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Food Allergy
Published in Praveen S. Goday, Cassandra L. S. Walia, Pediatric Nutrition for Dietitians, 2022
Alison Cassin, Ashley Devonshire, Stephanie Ward, Meghan McNeill
The mainstay of food allergy management is strict avoidance of the food allergen. The patient and family should be provided with clear education on allergen avoidance including label reading, cross-contact, and eating outside of the home. A weight-based epinephrine auto-injector should be carried at all times and the patient and family should receive education regarding its appropriate use and scenarios in which its use would be indicated.
Common Office Tests and Procedures for the Allergist
Published in Pudupakkam K Vedanthan, Harold S Nelson, Shripad N Agashe, PA Mahesh, Rohit Katial, Textbook of Allergy for the Clinician, 2021
Patients with systemic reactions should carry an epinephrine auto-injector. The auto-injector is also useful for delayed systemic reactions that have occurred after the patient has left the physician’s office.
Indications for and preparing and administering Hymenoptera vaccines
Published in Richard F. Lockey, Dennis K. Ledford, Allergens and Allergen Immunotherapy, 2020
David B.K. Golden, Farnaz Tabatabaian, Ulrich Müller-Gierok, Richard F. Lockey
Some subjects with positive venom skin tests have a low risk of a SAR, including those with no history of allergic sting reaction (asymptomatic sensitization), with large local reactions, and who had a cSR. Subsequent stings usually cause no SAR or a reaction that tends to be equal to, or less severe than the previous reactions. In both children and adults with a cSR, less than 3% had a more severe reaction to subsequent stings [28,31,32]. In a 15- to 20-year follow-up study of field stings in children, 87% of those with a history of cSR who were stung had no SAR, 7% had another mild cSR, and 6% a moderate SAR. None had a more severe SAR (anaphylaxis) [31]. The authors pointed out several significant types of selection bias in their survey and estimated that the true risk of anaphylaxis is less than 3% in children with a cSR. The two prospective studies of sting challenge in adults that included subjects with cSR showed a similarly low risk of anaphylaxis. Therefore, VIT is generally not recommended for subjects with cSR. However, it may be considered for highly exposed individuals or those with a severely impaired quality of life that does not always improve with a prescription for an epinephrine auto-injector and an admonition to carry it with them [33].
Formative and Validation Human Factors studies of a new disposable autoinjector for subcutaneous delivery of chronic disease therapies
Published in Expert Opinion on Drug Delivery, 2021
Claire Lageat, Anne Combedazou, Claire Ramus, Karen Guerrero, Cecile Frolet, Stanislav Glezer
Successful development of a new push-on-skin autoinjector for subcutaneous chronic drug delivery was achieved through iterative design and testing. Specifications were defined according to the user’s acceptance toward the force required to activate the start of injection and to maintain the autoinjector in place. Throughout the following formative studies, the occurrence of use errors was reduced when the participants read the IFU, and thanks to the design changes and IFU updates. During the validation study, while use errors were still observed when the participants had access to the IFU, providing a training prior the simulated testing almost eliminated the remaining use errors. Only two use errors were recorded in the trained arm, and these use errors were never experience from the third simulated injections. In addition, the evaluated autoinjector provides users with convenience, ease of use, confidence in controlling the start of injection and needle safety feature. Therefore, this newly developed autoinjector can be safely and efficiently used by health-care professionals, caregivers, and patients including hand impaired users, in both a clinical and non-clinical environment. These findings support an interest expressed by the target end-users for this new autoinjector.
Use of CGRP receptor blocker erenumab in the management of post-traumatic headache: a case series of 5 women
Published in Brain Injury, 2020
Jordan VanderEnde, Emma A. Bateman, Heather M. MacKenzie, Keith Sequeira
Given the presence of shared clinical features, advances in treatment for primary migraine headaches may provide meaningful insight into the underlying pathophysiology as well as novel treatment strategies for patients with PTH (1,10). Recent studies indicate that migraines may be driven in part by calcitonin gene-related peptide (CGRP), which acts as a vasodilator along intracranial perivascular nociceptors within the trigeminovascular system (11,12). Erenumab (Aimovig®, Novartis) is a human monoclonal antibody that blocks the CGRP receptor. This medication is self-administered subcutaneously by patients on a monthly basis using a pre-filled autoinjector. It has recently demonstrated both safety and efficacy for the management of both episodic and chronic migraine headaches (13,14). In a double-blinded, randomized, placebo-controlled trial with 656 patients, Tepper et al. (14) found that erenumab reduced the number of migraine days per month by an additional 2.4 days compared with placebo among individuals with chronic migraine; a mean reduction of 6.6 headache days per month was found with both the 70 mg and 140 mg dose of erenumab. The most commonly reported side effects were injection site pain (4%), constipation (4%), and muscle spasm (4%). In addition, 3% of patients taking 70 mg of erenumab and 1% of patients taking 140 mg had a serious adverse event including: intervertebral disc protrusion (<1%), appendicitis (<1%), costochondritis (<1%), fibroma (<1%), non-cardiac chest pain (<1%), radius fracture (<1%), abdominal adhesions (<1%), abdominal pain (<1%), and cartilage injury (<1%).
Hold the device against the skin: the impact of injection duration on user’s force for handheld autoinjectors
Published in Expert Opinion on Drug Delivery, 2020
Andreas Schneider, Philippe Mueller, Christoph Jordi, Philipp Richard, Peter Sneeringer, Ranjan Nayyar, Mary Yovanoff, Jakob Lange
Each participant sequentially simulated three injections using a standard handheld disposable autoinjector (YpsoMate®, Ypsomed AG, Burgdorf, Switzerland) described earlier [e.g. 26,28,44]. The selected autoinjector is well suited for studying the impact of injection duration on user’s force, as its push-on-skin handling concept has been demonstrated to support safe and effective drug self-administration across user groups and disease states [e.g. 26,45,46]. To complete the injection, participants needed to sustain a minimum force of 4.0 N to hold the device against the skin during the process. Independent of the user-controlled push-on-skin process to insert the needle into skin, the autoinjector contained a spring-driven mechanism automatically delivering the drug product. The autoinjector samples included in the study contained a 2.25 mL syringe (syriQ®, 27 G needle diameter, Schott, Mainz, Germany) pre-filled with 2.0 mL aqueous solution of polyethylene glycol of varying viscosities to achieve the targeted injection duration of 7–9 s for the short, 15–20 s for the intermediate, and 25–30 s for the long injection at standard temperature and atmosphere. The injection duration referred to the time required to deliver the drug product excluding holding time and safety margins due to system tolerances.