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What are Immunoglobulins?
Immunoglobulins, also known as antibodies, are protein molecules produced by plasma cells that are part of the immune system. There are five main types of immunoglobulins in the human body – IgG, IgA, IgM, IgD, and IgE. Together they help fight off infections and disease. Of these five types, IgG is the most abundant in the blood and extracellular fluid. IgG antibodies are produced in response to specific antigens from viruses, bacteria, and other foreign substances in the body.
What is Human Immunoglobulin (pH4)?
Human Immunoglobulin (pH4) for Intravenous Injection is a ready-to-use, sterile, pyrogen-free, liquid preparation of concentrated human immunoglobulin G (IgG) antibodies. It contains mainly IgG antibodies collected from pooled human plasma from thousands of screened donors. The production process subjects the immunoglobulins to several steps that remove or inactivate potential pathogens like viruses, bacteria, or other contaminants. The formulation is adjusted to a neutral pH of 4.25 using glycine. This makes it safe for intravenous administration and helps minimize the risk of adverse reactions.
Mechanism of Action
After intravenous injection, Human Immunoglobulin (pH4) utilizes the natural ability of IgG antibodies to provide immediate as well as long-lasting humoral immunity against various pathogens. The IgG antibodies present in the formulation bind to specific antigens and tag them for destruction and elimination from the body by recruitment of other players of the immune system. This activation of the immune response can compensate for immunodeficiencies where a patient’s own immune system is unable to produce adequate or appropriate antibodies. It may also help modulate certain autoimmune and inflammatory responses.
Approved Indications
Primary Immunodeficiency Diseases
Human Immunoglobulin (pH4) is frequently prescribed for the treatment of primary immunodeficiency diseases. These include conditions where patients have reduced antibody levels or function due to genetic disorders affecting B-cells, T-cells or other components of the immune system. Some examples include Common Variable Immune Deficiency (CVID), X-linked Agammaglobulinemia (XLA), and Hyper IgM Syndrome. Regular infusions help prevent recurrent bacterial infections by supplementing the antibody deficiency.
Idiopathic Thrombocytopenic Purpura (ITP)
It is also approved for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), a bleeding disorder where the immune system destroys the body’s own platelets. Immunoglobulin suppresses excessive platelet destruction, raising platelet counts and reducing risk of hemorrhage.
Guillain-Barré Syndrome (GBS)
For treatment of acute cellular mediated autoimmune neuropathies like Guillain-Barré Syndrome (GBS), it alters the immune response and balances inflammatory and anti-inflammatory factors to help stop nerve damage and allow for recovery.
Pediatric HIV Infection
Its use has also been found to be beneficial in pediatric HIV infections to decrease mortality and bacterial respiratory infections by enhancing specific antibody responses against common pathogens.
Administration and Dosing
Human Immunoglobulin (pH4) comes in prefilled syringes or vials for single use only. A qualified healthcare professional slowly infuses it intravenously over 1-6 hours depending upon the condition and dose.
The dosing is tailored individually based on the clinical condition, antibody levels, weight and other factors. On average, doses range between 300-600 mg/kg given every 3-4 weeks for primary antibody deficiencies or ITP. For GBS, a total dose of 2g/kg is divided over 5 days. During exposure to certain infectious agents, higher or supplemental doses may be warranted. It is important not to exceed the recommended maximum weekly dose of 800 mg/kg.
Safety and Adverse Effects
When administered correctly as prescribed, Human Immunoglobulin (pH4) is generally well-tolerated with mild and temporary adverse effects in about one-third of patients. Common side effects include headache, nausea, back or muscle pain during or after the infusion. Lower rates of severe potentially life-threatening reactions like anaphylaxis or thrombosis have also been reported.
To minimize risks, patients should be monitored closely during and after infusions. Those with history of prior severe reactions may require premedication with acetaminophen or antihistamines. Other safety measures involve screening donations, uses of validated viral inactivation methods and maintaining the purity, potency and stability of the formulation as per regulatory standards.
Conclusion
In conclusion, Human Immunoglobulin (pH4) for Intravenous Injection provides an important treatment option for a variety of immunodeficiency conditions and acute immune disorders through its mechanism of replacing or modulating adequate antibody levels. When given carefully as directed under medical guidance, it offers safe and effective therapy for managing many such challenging clinical scenarios.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile
