Subcutaneous Immunoglobulin (SCIg) Therapy General Information

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Immunoglobulins (commonly known as antibodies) are used to treat adults and children with primary immune deficiencies (PID), also known as inborn errors of immunity, and other medical conditions, who are unable to make enough of their own antibodies, or who have antibodies that don’t work properly.

Replacing these antibodies helps to protect against infection and can prevent long term damage from ongoing infections, such as chronic lung disease.

What is SCIg?

Subcutaneous Immunoglobulin (SCIg) infusions are given by slowly injecting purified immunoglobulin into fatty tissue just underneath the skin. SCIg:

Requires frequent administration (ranging from 1-3 times per week to once a fortnight) by patients or carers at home.
Involves slow diffusion of IgG from subcutaneous tissue.
Is associated with more consistent serum IgG levels due to frequent administration.
Is administered at multiple injection sites according to personal preference, usually in the lower abdomen. However, the outer edge of the thigh or back of the upper arm can also be used.

How are SCIg infusions given?

SCIg can be given at home using:

Mechanical infusion pumps - spring loaded or battery powered.
Push method - a manual method that does not require a pump, with the infusion pushed by hand through a syringe.

Immunoglobulin products are safe

SCIg is very well tolerated and safe. SCIg is made from plasma (the liquid part of blood), which comes from blood donors who are checked to make sure they are healthy and do not have certain infectious diseases.

Manufacturers also include steps in the processing of blood or plasma that inactivate or remove viruses.

This means that there is an extremely low (almost zero) chance of the transmission of blood borne viruses (such as Hepatitis B, Hepatitis C, HIV and Variant Creutzfeldt-Jakob disease (also called “mad cow disease”) via SCIg.

What are the risks associated with SCIg?

Reactions or side effects to SCIg include:

Common injection site reactions such as redness, swelling and itching.
- These are usually mild and go away over a day or two.
- Reactions are generally worse with the first few infusions and get better over time.
- Most itching is resolved by slowing the infusion.
Uncommon side effects such as headache, feeling hot, nausea, diarrhoea, sore throat, rash, increased cough and back pain.
- These are usually mild.
Extremely rare and serious side effects such as allergic reactions, kidney problems or blood clots.

If a reaction occurs you must inform your nurse specialist or doctor as soon as possible and get advice before having any more infusions.

For information about managing reactions see pages 6 and 7 of this document.

What needs to be done before starting SCIg?

ASCIA Transfer Care Plan for patients Before you start on SCIg, your nurse specialist will provide you with information and training on how to give SCIg at home. Nurses play a crucial role in educating and supporting people who are being treated with immunoglobulin products.

You will need to sign a consent form to say that you understand the need for treatment and the chance of reactions that may occur with the treatment.

An ASCIA Transfer Care Plan for patients is available at www.allergy.org.au/hp/papers/ascia-transfer-care-plan-irt

This plan has been developed as a medical document to be completed by an immunology or nurse specialist, when a patient is transitioning from:

Paediatric to adult medical care.
One region to another.
IVIg to SCIg.
SCIg to IVIg.

Choosing a SCIg infusion site

SCIg injection sites Using the same site for infusions can help reduce the amount of local swelling and redness that can occur after an infusion.

However, multiple (2-3) sites can be used on a rotating basis, according to patient preference.

Rotating the infusion site is preferable for some patients and this may reduce the risk of scar tissue developing.

SCIg injection sites are usually in the lower abdomen, but the outer edge of the thigh, buttocks or back of the upper arm can also be used. Avoid bony areas such as the hips.

When using the lower abdomen in adults and most children, the needle should be inserted at least 5cm away from the belly button.

If using more than one site at a time, make sure they are at least 5cm apart.

Note: Do not insert the needle where the skin is scarred, bruised, broken or inflamed (such as eczema).

Before infusion it is important to have your equipment ready – see the ASCIA Subcutaneous Immunoglobulin (SCIg) Equipment Checklist www.allergy.org.au/patients/immunodeficiencies/scig-therapy-equipment-checklist

An ASCIA Subcutaneous Immunoglobulin (SCIg) Infusion Checklist is also available at www.allergy.org.au/patients/immunodeficiencies/scig-infusion-checklist

It is recommended to have a cold pack, a non-drowsy antihistamine and an analgesic (pain medication) available in case of a mild reaction.

Examples of SCIg infusions are shown below.

SCig infusion

Documenting the SCIg infusion

Patients should record the following details in a SCIg infusion diary, which can be shown to the nurse or medical specialist:

Brand of SCIg product.
Batch number/sticker.
Date and time of infusion.
Time taken for infusion.
Date
Reactions to infusion.
Problems with product (e.g. visible particles - not used and returned).
Unused or wasted product (e.g. spilled/damaged or infusion stopped due to adverse reaction).

