Medications | Intravenous Immune Globulin - Adult/Pediatric - Inpatient/Ambulatory
1
Intravenous Immune Globulin (IVIG) -
Adult/Pediatric -
Inpatient/Ambulatory/Emergency Department
Consensus Care Guideline
Table of Contents
POPULATION/PROBLEM: .................................................................................................................................... 2
DEFINITIONS: ..................................................................................................................................................... 2
RECOMMENDATIONS: ........................................................................................................................................ 3
METHODOLOGY ................................................................................................................................................. 9
COLLATERAL TOOLS & RESOURCES .................................................................................................................... 10
APPENDIX. INDICATIONS FOR IVIG .................................................................................................................... 11
REFERENCES ...................................................................................................................................................... 19
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Population/Problem:
Intravenous Immunoglobulin (IVIG) is isolated from pooled human plasma and was originally
developed as prophylaxis against infections for individuals with primary immunodeficiency
disorders.1,2 IVIG is used to prevent and treat a growing number of indications. The expanded
use of IVIG is supported by varying quality of evidence. Numerous published guidelines
highlight the uses associated with this agent. UW Health monitors the use of IVIG because of
its association with both adverse events and high cost. Consensus care guidelines tailored to
UW Health serve to optimize use of this resource. The current revision is a regularly scheduled
review of available evidence to keep this guideline timely.
Definitions:
1. ABW: Actual Body Weight
2. Acute Idiopathic Thrombocytopenic Purpura: Acute bleeding with platelet count <
20,000/mm3
3. GVHD: Graft Versus Host Disease
4. IBW: Ideal Body Weight
5. Order Weight: the weight used to calculate the total IVIG dose
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Recommendations:
Ordering and Dosing
1. All patients must have a current documented weight and height prior to ordering IVIG. (UW Health
GRADE Very low quality evidence; strong recommendation)
2. Adult doses should be based on ideal body weight (IBW) unless dosing to a specific and measurable
IgG level3,4 (UW Health GRADE Low quality evidence; strong recommendation)
2.1. If actual body weight (ABW) is less than IBW, dose according to ABW.
3. Pediatric doses should be based on ABW.5,6 (UW Health GRADE High quality evidence; strong
recommendation)
4. Doses should be titrated to patient response. Aim for the minimum dose required to maintain optimal
clinical response defined by the disease-specific monitoring parameters presented in the Appendix.5,6
(UW Health GRADE High quality evidence; strong recommendation)
5. Doses should not exceed a maximum of 2 g/kg or 140 grams per day. (UW Health GRADE Very low
quality evidence; strong recommendation)
6. IVIG should be used according to the specified criteria for each indication listed in the Appendix. (UW
Health GRADE quality of evidence varies; strength of recommendation varies)
7. IVIG may limit the effectiveness of live attenuated virus vaccines, including the measles, mumps,
rubella (MMR) and varicella vaccines. These vaccines should be administered 2 weeks prior to IVIG
administration or delayed until 8 months after replacement of IVIG or 11 months following Kawasaki
Disease treatment. (UW Health GRADE Moderate quality evidence; strong recommendation)
7.1. The following live vaccines are not affected by IVIG administration: influenza, oral typhoid, yellow
fever, and rotavirus vaccines.
Documentation
8. Documentation should clearly state the medical necessity for initiation and continued use of IVIG.
(UW Health GRADE Very low quality evidence; strong recommendation)
9. Documentation should include:
9.1. History and physical
9.2. Test results, including written interpretation
9.3. Prior treatment therapies
9.4. When used for an appropriate indication, there should be evidence of a significant deficiency in
IgG blood levels prior to initiation of treatment and impaired ability to make specific antibodies
