Human normal immunoglobulin


Generic Medicine Info
Indications and Dosage
Intramuscular
Passive immunisation against hepatitis A infection
Adult: As 15-18% protein inj: Postexposure prophylaxis: 0.1 mL/kg given as soon as possible within 14 days of exposure. Preexposure prophylaxis in patients travelling to areas with endemic hepatitis A: <1 month length of stay: 0.1 mL/kg; 1-2 months length of stay: 0.2 mL/kg; >2 months length of stay: 0.2 mL/kg every 2 months. Doses are given via deep IM inj.

Intramuscular
Prevent or modify measles attack in immunocompromised patients
Adult: Postexposure prophylaxis in susceptible patients (unvaccinated individuals who have not previously had measles): As 15-18% protein inj: 0.25 mL/kg given via deep IM inj within 6 days after exposure.
Child: Postexposure prophylaxis in immunocompromised patients: As 15-18% protein inj: 0.5 mL/kg (Max: 15 mL) given via deep IM inj immediately after exposure.

Intramuscular
Passive immunisation against varicella infections
Adult: As an alternative agent to modify varicella in immunosuppressed patients only if varicella-zoster immune globulin is not available: As 15-18% protein inj: 0.6-1.2 mL/kg as a single dose via deep IM inj given promptly or within 72 hours of exposure. Recommendations may vary among countries (refer to specific product or local guidelines).

Intravenous
Multifocal motor neuropathy
Adult: Initially, 2,000 mg/kg given in divided doses over 2-5 consecutive days (e.g. 400 mg/kg once daily for 5 days). Maintenance: 1,000 mg/kg every 2-4 weeks or 2,000 mg/kg every 4-8 weeks. Doses are given via IV infusion (initial rate may be gradually increased based on tolerability). Dosage and frequency are individualised and adjusted according to the clinical response. Evaluate the therapy effect after each cycle. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product or local guidelines).

Intravenous
Chronic inflammatory demyelinating polyneuropathy
Adult: Initially, 2,000 mg/kg given in divided doses over 2-5 consecutive days (e.g. 400 mg/kg once daily for 5 days). Maintenance: 1,000 mg/kg as a single infusion over 1 day or 1,000 mg/kg divided into 2 doses over 2 consecutive days given every 3 weeks. Doses are given via IV infusion (initial rate may be gradually increased based on tolerability). Dosage and frequency are individualised and adjusted according to the clinical response. Continue for 2-3 months then assess response to therapy. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product or local guidelines).

Intravenous
Kawasaki disease
Adult: In combination with aspirin: 2,000 mg/kg as a single dose. Alternatively, 1,600-2,000 mg/kg in divided doses over 2-5 days may be given. Doses are given via IV infusion (initial rate may be gradually increased based on tolerability). Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product or local guidelines).

Intravenous
Guillain-Barre syndrome
Adult: 400 mg/kg daily for 5 consecutive days. Treatment may be repeated if relapse occurs. Doses are given via IV infusion (initial rate may be gradually increased based on tolerability). Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product or local guidelines).

Intravenous
Primary immunodeficiency
Adult: As replacement therapy in primary immunodeficiency diseases, including congenital agammaglobulinaemia, common variable deficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies: Initially, 400-800 mg/kg, followed by 200 mg/kg every 3-4 weeks. Maintenance: 200-800 mg/kg per month. Doses are given via IV infusion (initial rate may be gradually increased based on tolerability). Consistent IgG trough levels are reached after 3-6 months of therapy. Doses must be individualised and adjusted according to IgG trough concentrations, clinical response, or as necessary to achieve optimal protection against infections. Dosage, frequency and duration recommendations, instructions for administration, and switching between products or routes of administration may vary among individual products and between countries (refer to specific product or local guidelines).

