omalizumab (Xolair)
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Introduction
Tradename: Xolair (FDA approved 2003)
Indications
- asthma
- chronic autoimmune urticaria[7]
- antihistamine-refractory chronic spontaneous urticaria **
- adjunctive treatment of food allergies[8] FDA-approved ***
- atopic dermatitis[12]
- chronic rhinosinusitis with nasal polyps[13]
* may be cost-effective[10] ** ligelizumab appears to be the preferred agent in this class[14] *** not approved for emergency treatment of anaphylaxis[16]
Contraindications
- avoid[11]; disproportionate adverse events
Dosage
Adverse effects
- urticaria
- pruritus
- angioedema, anaphylaxis[3][4]; carries boxed warning[7]
- disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy & cardiac failure, pulmonary hypertension, cerebrovascular disorders, & embolic, thrombotic & thrombophlebitic events in patients treated with Xolair[5][9][11]
- nephrolithiasis[7]
- melanoma[7]
Laboratory
- serum IgE (30-700 U/mL) for eligibility[10]
- allergen-specific IgE testing[15]
Mechanism of action
- recombinant humanized monoclonal anti-IgE antibody
Notes
- cost $5000-$10,000/year (2003)
- cost $800 for a single 150 mg vial
More general terms
Additional terms
References
- ↑ Journal Watch 20(3): 27, 2000 (Feb 1) N Eng J Med 341:1966, 1999
- ↑ Journal Watch 21(17):140, 2001 Milgrom et al Pediatrics 108:e36, 2001
- ↑ 3.0 3.1 3.2 Prescriber's Letter 10(7):41 2003
- ↑ 4.0 4.1 FDA Medwatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair
- ↑ 5.0 5.1 FDA MedWatch - Omalizumab (marketed as Xolair): Early Communication about an Ongoing Safety Review http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172406.htm
- ↑ Busse WW et al. Randomized trial of omalizumab (Anti-IgE) for asthma in inner-city children. N Engl J Med 2011 Mar 17; 364:1005. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21410369
- ↑ 7.0 7.1 7.2 7.3 7.4 Saini S et al. A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine- refractory chronic idiopathic urticaria. J Allergy Clin Immunol 2011 Sep; 128:567 PMID: https://www.ncbi.nlm.nih.gov/pubmed/21762974
Maurer M et al Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria. N Engl J Med. February 24, 2013 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23432142 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1215372
Saini SS 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. J Invest Dermatol 2015 Jan; 135:67 PMID: https://www.ncbi.nlm.nih.gov/pubmed/25046337 - ↑ 8.0 8.1 Begin P et al Phase 1 results of safety and tolerability in a rush oral immunotherapy protocol to multiple foods using Omalizumab. Allergy, Asthma & Clinical Immunology 2014, 10:7 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24576338 <Internet> http://www.aacijournal.com/content/10/1/7
- ↑ 9.0 9.1 FDA Safety Alert. Sept. 26, 2014 Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm416408.htm
- ↑ 10.0 10.1 10.2 10.3 Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015
- ↑ 11.0 11.1 11.2 Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
- ↑ 12.0 12.1 Chan S, Cornelius V, Cro S et al Treatment Effect of Omalizumab on Severe Pediatric Atopic Dermatitis. The ADAPT Randomized Clinical Trial JAMA Pediatr. Published online Nov 25, 2019 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31764962 https://jamanetwork.com/journals/jamapediatrics/article-abstract/2755655
Wu AC Omalizumab for Atopic Dermatitis. Overtreatment or Lifesaver? JAMA Pediatr. Published online Nov 25, 2019 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31764954 https://jamanetwork.com/journals/jamapediatrics/article-abstract/2755651 - ↑ 13.0 13.1 Gevaert P et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol 2020 Sep; 146:595 PMID: https://www.ncbi.nlm.nih.gov/pubmed/32524991 Free article https://www.jacionline.org/article/S0091-6749(20)30752-1/fulltext
- ↑ 14.0 14.1 Nochaiwong S, Chuamanochan M, Ruengorn C et al Evaluation of Pharmacologic Treatments for H1 Antihistamine-Refractory Chronic Spontaneous Urticaria. A Systematic Review and Network Meta-analysis. JAMA Dermatol. Published online August 25, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34431983 https://jamanetwork.com/journals/jamadermatology/fullarticle/2783033
- ↑ 15.0 15.1 NEJM Knowledge+ Allergy/Immunology
- ↑ 16.0 16.1 Remaly J FDA Approves Drug to Reduce Accidental Food Allergies. Medscape. Feb 16, 2024 https://www.medscape.com/viewarticle/fda-approves-drug-reduce-accidental-food-allergies-2024a10003b3
- ↑ 17.0 17.1 Wood RA et al Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024. Feb 24. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38407394 https://www.nejm.org/doi/full/10.1056/NEJMoa2312382