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mepolizumab (Nucala)

Indications: - eosinophilic granulomatosis with polyangiitis (Churg-Strauss disease)* [6] - maintenance therapy for severe eosinophilic asthma in adults - high-risk eosinophilic COPD ? [4] - add-on therapy for chronic rhinosinusitis with nasal polyps [7] * only biologic agent approved for Churg-Strauss disease [6] Contraindications: - avoid [5]; disproprotionate adverse events Dosage: - intravenous infusion 75-750 mg at 4 week intervals - 100 mg SQ every 4 weeks [2] Adverse effects: - most common - headache, injection-site reactions, back pain, & fatigue - hypersensitivity reactions can occur in the 1st months of treatment - facial edema, tongue swelling, dyspnea - fainting, dizziness, lightheadedness - hives, rash - Herpes zoster Laboratory: - complete blood count - eosinophil count > 150-300/uL [6] Mechanism of action: - humanized monoclonal antibody against interleukin 5 (IL-5) - reduces numbers of blood eosinophils - reduces severe asthma exacerbations - does not improve FEV1 Notes: - FDA approved (Nov 2015) - editorialist notes that asthma exacerbations decreased by 50% with placebo in one study suggesting that frequent monitoring of patients may lead to better control without the need for expensive biologic therapy [1] - too expensive [3]

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

pharmaceutical monoclonal antibody biological response modifier; immune factor; immunomodulator; biomodulator pulmonary agent

References

  1. Ortega HG et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014 Sep 8; PMID: 25199059 - Bel EH et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014 Sep 8 PMID: 25199060 - Nair P Anti-interleukin-5 monoclonal antibody to treat severe eosinophilic asthma. N Engl J Med 2014 Sep 8 PMID: 25197762
  2. Brown T FDA Approves Mepolizumab (Nucala ) for Severe Asthma. Medscape Oncology. Nov 4, 2015 http://www.medscape.com/viewarticle/853957 - FDA News Release. November 4, 2015 FDA approves Nucala to treat severe asthma. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm471031.htm
  3. California Institute for Clinical and Economic Review, 2015 Mepolizumab (Nucala, GlaxoSmithKline plc.) for the Treatment of Severe Asthma with Eosinophilia: Effectiveness, Value, and Value-Based Price Benchmarks. http://ctaf.org/sites/default/files/u148/Asthma_Draft_Report_122115.pdf
  4. Hein I Mepolizumab Showing Promise for High-Risk Eosinophilic COPD Medscape - Sep 13, 2017. http://www.medscape.com/viewarticle/885596
  5. Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
  6. Medical Knowledge Self Assessment Program (MKSAP) 18, 19 American College of Physicians, Philadelphia 2018, 2022
  7. Boyles S Mepolizumab Offers Relief for Chronic Sinus Trouble - Anti-IL5 biologic cut polyp size, need for surgery in chronic rhinosinusitis with nasal polyps. MedPsge Today. Sept 10, 2020 https://www.medpagetoday.com/meetingcoverage/ers/88539 - Hopkins C et al Add-on mepolizumab for chronic rhinosinusitis with nasal polyps: SYNAPSE study European Respiratory Society International Congress (ERS 2020)