The document discusses the history and use of immunoglobulin therapy. It provides details on: 1. The history of immunoglobulin therapy beginning in the early 20th century and expanding in the 1940s after plasma fractionation processes were developed. 2. Immunoglobulin replacement therapy benefits those with immunodeficiency diseases involving poor IgG levels/function. It provides life-saving antibodies to fight infections. 3. Education plays a key role in successful self-administration of subcutaneous immunoglobulin therapy, with educators taking on roles to inform, advocate, and instruct patients. Patient concerns and reactions must be addressed.

2. Secretary for Ingid

3.  The history of human immunoglobulin
therapy
 Challenges of keeping up with global Ig
demand
 Role of the educator
 Rapid push method step by step
 Troubleshooting SCIG site reactions
and management
 Keys to success
 Patient case study
 Immune Deficiency and Pregnancy

4.  History of immunoglobulin replacement. The provision of antibodies to
prevent and treat infection began with the application of "curative
serum" in the first years of the last century.
 After the process of large-scale plasma fractionation was developed
in the 1940s, the general use of immunoglobulin expanded.
 Immunoglobulin (IgG) is the part of blood plasma that contains
antibodies. People suffering from immunodeficiency diseases
involving poor IgG levels and/or function often benefit from a
medical treatment called immunoglobulin replacement therapy, also
known as IVIg or SCIg.
 Immunoglobulin (antibody) replacement therapy is one of the most
important and successful therapies for people with primary
immunodeficiency diseases. Many of these people have insufficient
antibodies to adequately fight infections, and this therapy can be life
saving.
1. SAMJ November 2014, Vol.104, No. 11
2. https://www.allergy.org.au/patients/immune-deficiencies/immunoglobulin-replacement-therapy
The history of human
immunoglobulin therapy

5. The U.S. Polyvalent IG Market(IVIG/SCIG)
from 1986 to 2016
Source :The Marketing research Bureau,Inc (Orange, CT)
IG Living, August-September 2018

6. Burton J et al. Prof Case Manage. 2010;15:5-14.
Educator:
about disease and therapy
Advocate:
support and monitoring
is crucial for therapy
acceptance and adherence
Instructor:
self-administration

7.  Easy, approachable attitude
 Open communication channel
 Willingness to listen to patient’s concerns
 Attempt to understand their perceptions about therapy
 Understanding of age-appropriate issues with learning
 Pre-adolescent - interactive, hands-on learners
 Adolescent - resistant to formal education
 Adult - use information to deal with current problems
 A successful outcome depends on establishing the
right educational platform

8.  Patient should be given the option to design a regimen
with which they can achieve full compliance.
 Infusions could be given into a single site or a split
into multiple sites simultaneously.
 Decisions about the number of sites should me made
with the patient.
 Higher volume will likely require more sites
 Dosage is based on weight, consideration of
comorbidities, and clinical response.
 Needle Length should be chosen and selected
according to the amount of subcutaneous tissue the
patient has.
The Art and Science of Infusion nursing, volume 36, nr 1, January/ February 2013

9. Shapiro, R. (2010). J. Clin Immunol 30:301-307
Children’s Hopstial & Regional Medical Center, Immunology (2007)
Sussman&Associates, Immunology (2010)
SCIG is usually given through a programmable infusion pump,
but there is an option of administering SCIG via a rapid
subcutaneous push technique.
PUSH
Smaller dose multiple times a
week
3 to 20 ml per site
1 - 2 sites
2ml or 5ml syringe
Butterflies
Single needles
Two butterflies can be
connected via a “Y” connector
Needle length: 10 mm, 19 mm
Needle gauge: 23 or 25

11. Use appropriate learning tools:
 Instructional video
 Patient diary
 Lot nr, dose and reactions with each treatment.
 Important to diarise antibiotic usage, dosage and
reason for usage
 Assess patients – recommendation is at least 3 visits
or until patient feel comfortable.
 Ongoing support during transition period: 3-6 months
 Weekly contact – via phone and email
 Additional visits when adjusting infusion regimen

13. The temperature of the product can cause discomfort during
the transfusion.
It is recommended that the product is removed from the
refrigerator, at least on hour before SCIG therapy is started.
Medication is better tolerated at room temperature.

