Normal immunoglobulins are plasma products that remain the only treatment option for patients with primary immunodeficiencies which, in certain cases, are life-threatening. These medicines are in worldwide shortage and it is imperative to minimise the impact of these shortages by limiting their use to patients who have a clear indication for treatment. In addition, normal immunoglobulins represent a significant cost pressure for NHSAAA.
Considering the above, the use of normal immunoglobulins is restricted to specific indications and treatment must be initiated and reviewed by a Consultant.
Indications for normal immunoglobulin use are grouped into colour coded categories.
Treatment may be life-saving. Supply will be reserved for these indications in times of shortage.
Evidence base is reasonable but other treatment options are available. Treatment should be modified in times of shortage.
Evidence base is weak, in many cases because the disease is rare. Treatment should be considered on a case by case basis, prioritised against other competing demands.
The prescription of normal immunoglobulins is not permitted for these conditions.
A comprehensive list of colour-coded indications can be found on the National Plasma Products Expert Advisory Group Guidelines and Forms page and search for:
Treatment with normal immunoglobulins for grey or black indications is considered non-Formulary within NHSAAA. Any indication not listed in the National Guidelines is also non-Formulary. For grey indications, an Individual Patient Request Form should be completed and approved prior to immunoglobulin supply. The form can be found on AthenA / Code of Practice for Medicines Governance / Managed Entry Forms / IPTR application form.
Normal immunoglobulins should be prescribed generically with the exception of patients with primary immunodeficiency and those on home therapy. Any contraindications / allergies to specific brands must be documented on the request form and on the Hospital Electronic Prescribing and Medicines Administration (HEPMA) system, with a high risk infusion chart.
Haemato-oncology patients
The IV immunoglobulin administration in haemato-oncology patients guideline can be found on AthenA / Guidelines – Prescribing / Immunological Products and Vaccines / “IV immunoglobulins – haemato-oncology patients” or here (link active if connected to NHS network).
Information on dosing calculation in overweight patients can also be found on the National Plasma Products Expert Advisory Group Guidelines and Forms page.
Normal immunoglobulins must be ordered from pharmacy using a specific request form, which can be found on the National Plasma Products Expert Advisory Group Guidelines and Forms page. Contact your local Pharmacy department (see Appendix 6 for contact details) if you require further information on this.
| Guideline reviewed | April 2022 |
| Page updated | May 2022 |