Switching immunoglobulin products

We understand that having to change immunoglobulin products is an anxious and disturbing time for people who are dependant on immunoglobulin treatment as a life-long therapy. This article aims to help guide and reassure you through this process, and gives a checklist of questions to ask your immunology team when they discuss switching products with you.

Overall switching products should be done in a way that involves you in the decision making process and should always be carried out under supervision of your immunology team.

Why you may be asked to change your immunoglobulin therapy product

There are three reasons:

  1. Some products are being withdrawn by a company and replaced by an alternative.
  2. A company may no longer be able to provide certain products due to supply issues.
  3. The NHS has decided it will not make certain products available to patients e.g. NHS England has recently taken the decision to only fund a selected number of products to patients because of their lower cost.

What questions should I ask regarding switching products?

Here is a list of questions that we recommend you ask your immunology team:

  • Why am I being asked to switch?
  • Is this for a clinical reason?
  • Will the new immunoglobulin product work as well?
  • Will I have side effects and how will these be monitored?
  • Will my infusions take longer?
  • What happens if I do have new side effects, can I switch back?
  • Am I likely to have to switch again anytime soon?
  • Do I have to change?
  • Will my treatment be changed in future to limit my dose or will there be another change?

What should I expect if I have to switch products?

A medical or nursing member of your immunology team will discuss with you the issues surrounding the switching of product.  Please share any concerns or anxiety that you have about the switching process with them. Your doctors and nurses should be acting as your advocate during this process. If you are uncomfortable with being asked to change products your centre should respect your decision.

You should ask questions about what this will mean for you or your child [see the list above].  Your team will make decisions based on clinical need about which product is most suitable for you. When you switch to a new immunoglobulin product your treatment centre should bring you or your affected child into the clinic for the first infusion to monitor how well you or your child tolerate the new product.
As soon as you and your clinical team are confident that the new product is right for you or your child, you will be able to return to your normal pattern of infusions.

Under no circumstances should switching occur without medical supervision and oversight.

Is switching compulsory?

Patients on a product, which is no longer available, will have no choice but to switch to an alternative product. The immunology team looking after you will discuss the options available to you.

In other circumstances where, for example, the NHS is restricting access to certain products, the ultimate decision about which treatment switch is most appropriate for you rests with your clinical team. They should discuss the options available to you during your routine clinic visit.  Acting as your advocates, your doctors and nurses should ensure your wishes are taken into account in making any switching decision and you should be given the time you need to consider the switch proposed.  Remember if you are uncomfortable with being asked to change products your centre should respect your decision.

Please ensure that your doctor knows about any allergies you have, especially if you have ever had a severe reaction to any IG product.

Are all immunoglobulin products the same?

Immunoglobulin products are not all the same. Whether a particular IG product is right for you can depend on its ingredients and formulation.

Some of the key differences are related to:

Plasma pool and source – IG products are made from blood donations. Several thousand blood donations are pooled in the process.  For these reasons there is always a risk of catching an infection from one of the blood donors. This risk is very small due to the careful screening of donors and the extensive procedures that are used to eliminate pathogens. However companies producing IG products use different donor pools and it considered good practice to minimise risk even further by not switching patients to products derived from a different donor pool.

Infusion volume – formulations with a larger fluid volume should be avoided in patients who have to limit their fluid intake (for example because of heart failure, high blood pressure or kidney disease) and in infants.

IG concentration – the concentration of IG in products varies between 3% and 20%. Higher concentrations can be useful when higher doses need to be given. However, high concentrations of IG should be avoided in patients at risk of cardiovascular disease.

Immunoglobuln A level – this should be as low as possible for patients with any history of severe hypersensitivity reactions, including anaphylaxis.

Stabilisers – these ingredients (most often sugars) are added to ensure that the IG remains dissolved in the infusion solution.  The type and concentration of stabilisers in IG products can affect how suitable they are for certain patients.

Formulation – IG products mostly come as solutions but some come in a ‘freeze-dried’ form and need to be reconstituted according to the manufacturers instructions.

You can find out a lot more about immunoglobulin therapy, how products are made and how IG products may differ in these three booklets.

A guide to immunoglobulin therapy

Plasma derived therapies

Immunoglobulin replacement therapy – One size doesn’t fit all

Are all immunoglobulin products equally effective?

All IG products have to obtain a marketing approval licence from the European Medicines Agency to prove they have the right amount of specified protective antibodies in them and are effective. The licence states what the IG product can be used for.

What side effects may be experienced when switching?

Common side effects when switching IG product include headaches, chills and tiredness. Some patients may with just mild symptoms initially such as headache or tiredness.  Rarely patients may have more significant side effects when products are switched.

You will be supervised at your treatment centre to monitor any side effects you may experience and to ensure that you can tolerate the product. Please ask your clinical team for further information when switching is being discussed. You will be supervised during your first infusion of a different product to ensure that you can tolerate the product and to monitor any side effects you may have.  During this infusion you will be given advice, guidance and any training required for your new product.

Please keep a diary of any reactions you may have when using the new product.

How will the switching process be managed?

Any switching process needed should ideally be discussed at your next routine appointment. The actual switch would then occur at the next routine appointment after that.  To avoid extra visits some centres may contact you in advance and provide verbal and/or written information on switching and then switch at the next appointment if you are in agreement. For hospitals that have a large number of patients may the process of switching may take six months depending on the capacity of each centre.

Reviewed by Dr Matthew Buckland, Chair of the Immunodeficiency UK’s Medical Panel
Posted 24th November 2017