Subcutaneous immunoglobulin (SCIg) is a solution of human plasma proteins and in particular IgG antibodies with a broad spectrum of antibody activity. SCIg is prepared from large pools of human plasma and contains the typical IgG antibodies found in the normal population. SCIg is used for patients who need replacement of antibodies.
SCIg can be obtained under National Blood Supply arrangements. Refer to the National Blood Authority website about the supply of SCIg in Australia.
Always read and refer to the product information sheet of every product prior to administration.
What is the criteria for its use?
Clinicians are able to choose between the available SCIg products to best suit their patient's need within the requirements of State/territory or institutional policies.
SCIg is only approved for patients with a medical condition where there’s support for use cited in the Criteria for the Clinical Use of Intravenous Immunoglobulin in Australia, namely:
- primary immunodeficiency disease with antibody deficiency
- specific antibody deficiency
- acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT)
- secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT), and
- chronic inflammatory demyelinating polyneuropathy (CIDP), (including IgG and IgA paraproteinaemic demyelinating neuropathies).
Note: SCIg is approved for use for the treatment of CIDP under the national blood arrangements pending the outcome of a current Health Technology Assessment (HTA) review evaluating the use of immunoglobulin in the treatment of CIDP. For more information, please visit the NBA website.
In addition to the above, SCIg is also approved for patients who are:
- being treated by a clinical specialist within a hospital-based SCIg program where the hospital provides all resources and takes full accountability for the management and use of the SCIg product, at no additional cost to patients, and
- following a patient-specific SCIg request submitted to, and authorised by, Lifeblood.
Access to SCIg
The National Blood Authority (NBA) has established arrangements for access to immunoglobulin products for subcutaneous use.
In all States/territories government-funded SCIg is accessed online by registered users of BloodSTAR.
BloodSTAR is the National Blood Authority’s online system that facilitates authorisation, dispensing and reviews of immunoglobulin products such as SCIg.
To register for BloodSTAR you will need to create an account with the National Blood Authority’s BLOODportal.
- Evogam®
Evogam® is an Australian manufactured SCIg product. Evogam® is supplied by CSL Behring and available as a 16% solution in vial sizes 0.8 g/5 mL and 3.2 g/20 mL.
This link takes you to CSL Behring's web information about Evogam®. You can download the product information (PI) sheet from this web page.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, dosage and administration of Evogam.
- Hizentra®
Hizentra® an imported SCIg product. Hizentra® is supplied by CSL Behring and available as a 20% solution in vial sizes: 1 g/5 mL, 2 g/10mL, 4 g/20mL and 10 g/50mL.
Hizentra® product information and educational materials
This link takes you to CSL Behring's web information about Hizentra ® where you can download the product information (PI) sheet for this product.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, dosage and administration of Hizentra®.
- Cuvitru®
Cuvitru® an imported SCIg product. Cuvitru® is supplied by Takeda and available as a 20% solution in vial sizes: 1 g/5 mL, 2 g/10mL, 4 g/20mL and 8 g/40mL.
This link takes you to Takeda's web information about Cuvitru® where you can download the product information (PI) sheet for this product.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, dosage and administration of Cuvitru®.
- Hizentra® AU
Hizentra® AU an Australian manufactured SCIg product. Hizentra® AU is supplied by CSL Behring and available as a 20% solution (20 g/100 mL) in vial sizes: 1 g/5 mL and 4 g/20mL.
Hizentra® AU product information and educational materials
This link takes you to CSL Behring's web information about Hizentra® AU where you can download the product information (PI) sheet for this product.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, dosage and administration of Hizentra® AU.
Lifeblood has sent a letter to all Approved Health Providers regarding the introduction of Hizentra® AU and a copy can be found here.
- Xembify®
Xembify® an imported SCIg product. Xembify® is supplied by Grifols and available as a 20% solution (20 g/100 mL) in vial sizes: 1 g/5 mL, 2 g/10 mL, 4 g/20mL and 10 g/50 mL.
This link takes you to Therapeutic Goods Administration (TGA) website where you can download the product information (PI) sheet for Xembify®.
The PI details the pharmacology, indications, contraindications, precautions, adverse effects, use in pregnancy and lactation, dosage, and administration of Xembify®.To assist with developing hospital (or treating facility) administration protocols for Xembify®, Consumer Medicine Information is also available on the TGA website.
Lifeblood has sent a letter to all Approved Health Providers regarding the introduction of Xembify® and a copy can be found here.
Related resources
Comparison of Subcutaneous Immunoglobulin Products Available under National Blood Supply Arrangements from 6 December 2023
Information Sheet
