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XOLAIR Financial Support Tool

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We will need some information to determine which type of support may be an option for your patient.

For which of the following indications is your patient taking XOLAIR?

Does your patient’s primary insurance cover XOLAIR?
What type of primary insurance does your patient have?
Is your patient receiving any other form of financial assistance for XOLAIR?

(Not including primary insurance)

What type of assistance?

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  • Commercial insurance: An insurance plan you get from a private health insurance company. This can be insurance from your job, from a plan you bought yourself or from a Health Insurance Marketplace. Medicare and Medicaid are not considered commercial insurance. 

  • Public insurance: A health insurance plan you get from the federal or state government. This includes Medicare, Medicaid, TRICARE and DoD/VA insurance.

    • Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study [published correction appears in J Invest Dermatol. 2015;135(3):925]. J Invest Dermatol. 2015;135(1):67-75.

      Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study [published correction appears in J Invest Dermatol. 2015;135(3):925]. J Invest Dermatol. 2015;135(1):67-75.

    • Maurer M, Rosén K, Hsieh H-J, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria [published correction appears in N Engl J Med. 2013;368(24)(suppl):2340-2341]. N Engl J Med. 2013;368(10):924-935.

      Maurer M, Rosén K, Hsieh H-J, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria [published correction appears in N Engl J Med. 2013;368(24)(suppl):2340-2341]. N Engl J Med. 2013;368(10):924-935.

    • Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use. Curr Med Res Opin. 2019;35(8):1387-1395.

      Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use. Curr Med Res Opin. 2019;35(8):1387-1395.

    • XOLAIR. Prescribing information. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation.

      XOLAIR. Prescribing information. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation.

    • Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report [published online November 17, 2010]. Allergy. 2011;66(3):317​-330. doi:10.1111/j.1398​-9995.2010.02496.x

      Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report [published online November 17, 2010]. Allergy. 2011;66(3):317​-330. doi:10.1111/j.1398​-9995.2010.02496.x

    • Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA. Elsevier Saunders; 2012;291-306.

      Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA. Elsevier Saunders; 2012;291-306.

    • Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic urticaria, a form of chronic hives. https://www.roche.com/media/releases/med-cor-2020-12-01. March 2014. Accessed January 14, 2021.

      Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic urticaria, a form of chronic hives. https://www.roche.com/media/releases/med-cor-2020-12-01. March 2014. Accessed January 14, 2021.

    • Data on file. Genentech USA, Inc. South San Francisco, CA.

      Data on file. Genentech USA, Inc. South San Francisco, CA.

    • Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria [published online ahead of print, September 18, 2021]. Allergy. 2021;10.1111/all.15090. doi:10.1111/all.15090

      Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria [published online ahead of print, September 18, 2021]. Allergy. 2021;10.1111/all.15090. doi:10.1111/all.15090

    • Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-190. doi:10.1067/mai.2001.117880

      Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-190. doi:10.1067/mai.2001.117880

    • Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18(2):254-261.

      Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18(2):254-261.

    • Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.

      Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.

    • Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol. 2008;8(3):205-217.

      Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol. 2008;8(3):205-217.

    • Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704.

      Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704.

    • Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and lungs. Allergy. 2020;75(7):1582-1605.

      Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and lungs. Allergy. 2020;75(7):1582-1605.

    • Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.

      Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.

    • Allergens and allergic asthma. Asthma and Allergy Foundation of America. Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/

      Allergens and allergic asthma. Asthma and Allergy Foundation of America. Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/

    • Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO. Ann Allergy Asthm Immunol. 2017;119(6):524-532.e2.

      Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO. Ann Allergy Asthm Immunol. 2017;119(6):524-532.e2.

    • Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin Immunol. 2013;13(1):78-86.

      Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin Immunol. 2013;13(1):78-86.

    • Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe asthma patients eligible for mepolizumab therapy by age and age of onset of asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.

      Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe asthma patients eligible for mepolizumab therapy by age and age of onset of asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.

    • Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis, prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.

      Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis, prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.

