mepolizumab (Nucala)
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Indications
- eosinophilic granulomatosis with polyangiitis (Churg-Strauss disease)*[6]
- maintenance therapy for severe eosinophilic asthma in adults
- high-risk eosinophilic COPD when added to triple-inhaled therapy[4][8][9]
- 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
- hypersensitivity reactions can occur in the 1st months of treatment
- 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]
More general terms
References
- ↑ 1.0 1.1 Ortega HG et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014 Sep 8; PMID: https://pubmed.ncbi.nlm.nih.gov/25199059
Bel EH et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014 Sep 8 PMID: https://pubmed.ncbi.nlm.nih.gov/25199060
Nair P Anti-interleukin-5 monoclonal antibody to treat severe eosinophilic asthma. N Engl J Med 2014 Sep 8 PMID: https://pubmed.ncbi.nlm.nih.gov/25197762 - ↑ 2.0 2.1 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 - ↑ 3.0 3.1 California Institute for Clinical and Economic Review, 2015 Mepolizumab (Nucala<TM>, 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
- ↑ 4.0 4.1 Hein I Mepolizumab Showing Promise for High-Risk Eosinophilic COPD Medscape - Sep 13, 2017. http://www.medscape.com/viewarticle/885596
- ↑ 5.0 5.1 Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
- ↑ 6.0 6.1 6.2 6.3 Medical Knowledge Self Assessment Program (MKSAP) 18, 19 American College of Physicians, Philadelphia 2018, 2022
- ↑ 7.0 7.1 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) - ↑ 8.0 8.1 Sciurba FC, Criner GJ, Christenson SA et al Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype. N Engl J Med. 2025 May 1;392(17):1710-1720. PMID: https://pubmed.ncbi.nlm.nih.gov/40305712 Clinical Trial. https://www.nejm.org/doi/full/10.1056/NEJMoa2413181
- ↑ 9.0 9.1 Mahatole S, Roy S GSK's asthma drug wins FDA approval to treat 'smoker's lung'. Reuters. 2025. May 23. https://www.reuters.com/sustainability/boards-policy-regulation/gsks-asthma-drug-nucala-wins-fdas-approval-treat-smokers-lung-2025-05-22/