- 1 What is immunoglobulin replacement therapy?
- 2 What is the difference between intravenous and subcutaneous immunoglobulin?
- 3 Will I be given the choice between intravenous or subcutaneous immunoglobulin?
- 4 What is in the immunoglobulin?
- 5 Why do I need immunoglobulin?
- 6 What tests do I need to have before starting immunoglobulin?
- 7 I heard that some people have reactions to immunoglobulins
- 8 Are there any other safety problems with immunoglobulin?
- 9 What do the manufacturers do to make sure there are no infections in the immunoglobulin?
- 10 What kind of follow-up should I expect if I start immunoglobulin?
- 11 Why is it important to record the batches of immunoglobulin?
- 12 Is it possible I don’t need immunoglobulin any more?
- 13 What products are available?
- 14 How do hospitals ensure they don’t run out of immunoglobulin?
- 15 What if I want to go on holiday?
- 16 How do I ensure I’m doing home therapy safely?
- 17 Who can I contact if I want to discuss my treatment?
If you have any other queries about immunoglobulin therapy you would like answers to, please contact us.
What is immunoglobulin replacement therapy?
Immunoglobulin (IG) replacement therapy is a blood-based treatment. The immunoglobulin contains antibodies which will help fight infection. You have been recommended this treatment because your doctors have found that your immune system (or your child’s immune system) is not making antibodies. Immunoglobulin can be given intravenously or subcutaneously.
What is the difference between intravenous and subcutaneous immunoglobulin?
Intravenous immunoglobulin (IVIG) is given straight into the circulation system by a needle in a vein. Quite large amounts of immunoglobulin can be given this way and for this reason, treatment is only needed every three weeks or so, with each treatment lasting between two and four hours. If you have side effects with IVIG it is usually because it is being given too quickly. Initially you would have treatment in hospital, but most people can be trained to have it at home.
Subcutaneous immunoglobulin (SCIG) has been developed more recently than IVIG. In SCIG, immunoglobulin is delivered by a needle into the fatty tissues under the skin, where it enters the circulation slowly over a few days. There isn’t much room under the skin, so the dose of immunoglobulin given is smaller than with IVIG. For this reason, SCIG is usually given every week. Nearly everybody on SCIG learns how to have treatment at home, with each session lasting up to about two hours.
Will I be given the choice between intravenous or subcutaneous immunoglobulin?
Your immunology team will give you the information to help you decide which treatment you will have. You might want to consider the following factors:
- If you have really ‘bad’ veins, then IVIG is not an option for you.
- If you want to take ownership of your illness and keep away from hospital, then SCIG may be the best choice because you will probably learn how to have home therapy faster.
- On the other hand, if you decide you don’t want to be involved in your treatment and you don’t want to learn how to do it, IVIG in hospital may be an option for you.
- Clinical trials have shown that people using SCIG are more likely to be able to continue work, school and social activities than people receiving IVIG.
- For people receiving IVIG every three weeks or more, the levels of immunoglobulin in the circulation tend to fall quite a lot before the next infusion. Some people notice they feel more tired just before the IVIG infusion is due. This tends not to happen with weekly SCIG.
- On the other hand, because the level of immunoglobulin rises quite quickly during an IVIG infusion, side effects may be more likely, especially if the infusion is given quickly.
Your immunology centre will be able to offer you either treatment depending on these factors and your personal choice. Across the UK about 60 per cent of people with immune deficiency are on IVIG.
What is in the immunoglobulin?
Immunoglobulin is made from donated blood plasma. During manufacture everything except a type of immunoglobulin called IgG is removed from the plasma. IgG is very good at fighting bacteria and viruses. IgG has other effects too, so it isn’t just used for people with immune deficiency. You might hear about immunoglobulin being used in some people with neurological problems.
Why do I need immunoglobulin?
Immune deficient patients are at a greater risk of infection than others. Clinical trials have shown that for people with immune deficiency, immunoglobulin treatments result in fewer infections, and those infections that do happen tend to be less serious. There is also evidence that people with immune deficiency are more likely to enjoy good health over many years if they receive immunoglobulin correctly. Finally, your levels of wellbeing and your energy are likely to be better if you are on immunoglobulin. Please note that it may take several months before you feel these benefits.
What tests do I need to have before starting immunoglobulin?
Your immunologist will only recommend starting immunoglobulin if you have had tests which confirm it’s the right treatment for you. In cases of severe immune deficiency, only a couple of blood tests are required before the doctor will recommend immunoglobulin.