Intravenous
Idiopathic thrombocytopenic purpura
Adult: In patients at high risk of bleeding or given prior to surgery to correct platelet count: 800-1,000 mg/kg given on day 1, may be repeated once within 3 days. Alternatively, 400 mg/kg daily for 2-5 days may be given. Treatment may be repeated if relapse occurs. Doses are given via IV infusion (initial rate may be gradually increased based on tolerability). Dosage, frequency and duration recommendations may vary among individual products and between countries (refer to specific product or local guidelines).

Intravenous
Secondary immunodeficiency
Adult: As replacement therapy in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure or <4 g/L serum IgG levels: 200-400 mg/kg every 3-4 weeks. Doses are given via IV infusion (initial rate may be gradually increased based on tolerability). Doses must be individualised and adjusted according to IgG trough concentrations, individual clinical response, or as necessary to achieve optimal protection against infections. Dosage, frequency and duration recommendations may vary among individual products and between countries (refer to specific product or local guidelines).

Subcutaneous
Chronic inflammatory demyelinating polyneuropathy
Adult: As maintenance therapy after stabilisation with IVIg treatment: Initiate therapy 1 week after the last IVIg infusion. Recommended dose: 200-400 mg/kg weekly given in 1 or 2 sessions over 1 or 2 consecutive days. The starting dose may be a 1:1 conversion of the previous IVIg dose (calculated as a weekly dose). Adjust the dose based on clinical response. If symptoms worsen on 200 mg/kg weekly dose, dose may be increased to 400 mg/kg weekly. If symptoms worsen with 400 mg/kg weekly dose, consider re-initiating IVIg treatment and discontinuing the SC dose. Doses may be given via SC infusion using a device/pump or by manual push using a syringe (refer to detailed product guidelines for specific administration instructions). Infusion rate depends on the patient's needs. Dosage, frequency and duration recommendations, instructions for administration, and switching between products or routes of administration may vary among individual products and between countries (refer to specific product or local guidelines).

