Intravenous immune globulin (IVIG) is made of antibodies that have been extracted from blood donations from 3,000-10,000 healthy donors. IVIG is used to treat many autoimmune disorders, idiopathic diseases (disease of unknown cause), and infections.
Immunoglobulins (Ig) are glycoprotein molecules that function as antibodies. During an immune response, these antibodies, which are present in the bloodstream, detect and bind to antigens (foreign substances that are capable of inducing immune responses). Examples of antigens include bacteria, viruses, mold spores, dust mites, animal dander, and fungi. Once the antibodies attach to the antigen, white blood cells are stimulated to destroy the antigen. Since antibodies are present in the bloodstream, they are considered part of the humoral immune system.
Immune globulin products from human plasma were first used in 1952 to treat immunoglobulin deficiencies (like IgG deficiency). Initially, treatment was administered intramuscularly (injected into the muscle). Intravenous (injected into the vein) immune globulin was shown to be effective in autoimmune idiopathic thrombocytopenic purpura (ITP) in 1981. This method is generally preferred over intramuscular injections because it has shown to be more effective.
By providing antibodies to patients who have weakened immune systems, IGIV can help reduce the risk of infection. Treatment may help prevent patients with Kawasaki disease from developing coronary artery aneurysms (weakened of the main artery in the heart). IGIV may also help increase the number of platelets in patients who have idiopathic thrombocytopenia purpura (ITP).
The U.S. Food and Drug Administration (FDA) has approved immunoglobulin products for the treatment of primary immunodeficiencies, immune-mediated thrombocytopenia, Kawasaki disease, hematopoietic stem cell transplantation (in patients older than 20 years), chronic B-cell lymphocytic leukemia, and HIV in children.
Immune globulin products contain sterile, purified immunoglobulin G (IgG). The products typically contain more than 95% unmodified IgG and only trace amounts of immunoglobulin A (IgA) or immunoglobulin M (IgM). IgG antibodies are the smallest, but most abundant antibodies in the body, making up 75-80% of all the antibodies in the body. They are present in all body fluids. The IgG antibodies are considered the most important antibodies for fighting against bacterial and viral infections, and they are the only antibodies that can cross the placenta during pregnancy. IgA antibodies are primarily found in the nose, airway passages, digestive tract, ears, eyes, saliva, tears and vagina. These antibodies protect body surfaces that are frequently exposed to foreign organisms and substances from outside of the body. IgM antibodies present in the blood and lymph fluids, and they are the first antibodies that are produced in response to an infection.
Side effects from IVIG occur in less than five percent of patients, according to researchers. Common side effects typically occur immediately after infusions and may include flushing (reddening of the cheeks), headache, chills, dizziness, increased sweating, leg cramps, pain and tenderness at the injection site, tiredness, muscle pain, lower back pain, nausea, and low blood pressure.
Since IVIG is pooled from thousands of blood donors, it is theoretically possible that viruses or bacteria could be transmitted in the product. However, since 1985, all products are tested for HIV and hepatitis and the risk of contracting the virus is extremely low.
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General: Immune globulin products have been used to treat many autoimmune disorders, idiopathic (unknown cause) diseases, and infections. The beneficial effects of IVIG for the prevention infections in patients with primary immunodeficiency syndromes (disorders caused by intrinsic or genetic defects in the immune system) are well established. IVIG has also shown to prevent severe lower respiratory tract infections, but not upper respiratory tract and non-respiratory infections in patients with common variable immune deficiency (CVID). Researchers found that CVID patients with such infections respond better to surgery and medications.
IVIG is typically administered intravenously for about two to four hours a day for two to seven days. The patient usually receives another single dose every 10-21 days or every three to four weeks, depending on the type and severity of the condition. Patients typically start responding to treatment after about eight days. Continual treatment helps the patient maintain healthy levels of antibodies in the blood, which boosts their immune systems.
FDA-approved uses: The U.S. Food and Drug Administration (FDA) has approved IVIG for the treatment of primary immunodeficiencies, immune-mediated thrombocytopenia, Kawasaki disease, hematopoietic stem cell transplantation (in patients older than 20 years), chronic B-cell lymphocytic leukemia, and pediatric HIV type I infection. Patients who have these disorders have decreased levels of antibodies.