    • Siles RI, Hsieh FH. Allergy blood testing: a practical guide for clinicians. Cleve Clin J Med. 2011;78(9):585-592. doi:10.3949/ccjm.78a.11023

      Siles RI, Hsieh FH. Allergy blood testing: a practical guide for clinicians. Cleve Clin J Med. 2011;78(9):585-592. doi:10.3949/ccjm.78a.11023

    • National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. Bethesda, MD: National Institutes of Health; 2007. NIH publication 07-4051.

      National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. Bethesda, MD: National Institutes of Health; 2007. NIH publication 07-4051.

    • Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl 3):S1-S148.

      Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl 3):S1-S148.

    • Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol Pract. 2020;8:429-440.

      Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol Pract. 2020;8:429-440.

    • Sonora Quest Laboratories. Test Interpretation and Management Options—Utilizing ImmunoCAP® KU/L Results. Accessed March 19, 2020. https://www.sonoraquest.com/media/2315/immunocap-ref-range_test-menu_0318.pdf

      Sonora Quest Laboratories. Test Interpretation and Management Options—Utilizing ImmunoCAP® KU/L Results. Accessed March 19, 2020. https://www.sonoraquest.com/media/2315/immunocap-ref-range_test-menu_0318.pdf

    • Kerkhof M, Dubois AE, Postma DS, Schouten JP, de Monchy JG. Role and interpretation of total serum IgE measurements in the diagnosis of allergic airway disease in adults. Allergy. 2003;58(9):905-911.

      Kerkhof M, Dubois AE, Postma DS, Schouten JP, de Monchy JG. Role and interpretation of total serum IgE measurements in the diagnosis of allergic airway disease in adults. Allergy. 2003;58(9):905-911.

    • World Health Organization. Prevention of allergy and allergic asthma. Based on the WHO/WAO meeting on the prevention of allergy and allergic asthma; January 8-9, 2002; Geneva, Switzerland.

      World Health Organization. Prevention of allergy and allergic asthma. Based on the WHO/WAO meeting on the prevention of allergy and allergic asthma; January 8-9, 2002; Geneva, Switzerland.

    • Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma. Allergy. 2018;73(2):490-497.

      Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma. Allergy. 2018;73(2):490-497.

    • Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.

      Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.

    • Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.

      Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.

    • Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011;27(1):163-169.

      Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011;27(1):163-169.

    • Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J Allergy Clin Immunol. 2020;145(2):528-536.e1.

      Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J Allergy Clin Immunol. 2020;145(2):528-536.e1.

    • Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials [published correction appears in J Allergy Clin Immunol. 2021;147(1):416]. J Allergy Clin Immunol. 2020;146(3):595-605. doi:10.1016/j.jaci.2020.05.032

      Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials [published correction appears in J Allergy Clin Immunol. 2021;147(1):416]. J Allergy Clin Immunol. 2020;146(3):595-605. doi:10.1016/j.jaci.2020.05.032

    • Bachert C, Zhang L, Gevaert P. Current and future treatment options for adult chronic rhinosinusitis: focus on nasal polyposis. J Allergy Clin Immunol. 2015;136(6):1431-1440. doi:10.1016/j.jaci.2015.10.010

      Bachert C, Zhang L, Gevaert P. Current and future treatment options for adult chronic rhinosinusitis: focus on nasal polyposis. J Allergy Clin Immunol. 2015;136(6):1431-1440. doi:10.1016/j.jaci.2015.10.010

    • Hopkins C, Slack R, Lund V, Brown P, Copley L, Browne J. Long-term outcomes from the English national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Laryngoscope. 2009;119(12):2459-2465. doi:10.1002/lary.20653

      Hopkins C, Slack R, Lund V, Brown P, Copley L, Browne J. Long-term outcomes from the English national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Laryngoscope. 2009;119(12):2459-2465. doi:10.1002/lary.20653

    • DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550-555. doi:10.1002/lary.26391

      DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550-555. doi:10.1002/lary.26391

    • Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110-6.e1. doi:10.1016/j.jaci.2012.07.047

      Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110-6.e1. doi:10.1016/j.jaci.2012.07.047

    • Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.

      Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.

