ASCIA Guidelines – Standardised infusion rates for intravenous immunoglobulin replacement therapy

pdfASCIA Guidelines IVIG Infusion Rates 2018130.54 KB

Immunoglobulin replacement therapy (IRT) is the standard treatment for most children and adults with primary immune deficiencies and some other medical conditions.  The aim is to replace immunoglobulin to maintain normal IgG levels. The dose used is individualised for each patient. IRT may be given as intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg). 

When prescribing IVIg or SCIg, you must ensure that doses are rounded to the full vial size. Immunoglobulin is a plasma derived product and is a limited resource. Prescribing a dose that uses a partial vial results in unnecessary wastage.  Vial sizes vary between different products.  This must be taken into account before prescribing.

There are several intravenous immunoglobulin (IVIg) immunoglobulin products available. In both Australia and New Zealand the IVIg products imported for clinical use may change from time to time.

Products that are currently available include: 

  • Intragam® 10 is a 10% w/v solution of IgG produced by the CSL Behring from voluntary donors to the Australian Red Cross Blood Service. Intragam® 10 is available in 2.5 g in 25 ml, 10 g in 100 ml and 20 g in 200 ml. 
  • Privigen® is a 10% solution of IgG produced from imported plasma by CSL Behring, Australia. Privigen® is available in 5 g in 50 ml, 10 g in 100 ml, 20 g in 200 ml and 40 g in 400 ml. 
  • Flebogamma® is in both 5% and 10% solutions of IgG produced by Instituto Grifols, Spain. Flebogamma® 5% is available in 0.5 g in 10 ml, 2.5 g in 50 ml, 5 g in 100 ml, 10 g in 200 ml and 20 g in 400 ml. Flebogamma® 10% is available in 5 g in 50 ml, 10 g in 100 ml and 20 g in 200 ml. 

Infusion Rates

Individual products recommend different weight based rates of infusion. To avoid confusion, ASCIA has developed standardised infusion rates for both 5% and 10% solutions, regardless of product. These rates are generally well tolerated.

These recommended infusion rates are for patients with immune deficiency on replacement IVIg therapy. Patients using IVIg for other conditions such as Kawasaki disease or immunomodulation should follow local protocols.

Adverse reactions

Adverse reactions can be related to the rate of infusion and often resolve with stopping or slowing the infusion rate. However, a medical review may be required before re-starting the infusions to rule out other pathologies.

Severe reactions are uncommon and are most likely to occur during the first infusion, but may occur subsequently. Symptoms or signs of reactions may include: dyspnoea, wheezing, chest tightness, coughing, changes in blood pressure, tachycardia, flushing, fever, rigors, skin rash/urticaria, headache, vomiting, nausea and abdominal and back pain.

The following guide may be followed when adverse reactions occur. 

In response to a minor reaction (flushes, nausea, back or abdominal pain, dizziness and headache): 

  • Stop infusion immediately
  • Report any adverse effects immediately to the supervising medical officer and nurse, and request medical review
  • Once the patient is stable, consider administration at a slower rate. Adverse reactions are usually dependent on the infusion rate and most commonly occur in the first hour of infusion
  • If the reaction persists or the patient does not tolerate further administration, report the reaction, contact the product manufacturer and notify ARCBS or NZBS, including product batch number. 

In response to a severe allergic reaction (anaphylaxis) with respiratory or cardiac compromise: 

  • Stay with patient
  • Stop infusion immediately, maintaining patency of intravenous access
  • Administer oxygen
  • Implement medical emergency procedure
  • Prepare emergency medication for treatment of acute anaphylaxis for administration
  • Continuously monitor airway, breathing, circulation and neurological status (include urine output, volume, and colour)
  • Document event on patient medical record
  • Return remaining blood product to pathology with a pathology request form, indicating symptoms the patient experienced and testing required.

First Infusion

10% IVIG products: For the first infusion, Intragam® 10, Privigen®, Flebogamma® 10%, Kiovig® Octagam® 10% should be infused at a rate of 0.5 ml/kg/hour for the first 30 minutes. If there are no adverse reactions the rate can be increased every 30 minutes according to the table to a maximum rate of 3 ml/kg/hour (not to exceed 150 ml/hour).

5% IVIG products: For the first infusion, Flebogamma® 5% should be infused at a rate of 1 ml/kg/hour for the first 30 minutes. If there are no adverse reactions the rate can be increased every 30 minutes according to the table to a maximum rate of 6 ml/kg/hour (not to exceed 300 ml/hour).

  First Infusion
    10% IVIG products 5% IVIG products
    Intragam® 10,
Privigen®,
Flebogamma® 10%, Kiovig®,
Octagam® 10%
Flebogamma 5%
Step Time Rate (ml/kg/hour) Rate (ml/kg/hour)
1st 30 minutes 0.5 1
2nd 30 minutes 1 2
3rd 30 minutes 2 4
4th To complete infusion 31 62

1 Rate not to exceed 150 ml/hour; 2 Rate not to exceed 300 ml/hour. 

Subsequent Infusions

10% IVIG products: If there is no reaction to the first infusion, Intragam® 10, Privigen®, Flebogamma® 10%, Kiovig® Octagam® 10% should be infused at a rate of 0.5 ml/kg/hour for the first 15 minutes. If there are no adverse reactions the rate can be increased every 15 minutes according to the table to a maximum infusion rate of 3 ml/kg/hour (not to exceed 300 ml/hour). Patients considered at risk with co-morbidities (such as cardiac disease or renal failure) should have a maximum infusion rate of 200 ml/hour.

5% IVIG products: If  there is no reaction to the first infusion, Flebogamma® 5% should be infused at a rate of 1 ml/kg/hour for the first 15 minutes. If there are no adverse reactions the rate can be increased every 15 minutes according to the table to a maximum infusion rate of 3 ml/kg/hour (not to exceed 500 ml/hour). Patients considered at risk with co-morbidities (such as cardiac disease or renal failure) should have a maximum infusion rate of 300 ml/hour.

  Subsequent Infusion
    10% IVIG products 5% IVIG products
    Intragam® 10,
Privigen®,
Flebogamma® 10%, Kiovig®,
Octagam® 10%
Flebogamma 5%
Step Time Rate (ml/kg/hour) Rate (ml/kg/hour)
1st 15 minutes 0.5 1
2nd 15 minutes 1 2
3rd 15 minutes 2 4
4th To complete infusion 31 62


1
Rate not to exceed 300 ml/hour; 2 Rate not to exceed 500 ml/hour.

© ASCIA 2018

ASCIA is the peak professional body of clinical immunology and allergy specialists in Australia and New Zealand  

Disclaimer

This document has been peer reviewed by ASCIA members and is based on expert opinion and the available published literature at the time of review.  Information contained in this document is not intended to replace medical advice and any questions regarding a medical diagnosis or treatment should be directed to a medical practitioner.

This document has been developed independently by ASCIA, with an unrestricted grant from CSL Behring.  CSL Behring has not determined the content, and responsibility for this document remains for ASCIA. Development of this document is not influenced by CSL Behring or any other commercial organisations.

Content updated June 2018

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