In Australia, government-funded immunoglobulin products are restricted to conditions where:

• use is supported by scientific and clinical evidence, and
• other treatments are less effective or can’t be used.

This is because there is a limited supply of immunoglobulin products and they are expensive to manufacture. Careful management is needed to ensure that there is an adequate, secure and affordable supply of immunoglobulin products for Australians who need them.

The conditions and circumstances under which government-funded immunoglobulin products can be considered for use are set out in the Criteria for the Clinical Use of Immunoglobulin in Australia (the Criteria).

These are some examples of conditions where immunoglobulin products are used:

• immune deficiency (primary) – severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), X-linked agammaglobulinaemia (XLA).
• immune deficiency (secondary) – chronic lymphocytic leukemia, multiple myeloma, and reduced immune function following hematopoietic stem cell transplantation.
• neurological conditions – chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy, Guillain Barré syndrome, and myasthenia gravis.
• autoimmune / inflammatory conditions – immune thrombocytopenia, and autoimmune haemolytic anaemia.

Immunoglobulin products are usually given in one of two ways.

1. Intravenous immunoglobulin (IVIg) is given by injection into a vein. This method allows high doses to be given. High doses may be needed for patients with particular conditions, but can cause side effects in some people.
   
   Treatment takes place in an infusion clinic, usually in a hospital, every 3 to 4 weeks. Each infusion usually takes between 2 and 4 hours, but can take longer.
   
   
2. Subcutaneous immunoglobulin (SCIg) is given by injection into the tissue just under the skin, often in the abdomen or thigh. Only small doses can be given using SCIg, so infusions need to be given more often than with IVIg – usually once a week, depending on the dose needed. Smaller doses may be better tolerated by people who experience side effects from larger doses. Infusions take less time than for IVIg, usually around 1 to 2 hours.

SCIg can be given at home, using a mechanical infusion pump (spring loaded or battery powered) or by rapid push (where the infusion is pushed by hand through a syringe).Before you start on SCIg, you will need information and training on how to give SCIg at home. This can be provided by a specialist nurse. Your specialist nurse will continue to provide support and information on SCIg for as long as you need.

Is one method better than the other?

Both routes are effective. One method may suit better than another, depending on the condition and patient circumstances.

Do I have a choice?

You should discuss treatment options with your doctor and ask any questions you have about both methods if you think you might prefer one over the other.

Your doctor will recommend the treatment that is best suited to you, depending on your individual situation. This will depend on your diagnosis, the length of time that you are expected to be having treatment, and other factors such as whether you have any other conditions.

Your doctor’s recommendation will also depend on which products are available at the time.

Patients wishing to transition from IVIg to SCIg may need to be placed on a waiting list in some hospitals where SCIg programs are limited, to ensure the right training and support is available.

Read more about:

• Access to Subcutaneous Immunoglobulin (SCIg)
• Access to Subcutaneous immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• SCIg for primary immune deficiency disorders
• IVIg for primary immune deficiency disorders
  

Side effects can happen with all medicines, including immunoglobulin products. It is important to know how to recognise the symptoms and learn how to manage them.

What causes side effects?

Side effects can come from the method of infusion

The method used to give immunoglobulin products plays an important role in the types of side effects that might happen – subcutaneous injections can cause ‘local’ reactions at the site of infusion, such as swelling and redness. Intravenous infusions are more commonly associated with ‘systemic’ reactions affecting all of the body, such as headaches and body pain.

During intravenous infusions, a larger volume of immunoglobulin is released directly into the blood, whereas during subcutaneous infusions a smaller amount of immunoglobulin is injected into the fatty tissue beneath the skin and is absorbed more slowly. The spike in blood levels of immunoglobulin are thought to cause the systemic reactions.

• Side effects from intravenous immunoglobulin products (IVIg)

Reactions to IVIg are generally mild and are more likely to happen during the first few infusions. Once people have had a few infusions, they often describe a ‘sweet spot’ where the infusion rate feels comfortable and the side effects are reduced or stop.

