Contents

Search

omalizumab (Xolair)

Tradename: Xolair (FDA approved 2003) Indications: - asthma - reduces emergency department visits* in patients with moderate-severe asthma, inadequately controlled with inhaled glucocoritcoids, allergies to perennial airbone allergens & serum IgE 30-700 U/mL [10] - 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] - increases threshold for reaction to peanuts & other common food allergens [17] Contraindications: - avoid [11]; disproportionate adverse events Dosage: - 150-600 mg SQ every 2-4 weeks [3] (asthma) - 300-600 mg SQ single dose (urticaria) Adverse effects: 1) urticaria 2) pruritus 3) angioedema, anaphylaxis [3,4]; carries boxed warning [7] 4) 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] 5) nephrolithiasis [7] 6) 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

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

Related

immunoglobulin-E (IgE)

General

recombinant protein; chimer pharmaceutical monoclonal antibody

References

  1. Journal Watch 20(3): 27, 2000 (Feb 1) N Eng J Med 341:1966, 1999
  2. Journal Watch 21(17):140, 2001 Milgrom et al Pediatrics 108:e36, 2001
  3. Prescriber's Letter 10(7):41 2003
  4. FDA Medwatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair
  5. FDA MedWatch - Omalizumab (marketed as Xolair): Early Communication about an Ongoing Safety Review http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172406.htm
  6. 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: 21410369
  7. 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: 21762974 - Maurer M et al Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria. N Engl J Med. February 24, 2013 PMID: 23432142 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: 25046337
  8. 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 PMID: 24576338 http://www.aacijournal.com/content/10/1/7
  9. 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. Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015
  11. Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
  12. 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: 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: 31764954 https://jamanetwork.com/journals/jamapediatrics/article-abstract/2755651
  13. 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: 32524991 Free article https://www.jacionline.org/article/S0091-6749(20)30752-1/fulltext
  14. 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: 34431983 https://jamanetwork.com/journals/jamadermatology/fullarticle/2783033
  15. NEJM Knowledge+ Allergy/Immunology
  16. 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. Wood RA et al Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024. Feb 24. PMID: 38407394 https://www.nejm.org/doi/full/10.1056/NEJMoa2312382