Subcutaneous
Primary immunodeficiency
Adult: As replacement therapy in primary immunodeficiency diseases, including congenital agammaglobulinaemia, common variable deficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies: 200-500 mg/kg as a loading dose (may be divided over several days), followed by a maintenance dose administered at repeated intervals to reach a cumulative monthly dose of 400-800 mg/kg. Doses may be given via SC infusion using a device/pump or by manual push using a syringe (refer to detailed product guidelines for specific administration instructions). Infusion rate depends on the patient's needs. Dosage and dosing intervals must be individualised and adjusted according to IgG trough concentrations and clinical response (e.g. infection rate). Dosage, frequency and duration recommendations, instructions for administration, and switching between products or routes of administration may vary among individual products and between countries (refer to specific product or local guidelines).
Special Patient Group
Patients who are at risk of thrombosis: Consider administering the minimum dose and/or rate of infusion.
Renal Impairment
Intravenous:
Minimisation of the dose, infusion rate, and concentration of solution may be needed.
Reconstitution
For certain products that require reconstitution or further dilution: Reconstitute as indicated on the label. Gently swirl; avoid foaming. Do not shake or heat. Refer to specific local product information for detailed instructions.
Contraindications
Hypersensitivity. IgA deficiency (with anti-IgA antibodies and a history of hypersensitivity). Contraindications may vary among individual products (refer to specific product labelling for detailed information).
Special Precautions
Patient with known anti-IgA antibodies, agammaglobulinaemia or hypogammaglobulinaemia (with or without IgA deficiency), fluid overload; predisposition to renal dysfunction (e.g. pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, sepsis, paraproteinaemia, receiving nephrotoxic drugs); risk factors for thrombotic events (e.g. history of venous or arterial thrombosis, acquired or inherited thrombophilic disorders, hypercoagulable conditions, hyperviscosity, hypertension, prolonged immobilisation, indwelling central vascular catheters, estrogen use); risk factors for haemolysis (e.g. elevated C-reactive protein or erythrocyte sedimentation rate, non-O blood type, underlying associated inflammatory conditions). Obese and human normal immunoglobulin naive patients (IV). If plasmapheresis is needed for the patient's condition, administer IV/IM doses after completion of the plasmapheresis session. IM: Not indicated for hepatitis B prophylaxis and for use in patients with hepatitis A clinical manifestations or in those exposed for >2 weeks; not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella. Antibody titres for some pathogens, route of administration, infusion rate, and reconstitution requirements vary widely between individual products and from lot to lot; different formulations of human normal immunoglobulin should not be regarded as equivalent and not all products are interchangeable. In some countries, certain available brands of IVIg formulations may be administered via SC infusion for specific indications based on clinical judgment; however, IMIg or certain SCIg formulations must not be given via IV. Refer to local product-specific information and institutional guidelines for further dosing, route and administration instructions, or when switching between products. For the traceability of biological medicinal products, record the name and batch number of the product administered to each patient. Concomitant use with live vaccines. Renal impairment (IV). Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Thromboembolic events (e.g. MI, stroke, pulmonary embolism, DVT); aseptic meningitis syndrome (particularly for high doses and/or rapid IV/SC infusion); acute or delayed antiglobulin haemolysis; hypertension (≥180 mmHg systolic pressure or >120 mmHg diastolic pressure), hyperproteinaemia, hyponatraemia, increased serum viscosity; infusion or inj site reactions (e.g. erythema, pain, inflammation), haematoma; hypersensitivity reactions, including anaphylactic reactions; shock (particularly if SCIg is accidentally given via IV); neutropenia, volume overload, and precipitous fall in blood pressure with manifestations of anaphylaxis (IV).
Cardiac disorders: Tachycardia, palpitations.
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain.
General disorders and administration site conditions: Fatigue, asthenia, pyrexia, chills, chest pain.
Investigations: Increased hepatic enzymes, increased serum creatinine, decreased haemoglobin.
Metabolism and nutrition disorders: Fluid retention, dehydration, hyperbilirubinaemia.
Musculoskeletal and connective tissue disorders: Muscle spasms, myalgia, arthralgia, neck or back pain, muscle stiffness.
Nervous system disorders: Headache, paraesthesia, migraine, dizziness.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, dyspnoea, cough, nasal congestion, epistaxis, bronchospasm, wheezing, asthma.
Skin and subcutaneous tissue disorders: Urticaria, rash, hyperhidrosis, pruritus.
Vascular disorders: Flushing, hypotension.
Potentially Fatal: Non-cardiogenic pulmonary oedema, particularly transfusion-related acute lung injury (TRALI); renal dysfunction, including oliguria, acute renal failure, and osmotic nephrosis (particularly more common in IV preparations containing sucrose).
IV/Parenteral: C
Patient Counseling Information
Ensure adequate hydration prior to administration.
Monitoring Parameters
Closely monitor IgG trough concentrations and clinical response. Obtain renal function, including serum creatinine and BUN (before the initial infusion and as necessary); blood pressure, urine output, volume status; haemoglobin, haematocrit, platelets; presence of antineutrophil antibodies (particularly if TRALI is suspected), blood viscosity (in patients at risk for hyperviscosity). Closely assess for pulmonary adverse effects, neurologic symptoms (particularly if aseptic meningitis syndrome is suspected), and signs of thrombosis, haemolysis, infusion- or inj-related reactions, and anaphylaxis.
Drug Interactions
May interfere with the efficacy of live attenuated virus vaccines, such as measles, mumps, rubella, and varicella vaccines (for a period of approx 6 weeks to 3 months [may persist for up to 1 year for measles vaccines]). May increase the risk of adverse effects with loop diuretics (e.g. furosemide, bumetanide).
Lab Interference
May cause false-positive results for serologic testing and direct or indirect Coombs test. May result in falsely increased erythrocyte sedimentation rate and false-positive readings in assays that depend on the detection of beta-D-glucans for fungal infection diagnosis. Different products may impair the results of certain tests (refer to specific product guidelines).
Action
Description:
Mechanism of Action: Human normal immunoglobulin, derived from the pooled plasma of healthy donors, mainly contains a broad spectrum of IgG antibodies against a wide variety of bacteria and viruses. The IgG antibodies provide passive immunity by increasing the patient's antibody titre and antigen-antibody reaction potential and by preventing or modifying certain infectious diseases in susceptible individuals. In sufficient doses, it may restore abnormally low IgG levels to normal ranges and help against infections. Its mechanism of action in some indications has not been fully elucidated; in idiopathic thrombocytopenic purpura, it has been suggested that it may saturate the crystallisable fragment (Fc) receptors on the cells of the reticuloendothelial system, leading to decreased Fc-mediated phagocytosis of antibody-coated cells.
Onset: IV: Antibody levels immediately provided.
Duration: IV/IM: Immune effect: 3-4 weeks (variable).
Pharmacokinetics:
Distribution: Rapidly distributed between plasma and extravascular fluid. Crosses the placenta and enters breast milk. Volume of distribution: 0.05-0.13 L/kg.
Excretion: Elimination half-life: May vary among patients (IV); approx 23 days (IM).
Storage
IV/SC: Store between 2-8°C or ≤25°C. Do not freeze. Protect from light. IM: Store between 2-8°C. Do not freeze. Storage and stability recommendations may vary among individual products and between countries (refer to specific product guidelines).
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA02 - immunoglobulins, normal human, for intravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
J06BA01 - immunoglobulins, normal human, for extravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
References
Anon. Immune Globulin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 20/02/2024.