Fortunately, most people have mild immune deficiency and in this situation the doctor might try other treatments before immunoglobulin. For example, the immunologist might try giving you vaccines and checking how well you respond. This ‘vaccine challenge’ can take several weeks, as you have to have the vaccine, wait a few weeks before the blood tests and then get the results.
Alternatively, your doctor might suggest taking antibiotics for a few months and see how well these protect you from infection. This can be done whilst you are waiting the results of a vaccine challenge.
Finally, your immunologist might suggest trying immunoglobulin for a period of time, for example a year. If it is clear that you have benefitted, then they will recommend you continue it.
I heard that some people have reactions to immunoglobulins
Most people do not have reactions to immunoglobulins. This is why it’s safe to go on to home therapy.
The reactions that do sometimes happen include rashes, temperature, shivering or itching. You can also get a headache with immunoglobulin, although this tends to happen the next day.
When reactions do happen, there is usually one of two factors responsible:
- Immunoglobulin is given too fast. This is most likely to happen with IVIG because a larger dose is being given. Whenever anyone has a reaction during an infusion, the first thing they should do is slow the infusion right down.
- Immunoglobulin is given at a time when there is an infection. If you have a cold or a chest infection on the day of your infusion, you are more likely to have a reaction. Immunology teams will help you recognise the symptoms of infection, so that you can delay your infusion by a couple of days if necessary. Because immunoglobulin treatment takes a few months to reduce the risk of infections, this is most likely to happen when you have just started immunoglobulin.
If you continue to have reactions with immunoglobulin, your immunologist may recommend taking paracetamol or antihistamines first. Sometimes there are problems with one batch of immunoglobulin and the problems go away once the batch has changed. Very occasionally your immunologist will recommend you change your immunoglobulin product because reactions cannot be brought under control.
If you have reactions when you start immunoglobulin treatment, the chances are that they will be brought under control.
Are there any other safety problems with immunoglobulin?
Immunoglobulin is made from blood donations. Several thousand blood donations are pooled in the process. For these reasons there is always a possibility of catching an infection from one of the blood donors.
No one has ever caught HIV or hepatitis B from immunoglobulins. In the 1990s, a small number of people caught hepatitis C from immunoglobulin. These days, blood donors are selected very carefully and the manufacturing process contains steps to remove viruses and bacteria.
There have been no cases of infection being spread from person to person by immunoglobulin since the 1990s.
There are two theoretical risks from immunoglobulin. The first is from prion infection. Prions caused mad cow disease and then variant CJD in the 1990s, mainly in the UK. Prions have been spread from person to person by blood transfusions but never by immunoglobulin. But because of this theoretical risk, British plasma is still not used for making immunoglobulin.
The other risk is of new infections that start to affect humans, either because of global climate change or change in behaviour (e.g. feeding sheep to cows, in the case of mad cow disease). One example of this is a virus that affected people in New York and entered the blood supply there. This virus only became a problem because birds changed their migration pathways as a result of climate change.
It is very difficult to predict whether new infections, which could be spread by immunoglobulin, will appear in the future. However, the immunoglobulin manufacturers and immunologists around the world are constantly on the look out for any problems such as this.
What do the manufacturers do to make sure there are no infections in the immunoglobulin?
The first step the manufacturers take is to get to know the blood donors really well. People who donate blood for immunoglobulin cannot come in off the street, give the blood and get paid £50! Manufacturers insist that their donors donate regularly. Each time a donor attends the blood centre they are asked a lot of questions, ranging from their sex lives to any recent travel. They then donate the blood as well as having a series of blood tests to make sure they don’t have an infection. The blood is not released for processing until the blood tests have come back negative.
The second step is that the plasma is treated in a few different ways to get rid of infection. Depending on the manufacturer, the plasma will get a combination of heat treatment, addition of acid or detergent, and filtration.
Donor centres and immunoglobulin manufacturers have very high standards for minimising the risk of infection getting into the immunoglobulin supply. Donor centres and manufacturers are inspected regularly and will be closed down if there is any hint of a problem.
A final important safety step is carried out by immunologists, who either do annual hepatitis checks or save a sample of blood for infection testing. You will also be kept on the same immunoglobulin product once you have started. It is through this kind of surveillance that we can be so confident that infections are not being spread by immunoglobulin.
What kind of follow-up should I expect if I start immunoglobulin?