9.5. History of severe and recurrent infections when appropriate
9.6. Treatment goals/expected response from IVIG initiation and subsequent treatment.
9.6.1. For immune deficiency disorders, the prescriber should provide an IgG target goal.
9.7. Evidence that IVIG therapy is effective when writing orders for continued therapy.
Administration
Filters
10. Gammagard Liquid® product requires no filtration. Gammagard S/D® low IgA requires filtration with a
15 micron filter. (UW Health GRADE Moderate quality evidence; strong recommendation)
Premedications
11. Not all patients require premedication for successful administration, and it may be reasonable to
consider foregoing it. However, premedication increases the tolerability of IVIG for many patients.7
Effective options are presented in the table below. They should be administered 30 minutes prior to
the initiation the IVIG infusion. (UW Health GRADE Moderate quality evidence; strong
recommendation)
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Table 1. Frequently Used Premedications
Therapeutic Class Population
Adults Pediatrics
Analgesic Acetaminophen 650 mg orally once Acetaminophen 10 – 15 mg/kg orally
once; maximum = 650 mg
Antihistamine • Diphenhydramine 25 – 50 mg
orally or intravenous once
• Loratadine 10 mg orally once
• Cetirizine 10 mg oral once
• Fexofenadine 180 mg oral once
• Diphenhydramine 0.5 – 1 mg/kg
oral or IV once; maximum = 50 mg
• Loratadine oral once
o 2-5 yrs: 5 mg
o ≥ 6 yrs: 5 – 10 mg
• Cetirizine oral once
o 6 month – 2 yrs: 2.5 mg
o 2 – 5 yrs: 2.5 – 5 mg
o ≥ 6 yrs: 5 – 10 mg
• Fexofenadine oral once
o 2 – 11 yrs.: 60 mg
o ≥ 12 yrs: 180 mg
Corticosteroid • Dexamethasone 4 mg oral or IV
once
• Methylprednisolone 20 – 60 mg
IV once
• Dexamethasone 0.5 mg/kg oral or
IV once; maximum 4 mg
• Methylprednisolone 0.5 – 1 mg/kg
IV once (max 40 mg)
Adverse Reactions
12. The fluid status of the patient should be evaluated prior to administration. Overdose may lead to fluid
overload and hyperviscosity.8 (UW Health GRADE Moderate quality evidence; strong
recommendation)
12.1. Patients at risk of complications of fluid overload and hyperviscosity include elderly patients
and those with cardiac or renal impairment.
12.2. Strategies to lower risk of fluid overload are to use a low sodium product. The IVIG products
available on UW Health formulary are low sodium products; Gammagard Liquid®
(undetectable sodium) and Gammagard S/D® low IgA (0.85% sodium).
12.3. Strategies to lower risk of hyperviscosity:
12.3.1. Do not exceed the recommended dose
12.3.2. Large doses may need to be infused over several days
12.3.3. Ensure adequate hydration
12.3.4. Infuse at the slowest practical rate
12.3.5. Use a low osmolar product (e.g., Gammagard® Liquid)
12.3.6. Encourage patients to limit immobility in the days immediately following the infusion.
13. Common adverse reactions (with frequency) include:
13.1. Headache: 30.6%
13.2. Nausea and/or vomiting: 22%
13.3. Chills: 19.4%
13.4. Hypotension: 14%
13.5. Lightheadedness: ≤ 13%
13.6. Fever: 11.1%
13.7. Fatigue: 11.1%
13.8. Backache: 8.3%
13.9. Urticaria: 8%
13.10. Leg cramps: 6%
13.11. Flushing: 5.6%
14. Rare (<1%) but serious adverse reactions include: hemolysis transfusion-related acute lung injury,
arterial thrombosis, deep vein thrombosis, pulmonary embolism, myocardial infarction,
thromboembolism, aseptic meningitis syndrome, and acute renal failure.
14.1. Certain patient populations may be predisposed to renal dysfunction when receiving IVIG
products that contain sucrose. No UW Health formulary IVIG products contain sucrose.
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14.1.1. Patients over 65 years old
14.1.2. Patients with diabetes mellitus
14.1.3. Patients with renal impairment prior to treatment with IVIG
15. Infusion related reactions that occur with IVIG are typically due to an infusion rate that is too fast for
patient tolerability. Infusion reactions are more common in patients receiving their first IVIG infusions
or when changing to a different IVIG product. If there is an infusion reaction, stop or slow the rate of
infusion and treat as presented in Table 2 below.7,9 (UW Health GRADE Moderate quality evidence;
strong recommendation)
15.1. Restart the infusion at a slower rate once the reaction subsides.3,4 Decrease the infusion rate
by one half the rate at which the reaction occurred. (UW Health GRADE High quality evidence;
strong recommendation)
15.2. The rate can be titrated to a faster rate again as the patient tolerates.3,4 (UW Health GRADE
High quality evidence; strong recommendation)
15.3. If the patient has a history of infusion reactions, the prescriber should indicate in the order
Admin Instructions the maximum infusion rate desired (gram/hr). (UW Health GRADE Very low
quality evidence; strong recommendation)
15.4. Consider switching to a different IVIG product in patients unable to tolerate a particular product9
(UW Health GRADE Low quality evidence; weak/conditional recommendation)
15.5. Consider checking for anti-IgA antibodies in patients with infusion reactions and consider
