Immunoglobulin therapy

Intravenous immunoglobulin (IVIg) is registered for use in Australia for the treatment of a number of diseases where Ig replacement or immune modulation therapy is indicated, such as primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy. IVIg is also used to treat a growing number of unregistered indications where there is some clinical evidence for its utility. The significant cost and continuing substantial increase in demand for IVIg makes its supply and management a high priority. Under the national blood arrangements IVIg is provided through clinical governance and management framework which is described under National Framework for Immunoglobulin Products and facilitated through BloodStar (external site).

Subcutaneous immunoglobulin (SCIg) is similar to IVIg and provides an alternative method of infusion into the subcutaneous tissue. Hospitals participating in the national SCIg programs are required to provide an acknowledgement of the governing requirements by the Chief Executive or Director of Clinical Services (or equivalent) prior to ordering and providing SCIg products to their patients. There are a range of resources and materials which have been produced to support hospital based SCIg programmes (external site). The quick links are regularly updated.

Normal human immunoglobulin (NHIg) may be supplied for two purposes: the treatment of susceptible contacts of measles, hepatitis A, poliomyelitis and rubella, as directed by public health officials; and the treatment of immunodeficiency conditions for which the product is indicated (where IVIg and SCIg are both contraindicated).

Hyperimmune immunoglobulin products are similar to IVIg but are prepared from the plasma of donors with high titres of antibody against a specific organism or antigen.

Cytomegalovirus (CMV) immunoglobulin - is used to prevent CMV infection in bone marrow, renal, cardiac and liver transplant recipients, who are CMV antibody negative, where the donor is CMV antibody positive. It is also used for the treatment of established CMV infection in association with virucidal treatment.

Hepatitis B immunoglobulin - is administered intramuscularly and indicated for the prevention of an infection developing in a person who has been exposed to the hepatitis B virus, who has not received prior vaccination, or whose vaccination program is incomplete. It is also indicated for those whose antibody levels are inadequate.  In addition, Hepatitis B immunoglobulin helps prevent hepatitis B infection in infants born to mothers with hepatitis B.

Rh(D) immunoglobulin - is given intramuscularly as prophylaxis to Rh(D)-negative women during pregnancy and following birth of an Rh(D)-positive baby to help prevent Haemolytic Disease of the Newborn. An intravenous product is also available for use in large fetomaternal haemorrhage where administration of intramuscular Rh(D) Ig is either contraindicated or not practical, or for inadvertent or emergency transfusion of Rh(D) positive blood to an Rh(D) negative female of childbearing potential.

Tetanus immunoglobulin - is used intramuscularly for passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. It is also given to fully immunised individuals with a tetanus prone wound if more than 10 years have elapsed since the last dose of toxoid or vaccine. Tetanus Ig is also issued intravenously for management of tetanus infection.

Zoster immunoglobulin - is indicated for prophylaxis against varicella in patients who meet the following criteria: neoplastic disease (leukaemia or lymphoma), congenital or acquired immunodeficiency, undergoing immunosuppressive therapy with steroids or antimetabolites, and a negative or unknown prior history of chickenpox.

Further information regarding public health, infectious diseases and vaccination within WA.

The provision and supply of immunoglobulin (Ig) products under the national blood arrangements is managed and funded by the National Blood Authority (NBA) on behalf of all governments. If the product is ordered to treat a medical condition which is funded under Criteria for the clinical use of immunoglobulin in Australia (external site), the product is supplied and funded under the national blood supply arrangements. The National Blood Authority Australia has further guidance on Access to Government Funded Immunoglobulin Products in Australia (external site). The NBA does not manage individual requests to access Ig products outside of the conditions funded under the national blood arrangements.

As of the 1^st of December 2022, the Office of the Chief Medical Officer will cease approval of Jurisdictional Direct Order (JDO) requests for access to immunoglobulin products outside of the Criteria. Doctors seeking to prescribe immunoglobulin products outside of the Criteria, and utilise JDO arrangements for supply, must first obtain approval for use by their hospital Drug and Therapeutics Committee (DTC). The cost of Ig products raised through this process is borne solely and directly by the AHP. Only imported Ig products are available under this arrangement.

Other important notes

In circumstances where Ig cannot be accessed under the Criteria or Hospital DTC arrangements, it may be possible to access imported Ig directly from the relevant suppliers on a commercial basis and at private expense.

• Lifeblood information on immunoglobulin products (external site)
• Information on subcutaneous immunoglobulin (external site)
• AusPIPS | Primary Immune Deficiency Support (external site) patient information produced by Australian patient advocacy group
• Patients - Australasian Society of Clinical Immunology and Allergy (ASCIA) (external site) produce a wide range of evidence-based information for patients, consumers and carers
• Frequently asked consumer questions on subcutaneous immunoglobulin (external site)
• Patient information on immunoglobulin (external site)

Other resources

• Support materials, register for access and administrative support for BloodStar (external site)