Anon. Immune Globulin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 20/02/2024.

Buckingham R (ed). Normal Immunoglobulins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/02/2024.

CSL Behring (NZ) Limited. Privigen NZ (10% [100 g/L]), Solution for Intravenous infusion data sheet 09 March 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 20/02/2024.

CSL Behring (NZ) Ltd. Evogam (16% [16 g/100 mL]) Solution for Subcutaneous Injection data sheet 3 June 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 20/02/2024.

Cutaquig Solution (Octapharma USA Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 20/02/2024.

Flebogamma 5% DIF Solution for Infusion (Grifols Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 20/02/2024.

Gamastan Injection, Solution (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 20/02/2024.

Gamastan Solution for Intramuscular Injection (Grifols Therapeutics LLC). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 20/02/2024.

Gammagard S/D (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 20/02/2024.

Gammanorm 165 mg/mL Solution for Injection (Octapharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 20/02/2024.

Gammaplex 5% w/v, Solution for Infusion (Bio Products Laboratory Ltd). MHRA. https://products.mhra.gov.uk. Accessed 20/02/2024.

Gamunex-C Injection (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 20/02/2024.

Hizentra 200 mg/mL Solution for Subcutaneous Injection (CSL Behring GmbH). MHRA. https://products.mhra.gov.uk. Accessed 20/02/2024.

Hizentra 200 mg/mL Solution for Subcutaneous Injection in Pre-filled Syringe (CSL Behring GmbH). MHRA. https://products.mhra.gov.uk. Accessed 20/02/2024.

Hizentra Liquid (CSL Behring AG). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 20/02/2024.

Joint Formulary Committee. Normal Immunoglobulin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/02/2024.

Octagam 10% Solution for Infusion (Octapharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 20/02/2024.

Panzyga (Octapharma USA Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 20/02/2024.

Preston CL (ed). Loop Diuretics + Normal Immunoglobulins. Stockley's Drug Interactions [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/02/2024.

Privigen (DKSH Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 20/02/2024.

Subgam 160 mg/mL Solution for Injection (Bio Products Laboratory Limited). MHRA. https://products.mhra.gov.uk. Accessed 20/02/2024.

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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
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