product change to low IgA product (Gammagard S/D)10,11 (UW Health GRADE Low quality
evidence; weak/conditional recommendation)
Table 2. Treatment of Adverse Reactions
Therapeutic Class Population
Adults Pediatrics
Antihistamine • Diphenhydramine 25 – 50 mg
intravenous once
• Diphenhydramine 0.5 – 1 mg/kg IV;
maximum = 50 mg once
Corticosteroid • Dexamethasone 4 mg IV once
• Dexamethasone 0.5 mg/kg IV once;
maximum 4 mg
• Hydrocortisone sodium succinate 1
mg/kg IV once; maximum 100 mg
Monitoring
16. All patients should be continually monitored for adverse effects related to the administration of IVIG
and the infusion rate. (UW Health GRADE High quality evidence; strong recommendation)
16.1. Monitor for signs and symptoms of thrombosis, blood hyperviscosity, hemolysis, hemolytic
anemia, and acute lung injury. (UW Health GRADE High quality evidence; strong
recommendation)
17. The following vital signs can be monitored to assess the safety of the infusion: blood pressure, heart
rate, respiratory rate, oxygen saturation, and temperature. They can be measured before, during,
and/or after the infusion OR if the patient experiences new or worsening symptoms of an infusion
reaction. (UW Health GRADE High quality evidence; strong recommendation)
18. Periodic monitoring of renal function is recommended in patients that are judged to be at risk of acute
renal failure. (UW Health GRADE High quality evidence; strong recommendation)
Infusion Rates
19. Patient tolerability is always the first consideration for infusion rate. (UW Health GRADE High quality
evidence; strong recommendation)
20. IVIG infusion rate calculations should use the patient’s order weight (the same weight used to
calculate the total IVIG dose) (UW Health GRADE Very low quality evidence; conditional
recommendation)
20.1. For most adult patients, this will be IBW. If ABW is less than IBW, use ABW
20.2. For most pediatric patients, this will be ABW
20.3. If a patient has previously tolerated IVIG rates based on a different weight type, the use of a
weight other than the order weight may be specified in the Admin Instructions of the IVIG order
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21. Generally, infusion rates should be slower for the first two infusions or when IVIG products are
changed. The infusion rate for the first two administrations is presented for adults and pediatric
patients below in Table 3. If patients tolerate the initial infusions, an incrementally faster rate can be
used for subsequent infusions.7 For all infusions, a gradual titration approach to the maximal infusion
rate is recommended. (UW Health GRADE High quality evidence; strong recommendation)
22. Consider a slower infusion rate (e.g., maximum rate 2 mL/kg/hour) in patients with underlying renal
disease or who are at risk for developing thrombotic events, including individuals with a history of
thrombosis and those with cardiovascular risk factors. To decrease these risks, the patient should be
optimally hydrated. A product with a lower osmolality should be considered.3,4 (UW Health GRADE
High quality evidence; strong recommendation)
23. An infusion time longer than the maximum calculated infusion duration (8-12 hours) may be
considered for inpatients to decrease the risk of adverse reactions. A prolonged infusion time in
excess of the maximum calculated infusion duration may be considered when:
23.1. A dedicated line will be available for the full duration of the infusion and the administration of
other medications will not be delayed
23.2. The patient’s discharge time is not anticipated within 24 hours and will not be postponed to
complete infusion. (UW Health GRADE Very low quality evidence; conditional recommendation)
24. Patients being treated for Kawasaki Disease or Multisystem Inflammatory Syndrome in Children
(MIS-C) receive a high dose of IVIG at a slower rate due to high oncotic/volume load. The minimum
infusion time for these patients should not be less than 10 hours.127 (UW Health GRADE Moderate
quality evidence; strong recommendation)
Table 3. IVIG Infusion Rates for 10% Product (1 mL = 100 mg)
Use order weight for rate calculations unless otherwise specified in Admin Instructions
Initial IVIG Rate Titration (1st or 2nd Dose) Subsequent IVIG Infusions
Adults
• 0.5 mL/kg/hour x 15 minutes; then
• 1 mL/kg/hour x 15 minutes; then
• 1.5 mL/kg/hour x 15 minutes; then
• 2 mL/kg/hour for remaining volume
• 0.5 mL/kg/hour x 15 minutes; then
• 1 mL/kg/hour x 15 minutes; then
• 1.5 mL/kg/hour x 15 minutes; then
• 2 mL/kg/hour* x 15 minutes; then
• 3 mL/kg/hour x 15 minutes; then
• 4 mL/kg/hour x 15 minutes; then
• 5 mL/kg/hour for remaining volume
Initial IVIG Rate Titration (1st or 2nd Dose) Subsequent IVIG Infusions
Pediatrics
(except
Kawasaki
Disease or
MIS-C)
• 0.5 mL/kg/hour x 30 minutes; then
• 1 mL/kg/hour x 30 minutes; then
• 2 mL/kg/hour* x 30 minutes; then
• 3 mL/kg/hour x 30 minutes; then
• 4 mL/kg/hour for remaining volume
• 0.5 mL/kg/hour x 30 minutes; then