The most common side effects include body pain, nausea and headaches. These can usually be reduced by slowing the rate of the infusion or stopping it for a short time.

Making sure you have had plenty of water to drink is important before, during, and after treatment.

Ask your doctor or nurse about what can be done to help manage any side effects before taking any medicines such as paracetamol (Panadol) or antinausea tablets.

• Side effects from subcutaneous immunoglobulin products (SCIg)

SCIg products can also cause reactions such as headaches, but this happens less often than with IVIg. SCIg can cause side effects at the injection site, such as redness, swelling and soreness. These local reactions are normal and are usually gone by the next day. They are more common in people who have just started SCIg, especially in the first few months.

Ask your doctor or nurse about what you can try if you need help with managing these reactions, such as using an ice pack.

Both IVIg and SCIg products can rarely cause an allergic reaction. If you experience any symptoms including tightness in the chest, difficulty breathing, or skin rash, you should speak to your doctor or nurse immediately. Very rarely, more serious side effects related to blood circulation can occur. 

Read more about managing side effects of SCIg

Side effects from an immunoglobulin product can also depend on its ingredients and how it was made

There are a number of different brands of immunoglobulin products and these may have some slight differences in ingredients – for example, different stabilisers are added to immunoglobulin products to make them last longer.

As the manufacturing process of different products can vary, on rare occasions individual people may experience side effects in response to one product but not another. Most people don’t notice a difference between the brands, but changes to side effects can happen.

Talk to your doctor if you want to know more about the ingredients in your immunoglobulin product or if you notice any changes when you start a particular product.

Once you have started immunoglobulins, your response to treatment is assessed to find out how your condition is progressing (‘clinical benefit’). This might be at 3, 6 or 12 months, depending on your condition.

Evidence of clinical benefit is a requirement for ongoing access to government-funded immunoglobulin.

Immunoglobulin products are not always needed long term, and stopping immunoglobulin products may be an option for some people. For many conditions, doctors must regularly consider a trial of reducing or stopping immunoglobulin products. Requirements for each condition are set out in the Criteria for the Clinical Use of Immunoglobulins in Australia.

If you have an immune deficiency disorder

There are some cases where immune replacement therapy (IRT) may not be necessary. For example, around one in 10 people with common variable immunodeficiency (CVID) don’t need treatment with immunoglobulin products.

Some primary immune deficiencies don’t need treatment all the time. There is a type of CVID (known as possible CVID) where you may be able to stop treatment for a while.

However, most people with a primary immune deficiency disorder need ongoing treatment, known as immunoglobulin replacement therapy (IRT), to replace their missing immunoglobulins.

If you have a primary immune deficiency disorder, your treatment should not be interrupted once a diagnosis has been made, without discussion with your doctor. Your treatment will be reviewed regularly to make sure you are getting the right amount of immunoglobulin product to maintain normal levels and make sure you are free from infections.

Sometimes IRT is prescribed for people with a secondary immune deficiency (also called acquired), which may only before a limited time. Secondary immune deficiencies can happen when the immune system becomes weakened – for example, if your immune system has been damaged by medicines, such as some anti-cancer drugs. Once these are stopped, your immune system might start producing its own immunoglobulins again, so IRT won’t be needed anymore.

If your doctor thinks that you are at low risk of infection without using immunoglobulin products, they may suggest discontinuing treatment for a short period. This is usually recommended in the warmer months of the year when there is less chance of catching a winter cold or flu virus. You may be prescribed antibiotics during this time in case you get an infection.

Your doctor will ask you questions about recent infections, how severe they were, whether you had to go to hospital or take time off work. You will have to have some tests before considering a trial off immunoglobulin products. These may include measuring your immunoglobulin levels to make sure the amount of IgG in your blood is enough to work properly.

If you have signs or symptoms of frequent or severe infections after stopping immunoglobulin products, your doctor will usually restart your treatment as soon as possible.

If you have an inflammatory or autoimmune disorder

The length of treatment with immune modulation therapy (IMT) is different for each condition and each person too.

