immune globulin IV (IGIV)

Action and Spectrum

Actions and Spectrum:

Immune globulin intravenous (IVIG) is a preparation of antibodies derived from human blood plasma that is used to enhance or supplement the immune system. IVIG contains a wide spectrum of antibodies that can help fight off infections and modulate the immune response. Here are some of the actions and the spectrum of immune globulin IV:

• Immunomodulation: IVIG can modulate the immune system by affecting various components of the immune response. It can regulate the production and function of cytokines, chemokines, and other immune mediators, thereby helping to restore immune balance.
• Antibody replacement: IVIG is used to provide passive immunity by supplementing deficient or absent antibodies in individuals with primary immunodeficiency disorders. It contains a diverse range of antibodies, including IgG subclasses, which can help prevent infections caused by specific pathogens.
• Neutralization of toxins: IVIG contains antibodies that can neutralize certain toxins produced by bacteria and other microorganisms. These antibodies bind to the toxins and prevent them from exerting their harmful effects on the body.
• Anti-inflammatory effects: IVIG has been shown to have anti-inflammatory properties. It can inhibit the activation of immune cells and modulate the release of pro-inflammatory cytokines, helping to reduce inflammation in various autoimmune and inflammatory conditions.
• Modulation of autoimmune diseases: IVIG can be used in the treatment of several autoimmune diseases, such as immune thrombocytopenic purpura (ITP), Kawasaki disease, and Guillain-Barré syndrome. The exact mechanisms of action are not fully understood, but IVIG is thought to suppress autoantibody production, inhibit complement activation, and modulate immune cell function.
• Immunomodulation in transplantation: IVIG can be used in solid organ transplantation and hematopoietic stem cell transplantation to modulate the immune response and reduce the risk of rejection. It may also have a role in the treatment of graft-versus-host disease (GVHD) by suppressing immune-mediated damage.
• Off-label uses: IVIG is sometimes used off-label for other conditions, such as certain neurological disorders (e.g., chronic inflammatory demyelinating polyneuropathy, myasthenia gravis) and some infections (e.g., viral infections in immunocompromised individuals).

Drug Interaction

Adverse Reaction

Frequency defined

>10%

Fatigue (16.3%)

Headache (45%)

Nausea (13.8%)

Vomiting (11.3%)

Chills (11.3%)

Injection site reaction (13%)

1-10%

Back pain (10%)

Diarrhea (7.5%)

Pain (8.8%)

Cough (6.3%)

Hematocrit decreased (5.3%)

Stomach discomfort (6.3%)

Urticaria (6.5%)

Emesis (1.3%)

Flushing (1%)

Hypertension (1%)

<1%

Chills

Pain in extremity

Rigor

Diarrhea

Dizziness

Migraine

Vomiting

Flu-like symptoms

Leg cramps

Black Box Warning

Black Box Warning:

None

Contraindication / Caution

Contraindication / Caution:

Immune globulin IV (intravenous) is a medication derived from human plasma that contains antibodies to help boost the immune system. While generally considered safe, there are certain contraindications and cautions associated with its use. Here are some contraindications and precautions to be aware of when considering immune globulin IV:

• Hypersensitivity: Immune globulin IV should not be administered to individuals with a known hypersensitivity or severe allergic reaction to human immunoglobulins or any component of the formulation. Allergic reactions can range from mild to severe, including anaphylaxis, and require immediate medical attention.
• IgA deficiency with antibodies against IgA: Immune globulin IV should be used with caution in individuals with selective IgA deficiency or with known antibodies against IgA. These individuals have an increased risk of developing severe hypersensitivity reactions.
• Renal impairment: Patients with pre-existing renal (kidney) impairment may be at an increased risk of developing renal dysfunction or acute kidney injury following immune globulin IV administration. Dose adjustments and careful monitoring of renal function are necessary in such cases.
• Thrombosis or history of thrombosis: Immune globulin IV has been associated with an increased risk of thrombotic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE). This risk is particularly significant in individuals with a history of thrombosis, known risk factors for thrombosis, or those receiving high doses or prolonged treatment. Caution should be exercised, and the benefits and risks of treatment should be carefully evaluated in such cases.
• Hemolysis: Immune globulin IV may cause hemolysis (destruction of red blood cells) in patients with blood type A, B, or AB who have antibodies against the other blood types (e.g., anti-A or anti-B antibodies). Blood type and antibody screening should be performed before administering immune globulin IV to prevent hemolysis.
• Other cautionary measures: Immune globulin IV should be used with caution in patients with pre-existing cardiovascular or pulmonary conditions, a history of diabetes, elderly patients, and patients with volume depletion or at risk of fluid overload.

