What baseline assessments and ongoing monitoring (vital signs, laboratory tests, infusion rates, and adverse‑effect surveillance) are required for a patient receiving intravenous immunoglobulin (IVIG) therapy?

IVIG Monitoring Requirements

Patients receiving IVIG therapy require baseline assessment of renal function, complete blood count, liver enzymes, and IgA levels, followed by ongoing monitoring of vital signs during infusion, laboratory parameters every 6-12 months once stable, and vigilant surveillance for thromboembolic and renal complications, particularly in high-risk patients. 1, 2, 3

Baseline Assessments Before IVIG Initiation

Laboratory Testing

• Serum IgA levels must be checked before first IVIG administration due to rare but serious anaphylaxis risk in IgA-deficient patients 3
• Complete blood count with differential 4, 1
• Comprehensive metabolic panel including renal function (BUN, creatinine) and liver function tests (ALT, AST, alkaline phosphatase, total bilirubin) 4, 5
• Baseline IgG trough level (for immunodeficiency indications) 1, 2

Risk Factor Assessment

• Identify high-risk patients for thromboembolism: advanced age, previous thromboembolic events, immobilization, diabetes mellitus, hypertension, dyslipidemia 6, 7, 8
• Identify high-risk patients for renal failure: pre-existing renal disease, dehydration, diabetes mellitus, advanced age, hypertension, concurrent nephrotoxic medications 7
• History of cardiovascular disease 8

Infusion Monitoring

Vital Signs During Administration

• Monitor continuously during infusion and for at least 1 hour post-infusion for immediate adverse reactions 6, 7
• Blood pressure and heart rate monitoring for hypotension, hypertension, or tachycardia 6, 7
• Temperature monitoring for fever or chills 6, 7
• Respiratory rate and oxygen saturation for dyspnea 7

Infusion Rate Management

• Start with slow infusion rate, particularly in high-risk patients, to prevent renal failure, thromboembolic events, and aseptic meningitis 6, 7
• Use low concentration preparations when possible 7
• Ensure adequate hydration before and during infusion, especially in patients at risk for renal complications 6, 7

Ongoing Laboratory Monitoring

Frequency for Stable Patients

• IgG trough levels every 6-12 months once stable dosing is established (for immunodeficiency indications) 1, 2, 3
• Complete blood count and serum chemistry every 6-12 months 1, 2
• Monitor for leucocyte, erythrocyte, hematocrit, and hemoglobin changes 5

Frequency During Treatment Initiation or Adjustment

• IgG trough levels every 2 weeks during first 8 weeks if treatment-naïve or transitioning from another immunoglobulin product 2
• More frequent monitoring may be needed during dose adjustments 1

Liver Function Monitoring

• Liver enzymes (ALT, AST) should be monitored routinely as elevation may occur and can be preparation-dependent 5
• Monitor at baseline, during treatment initiation, and periodically thereafter 4, 5

Renal Function Monitoring

• Urine output and kidney function should be supervised, particularly in high-risk patients 7
• Monitor BUN and creatinine regularly, especially with sucrose-containing products 7

Adverse Event Surveillance

Immediate Reactions (During or Shortly After Infusion)

• Headache (most common, occurring in 30% of treatment courses) 6, 5
• Flushing, malaise, chest tightness 6, 7
• Fever, chills, myalgia, fatigue 6, 7
• Back pain, nausea, vomiting, diarrhea 6, 7
• Anaphylactic reactions, especially in IgA-deficient patients 7

Serious Late Complications (Within Days to Weeks)

• Thromboembolic events (arterial or venous): deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke—can occur during infusion or 1-8 days post-infusion 8, 5
• Acute renal failure: usually oliguric and transient, more common with sucrose-stabilized products 6, 7
• Aseptic meningitis 7, 9
• Hemolytic anemia, neutropenia 7

Monitoring Timeline for Thrombotic Complications

• Close monitoring required during entire infusion period and for at least 8 days post-infusion, as thrombotic manifestations can occur even in patients who previously tolerated multiple infusions without complications 8
• Thrombotic complications occurred during infusion in 50% of cases in one series, with remainder occurring 1-8 days post-infusion 8

Clinical Response Monitoring

For Immunodeficiency Indications

• Assess infection frequency and severity regularly—this is the primary endpoint, not achieving a specific trough IgG level 1, 2
• Document quality of life improvements 1
• Maintain antibiotics available at home for prompt treatment of breakthrough infections 1, 2

For Autoimmune/Neurological Indications

• Monitor disease-specific clinical parameters based on underlying condition 4, 3
• Assess for signs of disease progression or relapse 4

Critical Pitfalls to Avoid

• Never administer IVIG rapidly or without adequate hydration in high-risk patients—this significantly increases risk of renal failure and thromboembolism 6, 7
• Do not assume safety based on previous uneventful infusions—thrombotic complications can occur in patients who previously tolerated multiple infusions 8
• Avoid sucrose-containing products in patients with renal risk factors due to osmotic injury risk 6, 7
• Do not overlook IgA deficiency screening before first dose—failure to check can result in life-threatening anaphylaxis 3
• Recognize pseudohyponatremia following IVIG to avoid inappropriate interventions 7