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Nucala (mepolizumab) has over 400,000 patient years of exposure globally from launch* to 20231
*Q4 2015
The image above is a fictional patient for illustrative purposes
Nucala (mepolizumab) Indication
Nucala (mepolizumab) is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. Nucala is also indicated as an add-on therapy with intranasal corticosteroid for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.2
Nucala is not reimbursed for CRSwNP in the UK.
The safety profile of Nucala was consistent across real-world studies and RCTs2-8
| Frequency of Nucala (mepolizumab):2 | Adverse reactions include:2 |
|---|---|
| Very Common (>1/10) | Headache |
| Common (>1/100 to <1/10) | Lower respiratory tract infection Urinary tract infection Pharyngitis Hypersensitivity reactions (systemic allergic)* Nasal congestion Abdominal pain upper Eczema Back pain Arthralgia** Administration-related reactions (systemic non-allergic)*** Local injection site reactions Pyrexia |
| Uncommon (≥1/1,000 to <1/100) | Herpes zoster** |
| Rare (>1/10,000 to <1/1,000) | Anaphylaxis** |
*Systemic reactions including hypersensitivity have been reported at an overall incidence comparable to that of placebo in the severe eosinophilic asthma studies.
**From spontaneous post marketing reporting.
***The most common manifestations associated with reports of systemic non-allergic administration-related reactions from patients in the severe eosinophilic asthma studies were rash, flushing and myalgia; these manifestations were reported infrequently and in <1% of patients receiving 100mg subcutaneously.
Nucala is intended for long-term treatment. In patients with SEA, the need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's disease severity and level of control of exacerbations.2
In patients with CRSwNP, consideration can be given to alternative treatments in patients who have shown no response after 24 weeks of treatment for CRSwNP. Some patients with initial partial response may subsequently improve with continued treatment beyond 24 weeks.2
Abbreviations
CRSwNP, chronic rhinosinusitis with nasal polyps; RCTs, randomised control trials; SEA, severe eosinophilic asthma.
References
- GlaxoSmithKline. Post marketing mepolizumab exposure data. Data on File; REF-234396
- Nucala Summary of Product Characteristics.
- Pilette C; J Allergy Clin Immunol Pract; 2022;10;2646-2656.
- Khurana S, et al. Clin Ther; 2019;41:2041-2056.
- Bel EH, et al. N Engl J Med; 2014;371:1189-1197.
- Ortega HG, et al. N Engl J Med; 2014;371:1198-1207.
- Harrison T; Eur Respir J; 2020;56;1-14.
- Han JK, et al. Lancet Respir Med. 2021;9(10):1141-1153
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to GSK on 0800 221 441 or UKSafety@gsk.com.
April 2025 I PM-GB-MPL-WCNT-240019 (V1.0)