• 1 mL/kg/hour x 30 minutes; then
• 2 mL/kg/hour* x 30 minutes; then
• 3 mL/kg/hour x 30 minutes; then
• 4 mL/kg/hour x 30 minutes; then
• 5 mL/kg/hour for remaining volume
IVIG Rate Titration
Kawasaki
Disease or
MIS-C
• 0.5 mL/kg/hour x 30 minutes; then
• 0.8 mL/kg/hour x 30 minutes; then
• 1 mL/kg/hour x 30 minutes; then
• 1.5 mL/kg/hour x 30 minutes; then
• Infuse remaining volume at 2.3 mL/kg/hour over 8 hours
*2 mL/kg/hour is the suggested maximum rate for inpatients, age > 65 years, history of thrombosis,
presence of cardiovascular risk factors, renal insufficiency, or diabetes
The following tools are available in Health Link to help communicate and calculate IVIG infusion rates:
Tool Description Tool Name How to Use/Purpose
SmartPhrase .RXRIVIGINFUSIONRATE Verifying pharmacist adds SmartPhrase to
Admin Instructions field of IVIG orders to
communicate weight and maximum infusion
rate for nurse to use in IVIG rate calculator
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IVIG Rate Calculator Adult IVIG Calculator How to Find the IVIG Calculator in Health Link
Nurse inputs order weight (kg), total IVIG
dose (grams), and maximum infusion rate (if
applicable). The calculator will recommend
how to program the IV pump.
Pediatric IVIG Calculator
Pediatric – Kawasaki or MIS-C
Immune Globulin Administered by Subcutaneous Route
25. Administration by the subcutaneous route may be considered in patients who are treated for
immunodeficiencies, including clinically significant hypogammaglobulinemia secondary to protein
losses or chylous effusions. Subcutaneous administration is less likely to result in adverse effects and
may achieve more sustained IgG levels. Traditional immune globulin products labeled for
subcutaneous administration and available on the UW Health formulary include Gammagard Liquid®.
HyQvia®, indicated for hyaluronidase facilitated subcutaneous administration in patients aged 12
years and older, is also available on the UW Health formulary on a restricted basis. The goal is to
ultimately transition patients to self-administration (or administration by caregiver) in the home.
However HyQvia® is approved for outpatient administration during the initial dose ramp-up in patients
naïve to immune globulin or those transitioning from intravenous administration. (UW Health GRADE
High quality evidence; strong recommendation)
26. Subcutaneous immune globulins are often more concentrated (e.g., 20%) than product used for IVIG.
Independent insurance screening is necessary for subcutaneous immune globulin products and
administration. Previous insurance coverage of intravenous administration may not extend to
subcutaneous administration, even when using the same product.
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Disclaimer
Consensus care models assist clinicians by providing a framework for the evaluation and treatment of patients. This
guideline outlines the preferred approach for most patients. It is not intended to replace a clinician’s judgment or to
establish a protocol for all patients. It is understood that some patients will not fit the clinical condition contemplated by a
guideline and that a guideline will rarely establish the only appropriate approach to a problem.
Contact for Content:
Name: Erin Robinson, PharmD, Drug Policy Program
Email Address: erobinson@uwhealth.org
Contact for Changes:
Name: Philip Trapskin, PharmD; Drug Policy Program
Email Address: ptrapskin@uwhealth.org
Guideline Author(s):
Erin Robinson, PharmD, Pharmacy
Sara Shull, PharmD; Pharmacy
Review Individuals/Bodies:
Lisa Arkin, MD - Dermatology
Sheila Aton, PharmD - Pharmacy
Jason Bergsbaken, PharmD - Pharmacy
Monica Bogenschutz, PharmD – Pediatric Pharmacy
James Conway, MD – Pediatrics, Infectious Diseases/Immunology
Stephanie Gardon, MD – Neurology
Justin Endo, MD – Dermatology
Aric Hall, MD – Department of Medicine, Oncology
Noreen Hogan, RN – Oncology
Mark Juckett, MD – School of Medicine and Public Health, Hem/Onc
Thomas Keenan, MD, PhD – Dermatology
Christopher Luzzio, MD – Neurology
Mary Mably, RPh – Pharmacy
Didier Mandelbrot, MD – Department of Medicine, Nephrology
Sameer Mathur, MD – Department of Medicine, Allergy
Mark Moss, MD – Department of Medicine, Allergy
Daniel Rosenberg, MD – Department of Medicine, Allergy
Jennifer Sandra, PharmD - Pharmacy
Karen Schaser, RN – Transfusion/Infusion
Luke Schulz, PharmD - Pharmacy
Christine Seroogy, MD – Department of Pediatrics, Immunology
MaryAnn Steiner, PharmD – Quartz Pharmacy Program
Jill Strayer, PharmD – Pharmacy
Andrew Waclawik, MD – Neurology
Jo Wilson, MD – Department of Pediatrics, Peds Allergy
Committee Approvals/Dates:
Pharmacy & Therapeutics Committee (Last Periodic Review: Jan 2023)
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Methodology
Methods Used to Collect/Select the Evidence:
Electronic database searches (e.g., PUBMED) were conducted by the guideline author(s) and workgroup members to
collect evidence for review. Expert opinion and clinical experience were also considered during discussions of the
evidence.
