Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq

Exclusion Criteria

• •Medical Conditions:
• •1. Participant may not have any kind of disorders that, in the opinion of the investigator, may compromise the ability of the participant to give written informed consent and/or comply with any aspect of the study, and/or where any aspect of participation would be medically inadvisable for the underlying disorder.
• •2. Participant must not be pregnant on the day of the RDD.
• •3. Participants with uncontrolled asthma, active upper repiratory infection or other active infections, or cardiovascular disease. Asthma control will be assessed using the Asthma Control Test at screening.
• •Prior/Concomitant Therapies:
• •4\. Participants were not using antihistamine premedication(s) at the time of reactive HSRs.
• •5\. Participants are willing and able to resume and tolerate Palynziq at the reactive dose prior to the RDD.
• •6\. Participant must not be receiving concurrent injectables containing PEG with the exception of PEG-containing vaccines, such as COVID-19 vaccinations (see Section 6.7).
• •7.Participants receiving beta blockers.
• •Prior/Concurrent Clinical Study Experience 8. Participants may not be currently participating in an interventional study of any investigational product, device, or procedure, or any other BioMarin clinical trial or post-marketing study.
• •Other Exclusions 9. Participants must not be experiencing reactions that are not appropriate for RDD, including severe cutaneous adverse reactions (SCAR) as defined by the American Academy for Allergy, Asthma, and Immunology.