The exact protocol for follow-up varies between centres and will also vary depending on your particular situation. You could expect to be seen at least two or three times a year. Sometimes follow-up will be done by a junior doctor or a specially trained nurse. You might be asked to bring along the details of your infusions, including the number of batches and possibly a diary of any infections you have had.
You might expect to be assessed from the following points of view:
Is the treatment working?
Are you still having infections?
- Have you had to have antibiotics, take days off work or even go into hospital?
- Are you getting the correct amount of immunoglobulin (checked by doing a blood test)?
- Are your lungs healthy? You might have breathing tests or a CT scan of your lungs.
Are there any problems?
- Have you had any reactions? What caused them?
- A blood sample will be taken for liver tests and a sample frozen in case it needs testing for infection at a later date.
- You might be offered a technique review if you are on home therapy.
Has anything else changed?
- Have you had any other complications of immune deficiency?
- Are there any new treatments or tests that should be considered?
- Do you still understand why you are on immunoglobulin and what the possible risks are?
At monitoring visits, a huge amount of information will be swapped between you and the immunology team. This can be slightly stressful and it’s possible you won’t remember everything that has been said. You might want to prepare for the monitoring appointment by checking you have your infusion records and infection diary. A lot of people jot down any questions they think of in the days leading up to the appointment. You might want to take someone along to the appointment to remember what has been said, or you might just want to take notes.
Why is it important to record the batches of immunoglobulin?
Immunoglobulin is manufactured in batches. There are several thousand bottles of immunoglobulin in each batch. Very occasionally there are problems with some batches. For example, recently one batch of immunoglobulin caused some people to get an itchy rash. Because it was possible to see which batch was causing the rash, replacement immunoglobulin could be sent out quickly.
Is it possible I don’t need immunoglobulin any more?
The tests you had before starting immunoglobulin were designed to check whether you would need immunoglobulin for life. However, sometimes immunoglobulin is recommended for people whose immune deficiency may only be temporary. This can happen in small babies or when the immune system had been damaged by medications, for example. It’s also possible you were given immunoglobulin for a condition that is no longer regarded as needing immunoglobulin. In these situations there are blood tests that can be done to check how well your immune system is working. If you do stop immunoglobulin, your immunology team will monitor you closely.
What products are available?
There are about half a dozen immunoglobulin manufacturers and the different IVIG and SCIG products available vary slightly. However, each manufacturer must follow international standards on product safety. The blood donor centres and manufacturing plants of all the different companies are inspected from time to time.
How do hospitals ensure they don’t run out of immunoglobulin?
In the past, supplies of immunoglobulin from different manufacturers have been withdrawn from time to time. This has happened because, for example, a batch of immunoglobulin has caused a reaction, such as an itchy rash. Another problem is that immunoglobulin is being used to treat many more different diseases, not just immune deficiency. The UK is in a unique position owing to the fact we do not manufacture immunoglobulin because of the theoretical risk of prion infection. Finally, immunoglobulin costs more in some countries, so manufacturers make a greater profit in different parts of the world.
In the past, there have been occasions when supplies of an immunoglobulin product became very low. People on an affected product had to switch to a different one at very short notice.
For these reasons, the UK Government has taken steps to ensure we have a good supply of immunoglobulin at a national level. These steps include negotiating immunoglobulin prices and supplies with the manufacturer. The Department of Health also runs a scheme to make sure that if a crisis develops, immunoglobulin is reserved for patients who really need it, particularly people with immune deficiency.
What if I want to go on holiday?
Being on immunoglobulin should not affect your holidays. If you are on IVIG, a holiday of up to three weeks could be fitted into your infusion schedule. If you are on weekly SCIG, you will either need to take an infusion with you or have a bigger dose in the weeks before and after the break. Your immunology team will help you plan this.
How do I ensure I’m doing home therapy safely?
Your immunology team will be accredited as a home therapy training centre and will not allow you to go onto home therapy until you are safe. You might have to do a short exam! Once you are on immunoglobulin at home, your team will want to do an assessment every so often. It’s best if this can happen at home, but it can also be done at the hospital.
Who can I contact if I want to discuss my treatment?
Your immunology team will give you contact details which you can use if a problem arises at home. For example, if you think you have an infection and you want advice about delaying immunoglobulin. Some immunology centres only offer this service during office hours. This means you might want to plan your infusions for during the week until you have some confidence.
You can also call your immunology centre if you have other concerns that might be to do with immune deficiency.
Your GP and local emergency department will still be the best people to go to for all other problems; for example, if you had an injury that needed sorting out.