Ordering, collection, transport and storage of SCIg

Use the ASCIA SCIg Treatment Plan, which is available on the ASCIA website allergy.org.au/hp/papers/ascia-scig-treatment-plan
SCIg product needs to be ordered in advance.
Your nurse specialist or doctor will explain how and where to collect the SCIg product and this should be included in your SCIg treatment plan.
SCIg must be kept cool (2-8°C) for the journey home:
- When collecting SCIg you must provide a cool box or cool bag large enough to transport vials with an icepack. Ensure SCIg vials are not in direct contact with the ice, to avoid possible freezing.
- Take SCIg home immediately and place in a sealed container in the central part of the refrigerator.
Storage temperatures are dependent on product choice - your nurse specialist will tell you how to store the SCIg product you are using. However, the following principles should be followed for all SCIg products:

Store SCIg in original packaging until needed, and protected from light
Store SCIg between 2°C and 25°C and avoid extreme temperatures.
Do not freeze SCIg - never store below 2^oC and do not use SCIg that has been frozen.
Do not shake SCIg.

If you have a power or refrigerator failure and are unable to keep SCIg refrigerated:

Contact your nurse specialist as soon as practical for further advice.
If fridge is still cold, keep your supply in the fridge.
If the fridge is no longer cold, place SCIg in your transport cool box or cool bag with an ice pack.

Product from a vial is for single use only

Once the vial is opened, SCIg needs to be used as soon as possible as the product does not contain preservative.
If an infusion cannot be completed within the recommended time (which varies between 2 and 4 hours for different products), any unused product should be discarded.
All SCIg vials must be disposed of in the sharps container provided by your hospital. These should be returned to the hospital or pharmacy. SCIg vials must not be discarded in your household bin.

SCIg Products

There are currently three different brands of SCIg available in Australia and New Zealand:

Hizentra® - CSL Behring
Evogam® - CSL Behring
Cuvitru® - Takeda

SCIg Product - Hizentra®

Once removed from the refrigerator, store Hizentra® between 2°C and 25°C and use until expiry date.
Hizentra® is a clear, pale yellow to light brown solution.
Do not use if the solution is cloudy or contains particles.
Complete Hizentra® infusions within 4 hours of starting infusion.
For instructions go to https://www.nps.org.au/medicine-finder/hizentra-vial

SCIg Product - Evogam®

Once removed from the refrigerator, store Evogam® between 2°C and 25°C and use within two weeks.
Evogam® is a clear, pale-yellow to light brown solution.
Do not use if the solution is cloudy or contains particles.
Complete Evogam® infusions within 4 hours of starting the infusion.
For instructions go to https://www.nps.org.au/medicine-finder/evogam-solution-for-injection

SCIg Product – Cuvitru®

Cuvitru

Store between 2ºC and 8ºC, this is a change from below 25ºC.
The shelf life is now 36 months, this is an increase from 24 months.
Cuvitru® is a clear and colourless to a pale yellow or light brown solution.
Do not use if the solution is cloudy or contains particles.
Complete Cuvitru® infusions within 2 hours of starting the infusion.
For instructions go to https://www.nps.org.au/medicine-finder/cuvitru
Note: The National Blood Authority (NBA) advises that Cuvitru is transitioning to a revised temperature and storage requirement from 12 September 2022 in accordance with product registration changes on the Australian Register of Therapeutic Goods. Future Cuvitru stock will be labelled to specify the revised shelf life and temperature storage requirements.

Checking SCIg vials before an infusion

All SCIg vials should be checked for the following prior to an infusion:

Expiry date on the vial - DO Not Use if out of date.
Protective cap is in place - DO Not Use if seal is broken.
Solution in vial is clear - DO NOT USE if solution is cloudy, discoloured or contains particles.

Contact your nurse specialist if any of the above happens.

Use of SCIg when unwell, pregnant or breastfeeding

Contact your doctor or nurse specialist for further advice if you:

Are unwell with a fever.
Suspect you are pregnant.
Are breast feeding.

Your doctor and nurse specialist will work with you to develop a plan to respond to any adverse reaction.

SCIg and vaccinations

Some immunisations may not be required while on SCIg. Discuss this with your doctor.

Travelling with SCIg

ASCIA SCIg travel plan People travelling with SCIg should:

Plan well in advance before travelling.
Obtain advice from their doctor or nurse specialist before travelling, especially overseas, as an export permit may be required.
Use the ASCIA SCIg Travel Plan, completed by their nurse or medical specialist Travel Plans are available on the ASCIA website www.allergy.org.au/hp/papers/ascia-travel-plan-for-scig-patients
Take their SCIg Travel Plan and Treatment Plan in hand luggage.
Consider having a dose of Intravenous Immunoglobulin G (IVIg) before travel, which may be a convenient alternative.
Consider having extra SCIg infusions before and after the trip, for shorter periods of travel.
Pack SCIg in hand luggage when flying, whilst maintaining the cold chain and remembering to collect it before they leave the plane. SCIg must not be put into checked-in luggage.
Carry pain medication and a non-drowsy antihistamine in case of adverse reactions.
Take enough consumable equipment for the time they are away from home.
Pack enough SCIg for the trip and store this in original packaging until needed, in a cool box or cooler bag. It is important to keep SCIg at an appropriate temperature as specified for the product, at all times. Patients should check product information, and if uncertain, check with their nurse specialist. SCIg should never be stored below 2°C or above 25°C.

