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.
Prescription of SCIg often requires specialist consultation. Always read and refer to the product information sheet of every product prior to administration.
Criteria for 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.
Subcutaneous immunoglobulin is only approved for patients:
- with a medical condition where there is 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)
- 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.
- 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, the Blood Service.
Access to subcutaneous immunoglobulin
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® is an Australian manufactured SCIg product. Evogam® is supplied by CSL Behring and available as a 16% solution in vial sizes 0.8g/5 mL and 3.2g/20 mL supplied by CSL Behring. SCIg is used for patients who need replacement of antibodies.
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 & lactation, and dosage & administration of Evogam.
Hizentra® an imported SCIg product. Hizentra® is supplied by CSL Behring and available as a 20% solution in vial sizes 1g/5 mL, 2g/10mL, 4g/20mL and 10 g/50mL. SCIg is used for patients who need replacement of antibodies.
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 & lactation, and dosage & administration of Hizentra®. You can also download an order form to request copies of educational materials.