Methods Used to Formulate the Recommendations:
The workgroup members agreed to adopt recommendations developed by external organizations and/or arrived at a
consensus through discussion of the literature and expert experience. All recommendations endorsed or developed by the
guideline workgroup were reviewed and approved by other stakeholders or committees (as appropriate).
Methods Used to Assess the Quality of the Evidence/Strength of the Recommendations:
Internally developed recommendations, or those adopted from external sources without an assigned evidence grade,
were evaluated by the guideline workgroup using an algorithm adapted from the Grading of Recommendations
Assessment, Development and Evaluation (GRADE) methodology.
GRADE Methodology adapted by UW Health
GRADE Ranking of Evidence
High We are confident that the effect in the study reflects the actual effect.
Moderate
We are quite confident that the effect in the study is close to the true effect, but it is also
possible it is substantially different.
Low The true effect may differ significantly from the estimate.
Very Low The true effect is likely to be substantially different from the estimated effect.
GRADE Ratings for Recommendations for or Against Practice
Strong (S)
Generally, should be performed (i.e., the net benefit of the treatment is clear, patient values and
circumstances are unlikely to affect the decision.)
Conditional (C)
May be reasonable to perform (i.e., may be conditional upon patient values and preferences,
the resources available, or the setting in which the intervention will be implemented.)
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Collateral Tools & Resources
The following collateral tools and resources support staff execution and performance of the evidence-based model
recommendations in everyday clinical practice.
Metrics
• Adverse event reporting
Guidelines
• Kawasaki Disease: Diagnosis and Management- Pediatric- Inpatient
• MIS-C – Pediatric/Neonatal – Inpatient/Emergency Department
Order Sets & Smart Sets
• Inpatient Immune Globulin Infusion Adult Supplement Order Set [#1317]
• Inpatient Immune Globulin Infusion Pediatric Supplemental Order Set [#4161]
• Inpatient -Kawasaki Disease- Pediatric Supplemental Order Set [#8152]
• UWRX Infusion Center Order Set [#930]
• Inpatient – Multisystem Inflammatory Syndrome (MIS-C) – Pediatric – Admission Order Set [#9498]
Patient Resources
• Health Facts For You [#6868] – Intravenous Immune Globulin (IVIG)
Policies
• Medication Use in Outpatient Care Areas [UW Health Policy #15.2]
• Alaris System [UW Health Nursing Patient Care Policy # 1.24]
• Medication Delivery Via Tube System [UW Health Policy # 4.1]
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Appendix. Indications for IVIG
Immunology
Indication Criteria for Use Dose and Duration Monitoring Parameters Evidence Ranking UW Health
Recommendation
Rating
Primary Immunodeficiency
• Congenital
agammaglobulinemia12-15
• Common variable
immunodeficiency16,17
• Wiskott-Aldrich syndrome18
• X-linked
agammaglobulinemia19,20
• Severe combined
immunodeficiency
IgG value 2 standard
deviations below normal for
age
400-600 mg/kg every 4 weeks
Goal of therapy is to
prevent infections (i.e.
bronchiectasis).
Ideal trough IgG values:
within age and gender
appropriate normal
range.
Low Strong
Kawasaki syndrome21,22
Progressive form of the
disease, ongoing inflammation,
and/or elevated acute
inflammatory markers and
fever
2 gram/kg once, beginning
within 7 days of onset of fever
Inflammatory markers.
• Defervescence
• CRP
• ESR
High Strong
Re-treatment with 2 gram/kg
in a single dose may be given
when ongoing inflammation is
documented
High Strong
Idiopathic Thrombocytopenic
Purpura (ITP) 23-26
Management of acute bleeding
due to severe
thrombocytopenia and/or
platelet count less than
20,000/mm3 in adults, or less
than 30,000/mm3 in children.