    • Zazzali JL, Raimundo K, Trzaskoma B, Rosén KE. Improvements in health-related quality of life from GLACIAL: a phase III, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) receiving concomitant H1 antihistamines, H2 antihistamines, and/or leukotriene receptor antagonist (LTRA) treatment. Poster presented at: the 32nd Anniversary Fall Clinical Dermatology Conference; October 17–20, 2013; Las Vegas, NV.

      Zazzali JL, Raimundo K, Trzaskoma B, Rosén KE. Improvements in health-related quality of life from GLACIAL: a phase III, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) receiving concomitant H1 antihistamines, H2 antihistamines, and/or leukotriene receptor antagonist (LTRA) treatment. Poster presented at: the 32nd Anniversary Fall Clinical Dermatology Conference; October 17–20, 2013; Las Vegas, NV.

    • Finlay AY, Kaplan AP, Beck LA, et al. Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria. J Eur Acad Dermatol Venereol. 2017;31(10):1715​-1721.

      Finlay AY, Kaplan AP, Beck LA, et al. Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria. J Eur Acad Dermatol Venereol. 2017;31(10):1715​-1721.

    • Antonova E, Raimundo K, Trzaskoma B, Solari PG, Omachi T, Zazzali JL. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) treated with omalizumab: results of a randomized, double-blind, placebo-controlled clinical trial (GLACIAL). Poster presented at: the 2014 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology; November 6–10, 2014; Atlanta, GA.

      Antonova E, Raimundo K, Trzaskoma B, Solari PG, Omachi T, Zazzali JL. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) treated with omalizumab: results of a randomized, double-blind, placebo-controlled clinical trial (GLACIAL). Poster presented at: the 2014 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology; November 6–10, 2014; Atlanta, GA.

    • Casale TB, Murphy TR, Holden M, et al. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: results from XTEND-CIU, a 48-week, randomized, placebo-controlled study. Poster presented at: the American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress; March 2–5, 2018; Orlando, FL.

      Casale TB, Murphy TR, Holden M, et al. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: results from XTEND-CIU, a 48-week, randomized, placebo-controlled study. Poster presented at: the American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress; March 2–5, 2018; Orlando, FL.

    • Ludmann P. Hives: signs and symptoms. American Academy of Dermatology Association. Updated September 28, 2021. Accessed May 25, 2023. https://www.aad.org/public/diseases/a-z/hives-symptoms

      Ludmann P. Hives: signs and symptoms. American Academy of Dermatology Association. Updated September 28, 2021. Accessed May 25, 2023. https://www.aad.org/public/diseases/a-z/hives-symptoms

    • Hollis K, Proctor C, McBride D, et al. Comparison of Urticaria Activity Score Over 7 Days (UAS7) values obtained from once-daily and twice-daily versions: results from the ASSURE-CSU study. Am J Clin Dermatol. 2018;19(2):267​-274.

      Hollis K, Proctor C, McBride D, et al. Comparison of Urticaria Activity Score Over 7 Days (UAS7) values obtained from once-daily and twice-daily versions: results from the ASSURE-CSU study. Am J Clin Dermatol. 2018;19(2):267​-274.

    • Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the treatment of multiple food allergies. N Engl J Med. 2024;390(10):889​-899.

      Wood RA, Togias A, Sicherer SH, et al. Omalizumab for the treatment of multiple food allergies. N Engl J Med. 2024;390(10):889​-899.

    • FAIR Health. Food allergy in the United States: recent trends and costs. 2017. Accessed July 25, 2024.http://resource.nlm.nih.gov/101751558

      FAIR Health. Food allergy in the United States: recent trends and costs. 2017. Accessed July 25, 2024.http://resource.nlm.nih.gov/101751558

    • US Dept of Agriculture. Food allergies. Updated March 21, 2024. Accessed July 25, 2024. https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/food-allergies#2

      US Dept of Agriculture. Food allergies. Updated March 21, 2024. Accessed July 25, 2024. https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/food-allergies#2

    • Warren CM, Aktas ON, Manalo LJ, Bartell TR, Gupta RS. The epidemiology of multifood allergy in the United States: a population-based study. Ann Allergy Asthma Immunol. 2023;130(5):637​-648.e5.

