurrence after liver transplantation
• Sexual or household exposure to HBV
• Prophylaxis in non-responders to hepatitis B vaccine

For postexposure prophylaxis, HBIG (0.06 mL/kg or 5 mL for adults) should be administered as soon as possible after exposure, ideally within 24 hours and not later than 7 days 1.

Monitoring and Reporting

Any adverse events following HBIG administration should be reported to the Vaccine Adverse Event Reporting System (VAERS). This ongoing monitoring helps assess the safety profile of HBIG and identify any rare adverse reactions that may emerge 1.

Contraindications

HBIG is contraindicated in individuals with:

• History of anaphylactic reaction to human immunoglobulin products
• Severe thrombocytopenia or coagulation disorders that would contraindicate intramuscular injections (when administered IM)

Comparison with Hepatitis B Vaccine

It's important to note that HBIG (passive immunization) has a different safety profile compared to hepatitis B vaccine (active immunization). Unlike hepatitis B vaccine, HBIG has not been associated with neurological disorders like Guillain-Barré syndrome 1.

Human Medical Consultant's Note: While HBIG is generally well-tolerated, clinicians should remain vigilant for rare but serious adverse reactions, particularly in high-risk individuals. The benefits of preventing hepatitis B infection through HBIG administration typically outweigh the risks of adverse reactions.