Sometimes, autoimmune or inflammatory conditions become inactive or go into remission – your condition may have improved slowly, and the inflammatory processes that caused the damage may have stopped.

The only way to tell if your condition has become inactive is to do a trial where immunoglobulin treatment is gradually reduced over time or even stopped. In some cases, symptoms don’t return at all. If medical tests show that your condition has been stable for some time, your doctor may consider trying this approach.

Your doctor will check how your condition has progressed by measuring things specific to your condition, using recommended scales. These are set out in the Criteria for the Clinical Use of Immunoglobulin in Australia. Depending on your condition, these may include things like measuring tingling or weakness in your hands, or how well you can walk up stairs.

If your symptoms return, and you responded to treatment with immunoglobulin products before, you may be able to start immunoglobulin products again. If this is not the case, your doctor may recommend changing to a different treatment that may be more effective for you.

Read more about:

• The Criteria for the Clinical Use of Immunoglobulin in Australia
• Immunoglobulin products in Australia: information about access and consent
  

There is a chance that your symptoms return, but this will be different for each condition and for every person.

If you have been having IRT

If your blood does not contain enough immunoglobulins, you may be more likely to get infections that a healthy immune system would normally protect against. These include pneumonia, meningitis, and other infections that if left untreated can cause damage to organs such as the lungs. Some types of infections also tend to be more frequent, such as ear, sinus, and lung infections. If you get severe or frequent bacterial infections, you may need to take antibiotics for several months to prevent or treat them.

If reducing or stopping IRT means that you don’t have enough immunoglobulins, you may get more of these infections and develop long term problems from them.

Your doctor can discuss the possibilities of further illness or complications that may occur with you. If you have signs or symptoms of frequent or severe infections after stopping immunoglobulin products, your doctor can restart your treatment as soon as possible.

If you have been having IMT

For some people receiving IMT, symptoms may disappear and not return, even when treatment is stopped.

For others, symptoms can disappear for a period of time and then worsen again several months later—this is called relapse.

The chance of this happening is very different for each condition and will vary from person to person.

You should talk to your doctor straight away if your symptoms return or worsen. If this happens, there are many things that your doctor can do to help.

There may be several different treatments that are effective for your condition – these could include plasma exchange, corticosteroids, and immunosuppressive medicines. Alternatively, if required, you may be able to resume your immunoglobulin treatment.

Your doctor can discuss your treatment options with you and find a treatment plan that best manages your symptoms.

What you can do

Consider using a symptom diary to keep track of any signs or symptoms, good or bad, that you experience when your treatments are reduced or stopped. This might include changes to pain, fatigue, or activity, and how long the symptoms lasted.

Symptom diaries are useful to keep a record of any changes that you experience and help your doctors develop a more effective treatment plan.

It is useful to include other key personal information, such as any recent changes or stressful events that may have happened to you. 

Read more about the Criteria for the Clinical Use of Immunoglobulin in Australia

Getting enough sleep, healthy eating, managing stress and regular exercise will help your general health and well-being.

The best diet for the immune system is the same for everyone – healthy eating based on whole foods with limited processed starches, sugars, saturated fats and trans-fats. There is usually no need for a special diet, but this may depend on your diagnosis and any other conditions you have.

Read more about diet in primary immune disorders

Despite various claims, there are currently NO recommended supplements or other agents which have been proven in conventional medical studies to protect against infections or treat autoimmune diseases.

The relationship between diet and the immune system is two-way – the immune response is affected if nutrition is poor, which can increase the risk of infection. On the flip side, the immune response to some infections might affect your body’s ability to absorb nutrition.¹

There are several nutrients which are associated with a strong immune system or have a role in reducing chronic inflammation. For example, vitamin A and zinc are essential for a strong response by the immune system when it comes into contact with a foreign substance.²

However, the evidence on the effect of taking single nutrients to treat specific immune-related problems in humans is very limited.

