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.
Highlights
Omalizumab, a recombinant humanized monoclonal anti-IgE antibody, is indicated for patients with moderate to severe persistent allergic asthma, whose symptoms are inadequately controlled with high-dose inhaled corticosteroids either alone or in combination with a longacting b2-agonist [1,2,3]
Summary of recommendations Patient education: 1) Provide counseling about the benefits of the medication and the possibility of rare adverse events; 2) Discuss the potential signs and symptoms of anaphylaxis, reinforce with take-home handout; 3) Explain how the risk is reduced as time elapses post-dose and as the number of doses increases; 4) Link relative incidence of anaphylaxis to the duration of post-dose monitoring; and
7) Ensure the patient receives an epinephrine autoinjector and is instructed on its use Medications: 1) Where feasible, discontinue beta-blocker therapy before initiating omalizumab; and 2) Patients should continue to take other asthma medications unless the regimen is changed by the managing physician
Summary
Omalizumab, a recombinant humanized monoclonal anti-IgE antibody, is indicated for patients with moderate to severe persistent allergic asthma, whose symptoms are inadequately controlled with high-dose inhaled corticosteroids either alone or in combination with a longacting b2-agonist [1,2,3]. Summary of recommendations Patient education: 1) Provide counseling about the benefits of the medication and the possibility of rare adverse events; 2) Discuss the potential signs and symptoms of anaphylaxis, reinforce with take-home handout; 3) Explain how the risk is reduced as time elapses post-dose and as the number of doses increases; 4) Link relative incidence of anaphylaxis to the duration of post-dose monitoring; and. Treatment in clinic: 1) Assess airway breathing and circulation; 2) Inject epinephrine, 0.3 mg i.m., in the lateral thigh; 3) Epinephrine dosing should be repeated if necessary; 4) Contact emergency services; 5) Establish, monitor and maintain patency of the airway; 6) Place patient in recumbent position, with elevated lower extremities, if tolerated; 7) Administer oxygen; 8) Establish venous access with an i.v. line; keep open with normal saline; 9) Consider use of short-acting bronchodilator (e.g., salbutamol); and 10) Consider additional medications (e.g., H1 antihistamine, systemic corticosteroid). Post-reaction: 3) Permanently discontinue omalizumab in any patient who experiences a severe hypersensitivity reaction
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