Human normal immunoglobulin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Prevention of infections after bone marrow transplantation 500 mg/kg/wk. Increase platelet count in patients w/ idiopathic thrombocytopenic purpura 400 mg/kg/day for 2-5 consecutive days. Kawasaki disease 1.6-2 g/kg in divided doses over 2-5 days. Guillain-Barre syndrome 400 mg/kg/day for 5 consecutive days, repeat 4 wkly if needed. Allogenic bone marrow transplantation 500 mg/kg/wk, starting 7 days before transplantation and for up to 3 mth after transplantation. Primary antibodies deficiency Initial: 400-800 mg/kg, then 200 mg/kg 3 wkly. Maintenance: 200-800 mg/kg/mth. For secondary immunodeficiency syndromes: 200-400 mg/kg 3-4 wkly. IM Hepatits A 500 mg. Measles attack in immunocompromised patients Prevention: 750 mg w/in 6 days after exposure. To modify an attack: 250 mg. Primary rubella in pregnant women 750 mg.
Dosage Details
Intramuscular
Prevent or modify measles attack in immunocompromised patients
Adult: For prevention of an attack: 750 mg as an IM inj; to be given within 6 days after exposure (better efficacy if given within 72 hr). To modify an attack: 250 mg as an IM inj.
Child: For prevention of an attack: <1 yr: 250 mg; 1-2 yr: 500 mg; ≥3 yr: 750 mg, as a single IM inj. Dose should be given within 6 days after exposure (better efficacy if given within 72 hr). To modify an attack: <1 yr: 100 mg and ≥1 yr: 250 mg, as a single IM inj.

Intramuscular
Control outbreaks of hepatitis A, Prophylaxis against hepatitis A in immunocompromised patients
Adult: Recommended dose: 500 mg via deep IM inj.
Child: Recommended dose: <10 yr: 250 mg; ≥10 yr: 500 mg, to be given as deep IM inj.

Intramuscular
Primary rubella in pregnant women whereby pregnancy termination is unacceptable
Adult: 750 mg as an IM inj.

Intravenous
Raise platelet count in patients with idiopathic thrombocytopenic purpura
Adult: 400 mg/kg/day for 2-5 consecutive days. Alternatively, a dose of 800-1000 mg/kg may be given on day 1 and repeated on day 3 if needed. Doses to be given via IV infusion. Treatment may be repeated if relapse occurs.

Intravenous
Guillain-Barre syndrome
Adult: 400 mg/kg daily for 5 consecutive days, may repeat every 4 wk if needed.

Intravenous
Kawasaki disease
Adult: 1.6-2 g/kg in divided doses over 2-5 days, or 2 g/kg given as a single dose. To be used in conjunction with acetylsalicylic acid.

Intravenous
Allogenic bone marrow transplantation
Adult: As part of the conditioning regimen and after transplantation: 500 mg/kg/wk, starting 7 days before transplantation and for up to 3 mth after transplantation. In cases of persistent lack of antibody production, 500 mg/kg/mth may be used to normalise the antibody level.

Intravenous
Prophylaxis of infections after bone marrow transplantation
Adult: 500 mg/kg/wk, adjust dose according to response.

Parenteral
Immunocompromised patients or patients with primary antibodies deficiency
Adult: IV admin: Initially, 400-800 mg/kg, then 200 mg/kg every 3 wk, adjust according to trough-immunoglobulin levels; maintenance dose: 200-800 mg/kg/mth. In patients with secondary immunodeficiency syndromes: 200-400 mg/kg every 3-4 wk may be used. Alternatively, dose may be given via SC admin: Initial loading dose of 200-500 mg/kg (divided over several days), followed by maintenance doses at repeated intervals to achieve a cumulative mthly dose of 400-800 mg/kg.
Contraindications
Patients with selective immunoglobulin A deficiency. Prior anaphylactic reactions to immunoglobulin, blood or other blood-derived preparations.
Special Precautions
Increased risk of acute renal failure in patients with renal impairment, DM, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or >65 yr. High infusion rate may increased risk of adverse reactions. Ensure adequate hydration prior to IV infusion of immunoglobulin. Monitor urine output and serum creatinine levels during treatment. Avoid concurrent use of loop diuretics during IV infusion of immunoglobulin. Live vaccines should generally be given 3 wk before or 3 mth after admin of normal immunoglobulin. Different formulations and brands of human normal immunoglobulins may not be equivalent, thus individual literature should be consulted. Pregnancy and lactation.
Adverse Reactions
Dizziness, light-headedness, nausea, vomiting, allergic and cutaneous reactions. Local pain and tenderness at the site of inj. IV admin may lead to systemic effects such as headache, chills and fever.
IV/Parenteral: C
Drug Interactions
May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.
Lab Interference
May affect Coomb's test results used in haematologic studies or transfusion cross-matching procedures. IV immunoglobulin preparations containing maltose may falsely elevate blood glucose tests that use nonspecific methods based on glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye oxidoreductase.
Action
Description: Human normal immunoglobulin is derived from donations of pooled human plasma. It contains antibodies, mainly immunoglobulin G (IgG), to various bacteria and viruses present in the general population such as hepatitis A, measles, mumps, rubella and varicella. It has a distribution of IgG subclasses that is very close to that of the normal human plasma. It is therefore, used to provide passive immunisation against such diseases.
Pharmacokinetics:
Absorption: Levels usually take about 2 days to peak after SC admin.
Metabolism: IgG and IgG-complexes are broken down in the cells of the reticuloendothelial system.
Storage
Store at 2-8°C.
Disclaimer: This information is independently developed by MIMS based on Human normal immunoglobulin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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