Pregnancy / Lactation

Pregnancy consideration:

Pregnancy category: N/A

Lactation: Excretion into human milk is unknown

Pregnancy Categories:     

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.

Category N: There is no data available for the drug under this category.

Pharmacology

Pharmacology:

Immune globulin IV (intravenous) refers to a preparation of antibodies derived from pooled human plasma that is administered intravenously. It is commonly used in pharmacology to provide passive immunization or immune support to individuals with compromised immune systems or specific medical conditions.

Pharmacodynamics:

Mechanism of Action: The antibodies present in immune globulin IV provide passive immunity by neutralizing or binding to specific pathogens or toxins in the body. They can also modulate the immune system, regulate inflammation, and interact with various components of the immune response.

Pharmacokinetics:

Absorption:

Since immune globulin IV is administered directly into the bloodstream, absorption is not a relevant factor. The drug is immediately available for distribution throughout the body.

Distribution:

Following administration, immune globulin IV is rapidly distributed throughout the extracellular fluid, including plasma and interstitial spaces. It has a volume of distribution similar to that of plasma. The immunoglobulins in the product can circulate throughout the body, interacting with target antigens and exerting their therapeutic effects.

Metabolism:

Immunoglobulins are large proteins and are not typically metabolized in the same way as small-molecule drugs. Instead, they undergo catabolism in various tissues, including the liver and reticuloendothelial system. The metabolism of immunoglobulins mainly involves breaking down the protein structure into smaller peptides and amino acids for recycling within the body.

Elimination and Excretion:

The elimination of immune globulin IV occurs primarily via catabolism and excretion of the resulting breakdown products. The kidneys play a role in the elimination of smaller protein fragments, such as peptides and amino acids, which are filtered through the glomerulus and excreted in urine. The excretion of intact immunoglobulins through the kidneys is minimal.

Adminstartion

Administration:

Immune globulin IV (intravenous) refers to the administration of immunoglobulins (also known as antibodies) through the intravenous route. Immunoglobulins are proteins that are naturally produced by the immune system to help fight off infections and provide immune protection. When administered intravenously, immune globulin IV is used for various indications, including immune deficiencies, autoimmune disorders, and certain neurological conditions.

Patient Information Leaflet

Patient information leaflet

Generic Name: immune globulin IV (IGIV)

Why do we use immune globulin IV (IGIV)?

Immune globulin IV (IGIV) is used as a treatment for Guillain-Barré syndrome (GBS) due to its immunomodulatory effects. Guillain-Barré syndrome is a rare neurological disorder characterized by the immune system mistakenly attacking the peripheral nerves, leading to muscle weakness, numbness, and in severe cases, paralysis. IGIV therapy is considered a standard treatment option for GBS based on its potential to modify the immune response and alleviate symptoms.

• Immunomodulation: IGIV contains a concentrated mixture of immunoglobulins, including antibodies that can modulate the immune system. The exact mechanism of action is not fully understood, but IGIV is believed to work by several mechanisms. It may suppress the production of harmful autoantibodies that are targeting the peripheral nerves in GBS. IGIV may also interfere with the activation of immune cells and dampen the inflammatory response that contributes to nerve damage in GBS.
• Anti-inflammatory effects: GBS involves inflammation of the peripheral nerves, which contributes to nerve damage and the clinical symptoms. IGIV has anti-inflammatory properties and can help reduce inflammation by inhibiting pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6). By reducing inflammation, IGIV therapy may help protect the peripheral nerves from further damage and promote their recovery.
• Accelerated immune system recovery: GBS is typically a self-limiting condition, and the immune system eventually recovers and repairs the damaged nerves. IGIV therapy is thought to expedite this recovery process by providing a concentrated source of normal immunoglobulins. The exogenous immunoglobulins in IGIV may help compensate for the dysfunctional immune response in GBS, providing a “boost” to the immune system’s ability to repair the damaged nerves.
• Potential modulation of autoantibodies: In some cases of GBS, there is evidence of autoantibodies targeting specific components of peripheral nerves, such as gangliosides. IGIV therapy may help modulate the activity of these autoantibodies, reducing their harmful effects on nerve function.