Food allergy, anaphylaxis, dermatology, and drug allergyAmerican Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma and Immunology Joint Task Force Report on omalizumab-associated anaphylaxis
Section snippets
Summary of AAAAI/ACAAI OJTF recommendations
- 1.
Informed consent should be obtained from the patient after discussing the risks, benefits, and alternatives to Xolair (omalizumab).
- 2.
The patient should be educated regarding the signs, symptoms, and treatment of anaphylaxis (Table I).1, 2
- 3.
Patients should be prescribed and educated on the proper use of the epinephrine autoinjector and advised to carry this before Xolair (omalizumab) administration and for the next 24 hours after Xolair (omalizumab) administration.
- 4.
An assessment of the patient's
Monoclonal antibodies and hypersensitivity reactions
Recombinant chimeric or fully humanized mAbs are increasingly part of medical treatment not only in chronic inflammatory and malignant disease but also in allergic disease. Hypersensitivity reactions to biologic agents, including anaphylaxis, have been well described.4, 5, 6 Anaphylaxis has been reported with several different mAbs, including omalizumab. However, the prevalence is low (ie, ≤0.2%) for Xolair (omalizumab).7 Such reactions, in general, are least to most common with human (100%
Incidence of potential Xolair (omalizumab) anaphylactic reactions
The OJTF reviewed a composite report provided by pharmaceutical firms that manufacture and market Xolair (omalizumab), Genentech and Novartis, dated May 3, 2006, that included the pivotal Xolair (omalizumab) clinical trials, as well as the postmarketing reports filed with the Food and Drug Administration between June 1, 2003, and December 31, 2005. Also reviewed was the information provided in the revised Xolair (omalizumab) package insert that included postmarketing reports from June 2003
OJTF conclusions and recommendations
Based on the data summarized above, the OJTF concluded that Xolair (omalizumab) should only be administered by a physician or other licensed health care provider who has been trained to recognize and treat anaphylaxis and who has available appropriate medications, equipment, and staff to respond to anaphylaxis.3 It would not be appropriate to administer Xolair (omalizumab) at home or in a facility that did not have appropriate staff and equipment to treat anaphylaxis. Direct observation for 2
Pre–Xolair (omalizumab) administration patient assessment
Before each Xolair (omalizumab) administration, an assessment of the patient's current health status should be made to determine whether there were any recent health changes that might require withholding treatment. The preinjection assessment should include measurement of vital signs, an assessment of asthma control, and some measurement of lung function (eg, peak expiratory flow rate or FEV1) at every visit (Fig 1). Prescribing physicians should provide guidelines on the actions staff should
Informed consent
The administration of Xolair (omalizumab) should be balanced with regard to the possibility of anaphylaxis, and the risk to a particular patient, as well as the benefit, should be discussed. Informed consent should be obtained before beginning Xolair (omalizumab), and this can be documented in the medical record or as a written consent form.
If the physician's recommendation differs from established guidelines (ie, practice parameters) or package insert information, this should be included in
References (15)
Anaphylaxis, killer allergy: long-term management in the community
J Allergy Clin Immunol
(2006)- et al.
The incidence and management of infusion reactions to infliximab: a large center experience
Am J Gastroenterol
(2003) - et al.
Second symposium on the definition and management of anaphylaxis: summary report—Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium
J Allergy Clin Immunol
(2006) - et al.
Rates of retrieval of self-injectable epinephrine prescriptions: a descriptive report
Ann Allergy Asthma Immunol
(2006) The diagnosis and management of anaphylaxis: an updated practice parameter
J Allergy Clin Immunol
(2005)National Asthma Education and Prevention Program Expert Panel Report 3: guidelines for the diagnosis and management of asthma
(2007)Adverse effects of the humanized antibodies used as cancer therapeutics
Curr Opin Oncol
(2006)
Cited by (0)
Disclosure of potential conflict of interest: I. Finegold is on the speakers' bureau for Novartis, Genentech, Alcon, Sanofi-Aventis, and Teva. L. B. Schwartz has consulting arrangements with GlaxoSmithKline, Genentech/Novartis, and Mast Cell Pharmaceuticals; has patent licensing arrangements with Phadia; has received grant support from the National Institutes of Health, the Philip Morris Foundation, GlaxoSmithKline, and Genentech/Novartis; and is on the speakers' bureau for Genentech/Novartis and Teva. T. A. E. Platts-Mills has consulting arrangements with Bristol-Meyers-Squibb. D. V. Wallace has declared that she has no conflict of interest.