Human immunoglobulin-G (IgG) is indicated for:

• Treatment of primary immunodeficiency
• Use in combination with antibiotics in severe bacterial or viral infections
• A-/Hypogammaglobulinemia
• Idiopathic Thrombocytopenic Purpura (ITP)
• Guillain-Barré Syndrome
• Kawasaki Syndrome

This is a ready-to-use, sterile liquid preparation that is clear or slightly opalescent, and colorless to pale yellow in appearance. It contains purified human immunoglobulin-G (IgG) derived from pooled human plasma. The purification process involves thawing, cold ethanol fractionation, chromatography, virus inactivation using solvent/detergent (S/D) treatment, as well as nano-filtration and dia-filtration. The final product is stabilized with maltose and passed through a sterile filter before being filled into vials.

Neonates and infants: 5 mL (250 mg)/kg body weight daily for 3 consecutive days. Additional infusions may be required depending on the clinical condition.

Children and adults:

• For combined therapy with antibiotics in severe bacterial or viral infections and A-/Hypogammaglobulinemia: The usual dose is 2500–5000 mg for adults and 50–150 mg/kg for children as a single dose, administered by intravenous infusion. If given by IV injection, it should be administered slowly.
• For Idiopathic Thrombocytopenic Purpura (ITP): 200–400 mg/kg daily for 5 consecutive days. If no adequate response occurs, further doses should be discontinued.

For Guillain-Barré Syndrome: 400 mg/kg daily for 5 consecutive days.

For Kawasaki Syndrome: 400 mg/kg daily for 5 consecutive days (approximately) or a single dose of 2000 mg/kg by IV infusion. Treatment should ideally begin within 7 days of onset.

Administration: Human normal immunoglobulin is for intravenous use only. It should be administered slowly. The solution should be brought to room or body temperature before use. Recommended infusion rates:

• 0.01–0.02 mL/kg/min for the first 30 minutes
• Gradually increase up to a maximum of 0.06 mL/kg/min if tolerated

This corresponds approximately to 0.6–1.2 mL/kg/hour initially and up to 3.6 mL/kg/hour maximum.

General precautions:

• For intravenous use only
• Insert the needle vertically and carefully
• Discard if rubber fragments are seen
• Inspect visually before use; do not use if cloudy or discolored
• Large doses may be pooled using aseptic technique
• Do not mix with other IV fluids or medications
• Monitor for thrombosis risk
• Consider additional dosing in Kawasaki Syndrome if needed
• Be aware of reduced vaccine effectiveness after use
• Delay live vaccines (e.g., measles, mumps, rubella, varicella) for at least 3 months
• After high-dose therapy (e.g., ITP, Kawasaki), delay vaccination up to 6 months (or 11 months for measles if low risk)

There is a possibility that live vaccines (such as measles, mumps, rubella, and varicella vaccines) may be less effective in patients who have received human normal immunoglobulin. Therefore, vaccination should be postponed for at least 3 months after administration. If immunoglobulin is given within 14 days after vaccination, revaccination should be considered after more than 3 months.

Following high-dose administration (more than 200 mg/kg), such as in ITP and Kawasaki disease, live vaccines should be delayed for more than 6 months. In cases where the risk of measles infection is low, measles vaccination may be postponed for more than 11 months.

Human normal immunoglobulin may reduce the effectiveness of live vaccines such as measles, mumps, rubella, and varicella. Therefore, these vaccines should be administered either at least 3 weeks before or at least 3 months after immunoglobulin administration.

Contraindicated in patients with a history of anaphylaxis or severe systemic hypersensitivity reactions following administration of human normal immunoglobulin.

• Symptoms of shock may occur. If dyspnea, wheezing, chest pain, hypotension, or weak pulse are observed, discontinue administration and consider giving 0.1–0.5 mL epinephrine (1:1000) or corticosteroids.
• Rapid infusion may lead to hypotension.
• Liver function abnormalities, including jaundice and elevated ALT or AST levels, may occur; appropriate caution and treatment are required.
• Renal impairment may develop with human normal immunoglobulin. If signs such as dehydration, reduced urine output, or increased creatinine/BUN are noted, stop treatment and manage accordingly.
• Aseptic meningitis may occur, particularly after high-dose IVIG administration.
• Platelet count may decrease. Other possible adverse effects include drowsiness, chills, chest pain, abdominal discomfort, gluteal pain, and anxiety.

The safety of human normal immunoglobulin in pregnancy has not been fully established. There is a potential risk of transmission of infections such as parvovirus B19. In cases of maternal infection, fetal complications such as abortion, hydrops fetalis, or fetal death may occur. Therefore, it should be administered during pregnancy only if the expected benefit outweighs the potential risk. The safety of use in breastfeeding mothers has not been established.

Human normal immunoglobulin, derived from human plasma, carries a potential risk of transmitting infectious agents such as hepatitis viruses or other pathogens. Patients, especially those with hemophilia or immunodeficiency, should be appropriately vaccinated (e.g., hepatitis vaccines) and monitored for any signs of infection.

Thrombosis may occur irrespective of the route of administration, particularly in patients with risk factors such as advanced age, immobilization, hypercoagulable states, history of arterial or venous thrombosis, use of estrogen, indwelling central venous catheters, hyperviscosity, or cardiovascular risk factors. In such cases, the lowest effective dose and infusion rate should be used.

Severe hypersensitivity and anaphylactic reactions, including a sudden drop in blood pressure, may occur. Patients with IgA deficiency and anti-IgA antibodies are at increased risk of such reactions.

Patients with renal impairment (including acute renal failure), especially those with risk factors such as pre-existing renal disease, diabetes, age >65 years, hypovolemia, sepsis, paraproteinemia, or concomitant use of nephrotoxic drugs, should receive IVIG cautiously at the lowest effective dose and infusion rate.

Patients with hemolytic anemia or at risk of hemolysis (e.g., blood groups A, B, or AB) should be monitored, as IVIG may induce hemolysis, particularly at high doses.

Patients with cardiovascular or cerebrovascular disorders should be carefully monitored, as thromboembolic events (e.g., stroke, myocardial infarction, deep vein thrombosis, pulmonary embolism) may occur due to increased blood viscosity.

Aseptic Meningitis Syndrome (AMS) has been reported following high-dose or rapid IVIG infusion. Symptoms (e.g., severe headache, neck stiffness, photophobia, nausea, vomiting) usually appear within hours to days and resolve after discontinuation.

Patients should be informed of possible symptoms such as headache, nausea, dizziness, fever, drowsiness, and photophobia, and advised to seek medical attention if severe symptoms occur.

Patients with known IgA deficiency should take caution, as anaphylaxis may occur in those with anti-IgA antibodies.

IVIG may interfere with blood group antibody testing and may cause hemolysis or a positive direct antiglobulin (Coombs’) test.

Non-cardiogenic pulmonary edema (TRALI) has been reported following IVIG administration, presenting with respiratory distress, pulmonary edema, hypoxemia, fever, and occurring typically within 1–6 hours after infusion.

Vaccines, Anti-sera & Immunoglobulin

Store and transport the product at 2°C to 8°C. Protect from light and do not freeze. Keep out of the reach and sight of children.