Subcutaneous immunoglobulin (SCIg)

The National Blood Authority (NBA) has established arrangements for the supply of immunoglobulin products for subcutaneous use:

Evogam® is plasma-derived immunoglobulin for subcutaneous use. It is 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.

Evogam® product information

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® is a plasma-derived immunoglobulin for subcutaneous use. This is an imported product supplied by CSL Behring and available as a 20% solution in vial sizes 1g/5 mL, 2g/10mL, 4g/20mL and 10 g/50mL and 20 g/200 mL. SCIg is used for patients who need replacement of antibodies.

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 & lactation, and dosage & administration of Hizentra®. You can also download an order form to request copies of educational materials.

Gammanorm® is a plasma-derived immunoglobulin for subcutaneous use. This is an imported product supplied by Octapharma and available as a 16.5% solution in vial sizes 1650 mg/10 mL and 3300 mg/20 mL. SCIg is used for patients who need replacement of antibodies.

Gammanorm® product information

This link takes you to Octapharma’s web information about Gammanorm® 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 Gammanorm®.

Kiovig® is a plasma-derived immunoglobulin for subcutaneous and intravenous use. This is an imported product supplied by Baxalta, and available as a 10% solution in vial sizes 1g/10 mL, 2.5g/25mL, 5gm/50mL, 10g/100mL and 20g/200mL. SCIg is used for patients who need replacement of antibodies.

 

Clinicians are able to choose between the available SCIg products to best suit their patient's need within the requirements of any state/territory or institutional policies.

► Download the comparison of Evogam and Hizentra

► Download the comparison of Evogam, Gammanorm and Kiovig

 

Availability of Gammanorm and Kiovig

As of 1 January 2016, Gammanorm 16.5% and Kiovig 10% are not available to order for new patients; however, these products continue to be available to order for existing patients until 30 June 2016.  Any patients who require treatment beyond 30 June 2016 will need to be transitioned to another SCIg product, i.e., Evogam® or Hizentra®.
Further information on supply arrangements for imported Ig products in Australia is available on the National Blood Authority website.

 

Criteria for Use

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
    • secondary hypogammaglobulinaemia
  • 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 additonal cost to patients, and
  • following a patient-specific SCIg request submitted to, and authorised by, the Blood Service.

New IVIg/SCIg Authorisation Request Forms for access to government funded immunoglobulin products were implemented in all states and territories from 1 September 2015.

All the forms are available on the National Blood Authority website.  These forms have two pages that will need to be completed by the Prescriber and submitted to the Australian Red Cross Blood Service or other approved delegate, for assessment for access to government funded immunoglobulin product, in accordance with the Criteria for the clinical use of intravenous immunoglobulin in Australia.

► Download weekly order forms