Guidance

General product information and how to administer immunoglobulin (issued August 2020)

Updated 7 November 2024

Applies to England

General information

This document was originally published as the ‘Immunoglobulin handbook’ in 2008, and the full history of updates to the guidance is available at Immunoglobulin: when to use.

The human immunoglobulin preparations prepared by Bio Products Limited (BPL) and issued by the UK Health Security Agency (UKHSA) and NHS laboratories are prepared from pooled plasma from non-UK blood donors.

Non-UK pooled plasma has been used since March 1999 due to theoretical risk of the transmission of new variant Creutzfeldt-Jakob disease (nvCJD).

All immunoglobulins are prepared from HIV, hepatitis B and hepatitis C negative donors.

Subgam® (human normal immunoglobulin (HNIG)) from Bio Products Laboratory (BPL) is not licensed for prophylactic use against hepatitis A, measles or rubella. The product is, however, known to contain similar levels of measles antibody as licensed products.

The levels of hepatitis A antibody are around half the level of the licensing requirements for such a product (although higher than some other available HNIG preparations), but global supplies of suitable products are limited. Therefore UKHSA is recommending the use of Subgam for hepatitis A prophylaxis but at a higher dose.

The following preparations for intramuscular use are held centrally by Movianto and ordered through the Rabies and Immunoglobulin Service (RIgS).

Colindale (telephone number 0330 128 1020, 8am to 5.30pm) for delivery via ImmForm, and also by certain regional UKHSA and NHS laboratories:

• human normal immunoglobulin
• human varicella-zoster immunoglobulin
• human hepatitis B immunoglobulin
• human rabies immunoglobulin
• diphtheria antitoxin

The following intramuscular preparations are available and are chargeable through BPL (telephone number 020 8258 2200, 24 hours):

• human tetanus immunoglobulin (note 1)
• human anti-D immunoglobulin
• human hepatitis B immunoglobulin (note 2)
• human rabies immunoglobulin (note 2)
• human varicella-zoster immunoglobulin (note 2)

Note 1: Only tetanus immunoglobulin for IM use is now available from BPL. An IV tetanus immunoglobulin product is no longer available.

Note 2: These immunoglobulin preparations are available from UKHSA although they can be purchased directly from BPL where clinicians wish to use them outside the national Joint Committee of Vaccination and Immunisation (JCVI) guidance.

Tetanus specific immunoglobulin (TIG) should be used for the treatment and prevention of tetanus, if suitable stock can be sourced. However, where TIG cannot be obtained, UKHSA recommends that human normal immunoglobulin (IV and IM) preparations can be used. Further details about this are available at Tetanus: guidance for health professionals.

Vaccines, antitoxins and immunoglobulins are purchased by the Department of Health and Social Care (DHSC) specifically for use within the NHS. Similarly, products distributed by UKHSA on behalf of DHSC are provided for use within the NHS.

Only patients eligible for NHS treatment (those with an NHS number) are eligible to receive immunoglobulin products free of charge. Overseas patients can receive products through an NHS hospital or by temporary registration with a GP.

Private clinics and hospitals are advised to secure stocks of the products they require directly from the manufacturers.

Supplies of normal immunoglobulin for intravenous administration may be obtained from the manufacturers. Details are available in the British National Formulary Index of Manufacturers.

For dosage, precautions, contraindications and side effects please refer to individual product information.

Administration of immunoglobulin

When a large volume injection, such as an intramuscular preparation of immunoglobulin is to be given, this should be administered deeply into a large muscle mass such as the anterolateral aspect of the thigh. The upper outer quadrant of the buttock can also be used for immunoglobulin injection.

If more than 3ml is to be given to young children and infants or more than 5ml to older children and adults, the immunoglobulin should be divided into smaller amounts and given into different sites.

Administration of rabies immunoglobulin (RIG)

As much RIG as possible should be infiltrated into the depth of the wound and around the site of the wound, with the rest of the RIG given in the anterolateral thigh. Where more than 3mls is to be given to young children, or more than 5mls to older children and adults, the immunoglobulin should be divided and given at different sites.

Vaccine and RIG must never be given at the same anatomical site but can be given on the same day. RIG is not given after 7 days post initiation of rabies PEP vaccine (or to an individual who is already partially immunised).

See specific advice on administration of rabies immunoglobulin available at Rabies: risk assessment, post-exposure treatment, management.

Administration of immunoglobulin for measles

Immunosuppressed patients, as defined in chapter 6 of ‘Immunisation against infectious disease’, are at risk of severe measles and should be considered for intravenous immunoglobulin (IVIG) following any exposure to measles, which would need to be sourced from NHS hospital pharmacies.

HNIG products (manufactured for subcutaneous use) are used as post-exposure prophylaxis to attenuate measles in exposed, susceptible immunocompetent infants and pregnant women. These products may be given via intramuscular or subcutaneous routes. Given the urgent clinical need for measles post-exposure prophylaxis, it is reasonable and routine to use these available HNIG products intramuscularly as this means they can be given easily in the community or in outpatient settings.

Where more than 2 to 3mls is to be given to young children or more than 5mls to older children and adults, the immunoglobulin should be divided and given at different sites.

See specific advice on administration of HNIG for measles available at Administration of HNIG for measles post-exposure prophylaxis.

Normal and specific immunoglobulin

Advice on the use of normal immunoglobulin for:

• hepatitis A
• measles
• rubella
• polio

and specific immunoglobulins for:

• varicella-zoster
• hepatitis B
• rabies
• tetanus

is also contained in Immunisation against infectious disease (the Green Book). Further advice on the diseases and indications for immunoglobulin should be sought from this publication or the individual disease guidance found at Immunoglobulin: when to use.