A few small studies have shown that people with autoimmune diseases and CVID may have lower vitamin A, D or zinc levels.^3-7 But it is not known whether low vitamin levels increase the risk of autoimmune disease, or if taking vitamin D to boost levels improves immune function in people with these conditions. Research also shows that taking too much vitamin D can be harmful in some conditions.^8,9

It’s even more complicated when it comes to multivitamins and minerals – different nutrients can affect the same processes in the body and so it’s difficult to know what the benefits might be, or if these supplements can possibly cause harm.¹⁰

Some research shows that people who have immune disorders avoid exercise due to the mistaken fear that exercise can increase the risk of infection.¹¹

People with primary immune deficiencies and autoimmune conditions can generally enjoy exercise and sports without any complications.¹² Some primary immune disorders interfere with blood clotting so people with these conditions should discuss with their doctors how to exercise safely.¹³

The research shows that strength exercise programs, aerobic conditioning and balance training all have benefits for people with immune-related disorders, and can improve fatigue as well.^14-16 Just getting started with passive or gentle exercises will have benefits for your health and well-being.

There is no ‘one-size-fits-all’ approach to exercise for people with immune-related conditions. Talk to your doctor about an individual program that can be adjusted to suit as you progress.

There is no need to be concerned about keeping up your immunoglobulin treatments if you are planning to travel.

Discuss your travel plans with your doctor so they can help you plan how to continue your treatments as smoothly as possible.

There are infusion centres located around Australia where you can have your regular treatment if it is organised ahead of time. You will need to plan your trip carefully to make sure you still have your treatment when you need it.

The National Blood Authority has special provisions in place for people who are going overseas and need to continue treatment. You will normally need to apply at least 3 months before you leave Australia.

Find out more about:

• Travelling with SCIg
• Travel Plan for patients on SCIg (subcutaneous immunoglobulin) therapy
• Supply of Blood and Blood Related Products for use by Australian Residents Temporarily Overseas.
  

If you have an immune deficiency, there are simple things you can do to help manage your health and prevent infections, such as paying extra attention to good personal hygiene and hygiene around the home.

Watch the video Six steps to clean hands

If you’re a patient or carer of someone with an immune deficiency, autoimmune or inflammatory condition, there’s lots of help out there. Here are some places to go if you need more information about a condition, or somebody to talk to.

For people with inflammatory neuropathies (GBS or CIDP)

• Guillain Barré Syndrome Association of NSW
• Guillain Barré Syndrome Foundation of Australia
• The Inflammatory Neuropathy Support Group of Victoria
  

For people with immune deficiencies

• AusPIPS (Australian Primary Immunodeficiency Patient Support)
• Immune Deficiencies Foundation Australia

Professional organisations with consumer resources

• Australasian Society of Clinical Immunology and Allergy (ASCIA)
• Find more about Immunoglobulins

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2. Childs, CE, Calder, PC,Miles, EA. Diet and Immune Function. Nutrients 2019;11:1933.
3. Ardeniz, O, Avci, CB, Sin, A et al. Vitamin D deficiency in the absence of enteropathy in three cases with common variable immunodeficiency. Int Arch Allergy Immunol 2008;147:74-83.
4. Elf, K, Askmark, H, Nygren, I et al. Vitamin D deficiency in patients with primary immune-mediated peripheral neuropathies. J Neurol Sci 2014;345:184-8.
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13. Cleland, SY Siegel, RM. Wiskott-Aldrich Syndrome at the nexus of autoimmune and primary immunodeficiency diseases. FEBS Lett 2011;585:3710-4.
14. Simatos Arsenault, N, Vincent, PO, Yu, BH et al. Influence of exercise on patients with Guillain-Barre Syndrome: A systematic review. Physiother Can 2016;68:367-76.
15. Streckmann, F, Zopf, EM, Lehmann, HC et al. Exercise intervention studies in patients with peripheral neuropathy: a systematic review. Sports Med 2014;44:1289-304.
16. White, CM, Pritchard, J,Turner-Stokes, L. Exercise for people with peripheral neuropathy. Cochrane Database Syst Rev 2004;Cd003904.