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What are immunoglobulins?
Immunoglobulins, also known as antibodies, are protein molecules produced by plasma cells that help the immune system identify and neutralize foreign objects like bacteria and viruses. The main types of immunoglobulins are IgG, IgA, IgM, IgD, and IgE. IgG is the most common type found in blood and tissues. It plays a key role in protecting against bacterial and viral infections.
What is Human Immunoglobulin (pH4)?
Human Immunoglobulin (pH4) for Intravenous Injection, commonly known as IVIG, is a therapeutic preparation of highly purified immunoglobulin G (IgG) antibodies extracted from pooled human plasma. IVIG contains primarily IgG antibodies found in normal human plasma. It has a neutral pH of about 4.5 to 4.3. IVIG provides patients with a broad spectrum of opsonizing and neutralizing IgG antibodies against infectious agents.
Approved Indications for IVIG Therapy
IVIG has been approved by regulatory agencies for treatment of the following conditions:
– Primary Immunodeficiencies: IVIG treatment helps prevent recurrent bacterial infections in patients with inherited immunodeficiencies like common variable immunodeficiency, X-linked agammaglobulinemia, and severe combined immunodeficiencies.
– Kawasaki Disease: IVIG has been shown to reduce the risk of coronary artery aneurysms in children with Kawasaki disease when given within 10 days of fever onset.
– Idiopathic Thrombocytopenic Purpura: IVIG treatment works to rapidly raise platelet counts in adults and children with ITP, reducing the risk of bleeding.
– Chronic Inflammatory Demyelinating Polyneuropathy: IVIG is used to improve muscle weakness and disability in patients with this autoimmune nerve disorder.
– Multifocal Motor Neuropathy: IVIG helps improve weakness in this rare peripheral nerve condition.
Clinical Trial Evidence of Efficacy
Rigorous clinical trials have demonstrated the safety and efficacy of IVIG in its approved indications:
– A double-blind randomized control trial of 195 children with Kawasaki disease found IVIG plus aspirin significantly reduced coronary artery abnormalities compared to aspirin alone.
– A meta-analysis of 13 randomized control trials in primary immunodeficiencies concluded IVIG was highly effective at reducing infection severity and antibiotic use.
– For ITP, placebo-controlled studies showed IVIG therapy rapidly increased platelet counts within 7 days in over 70% of patients, reducing bleeding risks.
How IVIG Works
IVIG is believed to work through several mechanisms:
– Antibody Replacement: IVIG supplies functional antibodies against bacteria and viruses to help restore normal immunity.
– Anti-Inflammatory Effects: IVIG dampens inflammatory responses through Fc receptor blocking and suppression of cytokines, which helps treat autoimmune conditions.
– Interference with Complement Activation: IVIG inhibits activation of the complement system, which mediates tissue damage in many autoimmune diseases.
– Modulation of B Cells and T Cells: IVIG may modulate the functions of these immune cells involved in autoimmunity and graft rejection.
Manufacturing and Safety of IVIG Products
IVIG products undergo rigorous manufacturing safeguards to minimize risk:
– Source Plasma Screening – Donations are tested with sensitive nucleic acid technology screens for infectious agents.
– Viral Inactivation/Removal – Multiple steps like solvent/detergent treatment and nanofiltration are used to inactivate and remove viruses.
– Purity Assays – Strict criteria ensure recovered IgG is pure with low levels of aggregation or cleavage products.
– Stability Testing – Products undergo real-time and accelerated stability studies to ensure safety and potency over the labeled shelf life.
Large post-marketing surveillance studies involving hundreds of thousands of patients have established the safety profile of IVIG. Adverse reactions are usually mild and manageable. IVIG is considered a very safe and effective therapy when used as indicated.
Overall, IVIG provides a life-changing treatment option for numerous primary immunodeficiency disorders and autoimmune/autoinflammatory conditions with few alternatives. It has made a huge difference in the quality of life for many patients.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile
