Product Information
ImmunoRel 5% Injection is a sterile, preservative-free solution of human normal immunoglobulin G (IgG) derived from pooled human plasma. It contains a broad spectrum of antibodies against various pathogens, reflecting the donor population’s antibody repertoire. The preparation undergoes rigorous purification processes, including solvent-detergent treatment and chromatographic purification, to ensure safety and efficacy.
Administered intravenously, ImmunoRel provides immediate antibody levels, offering passive immunity to individuals with compromised immune systems or specific autoimmune conditions. Its applications range from replacement therapy in primary immunodeficiency disorders to immunomodulatory therapy in autoimmune diseases.
Indications
ImmunoRel 5% Injection is indicated for:
- Primary Immunodeficiency (PID): Replacement therapy in conditions such as congenital agammaglobulinemia, severe combined immunodeficiency syndromes (SCIDS), common variable immunodeficiency, X-linked immunodeficiency, and Wiskott-Aldrich syndrome.
- Idiopathic Thrombocytopenic Purpura (ITP): To increase platelet counts in patients with ITP, reducing the risk of bleeding.
- Kawasaki Disease: To prevent coronary artery aneurysms in combination with aspirin.
- B-cell Chronic Lymphocytic Leukemia (CLL): To prevent bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections.
- Pediatric HIV-1 Infection: To prevent serious infections in immunoglobulin-deficient children.
- Hematopoietic Stem Cell Transplantation (HSCT): To provide immunological support in transplant recipients.
Composition
Each 100 mL vial contains:
- Active Ingredient: 5 g of Human Normal Immunoglobulin (5% w/v).
- Stabilizer: Maltose (100 mg/mL).
- IgG Purity: ≥95%.
- IgA Content: ≤0.08 mg/mL.
Dosage and Administration
- Primary Immunodeficiency (PID):
- Initial Dose: 0.4–0.8 g/kg body weight.
- Maintenance Dose: 0.2–0.8 g/kg every 2–4 weeks to maintain IgG trough levels of at least 4–6 g/L.
- Idiopathic Thrombocytopenic Purpura (ITP):
- Adults and Children: 0.8–1 g/kg on Day 1; may repeat once within 3 days if necessary.
- Kawasaki Disease:
- 2 g/kg as a single dose in combination with aspirin.
- B-cell Chronic Lymphocytic Leukemia (CLL):
- 0.4 g/kg every 3–4 weeks to maintain adequate IgG levels.
- Pediatric HIV-1 Infection:
- 0.2–0.4 g/kg every 3–4 weeks.
- Hematopoietic Stem Cell Transplantation (HSCT):
- 0.5 g/kg every week from Day –7 to Day +90 post-transplant.
Note: Dosage may vary based on individual patient needs and clinical response. Administration should be under the supervision of a healthcare professional experienced in IVIG therapy.
Precautions
- Hypersensitivity: Contraindicated in patients with known hypersensitivity to human immunoglobulin or any component of the formulation.
- Renal Dysfunction: Use with caution in patients with pre-existing renal impairment; monitor renal function during therapy.
- Thromboembolic Events: Monitor for signs of thrombosis, especially in patients with risk factors.
- Aseptic Meningitis Syndrome (AMS): Be vigilant for symptoms such as severe headache, neck stiffness, and fever.
- Hemolysis: Monitor for signs of hemolysis, particularly in patients with blood group A, B, or AB.
- Transfusion-Related Acute Lung Injury (TRALI): Observe for respiratory distress and non-cardiogenic pulmonary edema.
- Vaccinations: May interfere with the efficacy of live attenuated virus vaccines; consult vaccination guidelines.
- Pregnancy and Lactation: Use during pregnancy only if clearly needed. Caution is advised when administered to nursing mothers.
Storage
- Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
- Do not freeze.
- Keep the vial in the outer carton to protect from light.
Note
- Administration: Inspect the solution visually for particulate matter and discoloration prior to administration. Do not use if the solution is turbid or contains particles.
- Monitoring: Regular monitoring of renal function, urine output, and serum creatinine is recommended, especially in patients at risk of renal impairment.
- Adverse Reactions: Common side effects include headache, nausea, chills, fatigue, fever, and back pain. Serious adverse reactions may include hypersensitivity reactions, renal dysfunction, thromboembolic events, and hemolysis.
