Appendix 5 - Normal Immunoglobulins

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.

Colour coded indications

Indications for normal immunoglobulin use are grouped into colour coded categories.

Red indications: High priority

Treatment may be life-saving. Supply will be reserved for these indications in times of shortage.

Blue indications: Medium priority

Evidence base is reasonable but other treatment options are available. Treatment should be modified in times of shortage.

Grey indications: Low priority (non-Formulary)

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.

Black indications: Use is not appropriate (non-Formulary)

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 page under Guidelines.

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.

Prescribing normal immunoglobulins

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).

Prescribing in overweight patients

For patients with BMI ≥30kg/m2 or if actual weight >20% more than ideal body weight (IBW), prescribers should consider using adjusted-body-weight dosing of immunoglobulin. An online calculator for calculating the dosing weight and IBW is available at: https://ivig.transfusionontario.org/dose/

Ordering normal immunoglobulins

Normal immunoglobulins must be ordered from pharmacy using a specific request form, which can be found on the National Plasma Products Expert Advisory Group page under Resources. Contact your local Pharmacy department (see Appendix 6 for contact details) if you require further information on this.

 

Guideline reviewed February 2025
Page updated February 2025



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