Managing side effects of SCIg

Swelling side effects SCIg Common local reactions at the infusion site include:

Mild or moderate swelling (egg sized lump).
Hardness.
Blanching (whiteness).
Redness at the infusion site.

These reactions are normal and short lived, usually gone by the next day. They are more common in people who have just started SCIg, especially in the first few months.

Most people start to notice a decrease in local reactions after about 8-10 weeks.

Over time, the skin will “get used” to the repeated infusions, and local reactions will lessen.

Using the same SCIg infusion site versus rotating sites

Using the same site for SCIg infusions can help to reduce the amount of local swelling and redness that can occur after an infusion. However, rotating the infusion site is preferable for some patients, and may reduce the risk of scar tissue developing.

General steps to take if an infusion site reaction occurs

infusion site reaction action If an infusion site reaction occurs, you should:

Apply gentle massage and warm or cold pack (according to your personal preference) to reduce discomfort. An ice pack should not be applied for four hours post infusion to ensure adequate absorption.
Not rub or scratch the infusion site.
Record site reactions in an infusion diary.
Report unusual site reactions, such as extreme pain or discomfort, blistering or spreading redness to your nurse specialist.
Refer to the table below for different ways to manage reactions or problems at the infusion site.

Management guide for SCIg infusion site reactions and problems

Site Issue	Possible Cause/s	Management Options
Redness	Common reaction, which usually settles over 24 hours. If redness is excessive: In some cases it may be due to an allergy or sensitivity to tape. Needle may not have been inserted correctly or needle may be too short.	If it does not cause discomfort, do nothing. Warm or cold pack for short periods may help with discomfort Wrap warm/cold packs in a cloth - do not apply directly to the skin Slow the infusion rate if uncomfortable Try using an over the counter non-drowsy antihistamine Check correct needle placement/length with your nurse specialist Consider alternative tapes/dressings to secure needle/s with your nurse specialist
Swelling	Common reaction, which usually settles over 24 hours, resulting from the amount of fluid being infused underneath the skin (amount of swelling should relate to the volume being infused).	If it does not cause discomfort, do nothing A warm pack for short periods may help with absorption. A cold pack for short periods may help with discomfort, but delays absorption Wrap warm/cold packs in a cloth - do not apply directly to the skin Take a walk to help with absorption Check correct needle placement/length with your nurse specialist May need to decrease volume at the site, reduce the rate or change the infusion site. This should be discussed with your nurse specialist
Itching or burning	Incorrect needle placement Incorrect needle length Irritation from tape Ig at needle tip, causing skin irritation	Do not scratch or rub Check needle placement and length Try using an over the counter non-drowsy antihistamine Consider alternative tapes/ dressings to secure needle/s Apply cold pack for short periods - wrap pack in a cloth - do not apply directly to the skin Discuss dry priming with your nurse specialist
Pain with infusions	Incorrect needle placement Incorrect needle length Infusion going too fast	Check needle placement/length Apply cold pack for short periods - wrap pack in a cloth - do not apply directly to the skin Slow infusion rate Try simple pain medication (such as paracetamol) before starting the infusion Take a walk to provide a distraction Check tape placement for pulling on skin or body hair Discuss with your nurse specialist
Blanching (whiteness)	Normal tightening of tissue that can occur as SCIg infuses into the fatty tissue under the skin.	Do nothing, usually goes away on its own when the fluid is absorbed Warm pack for short periods (may assist absorption) - wrap pack in a cloth - do not apply directly to the skin
Leaking from the infusion site	Incorrect needle insertion Incorrect needle length Amount of volume infused at the site	Check needle insertion May need to consider changes to volume, needle length or rate of infusion. Speak to your nurse specialist or doctor.

Management guide for other reactions to SCIg

Content updated September 2022

For more information go to www.allergy.org.au/patients/immunodeficiencies

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ASCIA is the peak professional body of clinical immunology and allergy specialists in Australia and New Zealand

Disclaimer

This document has been adapted with permission from resources developed by Perth Children’s Hospital Immunology Department (Department of Health, Western Australia), formerly Princess Margaret Hospital.

The content has been peer reviewed by ASCIA members and is based on expert opinion and the available published literature at the time of review. Information contained in this document is not intended to replace medical advice and any questions regarding a medical diagnosis or treatment should be directed to a medical practitioner. Development of this document is not influenced by commercial organisations.