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Intravenous Immunoglobulin (IVIG)Therapy

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Introduction

Concentrates of human globulin have been used to prevent infectious diseases for more than 50 years. Purified preparations of gammaglobulin are available for intravenous use (IVIG). IVIG has been used in a multitude of clinical scenarios, and the range of disorders in which it has positive therapeutic impact is likely to continue to increase.

Indications for IVIG

  1. Immune deficiency with antibody deficiency
  2. Idiopathic Thrombocytopenic Purpura
  3. Kawasaki disease
  4. Other

Preparations

In New Zealand the available intravenous preparations are:

  • Intragam®P in a 6% solution. Intragam®P is made using serum from New Zealand blood donors at the Commonwealth Serum Laboratory in Melbourne. It is available in 10,50 and 200ml vials containing 0.6, 3 and 12g of IgG.
  • Privigen in a 10% solution. Privigen is prepared from pooled plasma donations from European and North American donors. It is available in 5g (50mL), 10g (100mL) or 20g (200mL) bottles.

For further information about these products see:  http://www.clinicaldata.nzblood.co.nz/resourcefolder/ivig.php?dhbid=9

For information about which preparation is recommended for which patient groups see: http://www.clinicaldata.nzblood.co.nz/resourcefolder/documents/Introduction.of.a.commercial.intravenous.immunoglobulin.product.pdf

Dosage

The replacement dose for immunodeficiency patients is generally 400-600 mg/kg each 3 - 4 weeks. Assessment of dose adequacy will be made clinically and by measuring the trough IgG, which will generally be kept >7g/l. Most often the dose will be rounded to use the whole vial.

Immunomodulation (e.g. in treatment of ITP or Kawasaki's) will require higher doses of IVIG. In treatment of other conditions (e.g. haemolytic anaemia) very high doses have been used.

Prior to the first infusion informed consent needs to be obtained. There is a patient information leaflet on Intragam®P from the Blood Transfusion Service.

Premedication

Premedication is sometimes but not always required. Paracetamol and antihistamines can be useful; rarely patients may require premedication with corticosteroids.

Infusion

Infusion can be given via a butterfly, angiocath or central access. The Intragam®P should be allowed to reach room temperature. IVIG is given undiluted, and can be directly connected to the infusion giving set. It should not be used after its expiry date.

Vital signs (HR, RR, BP and temperature) should be monitored prior to the infusion and then each 30 minutes until the infusion is complete.

Infusions should be commenced at low rates and increased as tolerated. This is to minimise the chance of adverse reactions to infusion.

For Intragam®P:

  • For children <30kg start at 1ml/kg/hr for the first 15 minutes, 2ml/kg/hr for the next 15 minutes, 3ml/kg/hr for the next 15 min, and then 5ml/kg/hr until finished.
  • For children >30kg start at 20ml/hr then go 40, 80, 150ml/hr.

For Privigen:

  • Start at 0.3 mL/kg/hour
  • Double the rate every 30 minutes to a maximum rate of 2.4mL/kg/hour (as tolerated)
  • For treatment of PID and CIDP the maximum infusion rate is 4.8 mL/kg/hour but only from the fourth infusion onwards

In some situations (e.g. Kawasaki Disease) the rate may need to be slower if there is concern about cardiac function or fluid overload. The rate may also need to be slower in the presence of active infection.

Adverse Effects

A detailed description of adverse effects is found in the medsafe datasheet which can be viewed online.

Monitoring and Documentation

  • Immunoglobulins Immunodeficient patients should have IgG (+/- IgA and IgM) checked regularly. The trough IgG is a factor in determining whether a dose is adequate, but the clinical status of the patient is also important. After a change in IVIG dose it will take 3 - 5 half lives to reach a new steady state. The half-life of IVIG is 25 - 32 days in immunodeficient patients.
  • Consider checking serum immunoglobulins in patients about to receive IVIG for other indications, as immunodeficiency can be associated with, for example, haemolytic anemia or thrombocytopaenia.
  • Liver enzymes Should be monitored each 3-4 months.
  • Records Should be kept of the amount of IVIG given, condition of the patient and observations during infusion. The sticker from the bottle with the batch number of the IVIG should be placed in the patient's chart. This is important in case of reaction to the IVIG or should the need arise to trace recipients of particular batches.

References

Adverse effects of intravenous immunoglobulin therapy. Ryan ME et al. Clinical Pediatrics, Jan 1996, p23

Indications for the use of intravenous immunoglobulin. Keller T et al. Med J Aust, Aug 1993, p204

Indications for the use of intravenous gammaglobulin. Schiff R. Ann All, June 1992, p447

Therapy of immunologic disease. Polmar SH, Sorensen RU. In "Clinical Immunology" Rich et al, Mosby, 1996

Data sheet:  http://www.medsafe.govt.nz/profs/datasheet/i/IntragamPinj.pdf

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Document Control

  • Date last published: 17 December 2015
  • Document type: Clinical Guideline
  • Services responsible: Paediatric Immunology
  • Author(s): Jan Sinclair
  • Owner: Jan Sinclair
  • Editor: Greg Williams
  • Review frequency: 2 years

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