Omalizumab: Practical considerations regarding the risk of anaphylaxis

Abstract

Omalizumab has demonstrated efficacy among patients with moderate to severe persistent allergic asthma, whose symptoms are inadequately controlled with other controller agents. This therapy is generally well tolerated, but there are some safety considerations, the most important of which is the rare, but potentially life-threatening, occurrence of omalizumab-associated anaphylaxis.In Canada, data from the manufacturer of omalizumab indicate that the frequency of anaphylaxis attributed to Xolair in post-marketing use is approximately 0.2%. Other researchers, including the American Omalizumab Joint Task Force (OJTF), have suggested a lower overall frequency of 0.09%.This paper provides a summary of the epidemiologic research carried out to date and presents a concise, practical set of recommendations for the prevention, monitoring and management of omalizumab-associated anaphylaxis. Prevention tips include advice on patient education measures, concomitant medications and optimal administration. For the first three injections, the recommendation is to monitor in clinic for two hours after the omalizumab injection; for subsequent injections, the monitoring period should be 30 minutes or an appropriate time agreed upon by the individual patient and healthcare professional.In the event that a patient does experience omalizumab-associated anaphylaxis, the paper provides recommendations for handling the situation in-clinic and recommendations on how to counsel patients to recognize the potential signs and symptoms in the community and react appropriately.

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

“…However, the Omalizumab Joint Task Force reviewed the post-marketing reports compiled by the agent's manufacturer and estimated the incidence of anaphylaxis at approximately 0.09%. 105 Seventy-eight percent of reactions occurred within the first two hours after the injection and within the first three doses. For this reason, omalizumab is given in a clinic setting and it is suggested that individuals are observed for two hours following the three first doses, then for 30 minutes for the following injections.…”

Anti-hIgE gene therapy of peanut-induced anaphylaxis in a humanized murine model of peanut allergy

“…Adverse side effects have been reported with omalizumab therapy, including anaphylaxis, cardiovascular and cerebrovascular events, and malignancy, and there are reports of associated risks of low IgE levels and autoimmunity or increased risk for parasitic disease. [32][33][34][35][36][37] The overall incidence of adverse events reported has been similar across studies between subjects receiving omalizumab versus placebo, and the majority of treatment-related adverse events, mostly cardiovascular and cerebrovascular, and risk of parasitic infections were mild or moderate in severity in treated subjects.…”

Anaphylaxis and Status Asthmaticus after Omalizumab Injection: A Case Report

“…Omalizumab ile ilişkili anafilaksi sıklığı %0.2-0.09 arasında bildirilmektedir [2]. Bildirilen olgularda fatalite görülmemiş ve endotrakeal entübasyon ihtiyacı ortaya çıkmamıştır.…”