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Preparation & Administration of XOLAIR

XOLAIR Self-Injection With Prefilled Syringe Now Approved for Appropriate Patients as Determined by a Healthcare Provider

XOLAIR is intended for use under the guidance of a healthcare provider. Initiate therapy in a healthcare setting and once therapy has been safely established, the healthcare provider may determine whether self-administration of XOLAIR prefilled syringe by the patient or caregiver is appropriate, based on careful assessment of risk for anaphylaxis and mitigation strategies.

Choose which of your patients may be appropriate for XOLAIR self-injection with prefilled syringe

  • When selecting patients or caregivers for self-injection, patient-specific factors including the following criteria should be considered:
    • no prior history of anaphylaxis (including to XOLAIR or other agents, such as foods, drugs, biologics, etc.)
    • receipt of at least 3 doses of XOLAIR under the guidance of a healthcare provider, with no hypersensitivity reactions
    • ability to recognize symptoms of anaphylaxis
    • ability to treat anaphylaxis appropriately
    • ability to perform subcutaneous injections with XOLAIR prefilled syringe with proper technique according to the prescribed dosing regimen and Instructions for Use

Instruct Patients or Caregivers to Follow the Directions Provided in the "Instructions for Use" for Preparation and Administration of XOLAIR Prefilled Syringe

  • Adolescents 12 years of age and older: XOLAIR prefilled syringe may be self-administered under adult supervision
  • Pediatric patients 6 to 11 years of age: XOLAIR prefilled syringe should be administered by a caregiver

XOLAIR self-injection is available for appropriate patients in all approved indications.

What You Need to Know About XOLAIR Formulation Options

There are 2 options in XOLAIR formulation, vial or prefilled syringe.

Initiate XOLAIR only in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening. For more information on anaphylaxis, read Boxed WARNING

Be sure to review the full Prescribing Information, including Medication Guide, before administering XOLAIR to patients. Also, provide and instruct patients and caregivers to read the XOLAIR Medication Guide and Instructions for Use before starting treatment and before each subsequent treatment.

Option 1: Use a Prefilled Syringe

  • No reconstitution required
Xolair Prefilled Syringes

Preparation & Administration

XOLAIR Prefilled Syringe Self-Injection

Click on this video to see instructions on how to prepare and inject XOLAIR prefilled syringe.

Prefilled Syringe Overview

Click the tabs below, to learn more about preparing and administering the prefilled syringe

Preparing for the injection
Administering the injection
Giving the injection
After the injection
After the injection

Option 2: Reconstitute From a Vial (only in a healthcare provider office)

Supplies Needed to Reconstitute the Vial and Administer XOLAIR

Supplies Needed to Administer XOLAIR

Once the correct dose has been determined and the necessary supplies have been assembled, you are ready to begin.

Preparation & Administration of XOLAIR Lyophilized Powder

Click the tabs below to learn more about how to prepare the XOLAIR vial, reconstitute the dose, and administer the injection. 

Preparing the Vial

First, determine the number of vials that will need to be reconstituted. Each vial delivers 150 mg of XOLAIR.

XOLAIR Administration, Preparing the Vial
Reconstituting the Vial Dose of XOLAIR 
XOLAIR Administration, Reconstituting the Dose

After Reconstitution

After reconstitution, the XOLAIR solution is somewhat viscous and will appear clear or slightly opalescent. It is acceptable if there are a few small bubbles or foam around the edge of the vial; there should be no visible gel-like particles in the reconstituted solution. Do not use if foreign particles are present.

Stability After Reconstitution

The solution should be used for subcutaneous administration within 8 hours following reconstitution when refrigerated in the vial at 2°C to 8°C (36°F to 46°F) or within 4 hours of reconstitution when stored at room temperature. Reconstituted XOLAIR vials should be protected from direct sunlight.

XOLAIR is for single use only and contains no preservatives.

Note: Each XOLAIR vial delivers 150 mg of XOLAIR per 1.2 mL upon reconstitution with 1.4 mL of SWFI, USP.

Preparing the Reconstituted Dose of XOLAIR for Subcutaneous Use
XOLAIR Administration, Reconstituting the Dose Needle
Administering the Subcutaneous Injection for XOLAIR
XOLAIR Administration, Administering the Injection

Spoilage Replacement Program

If the XOLAIR prescribed for a labeled indication was spoiled and unable to be administered, the product might be eligible for replacement through the
Genentech Spoilage Replacement Program.*

*Subject to certain limitations and conditions. The Spoilage Replacement Program covers infused or injected Genentech products.

Contact a Representative

Fill out a contact form to get in touch with a XOLAIR representative to find out more about XOLAIR.

INDICATIONS
XOLAIR® (omalizumab) is indicated for:

  • Adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

    Limitations of Use: XOLAIR is not indicated for the relief of acute bronchospasm, status asthmaticus, or for treatment of other allergic conditions.

  • Add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

  • Chronic idiopathic urticaria 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 with asthma, 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 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 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 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) with asthma 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 with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen 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.

Acute Asthma Symptoms and Deteriorating Disease
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with XOLAIR.

Corticosteroid Reduction
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma or nasal polyps. Decrease corticosteroids gradually under the direct supervision of a physician. In CIU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions
In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between XOLAIR and these underlying conditions has not been established.

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 asthma or nasal polyps patients, because these levels may not reflect steady state free IgE levels.

ADVERSE REACTIONS

Asthma
In patients ≥12 years of age, the most common adverse reactions (≥1% more frequent in XOLAIR-treated patients) were: arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%). In pediatric patients 6 to <12 years of age, the most commonly observed adverse reactions (≥3% more frequent in XOLAIR-treated pediatric patients) were: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.

Nasal Polyps
The most common adverse reactions (≥3% incidence in XOLAIR-treated patients and more frequent than placebo) included: headache (8.1%), injection site reaction (5.2%), arthralgia (3.0%), upper abdominal pain (3.0%), and dizziness (3.0%).

Chronic Idiopathic Urticaria
The most common adverse reactions (≥2% 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

Asthma
In adults and adolescents with asthma, injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients. Severe injection site reactions occurred more frequently in XOLAIR‑treated patients compared with patients in the placebo group (12% vs 9%, respectively). The types of injection site reactions in asthma studies included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.

Nasal Polyps
Injection site reactions occurred at a rate of 5.2% in XOLAIR-treated patients compared with 1.5% in placebo-treated patients. Injection site reactions were mild to moderate severity and none resulted in study discontinuation.

Chronic Idiopathic Urticaria
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.

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 with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of XOLAIR, including the risk of malignancy. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More XOLAIR-treated patients were diagnosed with severe asthma (50%) compared to the non-XOLAIR-treated patients (23%). A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR-treated patients (13.4) compared to non-XOLAIR-treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8), pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs 1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. 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.

    • XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation; 2021.

      XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation; 2021.

    • 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. doi:10.1016/j.jaci.2007.07.056.

      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. doi:10.1016/j.jaci.2007.07.056.

    • Moore WC, Bleecker ER, Curran-Everett D, et al. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute’s Severe Asthma Research Program. J Allergy Clin Immunol. 2007;119(2);405-413.

      Moore WC, Bleecker ER, Curran-Everett D, et al. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute’s Severe Asthma Research Program. J Allergy Clin Immunol. 2007;119(2);405-413.

    • World Health Organization. Prevention of Allergy and Allergic Asthma. Geneva, Switzerland: World Health Organization; 2003.

      World Health Organization. Prevention of Allergy and Allergic Asthma. Geneva, Switzerland: World Health Organization; 2003.

    • Miller CW, Krishnaswamy N, Johnston C, Krishnaswamy G. Severe asthma and the omalizumab option. Clin Mol Allergy. 2008;6:4. doi:10.1186/1476-7961-6-4.

      Miller CW, Krishnaswamy N, Johnston C, Krishnaswamy G. Severe asthma and the omalizumab option. Clin Mol Allergy. 2008;6:4. doi:10.1186/1476-7961-6-4.

    • Storms W. Allergens in the pathogenesis of asthma: potential role of anti-immunoglobulin E therapy. Am J Respir Med. 2002;1(5):361-368.

      Storms W. Allergens in the pathogenesis of asthma: potential role of anti-immunoglobulin E therapy. Am J Respir Med. 2002;1(5):361-368.