      Warren CM, Aktas ON, Manalo LJ, Bartell TR, Gupta RS. The epidemiology of multifood allergy in the United States: a population-based study. Ann Allergy Asthma Immunol. 2023;130(5):637​-648.e5.

    • HR Rep No. 110-571, pt 1 (2008). Accessed July 18, 2024. https://www.congress.gov/congressional-report/110th-congress/house-report/571/1?outputFormat=pdf

      HR Rep No. 110-571, pt 1 (2008). Accessed July 18, 2024. https://www.congress.gov/congressional-report/110th-congress/house-report/571/1?outputFormat=pdf

    • Gupta RS, Warren CM, Smith BM, et al. The public health impact of parent-reported childhood food allergies in the United States. Pediatrics. 2018;142(6):e20181235.

      Gupta RS, Warren CM, Smith BM, et al. The public health impact of parent-reported childhood food allergies in the United States. Pediatrics. 2018;142(6):e20181235.

    • US Census Bureau. Age and Sex, American Community Survey, ACS 1-Year Estimates Subject Tables, Table S0101, 2022. Accessed July 22, 2024. https://data.census.gov/table/ACSST1Y2022.S0101

      US Census Bureau. Age and Sex, American Community Survey, ACS 1-Year Estimates Subject Tables, Table S0101, 2022. Accessed July 22, 2024. https://data.census.gov/table/ACSST1Y2022.S0101

    • Clark S, Espinola J, Rudders SA, Banerji A, Camargo CA. Frequency of US emergency department visits for food-related acute allergic reactions. J Allergy Clin Immunol. 2011;127(3):682​-683.

      Clark S, Espinola J, Rudders SA, Banerji A, Camargo CA. Frequency of US emergency department visits for food-related acute allergic reactions. J Allergy Clin Immunol. 2011;127(3):682​-683.

    • Sampson HA, Aceves S, Bock SA, et al. Food allergy: a practice parameter update–2014. J Allergy Clin Immunol. 2014;134(5): 1016-​1025.e43.

      Sampson HA, Aceves S, Bock SA, et al. Food allergy: a practice parameter update–2014. J Allergy Clin Immunol. 2014;134(5): 1016-​1025.e43.

    • Boyce JA, Assa’ad Amal, Burks AW, et al; NIAID-Sponsored Expert Panel. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010;126(suppl 6):S1-S58.

      Boyce JA, Assa’ad Amal, Burks AW, et al; NIAID-Sponsored Expert Panel. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010;126(suppl 6):S1-S58.

    • Santos AF, Riggioni C, Agache I, et al. EAACI guidelines on the diagnosis of IgE-mediated food allergy. Allergy. 2023;78(12):3057​-3076.

      Santos AF, Riggioni C, Agache I, et al. EAACI guidelines on the diagnosis of IgE-mediated food allergy. Allergy. 2023;78(12):3057​-3076.

    • Oettgen HC. Mast cells in food allergy: inducing immediate reactions and shaping long-term immunity. J Allergy Clin Immunol. 2023;151(1):21-25.

      Oettgen HC. Mast cells in food allergy: inducing immediate reactions and shaping long-term immunity. J Allergy Clin Immunol. 2023;151(1):21-25.

    • Anvari S, Miller J, Yeh CY, Davis CM. IgE-mediated food allergy. Clinic Rev Allergy Immunol. 2019;57(2):244​-260.

      Anvari S, Miller J, Yeh CY, Davis CM. IgE-mediated food allergy. Clinic Rev Allergy Immunol. 2019;57(2):244​-260.

    • Zablotsky B, Black LI, Akinbami LJ. Diagnosed allergic conditions in children aged 0–17 years: United States, 2021. NCHS Data Brief. 2023;(459):1-8.

      Zablotsky B, Black LI, Akinbami LJ. Diagnosed allergic conditions in children aged 0–17 years: United States, 2021. NCHS Data Brief. 2023;(459):1-8.

    • Mahdavinia M, Fox SR, Smith BM, et al. Racial differences in food allergy phenotype and health care utilization among US children. J Allergy Clin Immunol Pract. 2017;5(2):352​-357.e1.