Acute: 1 gram/kg daily for 1-2
days
Maintain platelet count >
than 20,000/mm3 in
adults, or > greater than
30,000/mm3 in children:
• Acute: Monitor
platelet count
daily
• Chronic:
Monitor
platelet count
every 4 weeks
Documented bleeding
episodes
Moderate Strong
Chronic: 1 gram/kg
intermittently as to maintain
platelet count
Secondary Immunodeficiency
due to CLL27,28 IgG of less than 400 mg/dL 400 mg/kg every 4 weeks
Maintain a serum trough
level IgG values >400
mg/dL
Moderate Strong
Systemic Juvenile Idiopathic
Arthritis (JIA) 29,30
Resistant to other forms of
therapy
1 to 2 gram/kg bimonthly for
the first 2 months, then
monthly for up to 6 months.
Efficacy appears to be
short lived, Substantial
clinical improvement
must be shown and
document after 4-6
courses
Moderate Weak/Conditional
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Immunology
Indication Criteria for Use Dose and Duration Monitoring Parameters Evidence Ranking UW Health
Recommendation
Rating
Normogammaglobulinemia with
impaired specific antibody
production (Qualitative antibody
deficiency) 31
Recurrent infections requiring
antibiotic treatment and well-
documented severe
polysaccharide non-
responsiveness
400 mg/kg every 4 weeks;
Consider discontinuation or
drug holiday (5 months)
preferably in temperate
climate) to assess efficacy
Decrease number of
infections Very Low Weak/Conditional
Neurology and Neuromuscular
Indication Criteria for Use Dose and Duration Monitoring Evidence
Ranking
UW Health
Recommendation
Rating
Autoimmune Encephalopathy32
Used in combination with
corticosteroids or
plasmapheresis.
400 mg/kg for 5 days
Improvement in functional
status (neurologic,
psychiatric)
Very low Weak/Conditional
Chronic Inflammatory
Demyelinating Polyneuropathy
(CIDP) 33-40
Used as monotherapy
Can be used in combination
with corticosteroids or
immunosuppressants or as
an alternative to
plasmapheresis
Induction:
2 gram/kg administered as
divided doses over 2 to 5
consecutive days
IVIG should be used for 2
to 3 months before
determining whether the
patient has responded.
If there is no benefit after
2 to 3 months, IVIG
therapy should be
discontinued
Aim for minimum dose to
maintain optimal
functional status. (i.e.
physical function;
mobility/ambulation,
fatigue)
High Strong
Maintenance:
1 gram/kg given over 1 to 2
days every 3 weeks for 2 to 3
months before determining
response to therapy.
Further tapering of dose or
frequency and duration of
treatment depend on clinical
response
Guillain-Barre
Syndrome (GBS)37,41-44
Used as first line agent for
rapidly progressive form of
disease.
May be used as an
alternative to plasmapheresis
400 mg/kg daily for 5 days or
1 gram/kg for 2 days
Improvement in functional
status (i.e. physical
function, mobility,
respiratory status)
High Strong
Moderate-Severe Myasthenia
Gravis (MG) 45-49
Used when other treatments
have been ineffective.
Unresponsive/Intolerant to
steroids
Induction:
400 mg/kg daily for 5 days or
1gram/kg for 2 days
Measurable response
must be documented
within 6 months. (i.e.
physical function;
High Strong
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Neurology and Neuromuscular
Indication Criteria for Use Dose and Duration Monitoring Evidence
Ranking
UW Health
Recommendation
Rating
Myasthenic Crisis:
First line therapy
As an alternative treatment to
plasma exchange or
thymectomy
Maintenance:
400mg/kg every 4 weeks
mobility/ambulation,
fatigue)
If there is no benefit after
6 courses, IVIG therapy
should be discontinued.
Multifocal Motor Neuropathy
(MMN) 50
Multifocal motor neuropathy
with persistent conduction
block as diagnosed by a
neurologist
Induction: 2 gram/kg in 2 to 5
divided doses.
Maintenance: 400 mg/kg to 1
gram/kg every 2-6 weeks
after induction dosing
regimen
The amount per dose should
be titrated to the individual’s
response. Aim for minimum
dose to maintain optimal
functional status.
Improvement in functional
status Moderate Weak/ Conditional
Stiff Person Syndrome (SPS) 51,52
Significant functional
impairment in patients who
have a verified diagnosis of
stiff person syndrome made
by a neurologist
Used when standard
treatment with diazepam is no
longer effective
Induction: 2 gram/kg in 2 to 5
divided doses Improvement in functional
status
Duration of benefit ranges
from 6 weeks to one year.
Moderate Strong
Maintenance:
1 gram/kg x 2 days monthly x
3 months
Moderate Strong
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Hematology
Indication Criteria for Use Dose and Duration Monitoring Evidence Ranking UW Health
Recommendation
Rating
Bone Marrow Transplantation
(prevention of Graft Versus Host
Disease (GVHD) and infection)
Adult and Pediatric53-57
Low Ig levels pre-transplant
defined as IgG of less than
500 mg/dL.
