Observation periods and advisability of epinephrine auto-injectors for biologic agents
Question:
1/25/2018
Monitoring for biologics: There are published recommendations for the monitoring period after omalizumab. (2h for first 3 injections, then 30 minutes for subsequent). There is also a recommendation that patients have self-injectable epinephrine. Has there been any change based on additional post-marketing data?
Mepolizumab reports an incidence of systemic hypersensitivity reactions in the package insert (that was higher in the placebo group) and recommends an unspecified monitoring period. I understand there has been post-marketing anaphylaxis reported, but I have not been able to find out about the timing of the reported event(s). Is there a recommended monitoring period for this drug?
Benralizumab reports hypersensitivity reactions have occurred within hours of administration, but may be delayed. Is there a recommended monitoring period for this drug?
Reslizumab reports 0.3% incidence of anaphylaxis during or within 20 minutes of the IV infusion. Is there a recommendation to monitor for 20-30 minutes post infusion?
Dupilumab lists a hypersensitivity warning, but does not state any specific incidence, and is approved for home administration after appropriate training.
Is there a recommendation for patients receiving any of the above 4 drugs to have self-injectable epinephrine prescribed?
Answer:
We asked Dr Tom Casale to weigh in on your questions. Here is his response:
There has been no change in the monitoring period for omalizumab. Regarding the others (benralizumab, reslizumab and dupilumab) there are no recommendations for waiting periods or prescribing of epinephrine auto-injectors for these agents.
I hope this answer is helpful to you.
Jacqueline A. Pongracic, MD, FAAAAI