Immune Globulin

Immune globulin intravenous (IGIV) is used to manage various immunodeficiency states, such as: Primary immunodeficiency to replace missing immunoglobulin Immune thrombocytopenic purpura to increase platelets B-cell chronic lymphocytic leukemia to help prevent certain infections Kawasaki syndrome, to prevent aneurysm caused by a weakening of the main artery in the heart Other autoimmune or immunodeficiency conditions, as immunomodulatory and anti-inflammatory therapy. IGIV is given as a slow infusion into a vein, usually once every 3 to 4 weeks. IVIG is a pooled immunoglobulin concentrate derived from thousands of healthy donors, containing diverse antibodies against infections and self-antigens. Composed mainly of IgG (90 %+), IVIG is prepared using cold ethanol precipitation and works by providing passive immunity by neutralizing pathogens and activating immune cells for broader disease protection. IVIG products differ in their excipients, such as stabilizing agents like sugars (glucose, maltose, D-sorbitol) or amino acids (glycine, proline) that prevent protein aggregation. They also vary in sodium content, pH, osmolality, and immunoglobulin levels (IgA ranges from 0.06-40 mg across preparations). Each product has specific approved therapeutic indications. Intravenous immunoglobulins have been available since the 1980s.

Immune globulin intravenous (IGIV) is used to manage various immunodeficiency states, such as: Primary immunodeficiency to replace missing immunoglobulin Immune thrombocytopenic purpura to increase platelets B-cell chronic lymphocytic leukemia to help prevent certain infections Kawasaki syndrome, to prevent aneurysm caused by a weakening of the main artery in the heart Other autoimmune or immunodeficiency conditions, as immunomodulatory and anti-inflammatory therapy. IGIV is given as a slow infusion into a vein, usually once every 3 to 4 weeks. IVIG is a pooled immunoglobulin concentrate derived from thousands of healthy donors, containing diverse antibodies against infections and self-antigens. Composed mainly of IgG (90 %+), IVIG is prepared using cold ethanol precipitation and works by providing passive immunity by neutralizing pathogens and activating immune cells for broader disease protection. IVIG products differ in their excipients, such as stabilizing agents like sugars (glucose, maltose, D-sorbitol) or amino acids (glycine, proline) that prevent protein aggregation. They also vary in sodium content, pH, osmolality, and immunoglobulin levels (IgA ranges from 0.06-40 mg across preparations). Each product has specific approved therapeutic indications. Intravenous immunoglobulins have been available since the 1980s.

You may not be able to use this medicine if you: have had an allergic reaction to an immune globulin or blood product; have an immune globulin A (IgA) deficiency with antibodies to IgA; or are allergic to corn. IGIV can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. Tell your doctor if you: have heart problems, blood circulation problems, or "thick blood" have a stroke or a blood clot have kidney disease have diabetes have an infection called sepsis use estrogens (birth control pills or hormone replacement therapy) have been on long-term bed rest have a central intravenous (IV) catheter in place are pregnant or intend to become pregnant are breastfeeding.

The most common side effects of intravenous immune globulins are: headache fatigue/tiredness infusion site reactions (pain, swelling, burning, or irritation where the IV needle was inserted) nausea sinusitis (stuffy nose, sinus pain) increased blood pressure diarrhea dizziness lack of energy. Other reported side effects include: back pain, joint pain fever, chills, sweating, warmth, or tingling stomach pain fast heartbeats.

Immune globulin products contain a boxed warning for thrombosis, renal dysfunction, and acute renal failure. Thrombosis (blood clots). IVIG products can cause blood clots. The risk is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place. Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg. Renal (kidney) damage . IVIG products can also harm your kidneys, especially if you have kidney disease or you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination. Intravenous immune globulins may also cause the following serious side effects: Hypersensitivity reactions . Do not use IVIG in people with a history of anaphylactic or severe systemic reactions to human immunoglobulin or in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Aseptic meningitis syndrome (inflammation of the lining of the brain) may occur rarely with infrequently with IGIV treatments. It usually begins within several hours to 2 days following IGIV treatment. Call your healthcare provider at once if you develop a severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, or vomiting. Hemolysis (a breakdown in red blood cells) and delayed hemolytic anemia can develop following IGIV therapy. Call your healthcare provider at once if you develop fatigue, increased heart rate, yellowing of skin or eyes, or dark-colored urine. Fluid in the lungs (noncardiogenic pulmonary edema) related to the infusion (transfusion-related acute lung injury [TRALI]) has been reported following IVIG infusions, typically within 1 to 6 hours of treatment. Tell your doctor immediately if you have difficulty breathing, chest pain, blue lips or extremities, or develop a fever. Dehydration symptoms . Seek urgent medical attention if you start feeling very thirsty or hot, are unable to urinate, start sweating excessively, or your skin feels hot and dry. Immune globulin is made from donated human plasma and may contain viruses or other infectious agents . Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks. Some side effects may occur during the injection . Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face. This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Immune globulin products contain a boxed warning for thrombosis, renal dysfunction, and acute renal failure. Thrombosis (blood clots). IVIG products can cause blood clots. The risk is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place. Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg. Renal (kidney) damage . IVIG products can also harm your kidneys, especially if you have kidney disease or you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination. Intravenous immune globulins may also cause the following serious side effects: Hypersensitivity reactions . Do not use IVIG in people with a history of anaphylactic or severe systemic reactions to human immunoglobulin or in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Aseptic meningitis syndrome (inflammation of the lining of the brain) may occur rarely with infrequently with IGIV treatments. It usually begins within several hours to 2 days following IGIV treatment. Call your healthcare provider at once if you develop a severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, or vomiting. Hemolysis (a breakdown in red blood cells) and delayed hemolytic anemia can develop following IGIV therapy. Call your healthcare provider at once if you develop fatigue, increased heart rate, yellowing of skin or eyes, or dark-colored urine. Fluid in the lungs (noncardiogenic pulmonary edema) related to the infusion (transfusion-related acute lung injury [TRALI]) has been reported following IVIG infusions, typically within 1 to 6 hours of treatment. Tell your doctor immediately if you have difficulty breathing, chest pain, blue lips or extremities, or develop a fever. Dehydration symptoms . Seek urgent medical attention if you start feeling very thirsty or hot, are unable to urinate, start sweating excessively, or your skin feels hot and dry. Immune globulin is made from donated human plasma and may contain viruses or other infectious agents . Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks. Some side effects may occur during the injection . Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face. This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

200 to 400 mg/kg (300 (300)) As recommended. IV — Once in a Month or As Required

100 to 200 mg (150 (150)) As recommended. IM — Once in a Month or As Required. Under 1 year or less children

4 mg/kg (4 (4)) 24 hourly Intravenous — For 2---5 days

Intravenous immune globulins can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve). IVIG may have a short-term effect on your immune response to live virus vaccines, such as measles, mumps, rubella, and varicella. Talk to your doctor about the best time to be immunized. May also interfere with the results of certain laboratory tests. Other drugs may affect IVIG, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Inj Store in refrigerator. Do not Freeze.