Venom IT - Rapid Desensitization

Venom Immunotherapy
Rapid Desensitization (Modified Rush Protocol) Bob Erskine Associate Scientific Director
Polistes (Wasp)
1
November 2010
2010
ALK Overview
Insect Sting Allergy

Patients sensitized to proteins in insect venom ~5% of population is truly allergic Systemic reaction to first sting uncommon Allergen is injected by insect Direct route for a relatively large quantity of allergen Most reactions are local Swelling Inflammation Large Local Reactions Systemic reactions occur Body reacts at sites remote from the sting May be limited to itching, swelling More serious when anaphylaxis occurs At least 40-50 deaths per year in the U.S. (more likely unreported)
2010 ALK Overview
Stinging Insects
The Culprits Insects from the order Hymenoptera
Yellow Jackets (Vespula sp.) Hornets (Dolichovespula sp.) Wasps (Polistes sp.)
Honey Bees (Apis mellifera)
Fire Ants (Solenopsis sp.)
2010
ALK Overview
Venom Immunotherapy
History Prior to 1978
Whole Body Extracts used for immunotherapy Entire insects were dried, ground, extracted Felt to be effective
1978
Entomologist at Penn State U. developed methods to remove venom sacs from insects, collect venom. Breakthrough study published by Hunt et al.
Compared WBE, Purified Venom, Placebo. Conducted sting challenges WBE was no better than Placebo ~40% efficacy Purified Venom provided >95% efficacy Purified Venom supplied by Vespa Laboratories (now part of ASM)
2010
ALK Overview
Venom Immunotherapy
Current Single Species (YJ, YH, WFH, Wasp, or HB)
Extracts supplied for 100 g/mL venom protein at highest dose Maintenance = 1.0cc = 100ug total protein
Wasp Extract
5 Common Species
Yellowjacket Extract
6 Common Species
Mixed Vespid (YJ, YH, & WFH)

For patients sensitive to all 3 Extracts supplied for 300 g/mL venom protein at highest dose Maintenance = 1.0cc = 300ug = full 100ug dose of all three species
2010
ALK Overview
Venom Immunotherapy
Current Build-up
Traditional = start dilute, advance weekly over several months Cluster = multiple doses per week to reach maintenance sooner Rush = rapid advancement over 1 to 3 days (hospital setting advised)
Treatment duration
Maintenance advised every 4-6 weeks Treatment continues indefinitely for many patients
2010
ALK Overview
Venom Extracts for Treatment

Products
Immunotherapy Treatment
Yellow Jacket Wasp Yellow Hornet White Faced Hornet Honey Bee Mixed Vespid (YJ + YH + WFH)
How Supplied
Treatment Kit (6 single-dose vials)
Multi-dose Vial (10-dose vial)
2010
ALK Overview
Extract Preparation
Reconstitute Freeze-Dried Venom Human Serum Albumin is required diluent
Saline, 0.4 % phenol, 0.03% serum albumin
Reconstitute according to package insert

1.2 mL for vials in Treatment and Diagnostic Kits 11.0 mL for multi-dose vials
1.8 mL pre-filled vials for preparing dilution series

1.8 mL pre-filled HSA
Concentrate 100 g/mL protein 300 ug/mL (Mixed Vespid) Prepare Dilution Series 10 g/mL 1 g/mL 0.1 g/mL 0.01 g/mL 0.001 ug/mL (if neccesary)
9
0.2 mL
0.2 mL
0.2 mL
0.2 mL
100 g/mL
10 g/mL
1.0 g/mL
0.1 g/mL
0.01 g/mL
2010
ALK Overview
Cluster vs. Traditional

ALK Pharmalgen Package Insert
Cluster Protocol 9 weeks to maintenance Traditional Protocol 15 weeks to maintenance
Key differences
First dose at lower starting concentration Multiple doses per visit Achieve maintenance at week 9
10
2010
ALK Overview
Visit #1
Cluster Protocol 9 weeks to maintenance
0.01 g/mL
3 injections
0.1 g/mL 30 minute wait after each dose
1.0 g/mL
10 g/mL
100 g/mL
11
2010
ALK Overview
Visit #2
0.01 g/mL
0.1 g/mL
1.0 g/mL
3 injections
30 minute wait after each dose
10 g/mL
100 g/mL
12
2010
ALK Overview
Visit #3
0.01 g/mL
0.1 g/mL
1.0 g/mL
3 injections
10 g/mL 30 minute wait after each dose
100 g/mL
13
2010
ALK Overview
Visit #4
0.01 g/mL
0.1 g/mL
1.0 g/mL
10 g/mL
2 injections
14
2010
ALK Overview
Visit #5
0.01 g/mL
0.1 g/mL
1.0 g/mL
10 g/mL
2 injections
15
2010
ALK Overview
Visit #6
0.01 g/mL
0.1 g/mL
1.0 g/mL
10 g/mL
2 injections
16
2010
ALK Overview
Visit #7
0.01 g/mL
0.1 g/mL
1.0 g/mL
10 g/mL
2 injections
17
2010
ALK Overview
Visit #8
0.01 g/mL
0.1 g/mL
1.0 g/mL
10 g/mL
2 injections
18
2010
ALK Overview
Visit #9
0.01 g/mL
0.1 g/mL
1.0 g/mL
10 g/mL
1 injection
100 g/mL 30 minute wait after dose
19
2010
ALK Overview
Venom Expiration
20
2010
ALK Overview
10
More Information
Review Articles
J Allergy Clin Immunol. 2011 Apr;127(4):852-4 e23.
http://allergyparameters.org/file_depot/0-10000000/3000040000/30326/folder/73825/2011_StingingInsect.pdf
David Golden, Annals of Allergy Asthma & Immunology, 2006 vol. 96
Full Prescribing Information ALK Pharmalgen Package Insert

http://www.alk-abello.com/US/products/productinformation/
21 2010
ALK Overview
11

Venom IT - Rapid Desensitization

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Venom IT - Rapid Desensitization

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Venom Immunotherapy

Insect Sting Allergy

Honey Bees (Apis mellifera)

Fire Ants (Solenopsis sp.)

Mixed Vespid (YJ, YH, & WFH)

Venom Extracts for Treatment

Reconstitute according to package insert

1.8 mL pre-filled vials for preparing dilution series

Cluster vs. Traditional

David Golden, Annals of Allergy Asthma & Immunology, 2006 vol. 96

Full Prescribing Information ALK Pharmalgen Package Insert

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