      Mahdavinia M, Fox SR, Smith BM, et al. Racial differences in food allergy phenotype and health care utilization among US children. J Allergy Clin Immunol Pract. 2017;5(2):352​-357.e1.

    • Sicherer SH, Sampson HA. Food allergy: a review and update on epidemiology, pathogenesis, diagnosis, prevention, and management. J Allergy Clin Immunol. 2018;141(1):41-58.

      Sicherer SH, Sampson HA. Food allergy: a review and update on epidemiology, pathogenesis, diagnosis, prevention, and management. J Allergy Clin Immunol. 2018;141(1):41-58.

    • Lieberman JA, Chehade M. Use of omalizumab in the treatment of food allergy and anaphylaxis. Curr Allergy Asthma Rep. 2013;13(1):78-84.

      Lieberman JA, Chehade M. Use of omalizumab in the treatment of food allergy and anaphylaxis. Curr Allergy Asthma Rep. 2013;13(1):78-84.

    • El Ansari YS, Kanagaratham C, Oettgen HC. Mast cells as regulators of adaptive immune responses in food allergy. Yale J Biol Med. 2020;93(5):711​-718.

      El Ansari YS, Kanagaratham C, Oettgen HC. Mast cells as regulators of adaptive immune responses in food allergy. Yale J Biol Med. 2020;93(5):711​-718.

    • Ruiter B, Shreffler WG. The role of dendritic cells in food allergy. J Allergy Clin Immunol. 2012;129(4):921​-928.

      Ruiter B, Shreffler WG. The role of dendritic cells in food allergy. J Allergy Clin Immunol. 2012;129(4):921​-928.

    • Gupta S, Warren C, Seetasith A, Schuldt R, Gupta R, Casale TB. Mental health concerns of patients and their caregivers in the food allergy research & education (FARE) patient registry add to the burden of food allergy. Poster presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Scientific Meeting; February 24-27, 2023; San Antonio, TX.

      Gupta S, Warren C, Seetasith A, Schuldt R, Gupta R, Casale TB. Mental health concerns of patients and their caregivers in the food allergy research & education (FARE) patient registry add to the burden of food allergy. Poster presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Scientific Meeting; February 24-27, 2023; San Antonio, TX.

    • Vandenplas Y. Prevention and management of cow’s milk allergy in non-exclusively breastfed infants. Nutrients. 2017;9(7):731.

      Vandenplas Y. Prevention and management of cow’s milk allergy in non-exclusively breastfed infants. Nutrients. 2017;9(7):731.

    • Don’t let hidden holiday allergies ruin your good cheer. American College of Allergy, Asthma & Immunology. Published April 11, 2019. Accessed February 12, 2024. https://acaai.org/news/dont-let-hidden-holiday-allergies-ruin-your-good-cheer/

      Don’t let hidden holiday allergies ruin your good cheer. American College of Allergy, Asthma & Immunology. Published April 11, 2019. Accessed February 12, 2024. https://acaai.org/news/dont-let-hidden-holiday-allergies-ruin-your-good-cheer/

    • Hill DJ, Heine RG, Hosking CS. The diagnostic value of skin prick testing in children with food allergy. Pediatr Allergy Immunol. 2004;15(5):435​-441.

      Hill DJ, Heine RG, Hosking CS. The diagnostic value of skin prick testing in children with food allergy. Pediatr Allergy Immunol. 2004;15(5):435​-441.

    • Fierstein JL, Brown D, Gupta R, Bilaver L. Understanding food-related allergic reactions through a US national patient registry. J Allergy Clin Immunol Pract. 2021;9(1):206​-215.e1.

      Fierstein JL, Brown D, Gupta R, Bilaver L. Understanding food-related allergic reactions through a US national patient registry. J Allergy Clin Immunol Pract. 2021;9(1):206​-215.e1.

    • Permaul P, Stutius LM, Sheehan WJ, et al. Sesame allergy: role of specific IgE and skin-prick testing in predicting food challenge results. Allergy Asthma Proc. 2009;30(6):643​-648.

      Permaul P, Stutius LM, Sheehan WJ, et al. Sesame allergy: role of specific IgE and skin-prick testing in predicting food challenge results. Allergy Asthma Proc. 2009;30(6):643​-648.

    • Soy. American College of Allergy, Asthma & Immunology. Updated April 9, 2019. Accessed July 22, 2024. https://acaai.org/allergies/allergic-conditions/food/soy/

      Soy. American College of Allergy, Asthma & Immunology. Updated April 9, 2019. Accessed July 22, 2024. https://acaai.org/allergies/allergic-conditions/food/soy/

    • Sokol K, Rasooly M, Dempsey C, et al. Prevalence and diagnosis of sesame allergy in children with IgE-mediated food allergy. Pediatr Allergy Immunol. 2020;31(2):214​-218.

      Sokol K, Rasooly M, Dempsey C, et al. Prevalence and diagnosis of sesame allergy in children with IgE-mediated food allergy. Pediatr Allergy Immunol. 2020;31(2):214​-218.

    • Verstege A, Mehl A, Rolinck-Werninghaus C, et al. The predictive value of the skin prick test weal size for the outcome of oral food challenges. Clin Exp Allergy. 2005;35(9):1220​-1226.

      Verstege A, Mehl A, Rolinck-Werninghaus C, et al. The predictive value of the skin prick test weal size for the outcome of oral food challenges. Clin Exp Allergy. 2005;35(9):1220​-1226.

    • Giannetti A, Ruggi A, Ricci G, Giannì G, Caffarelli C. Natural history of hazelnut allergy and current approach to its diagnosis and treatment. Children (Basel). 2023;10(3):585.

      Giannetti A, Ruggi A, Ricci G, Giannì G, Caffarelli C. Natural history of hazelnut allergy and current approach to its diagnosis and treatment. Children (Basel). 2023;10(3):585.

    • Cortot CF, Sheehan WJ, Permaul P, et al. Role of specific IgE and skin-prick testing in predicting food challenge results to baked egg. Allergy Asthma Proc. 2012;33(3):275​-281.

      Cortot CF, Sheehan WJ, Permaul P, et al. Role of specific IgE and skin-prick testing in predicting food challenge results to baked egg. Allergy Asthma Proc. 2012;33(3):275​-281.

    • Koplin JJ, Perrett KP, Sampson HA. Diagnosing peanut allergy with fewer oral food challenges. J Allergy Clin Immunol Pract. 2019;7(2):375​-380.

      Koplin JJ, Perrett KP, Sampson HA. Diagnosing peanut allergy with fewer oral food challenges. J Allergy Clin Immunol Pract. 2019;7(2):375​-380.

    • Feng C, Kim JH. Beyond avoidance: the psychosocial impact of food allergies. Clin Rev Allergy Immunol. 2019;57(1):74-82.

      Feng C, Kim JH. Beyond avoidance: the psychosocial impact of food allergies. Clin Rev Allergy Immunol. 2019;57(1):74-82.

    • Chokshi NY, Maskatia Z, Miller S, Guffey D, Minard CG, Davis CM. Risk factors in pediatric shrimp allergy. Allergy Asthma Proc. 2015;36(4):65-71.

      Chokshi NY, Maskatia Z, Miller S, Guffey D, Minard CG, Davis CM. Risk factors in pediatric shrimp allergy. Allergy Asthma Proc. 2015;36(4):65-71.

    • Saleh-Langenberg J, Flokstra-de Blok BM, Goossens NJ, Kemna JC, van der Velde JL, Dubois AE. The compliance and burden of treatment with the epinephrine auto-injector in food-allergic adolescents. Pediatr Allergy Immunol. 2016;27(1):28-34.

      Saleh-Langenberg J, Flokstra-de Blok BM, Goossens NJ, Kemna JC, van der Velde JL, Dubois AE. The compliance and burden of treatment with the epinephrine auto-injector in food-allergic adolescents. Pediatr Allergy Immunol. 2016;27(1):28-34.

    • Portnoy JM. Appropriate allergy testing and interpretation. Mo Med. 2011;108(5):339​-343.

      Portnoy JM. Appropriate allergy testing and interpretation. Mo Med. 2011;108(5):339​-343.

    • Sicherer SH, Warren CM, Dant C, Gupta RS, Nadeau KC. Food allergy from infancy through adulthood. J Allergy Clin Immunol Pract. 2020;8(6):1854​-1864.

      Sicherer SH, Warren CM, Dant C, Gupta RS, Nadeau KC. Food allergy from infancy through adulthood. J Allergy Clin Immunol Pract. 2020;8(6):1854​-1864.

    • Li PH, Rutkowski K, Kennard L, et al. Challenge-confirmed peanut allergy in older patients: performance of skin tests, specific immunoglobulin E, and ara h 2. Ann Allergy Asthma Immunol. 2018;120(3):334​-335.

      Li PH, Rutkowski K, Kennard L, et al. Challenge-confirmed peanut allergy in older patients: performance of skin tests, specific immunoglobulin E, and ara h 2. Ann Allergy Asthma Immunol. 2018;120(3):334​-335.

    • Groetch M, Mudd K, Woch M, et al. Retail food equivalents for post-oral immunotherapy dosing in the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food-Allergic Children and Adults (OUtMATCH) clinical trial. J Allergy Immunol Pract. 2023;11(2):572​-580.e2.

      Groetch M, Mudd K, Woch M, et al. Retail food equivalents for post-oral immunotherapy dosing in the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food-Allergic Children and Adults (OUtMATCH) clinical trial. J Allergy Immunol Pract. 2023;11(2):572​-580.e2.

    IMPORTANT SAFETY INFORMATION

    INDICATION

    XOLAIR® (omalizumab) is indicated for:

    • The treatment of chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.


      Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria.

    WARNING: Anaphylaxis

    Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.


    CONTRAINDICATIONS

    XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.

    WARNINGS AND PRECAUTIONS

    Anaphylaxis: Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports. In premarketing clinical trials in patients for a different indication, anaphylaxis was reported in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.

    A case-control study in asthma patients showed that, among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis.

    In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. Approximately 60% to 70% of anaphylaxis cases have been reported to occur within the first three doses of XOLAIR, with additional cases occurring sporadically beyond the third dose.

    Initiate XOLAIR only in a healthcare setting equipped to manage anaphylaxis which can be life-threatening. Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur.

    Once XOLAIR therapy has been established, administration of XOLAIR prefilled syringe or autoinjector outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients. Patient selection, determined by the healthcare provider in consultation with the patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (e.g. prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with XOLAIR prefilled syringe or autoinjector with proper technique according to the prescribed dosing regimen and Instructions for Use.

    Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction.

    Malignancy: Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of adults and adolescents (≥12 years of age) for a different indication and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known.

    A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829 non-XOLAIR-treated adolescent and adult patients for a different indication found that the incidence rates of primary malignancies (per 1000 patient years) were similar in both groups (12.3 vs 13.0, respectively). Study limitations which include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%) preclude definitively ruling out a malignancy risk with XOLAIR.

    Corticosteroid Reduction: In CSU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

    Fever, Arthralgia, and Rash: In post-approval use, some patients have experienced a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.

    Parasitic (Helminth) Infection: Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.

    Laboratory Tests: Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase following administration of XOLAIR and may remain elevated for up to 1 year following discontinuation of XOLAIR.

    Potential Medication Error Related to Emergency Treatment of Anaphylaxis
    XOLAIR should not be used for the emergency treatment of allergic reactions, including anaphylaxis. In studies to simulate use, some patients and caregivers did not understand that XOLAIR is not intended for the emergency treatment of allergic reactions, including anaphylaxis. The safety and effectiveness of XOLAIR for emergency treatment of allergic reactions, including anaphylaxis, have not been established. Instruct patients that XOLAIR is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.

    ADVERSE REACTIONS

    Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% incidence in XOLAIR-treated patients and more frequent than in placebo) for XOLAIR 150 mg and 300 mg, respectively, included: headache (12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper respiratory tract infection (1%, 3%), and cough (1%, 2%).

    Injection Site Reactions: Injection site reactions of any severity occurred in more XOLAIR-treated patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria. None of the events resulted in study discontinuation or treatment interruption.

    Injection Site Reactions in Healthy Adults: In an open label trial in healthy adults, in which the 300 mg/2 mL autoinjector was compared to the 300 mg/2 mL prefilled syringe, injection site reactions (e.g., induration, pain, erythema, hemorrhage, swelling, discomfort, bruising, hypoesthesia, edema, pruritus) were observed in 24% (16/66) of subjects treated with the autoinjector compared with 14% (9/64) of subjects treated with the prefilled syringe.

    Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma: A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non-XOLAIR-treated patients ≥12 years of age for a different indication to evaluate the long term safety of XOLAIR, including the risk of malignancy. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.

    Pregnancy: Data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk.

    You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

    Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.

    WARNING: Anaphylaxis

    Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.

    INDICATION

    XOLAIR® (omalizumab) is indicated for:

    • The treatment of chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.


      Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria.


    CONTRAINDICATIONS

    XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.

    WARNINGS AND PRECAUTIONS

    Anaphylaxis: Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports. In premarketing clinical trials in patients for a different indication, anaphylaxis was reported in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.

    A case-control study in asthma patients showed that, among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis.

    In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. Approximately 60% to 70% of anaphylaxis cases have been reported to occur within the first three doses of XOLAIR, with additional cases occurring sporadically beyond the third dose.

    Initiate XOLAIR only in a healthcare setting equipped to manage anaphylaxis which can be life-threatening. Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur.

    Once XOLAIR therapy has been established, administration of XOLAIR prefilled syringe or autoinjector outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients. Patient selection, determined by the healthcare provider in consultation with the patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (e.g. prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with XOLAIR prefilled syringe or autoinjector with proper technique according to the prescribed dosing regimen and Instructions for Use.

    Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction.

    Malignancy: Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of adults and adolescents (≥12 years of age) for a different indication and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known.

    A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829 non-XOLAIR-treated adolescent and adult patients for a different indication found that the incidence rates of primary malignancies (per 1000 patient years) were similar in both groups (12.3 vs 13.0, respectively). Study limitations which include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%) preclude definitively ruling out a malignancy risk with XOLAIR.

    Corticosteroid Reduction: In CSU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

    Fever, Arthralgia, and Rash: In post-approval use, some patients have experienced a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.

    Parasitic (Helminth) Infection: Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.

    Laboratory Tests: Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase following administration of XOLAIR and may remain elevated for up to 1 year following discontinuation of XOLAIR.

    Potential Medication Error Related to Emergency Treatment of Anaphylaxis
    XOLAIR should not be used for the emergency treatment of allergic reactions, including anaphylaxis. In studies to simulate use, some patients and caregivers did not understand that XOLAIR is not intended for the emergency treatment of allergic reactions, including anaphylaxis. The safety and effectiveness of XOLAIR for emergency treatment of allergic reactions, including anaphylaxis, have not been established. Instruct patients that XOLAIR is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.

    ADVERSE REACTIONS

    Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% incidence in XOLAIR-treated patients and more frequent than in placebo) for XOLAIR 150 mg and 300 mg, respectively, included: headache (12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper respiratory tract infection (1%, 3%), and cough (1%, 2%).

    Injection Site Reactions: Injection site reactions of any severity occurred in more XOLAIR-treated patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria. None of the events resulted in study discontinuation or treatment interruption.

    Injection Site Reactions in Healthy Adults: In an open label trial in healthy adults, in which the 300 mg/2 mL autoinjector was compared to the 300 mg/2 mL prefilled syringe, injection site reactions (e.g., induration, pain, erythema, hemorrhage, swelling, discomfort, bruising, hypoesthesia, edema, pruritus) were observed in 24% (16/66) of subjects treated with the autoinjector compared with 14% (9/64) of subjects treated with the prefilled syringe.

    Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma: A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non-XOLAIR-treated patients ≥12 years of age for a different indication to evaluate the long term safety of XOLAIR, including the risk of malignancy. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.

    Pregnancy: Data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk.

    You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

    Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.