1. Use of Subcutaneous IgG in Patients on Concomitant Anticoagulant and Antiplatelet Therapy
Mark R. Stein,1 Kelly Farnan,1 Danielle Eufrasio,1 Carla Duff, 2 Jerry Hunter,3 Diana Ochoa,4 Marie-Claude Levasseur,5 Loris Aro,6 Annette Zampelli7
1Allergy Associates of the Palm Beaches, North Palm Beach, FL, USA; 2University of South Florida, Tampa, FL, USA; 3Arizona Allergy Associates, Phoenix, AZ, USA; 4Allergy/Immunology Research Center of North Texas, Dallas, TX, USA; 5University Health Center, Sainte-Justine Hospital, Montreal, QC, Canada; 6Toronto Allergy Group, Toronto, ON, Canada; 7CSL Behring, LLC, King of Prussia, PA, USA
The International Nursing Group for Immunodeficiencies
October 3-6, 2012, Florence, Italy

2. Disclosures and Acknowledgments
MRS has served as a speaker, consultant, and/or investigator for Baxter Healthcare Corp, CSL Behring, Merck, and Teva. CD, JH, MCL, and LA are nurse consultants for CSL Behring. DO is a nurse consultant for CSL Behring and has served on an advisory board for Baxter Healthcare. AZ is employed by CSL Behring.
This presentation was supported by CSL Behring, LLC.
Medical writing and editorial support was provided by Daniel McCallus, PhD, of Complete Publication Solutions, LLC, and was funded by CSL Behring, LLC.

3. Introduction Primary or Secondary Immunodeficiency Disease (PIDD/SIDD)
Standard treatment:
Intravenous immunoglobulin (IVIG)1
Subcutaneous immunoglobulin (SCIG)1
High prevalence of thrombotic risks in the general population2
Many patients with PIDD/SIDD are also prescribed anticoagulant and antiplatelet (AC/AP) drugs for the treatment and prophylaxis of thrombotic, cardiac, and vascular diseases3
Some disorders associated with PIDD have congenital cardiovascular manifestations that require AC/AP
1. Fried AJ and Bonilla FA. Clin Microbiol Rev. 2009;22(3):
2. Heidenreich PA, et al. Circulation. 2011;123(8):
3. Alexander KP and Peterson ED. Circulation. 2010;121(17):

4. Rationale and Objective
Infusion-site bleeding or bruising at the site of SCIG administration due to the activity of AC/AP medication was theoretical concern
Objective
To establish the safety of concomitant SCIG and AC/AP therapy

5. Study Design
Multicenter retrospective chart review of tolerability data
Patient inclusion criteria:
PIDD or SIDD
Receiving treatment with 20% SCIG (Hizentra®, CSL Behring, LLC, King of Prussia, PA) or 16% SCIG (Vivaglobin®, CSL Behring, LLC; no longer available in the United States)
Prescribed concomitant AC/AP medications

6. Patient Descriptions
26 of the total 33 patients were part of a larger (n=47) retrospective single-center study on safety and efficacy of SCIG in the elderly
Parameter
Patients, n (%)
N=47
PIDD diagnosis
Hypogammaglobulinemia
29 (61.7)
IgG subclass deficiency or specific antibody deficiency
9 (19.1)
Hypogamma globulinemia and subclass deficiency or specific antibody deficiency or another immunodeficiency
9 (19.1
Medical history
Serious acute bacterial infections
31 (68.1)
Chronic infections
44 (93.6)
Comorbid conditions
COPD
7 (14.9)
Type 1 diabetes
4 (8.5)
Type 2 diabetes
3 (6.4)
Stein et al. Postgrad Med. 2011; 123:

7. Patient Descriptions Cont.
Concomitant medication use in the larger study population
Parameter
Patients, n (%)
N=47
Brochodilators/inhaled corticosteroids
29 (61.7)
Proton pump inhibitors
21 (44.7)
Statins/antilipidemics
Nasal sprays
17 (36.2)
Antihistamines
16 (34.0)
Diuretics/antihypertensives
Antidepressants
11 (23.4)
Bone resorption inhibitors
10 (21.3)
Thyroid hormone
9 (19.1)
Stein et al. Postgrad Med. 2011; 123:

8. AC/AP Use: Patient Descriptions
33 patients total
26 from larger single-center in elderly, 7 from other centers
Age
Median: 70 years
Range: 3−89 years
AC/AP medications
Included:
Aspirin, warfarin, clopidogrel, and heparin
Used for:
Treatment and/or prophylaxis for thrombotic and vascular diseases
ie, pulmonary embolism, congenital heart disease, chronic atrial fibrillation/flutter

9. Concomitant AC/AP Medications
The most common concomitant medication was aspirin (18/33 patients, 55%)
A large percentage of patients were on warfarin (10/33 patients, 30%)
Few patients used clopidogrel alone or aspirin combined with either clopidogrel or heparin (5/33 patients, 12%)
Types of concomitant AC/AP medications in patients treated with SCIG

10. Patient SCIG Administration Parameters
SCIG was administered using a variety of different regimens
Mean duration of use,
months (range)
22.2 (5−49)
Mean total dose,
mg/kg/month
441
Number of sites per infusion 1
2-3 ≥4 3 21 9
Method of SCIG Administration
Syringe Pump
Push 30
Site of infusion
Abdomen
Arm
Thigh
Multiple body areas 24 5
SCIG administration frequency
>1X/week
Weekly
Every 2 weeks 27

11. Results Local site reactions
Mild, transient, and similar to those previously described4
Infusion-site bleeding/bruising: observed in only 1 patient
A 62-year-old white male
Immune thrombocytopenic purpura and SIDD
Receiving aspirin (81 mg/day)
SCIG dose of 710 mg/kg per month via syringe push, 20 mL in 1 site (abdomen), 4 times per week
Reported mild bruising during the first month of SCIG treatment
4. Jolles S, et al. Clin Immunol. 2011;141(1):

12. Case Study 1 21-year-old female First SCIG treatment
16% SCIG dose of 696 mg/kg per month via syringe push
Concomitant warfarin therapy (5 mg/d) for treatment of prior pulmonary embolism
First SCIG treatment
Two 5 mL push injections (2 hours apart), followed by two 10 mL injections (1 hour apart)
No photo available
Subsequent SCIG treatments
One 20 mL push injection in one site over 15 minutes
3 times per week
Patient outcomes
No bruising, bleeding, or skin reactions at the infusion site, despite increase in general bruisability since starting warfarin
After 8 months of well-tolerated SCIG, restarted IVIG for personal reasons
Before
Week 4 Infusion
After
Week 4 Infusion

13. Case Study 2 33-year-old female First SCIG treatment
16% SCIG dose of 750 mg/kg per month via syringe push
Concomitant warfarin therapy (alternating 9/10 mg/day) for chronic atrial flutter
First SCIG treatment
Two 5 mL push injections (2 hours apart), followed by two 10 mL injections (1 hour apart)
Subsequent SCIG treatments
One 20 mL push injection in one site over 15 minutes
3 times per week
Patient outcomes
No bruising, bleeding, or skin reactions at the infusion site
Before
After
First SCIG treatment
Before
After
Week 4 Infusion

14. Conclusions
The concurrent use of AC/AP medications in this group of patients with PIDD or SIDD aged 3-89 years did not increase the occurrence of local site complications after 16% SCIG or 20% SCIG treatment.
In patients with PIDD or SIDD and comorbid cardiovascular or thrombotic disorders treated with AC/AP medications, the use of 16% or 20% SCIG was well tolerated.