Pre-transplant:
250 mg/kg to a maximum of
20 grams on days -7 and -2
before transplant.
IgG values >500
mg/dL.
IgG levels be
monitored every 2
weeks in patients
receiving IVIG due to
the shorter half-life
Moderate Strong
Post-transplant:
Weekly through day 100. Moderate
Strong
Autoimmune Hemolytic Anemia58
Following failure of
immunosuppression with
corticosteroids and cytotoxic
agents prior to consideration
for splenectomy
500 mg/kg/day for 5 days Hemoglobin level ; Clinical status Low Weak/Conditional
Persisting
hypogammaglobulinemia
secondary to rituximab therapy59,60
Documentation of recurrent
and/or severe infections,
significant
hypogammaglobulinemia,
and impaired specific
antibody production
200 – 400 mg/kg monthly
until IVIG level exceed 550
mg/d; then as needed to
maintain IVIG nadir between
550-600 mg/dL
Resolution of severe
infection and IVIG
level
Very Low Weak/Conditional
Severe thrombocytopenia
(Hematology consult required)61
Severe thrombocytopenia
and at least ONE of the
following
• Severe or life-
threatening bleeding
• Urgent need for
invasive diagnostic
procedure or surgery
• Severe
thrombocytopenia
duration of at least 7
days expected after
high dose
chemotherapy (HLA-
matched or cross
matched platelets
should be tried first)
1 gram/kg/day as continuous
IV infusion for 2 days
PLUS
apheresis platelets given at
rate of 1 unit per 4 hours, as
continuous infusion, started
concurrently with IVIG and
continued x 72 hours
Platelet levels Low Weak/Conditional
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15
Transplantation
Indication Criteria for Use Dose and Duration Monitoring Evidence Ranking UW Health
Recommendation
Rating
Antibody Mediated Rejection62-76
Evidence of acute or chronic
active rejection; presence of
rejection established by
biopsy and laboratory test to
assess the presence and
strength of antibodies to
donor.
See UW Health Kidney
Rejection Treatment
Protocols for definitions of
rejection type by Banff
criteria and timing. Also see
concurrent therapy.
• Early rejection: 100
mg/kg for 4-6 doses after
plasma exchange then
500 mg/kg/week x 4
weeks
• Late rejection and
persistent rejection: 500
mg/kg/week x 4 weeks
Reduction in donor-
specific antibodies and
graft function by biopsy
Moderate Weak/Conditional
BK virus (polyoma) associated
nephropathy77
Failure of decreased
immunosuppression to clear
viremia
500 mg / kg (maximum of 70
grams) every week for four
doses;
Viral clearance and graft
function Very Low Weak/Conditional
Cytomegalovirus associated
disease78-80
Failure of decreased
immunosuppression in
combination with anti-viral
therapy to clear viremia
500 mg/kg once; may repeat
once weekly for three doses
with severe disease; total
dose should not exceed 2
gram/kg
Viral clearance and graft
function Low Weak/Conditional
Transplant Desensitization81-87
Dependent on type of
transplant (living or
deceased) and amount of
preformed antibodies
detected in solid antigen
bead testing done prior to
transplant
See Solid Organ Transplant
Departmental Protocol for
live (D2) and deceased (D5c)
donors
• 100 mg/kg after each
plasma exchange
o D2- X2-3 doses before
and after transplant
o D5c- one dose before
transplant and X2-3
doses after transplant
Post reperfusion biopsy Low Weak/Conditional
Waitlist Desensitization88-90
Candidates on the kidney
transplant waitlist approved
for waitlist desensitization by
the desensitization
committee.
Solid Organ Transplant
Departmental Protocol
should be followed and
referred to as a resource OR
2 gram/kg administered
monthly for 6 months with
monitoring of donor specific
antibodies
After 6 months, the
clinical response is
assessed by the
desensitization
committee to determine
whether the patient
should receive second
cycle of 6 monthly
doses of IVIG.
