- March 30, 2023
- 8:30 AM - 4:15 PM ET
- Organized By:
Immune Globulins (IGs) are used extensively to treat primary and secondary antibody deficiencies, and a variety of autoimmune diseases. The purpose of the workshop is to gain insight and to identify measures to prevent hypersensitivity reactions associated with specific lots of Immune Globulins (IG). The symptoms of these reactions typically include urticaria, hives, pruritis, and orofacial swelling. Occasionally, these skin-related symptoms are accompanied by chest pain or shortness of breath. In some patients, anaphylaxis-like events have been reported.
Although hypersensitivity is listed as a possible reaction to IG products, FDA and manufacturers have observed excessive numbers of hypersensitivity reactions for specific lots of IG. Such lots occur episodically and unpredictably. This phenomenon has led to voluntary market withdrawals of IG product lots and adversely affected a proportion of patient recipients. Resulting withdrawals of product lots and quarantine of manufacturing intermediates can adversely affect IG supply. The cause of these reactions is unknown.
TOPICS FOR DISCUSSION:
- Clinical presentations and epidemiology of patients with hypersensitivity reactions to specific lots of IG
- Pathogenesis of Type I hypersensitivity reactions
- Manufacturer investigations – including plasma donor factors, potential recipient risk factors, and manufacturing and laboratory investigations of implicated plasma units and IG lots
The overarching workshop goals are to enhance patient safety and preserve product availability. The objectives of the workshop are to share knowledge that will contribute to prevention of lot-specific hypersensitivity reactions, and to seek opinions from scientific experts on:
- The most likely root cause(s) of reactions
- Potential recipient risk factors
- Development of pragmatic in vitro methods to identify plasma units or products that mediate lot-specific hypersensitivity
This is a virtual webcast only event. The link for viewing/participation will be provided within your Eventbrite confirmation upon registration.
To register for this public workshop, please visit the following website: https://www.eventbrite.com/e/immune-globulin-hypersensitivity-reactions-root-causes-and-mitigation-tickets-558320711277. Registration is free and based on space availability. If you need special accommodations due to a disability, please contact Loni Warren Henderson or Sherri Revell no later than March 23, 2023 (subject line: IG Hypersensitivity Workshop) at the contact information provided below.
FOR FURTHER INFORMATION CONTACT:
Loni Warren Henderson or Sherri Revell, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, Silver Spring, MD 20993, or 240-402-8180, or CBERPublicEvents@fda.hhs.gov (subject line: IG Hypersensitivity Workshop)
|Transcript - Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation||pdf (1.82 MB)|