14. Check the batch numbers and the expiry date on the vials.
Make sure to write the batch number and expiry date into
your patient diary.
Visually inspect the vials to confirm that the solution is clear
with no visible particles.

15. Wash your working surface thoroughly
with a surface disinfectant
Wash hands with an antiseptic soap

16. Using aseptic technique, attach the syringe to the
butterfly by rotating the syringe clockwise.

17. Push down on the plunger until the tubing is filled. Prime the
tubing gently and stop around 2 cm before the needle tip.
Try to avoid any dripping from the needle end.
Dry therapy / or dry priming of the needle set is one of the
most important stages in SCIG therapy!
(Leading to less local side effects)

19. Identify target site and ensure clockwise rotation for each
infusion.
When using multiple sites, sites should be (5cm) apart and
(5cm) away from umbilicus

21. Take cover/sleeve off subcutaneous needle
Hold the “wings” in one hand so that the needle is not
contaminated
Grasp and pinch up the skin between thumb and index
finger to provide a bit of tension
Insert the butterfly needle at 45-degree angle
45°

22. When the butterfly is in place, gently pull back the syringe plunger to
see if any blood is flowing back into the tubing.
Secure the butterfly by applying tape or an adhesive dressing over
the site.

23.  Get into a routine of doing your infusion on the same day at
the same time
◦ With push infuse up to 20 ml per site
 Pediatric patients and thin adults may only be able to
tolerate 10-15 ml per site
 May need multiple sites to infuse medication. Most
patients can push 2 sites simultaneously
 Do not infuse in or near the umbilicus, scars, stretch
marks, or bruise
 If needed, numb infusion sites prior to infusion
◦ Push medication at a rate of 1 ml/minute, increase rate as
tolerated
◦ Should feel pressure, but infusion should not hurt. If painful,
slow down the rate
 When infusion is complete, remove needles and dispose of
supplies in sharps container
 Complete infusion diary
Children’s Hopstial & Regional Medical Center, Immunology
(2007)
Sussman&Associates, Immunology (2010)

24. Injection-site reaction
Blanching
Redness/Rash
Itching
Discomfort
Swelling
•Assess for tape allergy; change to paper/hypoallergenic
tape
•Assess size–choose a needle size that is consistent with
volume being infused
•Assess length of catheter–may be too short and fluid may
be leaking into intradermal layer
•Assess site location–may be too close to muscle
•Decrease rate of infusion or decease volume per site
•Avoid tracking lgG through the intradermal tissue by not
allowing drops of lgG on needle tip prior to needle insertion
•Assess appropriateness of rotating sites
•Consider use of topical anesthetic ointment or anesthetic
device
Leaking at catheter site
•Assess catheter; ensure it is affixed securely and fully
inserted
•Assess placement–may be in location that is subject to
movement; advise regarding selection of site
•Assess length of catheter–may be too short; suggest
change
•Assess infusion volume–amount per site may be too great;
adjust volume
•Assess rate of infusion; adjust rate

25. Extreme discomfort with
needle
•Assess needle length–may be too long and irritating
abdominal wall
•Try catheter that allows introducer needle to be removed,
leaving indwelling flexible cannula catheter
•Try ice or topical anesthetic cream prior to insertion or try
use of anesthetic device
Long infusion time
•Assess infusion; drug should be at room or body
temperature
•Assess volume per site, rate of infusion, and number of
sites, or adjust infusion regimen
•Arrange observation of patient technique (specialty
pharmacy provider or office visit)
•Remove and discard catheter that demonstrated blood
return; use new set (notify supplier of need for
replacement)
Blood return observed
•Remove and discard catheter that demonstrated blood
return; use new set (notify supplier of need for
replacement)