Low Weak/ conditional
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Dermatology
Indication Criteria for Use Dose and Duration Monitoring Evidence Ranking UW Health
Recommendation
Rating
Pemphigus Vulgaris/Pemphigus
Foliaceus with IVIG as
monotherapy91-95
Treatment refractory
patients; failure of systemic
corticosteroids and
immunosuppressants;
paraneoplastic disease
1-2 gram/kg ; total dose
divided equally and given
daily for 3-5 days every 4
weeks; decrease frequency
after disease controlled
(every 6, 8, 10, 12, 14, 16
weeks) When given 16
weeks x 2 consider
discontinuation for disease
remission
Reduction or
discontinuation of
steroid; disease
remission
Moderate Weak/Conditional
Pemphigus Vulgaris
Rituximab + IVIG96,97
Treatment refractory
(inadequate response to
conventional immune
suppressive therapy + IVIG)
patients when given in
combination with rituximab
2 gram/kg every 3 weeks for
2 doses starting in week 3 of
rituximab therapy; then once
monthly for 4 doses
Discontinuation of
steroid; disease
remission
Low Weak/conditional
Bullous pemphigoid and
Mucous-membrane (cicatricial)
pemphigoid91,93-95
Treatment refractory
patients; failure of systemic
corticosteroids and
immunosuppressants;
paraneoplastic disease
1-2 gram/kg ; total dose
divided equally and given
daily for 3-5 days every 4
weeks; decrease frequency
after disease controlled
(every 6, 8, 10, 12, 14, 16
weeks) When given 16
weeks x 2 consider
discontinuation for disease
remission
Reduction or
discontinuation of
steroid; disease
remission
Low Weak/Conditional
Stevens-Johnson Syndrome;
toxic epidermal necrolysis98-102
First line for treatment of
severe disease in
conjunction with withdrawal
of offending medication and
supportive care
1-2 gram/kg daily for up to 3
consecutive days or until
symptoms resolve; pt should
be evaluated daily before
each dose
Symptom
resolution Low Weak/ Conditional
Drug Reaction with Eosinophilia
and Systemic Symptoms
(DRESS)103-105
Life-threatening reaction
refractory to corticosteroids
1 gram/kg daily for up to 3
consecutive days or until
symptoms resolve; pt should
be evaluated daily before
each dose
Symptom resolution Low Weak/ Conditional
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17
Infectious Disease
Indication Criteria for Use Dose and Duration Monitoring Evidence
Ranking
UW Health
Recommendation
Rating
HIV-associated
thrombocytopenia106 When platelets are less than 50,000
1 gram/kg/day for two
consecutive days per
week for 4 weeks
Platelet count;
Signs and symptoms
of IVIG adverse
effects
Moderate Weak/Conditional
Necrotizing Fasciitis107-112
Critically ill patients with staph or strep
necrotizing soft tissue infection
Between 200 mg/kg/day
and 2 gram/kg/day for 1 to
5 days
Improvement of soft
tissue infection High Weak/Conditional
Multisystem Inflammatory
Syndrome in Children (MIS-
C)113,114
MIS-C with features of Kawasaki
Disease (KD), or moderate to severe
disease without KD features (i.e.,
shock or myocardial dysfunction)
2 gram/kg (IBW) once;
max dose = 100 grams
For patients with concern
for significant cardiac
dysfunction: 1 gram/kg
once daily x 2 days; max
dose = 50 grams
Cardiac function and
fluid status
Inflammatory
markers.
• Defervescence
• CRP
• ESR
Additional labs:
• CBC (w/ Diff)
• CMP
Very Low Weak/Conditional
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18
Connective Tissue Disease
Indication Criteria for Use Dose and Duration Monitoring Evidence Ranking UW Health
Recommendation
Rating
Lupus erythematosus (cutaneous
or systemic)115-119 Severe, refractory disease
1 gram/kg on 2 consecutive
days then
Systemic: 1 gram/kg once
monthly until symptoms
resolve
Cutaneous: between 400
mg/kg and 2 gram/kg per
month until symptoms
resolve
Erythrocyte
sedimentation rate, C-
reactive protein, urine
protein, serum
creatinine, anti-double
stranded RNA, and
complement (C3 & C4)
Low Weak/Conditional
Refractory Dermatomyositis120-123
Unresponsive/intolerant to
steroids and
immunosuppressants;
Significant skin involvement;
paraneoplastic disease
1 gram/kg x 2 consecutive
days monthly for 3 to 6
months
Improved clinical status
(increase muscle
strength, improved
cutaneous disease,
decreased CK level);
able to taper steroids
Moderate Weak/Conditional
Refractory Polymyositis120,123
Second line therapy for
patients not responding to
immunosuppressive
treatment; paraneoplastic
disease
1 gram/kg x 2 consecutive
days monthly for 3 to 6
months
Improved clinical status
(increase muscle
strength, improved
cutaneous disease,
decreased CK level);
able to taper steroids
Low Weak/Conditional
Inappropriate Uses
1. Alzheimer’s disease124 (UW Health GRADE Moderate quality evidence; strong recommendation)
2. Wegener’s granulomatosis125 (UW Health GRADE Moderate quality evidence; strong recommendation)
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19
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