Other uses: IVIG has been used to treat many other conditions, including aplastic anemia, pure red cell aplasia, diamond-Blackfan anemia, autoimmune hemolytic anemia (immune system attacks red blood cells), hemolytic disease (destruction of red blood cells) of the newborn, acquired factor VIII inhibitors, acquired von Willebrand disease, immune-mediated neutropenia (low levels of neutrophils, which are white blood cells), refractoriness to platelet transfusion, neonatal alloimmune/autoimmune thrombocytopenia, post-transfusion purpura, thrombotic thrombocytopenia purpura/hemolytic uremic syndrome, epilepsy (seizure disorder), pediatric intractable Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, myasthenia gravis, Lambert-Eaton myasthenic syndrome, multifocal motor neuropathy, multiple sclerosis (degenerative disease of the brain and spinal cord), rheumatoid arthritis (adult and juvenile), systemic lupus erythematosus (autoimmune disorder that causes chronic inflammation), systemic vasculitides, dermatomyositis, polymyositis, inclusion-body myositis, Wegener granulomatosis, adrenoleukodystrophy, amyotrophic lateral sclerosis, weakened heart muscle, chronic fatigue syndrome, congential heart block, cystic fibrosis (inherited disease causing the body to produce too much mucus), autoimmune blistering dermatoses, diabetes mellitus, acute idiopathic dysautonomia, acute disseminated encephalomyelitis, endotoxemia, hemolytic transfusion reaction, hemophagocytic syndrome, acute lymphoblastic leukemia, lower motor neuron syndrome, multiple myeloma (type of cancer), human T-cell lymphotrophic virus-1-associated myelopathy, nephritic syndrome, membranous nephropathy, euthyroid ophthalmopathy, opsoclonus-myoclonus, recurrent ear infections, paraneoplastic cerebellar degeneration, paraproteinemic neuropathy (abnormal functioning of the nerves), parvovirus infection (general), POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, progressive lumbosacral plexopathy, lyme radiculoneuritis, Rasmussen syndrome, Reiter syndrome, acute renal failure, thrombocytopenia (nonimmune), streptococcal toxic shock syndrome, veitis, Vogt-Koyanagi-Harada syndrome, solid organ transplantation, surgery, trauma, burns, and asthma.
Intravenous immunoglobulin (IVIG) consists of the antibodies extracted from pooled blood donations from 3,000-10,000 healthy donors. In some instances, blood from as many as 100,000 donors is used.
Immune globulin products contain sterile, purified immunoglobulin G (IgG). The products typically contain more than 95% IgG. Most preparations contain trace amounts of IgA, which may sensitize an IgA-deficient patient during long-term treatment. Patients who suffer from severe, recurrent viral or bacterial respiratory tract infections or have isolated IgA deficiency (and additional IgG2 and IgG4 deficiency) may develop severe anaphylactic reactions after IVIG treatment, which may be life threatening. Therefore, these patients should receive the first infusion in the hospital under medical supervision.
Immune globulin products also contain small amounts of cytokines, CD4 cells, CD8 cells, and human leukocyte antigens (HLA). Cytokines are produced by immune cells to stimulate the immune response. CD4 cells detect antigens in the body. CD8 cells detect and destroy body cells that are infected with a bacteria, virus or fungi. HLA molecules help the body's immune system distinguish between self and non-self (foreign or invading) substances.
IVIG is available in different concentration (strengths). The U.S. Food and Drug Administration (FDA) has approved Gammagard S/D®, Gammar-P IV®, Gamimune-N®, Iveegam®, Polygam® S/D, Sandoglobulin® Venoglobulin-I®, Venoglobulin-S®, Carimune/Panglobulin®, Gamunex®, and Baxter AG®.
monitoring ivig use
Patients receiving intravenous immune globulin (IVIG) therapy should be closely monitored. During a physical examination, healthcare providers should obtain a complete medical history, including whether a patient has ever had liver or kidney disease or reactions to blood products or transfusions.
Kidney function tests should be performed because there have been reports of kidney failure associated with IVIG.
A complete blood count (CBC) should be conducted because patients who receive IVIG have a risk of developing hyperproteinemia (high levels of protein in the blood), increased serum viscosity and pseudohyponatremia (low levels of sodium in the blood), thrombosis (blood clots deep in the legs), transient serum sickness, transient neutropenia, or severe cutaneous vasculitis.