26. Although extremely rare, there may be allergic / Anaphylactic reactions
 Human normal immunoglobulin can rarely induce a fall in blood
pressure with anaphylactic reaction, even in patients who had
tolerated previous treatment with human normal immunoglobulin.
 Suspicion of allergic or anaphylactic type reactions requires
immediate discontinuation of the injection. In case of shock,
standard medical treatment should be administered
Keep EpiPen on standby and teach patient how to use it correctly
Keep remedies available for local pain or skin allergies i.e. anti
inflammatory gel or antihistamine cream.
Unusual pain:
 Normally indication that a vein was penetrated
 Withdraw the needle and rotate to a different site

27.  Make sure the patient has realistic expectations with regard to
local reactions
 Establish a dialogue where the patient is comfortable
expressing his/her concerns
 Adjust the infusion regimen as many times as necessary until
it is easy for the patient to comply
 Encourage patients to drink enough water during and after
therapy
 Changes to consider
◦ Needle length – try different length of needles
◦ Needle changes - try different needle types and brands
◦ Location of sites
◦ Site volume
◦ Infusion rates – The infusion rate is directly related to
ultimate success
◦ Address and attempt to resolve patient’s concerns in a
timely manner
 Provide re-assurance, comfort and support where needed

28.  Initial expected
adverse effects
◦ Variable presentation
 Redness
 Swelling
 Discomfort
 Rash
 Blanching of site
(looks white)
 Itching
15 minutes prior to
end of infusion
End of infusion 8 hours
post infusion
24 hours
post infusion
15 minutes prior to
end of infusion
End of infusion 8 hours
post infusion
24 hours
post infusion
Mild
Moderate
Data on file, CSL Behring: King of Prussia, PA; 2011.

29.  48 year old Female, 55 kg
 Childhood respiratory problems
◦ Asthma
◦ Hospitalisation: Respiratory Infections
◦ Numerous allergies
 Lifelong urinary problems
◦ Frequent hospitalisations from early years (<1 yr.)
◦ Frequent infections
◦ Procedures: radical cystectomy (2013)
 Cushing's - syndrome and secondary Addisons’s disease
due to long term cortisone use (2010)
 Placed on to SCIG therapy 2 months ago

30. • Reaction was delayed by 24 hours and it worsened up to 48
• Advantan cream was applied to effected areas and
Celestemine was taken
• Due to cystectomy and cortisone treatment patient was
inclined to water retention.
• Suspected reason is that the needle went intradermal
because of the retention and the needle size 9mm was too
short.
• Injection site was changed to stomach area and needle
length was increased to 12mm the problem was resolved
Severe Injection-Site Reaction
Over Time

32.  Pregnant immune deficient women have
different needs than non pregnant
immune deficient women.
 Increased risk of infection
 Increased risk of fetal loss
 Trans placental IgG transports plays a
role in protecting the infant from
infections.
 Stable IgG levels in the mother equate to
higher cord blood IgG levels in the
infant.
Danieli, MG, et al. Management of a pregnant woman with common variable immunodeficiency and previous reactions to
intravenous IgG administration. BMJ Case Reports
Brinker, K et al. Common variable immune deficiency and treatment with intravenous immunoglobulin during pregnancy. Ann
Allergy Asthma Immunology

33.  Few published reports in regards to Ig replacement therapy during
pregnancy.
 No prospective studies
 All data has been gathered retrospectively
 Pregnancy is listed as a precaution for Ig therapy.
 However most providers agree the benefits of Ig therapy outweigh
the risks.
 There is no standard approach on Ig dosing strategy for pregnant
women.
 Multiple case reports indicate the need to increase the dosage of
IVIG in pregnancy to maintain therapeutic IgG levels.
 Patients can infuse anywhere in the abdomen.
 Farther into the pregnancy they prefer to use the upper abdomen
above the belly button.
 At least 5 cm away from belly button and from stretch marks
Duff, C et al. Successful Use of 20% Subcurtaneous Immunoglobulin in Pregnant Women with Primary
Immune Deficency. Ann Allergy Asthma Immunology
Vaughan, L. Immune Globulin and Pregnancy. IgLiving

34.  Carla Duff – President Ingid
 Dorethea Grosse-Kreul- Vice president
 Rare diseases-South Africa
 Prof Jonny Peter – UCT South Africa

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