What are the contraindications for Intravenous Immunoglobulin (IVIG) therapy?

Contraindications for IVIG Therapy

The only absolute contraindication to IVIG is a history of anaphylactic or severe systemic allergic reactions to human immunoglobulin preparations, though even IgA deficiency with anti-IgA antibodies is not an absolute contraindication. 1, 2

Absolute Contraindication

• Prior anaphylaxis to human immunoglobulin products is the primary contraindication, requiring extreme caution or alternative therapy 2, 3

Relative Contraindications (Require Careful Risk-Benefit Assessment)

IgA Deficiency with Anti-IgA Antibodies

• IgA deficiency is NOT an absolute contraindication to IVIG therapy, despite common misconceptions 1
• Very rare patients who lack serum IgA (<7 mg/dL) have experienced anaphylaxis after IVIG administration, potentially due to high levels of IgG anti-IgA antibodies reacting with trace IgA contaminating the IVIG product 1
• The risk to any individual IgA-deficient patient is very small, and the rarity of these events must be emphasized 1
• Some patients who experienced anaphylaxis with IVIG have successfully tolerated subcutaneous immunoglobulin (SCIg) without reactions 1, 4
• IgA-depleted IVIG preparations can be safely used in patients with high-titered anti-IgA antibodies, with only 5.3% experiencing mild to moderate infusion reactions over long-term use 5
• IgA deficiency with detectable IgA antibodies was historically listed as a contraindication in older product labeling, but current evidence supports cautious use with appropriate products 6

Severe Thrombocytopenia or Coagulation Disorders

• For intramuscular immunoglobulin preparations only, severe thrombocytopenia or any coagulation disorder that would contraindicate IM injections should prompt use of IV formulations instead 2
• This does not apply to IVIG, which is administered intravenously 2

High-Risk Situations Requiring Precautions (Not Contraindications)

Renal Dysfunction Risk Factors

• Pre-existing renal insufficiency increases risk of acute renal failure, which typically occurs in insufficiently hydrated patients receiving sucrose-stabilized products due to osmotic injury 7
• Ensure adequate hydration and use slow infusion rates to prevent renal complications 7

Thromboembolic Risk Factors

• Advanced age, previous thromboembolic events, immobilization, diabetes mellitus, hypertension, dyslipidemia, or conditions requiring high-dose IVIG at rapid infusion rates increase thrombotic risk due to hyperviscosity 7
• Use slow infusion rates and maintain good hydration to minimize thromboembolic complications 7

Special Clinical Scenarios

First-Time or Long-Interval Administration

• Initial infusions to immunodeficient patients who have not been treated during the previous 8 weeks or never treated should proceed with extreme caution, as these patients are at risk of potentially serious complement-mediated adverse reactions 6

Pregnancy and Pediatrics

• IVIG has been safely used to treat conditions during pregnancy and in children, with no specific contraindications in these populations 1

Common Pitfalls to Avoid

• Do not automatically exclude patients with IgA deficiency from IVIG therapy—assess for anti-IgA antibodies and consider IgA-depleted products 1, 5
• Do not confuse relative contraindications with absolute contraindications—most "contraindications" are actually risk factors requiring slower infusion rates and monitoring 7, 3
• Do not administer rapid infusions in high-risk patients without appropriate precautions, as most serious adverse events are rate-related and preventable 7, 3