Specialist Working Group for Haematology
Proposed changes to the Criteria for the clinical use of intravenous immunoglobulin in Australia
ITEM
Condition Name
Condition Short
Name
CRITERIA FOR THE CLINICAL USE OF
INTRAVENOUS IMMUNOGLOBULIN
IN AUSTRALIA, SECOND EDITION
(CRITERIA)
PROPOSED V3 CHANGES TO THE CRITERIA AND
BLOODSTAR
RATIONALE FOR PROPOSED V3
CHANGES
Haemolytic disease of the
newborn (HDN)
HDN
Haemolytic disease of the fetus and newborn
(HDFN)
HDFN
Change of name to include
recognition of the fetus.
Haematology
Haematology
7
7
No change.
Small case studies only; insufficient
data (Category 4a)
Small case studies only; insufficient data
(Category 4a)
No change.
HDN arises from foetomaternal
antigen incompatibility and can
HDN arises from fetomaternal antigen
incompatibility and can result in clinically
No change
Used in drop down lists
or where space is
limited
Specialty
Keywords
Used for key word
search. Separate with
semi colon
Chapter
Specific
Conditions
List all specific
conditions separated by
semi-colon
Level of Evidence
There should be no
change to the published
text
Description and
Diagnostic
ITEM
CRITERIA FOR THE CLINICAL USE OF
INTRAVENOUS IMMUNOGLOBULIN
IN AUSTRALIA, SECOND EDITION
(CRITERIA)
There should be no
change to the published
text
result in clinically significant
foetal/neonatal haemolysis, severe
anaemia and hyperbilirubinaemia.
significant foetal/neonatal haemolysis, severe
anaemia and hyperbilirubinaemia.
Justification for
Evidence
Category
Although prophylaxis programs
have reduced the frequency of
Rhesus (Rh) D HDN, antibodies to
RhD remain the most common
cause in Australia. Antibodies to
other antigens in the Rh system
(e.g. Rhc, E), ABO and other
antigens (e.g. K) may also cause
disease ranging from mild to lifethreatening.
Although prophylaxis programs have reduced the
frequency of Rhesus (Rh) D HDN, antibodies to
RhD remain the most common cause in Australia.
Antibodies to other antigens in the Rh system
(e.g. Rhc, E), ABO and other antigens (e.g. K) may
also cause disease ranging from mild to life threatening.
There should be no
change to the published
text
Diagnosis is
required
Diagnosis must be
verified
Exclusion Criteria
PROPOSED V3 CHANGES TO THE CRITERIA AND
BLOODSTAR
RATIONALE FOR PROPOSED V3
CHANGES
SWG have suggested updating
with the addition of
recommendation 7 from the
Patient Blood management
guideline – module 7 –
paediatric and neonatal.
In infants with HDFN, the routine use of IVIg is not
recommended in national Australian clinical
guidelines.
By which
speciality
By which
speciality
Bullet list of exclusion
criteria
Indications
Qualifying Criteria IVIg may be used in selected cases
in consultation with experts in
foetomaternal medicine and
National Blood Authority
IVIg may be used in selected cases in consultation
with experts in fetomaternal medicine and
transfusion medicine.
pg. 2
Spelling correction to
fetomaternal.
Addition of Expert opinion
ITEM
CRITERIA FOR THE CLINICAL USE OF
INTRAVENOUS IMMUNOGLOBULIN
IN AUSTRALIA, SECOND EDITION
(CRITERIA)
transfusion medicine.
Review Criteria
Dose
Refer to the current product
information sheet for further
information.
The aim should be to use the
lowest dose possible that achieves
National Blood Authority
PROPOSED V3 CHANGES TO THE CRITERIA AND
BLOODSTAR
In maternity patients with a fetus affected by
HDFN who is at high risk of early fetal hydrops or
death, a course of weekly IVIg should be
considered. (Expert opinion point 4, Patient Blood
Management Guidelines – Module 6 – Paediatric
and neonatal, Section 3.5.2.)
RATIONALE FOR PROPOSED V3
CHANGES
point 4 from the recent drafting
of the Patient Blood
Management Guidelines Module 6 - paediatric and
neonatal. Further consideration
to formal criteria and dose will
be given to this condition when
chapter 7 is re-developed in the
next phase of the SWG work
program.
Refer to the current product information sheet for No change.
further information.
The aim should be to use the lowest dose possible
that achieves the appropriate clinical outcome for
each patient.
pg. 3
ITEM
CRITERIA FOR THE CLINICAL USE OF
INTRAVENOUS IMMUNOGLOBULIN
IN AUSTRALIA, SECOND EDITION
(CRITERIA)
PROPOSED V3 CHANGES TO THE CRITERIA AND
BLOODSTAR
RATIONALE FOR PROPOSED V3
CHANGES
the appropriate clinical outcome
for each patient.
BIBLIOGRAPHY
Gottstein, R & Cooke, RW 2003, ‘Systematic review of intravenous immunoglobulin in haemolytic disease of the newborn’, Archives of Disease in
Childhood – Fetal Neonatal Edition, vol. 88, no. 1, pp. F6–10.
Kaplan, M, Vreman, HJ, Hammerman, C, et al 1996, ‘Intravenous immune globulin in neonatal ABO isoimmunisation: factors associated with clinical
efficacy’, Biology of the Neonate, vol. 70, pp. 69–72.
Miqdad, AM, Abdelbasit, OB, Shaheed, MM, et al 2004, ‘Intravenous immunoglobulin G therapy for significant hyperbilirubinaemia in ABO
haemolytic disease of the newborn’, Journal of Maternal-Fetal and Neonatal Medicine, vol. 16, no. 3, pp. 163–6.
Patient Blood Management guidelines – Module 6 – Paediatric and neonatal, section 3.5.2
END OF DOCUMENT
National Blood Authority
pg. 4
National Blood Authority
pg. 5