Patients should be tested for hepatitis because there have been reports of hepatitis transmission through IVIG.
Immunoglobulin levels should be tested to make sure the patient does not have IgA deficiency. Individuals who are IgA deficient should not receive IVIG because they may experience a severe allergic reaction called anaphylaxis.
Rheumatoid and cryoglobulin levels should be tested because IVIG may cause blood disorders.
General: Since intravenous immune globulin (IVIG) is pooled from thousands of blood donors, it is theoretically possible that viruses or bacteria could be transmitted in the product. However, since 1985, all products are tested for HIV and hepatitis.
Side effects from IVIG occur in less than five percent of patients, according to researchers. Common side effects typically occur immediately after infusions, and may include flushing (reddening of the cheeks), headache, chills, dizziness, increased sweating, leg cramps, pain and tenderness at the injection site, tiredness, muscle pain, lower back pain, nausea, and low blood pressure.
If side effects occur during treatment, the infusion should be slowed or stopped to alleviate symptoms. If symptoms are anticipated, the patient may take antihistamines and/or intravenous hydrocortisone to prevent a reaction.
Anaphylaxis: IVIG can induce serious anaphylactic reaction in patients who have immunoglobulin A (IgA) deficiency. This happens in about one out of 500 to 1,000 patients. Anaphylaxis is a rapid, allergic reaction that affects the whole body. Anaphylaxis typically occurs immediately after treatment and is associated with sensitization to IgA in patients with IgA deficiency. Symptoms of anaphylaxis can vary from mild to severe and may be potentially life threatening. The most dangerous symptoms are low blood pressure, breathing difficulties, shock, and loss of consciousness, all of which can be fatal. Using IgA-depleted immune globulin may help prevent this reaction from occurring. The presence of IgG anti-IgA antibodies is not always associated with severe adverse reactions to IVIG.
Aseptic meningitis: There have been rare reports of aseptic meningitis after IVIG infusions. Patients should tell their healthcare providers if they experience fever, neck stiffness, headache, confusion, nausea, or vomiting.
Cardiovascular: There have been rare reports of heart attacks after IVIG. A common side effect of IVIG is low blood pressure.
Kidney failure: There have been reports of kidney failure after IVIG infusions, although it is uncommon. From June 1985 through November 1998, the U.S. Food and Drug Administration (FDA) received 88 reports of kidney damage related to IVIG in the United States. Acute kidney failure associated with IVIG therapy occurs with the sucrose-stabilized formulation, but not with the D-sorbitol-stabilized formulation. Patients who experience decreased urination, sudden weight gain, swelling of the legs or ankles, or shortness of breath should consult their healthcare providers immediately because these may be signs of kidney failure. Patients should tell their healthcare providers if they have kidney diseases because they may have an increased risk of developing kidney failure.
Liver disease: Hepatitis C has been transmitted to patients via IVIG.
Skin infection: Life-threatening human parvovirus B19 infections have been transmitted via IVIG.
Other: Other side effects may include post-infusion hyperproteinemia (high levels of protein in the blood), increased serum viscosity and pseudohyponatremia (low levels of sodium in the blood), thrombosis (blood clots deep in the legs), transient serum sickness, transient neutropenia, severe cutaneous vasculitis, dermatitis (such as eczema), and hair loss.
Patients should tell their healthcare providers if they are taking any drugs (prescription or over-the-counter), herbs, or supplements because they may interact with treatment.
Since intravenous immune globulin (IVIG) may cause kidney failure, it is especially important for patients to tell their healthcare providers if they are 65 years old or older or if they have ever had kidney disease, diabetes, sepsis, plasma cell disease ,or volume depletion. Patients should also tell their doctors if they are taking amikacin (Amikin®), gentamicin (Jenamicin®), streptomycin, or other drugs that can cause kidney damage. Patients who experience decreased urination, swelling of the legs or ankles, sudden weight gain, or shortness of breath should consult their healthcare providers immediately because these are common symptoms of kidney failure.
Patients should tell their healthcare providers if they are allergic to any drugs.
Patients who are pregnant, plan to become pregnant, or are breastfeeding should consult their healthcare providers before undergoing IVIG therapy.
Patients should tell their healthcare providers if they have had received any live vaccines (vaccines that contain live viruses), such as measles, mumps, and rubella (MMR), in the last three months. These vaccines may be ineffective if IVIG is administered during this time.