Human Normal Immunoglobulin (10%) is a sterile, highly purified, concentrated solution of immunoglobulin G (IgG) antibodies derived from pooled human plasma of thousands of donors. It contains a broad spectrum of IgG antibodies reflective of the general population's immunity. In the Indian context, it is a critical therapy for primary and secondary immunodeficiencies, autoimmune disorders, and specific infectious diseases, providing passive immunity and immunomodulation.
Adult: **Immunodeficiency:** 300-600 mg/kg every 3-4 weeks, titrated to maintain trough IgG >5-6 g/L. **ITP:** 1 g/kg/day for 1-2 days OR 400 mg/kg/day for 5 days. **GBS/CIDP:** 2 g/kg divided over 2-5 days. **Kawasaki:** 2 g/kg as a single infusion with aspirin.
Note: For IV use only. Must be infused via separate line. Start at a slow rate (e.g., 0.5-1 mg/kg/min) for first 30 min. If tolerated, gradually increase to a maximum of 3-6 mg/kg/min (as per product-specific guidelines). Pre-medication with antipyretics (paracetamol) and antihistamines (hydroxyzine) is common to prevent infusion reactions. Do not mix with other medications. Use immediately after opening.
Mechanism is multifactorial and depends on the indication. For immunodeficiency: Provides passive immunity by supplying a wide range of opsonizing and neutralizing IgG antibodies against bacterial and viral pathogens. For autoimmune/ inflammatory disorders: Exerts immunomodulatory effects via Fc receptor blockade on macrophages and dendritic cells, neutralization of autoantibodies and cytokines, inhibition of complement activation, and modulation of T and B cell function.
Pregnancy: Category C. Should be used only if clearly needed. No well-controlled studies. Immunoglobulins cross the placenta, especially in the third trimester. Used clinically for conditions like ITP in pregnancy. Benefits often outweigh risks.
Driving: May cause dizziness, headache, or fatigue. Patients should be cautioned about driving or operating machinery until they know how the infusion affects them.
| Live Attenuated Vaccines (e.g., MMR, Varicella, Yellow Fever) | IVIg may interfere with the immune response to live vaccines for up to 3-12 months. May reduce vaccine efficacy. | Major |
| Other Immunosuppressants (e.g., high-dose corticosteroids, cyclophosphamide) | Additive immunosuppression, increasing risk of infections. May also have synergistic therapeutic effects in autoimmune conditions. | Moderate |
| Diuretics (e.g., Furosemide) | Concurrent use with IVIg may increase risk of renal dysfunction. Ensure adequate hydration. | Moderate |
| Nephrotoxic drugs (e.g., Aminoglycosides, NSAIDs, Amphotericin B) | Increased risk of acute renal failure. | Major |
Same composition (Human Normal Immunoglobulin (10%)), different brands: