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Patients & Caregivers

TRIAL INFORMATION

STUDY DESIGN FOR IgE-MEDIATED FOOD ALLERGY TRIAL*

OUtMATCH: A phase 3 clinical study evaluating XOLAIR for IgE-mediated food allergy4

STUDY DESIGN4,46

  • The safety and efficacy of XOLAIR was evaluated in a multicenter, randomized, double-blind, placebo-controlled study in 168 patients (165 pediatric and 3 adult) who were allergic to peanut and at least 2 other foods, including milk, egg, wheat, cashew, hazelnut, or walnut4
  • At baseline, participants experienced dose-limiting symptoms (eg, moderate to severe skin, respiratory, or gastrointestinal symptoms) in response to a single dose of ≤100 mg of peanut protein and ≤300 mg of protein for each of the other 2 foods (milk, egg, wheat, cashews, hazelnut, or walnut) during the screening DBPCFC4
  • Patients were randomized to receive XOLAIR or placebo, followed by a repeat of the 4 DBPCFCs (ie, challenges with peanut protein, 2 other qualifying foods, and a negative placebo)4,8,46

*OUtMATCH study design.
†Study included 3 adult patients (≥18 years of age).4

Open-label extension study

Fifty-nine pediatric patients who completed the first stage of the trial entered a 24-week open-label extension. The pediatric analysis set (n=38) consisted of patients who received XOLAIR in the first 16 to 20 weeks. Treatment continued for 20-24 weeks, and was followed by another 4 food challenges (ie, challenges with peanut protein, 2 other qualifying foods, and a negative placebo) to evaluate the effects of longer duration of treatment. All blinded oral food challenges occurred within a maximum period of 28 days; therefore, the open-label extension could last up to 28 weeks.4,8,46

 

Studied in a broad range of patients*† with IgE-mediated food allergy

Study Demographics4,8
Patients aged 1 year to <6 years of age 61
Patients aged 6 to <18 years of age 104
Mean age of pediatric patients  8 years
<6 years of age 37%
6 to <12 years of age  38%
12 to <18 years of age 25%
Male 56%
History of asthma  55%
Mean total IgE concentration at baseline 810 IU/mL
White 63%
Asian 13%
Black 7%
Hispanic 9%

Models are for illustrative purposes only. Individual results may vary.    

*Efficacy data based on pediatric population (n=165).4
†Study included 3 adult patients (≥18 years of age).4

 

Key inclusion criteria4,46

  • Age 1-55 years
  • History of allergy to peanut and at least 2 of the following: cashew, milk, egg, walnut, wheat, or hazelnut
  • Dose-limiting symptoms (eg, moderate to severe skin, respiratory, or gastrointestinal symptoms) that occur after a single dose of ≤100 mg of peanut protein and ≤300 mg of the other allergens listed, and a negative placebo (oat) challenge
  • Body weight (as measured at screening) and total serum lgE level (as measured within 3 months of screening) suitable for dosing with XOLAIR

 

Key exclusion criteria46

  • Poorly controlled or severe asthma
  • Poorly controlled atopic dermatitis
  • History of severe anaphylaxis (defined as anaphylaxis resulting in neurologic compromise or intubation) to participant-specific foods
  • Previous immunotherapy for any of the protocol-specified foods within 6 months of screening
  • Monoclonal antibody therapy within 6 months of screening
  • History of eosinophilic gastrointestinal disease within 3 years of screening
  • Treatment with a burst of oral, intramuscular, or intravenous steroids of more than 2 days for an indication other than asthma/wheezing within 30 days of screening
  • Currently receiving oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical)

 

NEXT: Clinical Trial Results

IgE=immunoglobulin E.

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    • 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 reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.

      XOLAIR is to be used in conjunction with food allergen avoidance.


      Limitations of Use: XOLAIR is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

    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.

    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. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for IgE-mediated food allergy patients, because these levels may not reflect steady state free IgE levels.

    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

    IgE-Mediated Food Allergy: The most common adverse reactions (≥3% incidence in XOLAIR-treated patients) included: injection site reaction (15.5%) and pyrexia (6.4%). Safety data obtained from adults (n=3) in this trial was limited.

    Injection Site Reactions: Injection site reactions occurred at a rate of 15.5% in XOLAIR-treated patients compared with 10.9% in placebo-treated patients. The types of injection site reactions included: urticaria, discomfort, erythema, pain, and rash. All injection site reactions were mild to moderate severity and none resulted in study discontinuation.

    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 for a Different Indication: 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 reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.

      XOLAIR is to be used in conjunction with food allergen avoidance.


      Limitations of Use: XOLAIR is not indicated for the emergency treatment of allergic reactions, including 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.

    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. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for IgE-mediated food allergy patients, because these levels may not reflect steady state free IgE levels.

    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

    IgE-Mediated Food Allergy: The most common adverse reactions (≥3% incidence in XOLAIR-treated patients) included: injection site reaction (15.5%) and pyrexia (6.4%). Safety data obtained from adults (n=3) in this trial was limited.

    Injection Site Reactions: Injection site reactions occurred at a rate of 15.5% in XOLAIR-treated patients compared with 10.9% in placebo-treated patients. The types of injection site reactions included: urticaria, discomfort, erythema, pain, and rash. All injection site reactions were mild to moderate severity and none resulted in study discontinuation.

    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 for a Different Indication: 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.