Intravenous Immunoglobulins

Intravenous Immunoglobulins

General

All ARCBS-CSL immunoglobulins are procured from voluntary, non-remunerated blood donors. During the manufacturing process all immunoglobulins undergo either a one or two stage viral inactivation.

Prescription of these products often requires specific specialist consultation. Currently three IVIg products are available. For more information on these use the links below:

Storage

Stored at 2ºC to 8ºC (refrigerate – do not freeze).
Protect from light. Do not use after the expiry shown on the label.
Octagam: stored below 25°C.

Indications for Use

To ensure demand can be met from the limited supply, intravenous immunoglobulin (IVIg) is issued in accordance with the Criteria for the clinical use of Intravenous Immunoglobulin in Australia (2008) which have been developed to assist clinicians and transfusion medicine professionals to identify the conditions and circumstances for which the use of intravenous immunoglobulin (IVIg) is appropriate and funded under the National Blood Arrangements.

Forms for ordering IVIg can be accessed here.

A summary of the criteria is shown below.

The full criteria are available at the NBA website.  Hard copies and a quick reference guide can also be ordered via the NBA website.

Conditions for which IVIg has an established therapeutic role
(Chapter Five of the Criteria)

  • Chronic lymphocytic leukaemia
  • Multiple myeloma
  • Non-Hodgkin's lymphoma
  • Other relevant haematological malignancies
  • Chronic inflammatory demyelinating polyneuropathy
  • Guillain-Barré syndrome
  • ITP refractory
  • ITP with life-threatening haemorrhage
  • ITP in pregnancy
  • ITP in specific circumstances (surgery, corticosteroids, contraindicated, chronic ITP)
  • ITP associated with HIV
  • Polymyositis
  • Dermatomyositis
  • Inclusion body myositis
  • Kawasaki disease
  • Lambert-Eaton myasthenic syndrome
  • Multifocal motor neuropathy with persistent conduction block
  • Myasthenia gravis
  • Neonatal haemochromatosis
  • Common variable immunodeficiency
  • Neonatal haemochromatosis
  • Common variable immunodeficiency disease
  • Severe combined immunodeficiency
  • Transient hypogammaglobulinaemia of infancy 
  • X linked agammaglobulinaemia
  • Wiskott-Aldrich syndrome
  • Other Primary Immunodeficiency
  • Stiff person syndrome

Conditions for which IVIg has an emerging therapeutic role
(Chapter Six of the Criteria)

  • Acute disseminated encephalomyelitis
  • Wegener’s granulomatosis
  • Microscopic polyangiitis
  • Churg-Strauss syndrome
  • ANCA-positive idiopathic rapidly progressive glomerulonephritis
  • Autoimmune haemolytic anaemia
  • Bullous pemphigoid
  • Cicatricial pemphigoid
  • Evans syndrome
  • Foeto-maternal/neonatal alloimmune thrombocytopenia (antenatal)
  • Foeto-maternal/neonatal alloimmune thrombocytopenia (neonatal)
  • Haemophagocytic syndrome
  • High-risk allogeneic haemopoitic stem cell transplantation (for prevention of GvHD)
  • ITP in children
  • IgM para-proteinaemic neuropathy
  • Kidney transplantation – pre-transplant
  • Kidney transplantation – post-transplant
  • Multiple Sclerosis in pregnancy
  • Multiple sclerosis – severe relapse with no response to high dose methylprednisolone
  • Opsoclonus myoclonus ataxia
  • Pemphigus foliaceus
  • Pemphigus vulgaris
  • Post transfusion purpura
  • Secondary hypogammaglobulinaemia (excludes haem malignancies)
  • Specific antibody deficiency
  • Toxic epidermal necrolysis/Steven Johnson syndrome
  • TSS – Streptococcal
  • TSS - Staphyloccocal

Conditions for which IVIg use is in exceptional circumstances only
(Chapter Seven of the Criteria)

  • Acute leukaemia in children
  • Autoimmune congenital heart attack
  • Autoimmune diabetic neuropathy
  • Autoimmune neutropenia
  • Autoimmune uveitis
  • Catastrophic antiphospholipid syndrome
  • Coagulation factor inhibitors
  • Devic disease (neuromyelitis optica)
  • Epidermolysis bullosa acquisita
  • Epilepsy (rare childhood cases)
  • Graves opthalmopathy
  • Haemolytic disease of the newborn
  • Haemolytic transfusion reaction
  • HIV in children
  • Myocarditis in children
  • PANDAS/tic disorders
  • Paraneoplastic syndromes
  • Potassium channel antibody-associated encephalopathy
  • Pure red cell aplasia
  • Pure white cell aplasia
  • Scleromyxedema
  • Sepsis – neonatal
  • Sjogren’s syndrome
  • Solid organ – heart
  • Solid organ – lung
  • Solid organ – heart/lung
  • Solid organ – liver
  • Solid organ – pancreas
  • Solid organ – other
  • Susac syndrome
Conditions for which IVIg use is not indicated
(Chapter Eight of the Criteria)

  • Acute optic neuritis
  • Acute rheumatic fever
  • Adrenoleukodystrophy
  • Amegakaryocytic thrombocytopenia
  • Antiphospholid syndrome (non-obstetric)
  • Aplastic anaemia/pancytopenia
  • Asthma
  • Atopic dermatitis/eczema
  • Autism - young adults
  • Autologous haemopoietic stem cell transplantation
  • Cardiac surgery with bypass - prophylaxis
  • Congestive cardiac failure
  • Crohn's disease
  • Diamond Blackfan syndrome
  • Female infertility
  • Gloerulonephritis - IgA nephritis
  • Haemolytic uraemic syndrome
  • Henoch-Schonlein purpura
  • HIV/AIDS - adult
  • Idiopathic dilated cardiomyopathy
  • Linear IgA disease
  • Lupus nephritis
  • Motor neuron disease/amyotrophic lateral sclerosis
  • Myalgic encephalomyelitis
  • Narcolepsy/cataplexy
  • Nephrotic syndrome
  • Obsessive compulsive disorders
  • Paraneoplastic cerebellar degeneration (Yo antibodies)
  • Polyneuropathy of critical illness
  • Recurrent foetal loss (with or without antiphosphilipid syndrome)
  • Rheumatoid arthritis
  • Sensory neuropathy associated with anti-Hu antibodies
  • Sepsis (other than neonatal)
  • Sickle cell disease
  • Systemic lupus erythematosus
  • Ulcerative colitis

At the time of writing, clinical trials were proceeding for the use of IVIg in sepsis. The results of these trials may be taken into account in the first review of this document and its recommendations.

When IVIg can not be accessed under the National arrangements, if the clinician considers that the patient would benefit from IVIg therapy, the clinician may still obtain IVIg through the Jurisdictional Direct Order (JDO) provision. Note that procedures for accessing IVIg under JDO arrangements will vary and only imported IVIg is available under JDO arrangements.

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