    • Fahy JV, Fleming HE, Wong HH, et al. The effect of an anti-IgE monoclonal antibody on the early- and late-phase responses to allergen inhalation in asthmatic subjects. Am J Respir Crit Care Med. 1997;155(6):1828-1834.

      Fahy JV, Fleming HE, Wong HH, et al. The effect of an anti-IgE monoclonal antibody on the early- and late-phase responses to allergen inhalation in asthmatic subjects. Am J Respir Crit Care Med. 1997;155(6):1828-1834.

    • 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. doi:10.1016/j.jaci.2009.09.021.

      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. doi:10.1016/j.jaci.2009.09.021.

    • 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. doi:10.1185/03007995.2010.539502.

      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. doi:10.1185/03007995.2010.539502.

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

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

    • Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE 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-IgE 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.

    • Solèr 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.

      Solèr 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.

    • 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.

    • Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.

      Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.

    • 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.

    • Test interpretation and management options utilizing the ImmunoCAP® KU/L score. Mid America Clinical Laboratories website. Published July 2009. Accessed July 6, 2017.

      Test interpretation and management options utilizing the ImmunoCAP® KU/L score. Mid America Clinical Laboratories website. Published July 2009. Accessed July 6, 2017.

    • 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.

    • 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.

    • Zuberbier T, Asero R, Bindslev-Jensen C, et al. EAACI/GA2LEN/EDF/WAO guideline: management of urticaria. Allergy. 2009;64(10):1427-1443. doi:10.1111/j.1398-9995.2009.02178.x.

      Zuberbier T, Asero R, Bindslev-Jensen C, et al. EAACI/GA2LEN/EDF/WAO guideline: management of urticaria. Allergy. 2009;64(10):1427-1443. doi:10.1111/j.1398-9995.2009.02178.x.

    • van der Valk PGM, Moret G, Kiemeney LALM. The natural history of chronic urticaria and angioedema in patients visiting a tertiary referral centre. Br J Dermatol. 2002;146(1):110-113. doi:10.1046/j.1365-2133.2002.04582.x.

      van der Valk PGM, Moret G, Kiemeney LALM. The natural history of chronic urticaria and angioedema in patients visiting a tertiary referral centre. Br J Dermatol. 2002;146(1):110-113. doi:10.1046/j.1365-2133.2002.04582.x.

    • Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic urticaria, a form of chronic hives. https://www.roche.com/media/releases/med-cor-2014-03-24.htm. 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-2014-03-24.htm. March 2014. Accessed January 14, 2021.

    • US Department of Health and Human Services. Determination that astemizole 10-milligram tablets were withdrawn from sale for safety reasons. Federal Register. 1999;64(162):45973-45974.

      US Department of Health and Human Services. Determination that astemizole 10-milligram tablets were withdrawn from sale for safety reasons. Federal Register. 1999;64(162):45973-45974.

    • 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. doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75. doi:10.1038/jid.2014.306.

      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. doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75. doi:10.1038/jid.2014.306.

    • 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):2340-2341]. N Engl J Med. 2013;368(10) (suppl):924-935. doi:10.1056/NEJMoa1215372.

      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):2340-2341]. N Engl J Med. 2013;368(10) (suppl):924-935. doi:10.1056/NEJMoa1215372.

    • Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA2LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. The 2017 revision and update [published online January 15, 2018]. Allergy. 2018;73(7):1393-1414. doi:10.1111/all.13397.

      Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA2LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria. The 2017 revision and update [published online January 15, 2018]. Allergy. 2018;73(7):1393-1414. doi:10.1111/all.13397.

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

    • Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704. doi:10.1038/nm.2755.

      Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704. doi:10.1038/nm.2755.

    • Shin JS, Greer AM. The role of FcεRI expressed in dendritic cells and monocytes. Cell Mol Life Sci. 2015;72(12):23492360. doi:10.1007/s00018-015-1870-x.

      Shin JS, Greer AM. The role of FcεRI expressed in dendritic cells and monocytes. Cell Mol Life Sci. 2015;72(12):23492360. doi:10.1007/s00018-015-1870-x.

    • 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: standardized endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99. doi:10.1164/rccm.200801-060ST.

      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: standardized endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99. doi:10.1164/rccm.200801-060ST.