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Safety profile of Nucala in patients with CRSwNP (Chronic Rhinosinusitis with Nasal Polyps)

Safety profile of Nucala from Phase III clinical study1

Any on-treatment AE 169 (82%) 168 (84%)
AE related to study treatment 30 (15%) 19 (9%)
AEs leading to permanent discontinuation of study treatment 4 (2%) 4 (2%)
AEs leading to withdrawal from the study 0 1 (1%)
Most frequent on-treatment AEs    
Nasopharyngitis 52 (25%) 46 (23%)
Headache 37 (18%) 44 (22%)
Sinusitis 10 (5%) 22 (11%)
Any on-treatment SAE 12 (6%) 13 (6%)
SAEs related to study treatment 0 1 (1%)
Fatal SAEs§ 0 1 (1%)

Nucala has been studied in over 3,000 patients in 26 clinical trials across multiple eosinophilic conditions.2*

SYNAPSE is a 52-week, randomised, double-blind, parallel group Phase III study assessing the clinical efficacy and safety of Nucala 100mg SC as an add-on to maintenance treatment in adults with severe bilateral nasal polyps, compared to placebo.1

*Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older; as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control; as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA); as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.3

†Reported in 5% or more patients in any treatment group.1

Transient ischaemic attack.1

§Due to myocardial infarction during the follow-up period.1

AE, adverse event; CRSwNP, chronic rhinosinusitis with nasal polyps; IL, interleukin; SAE, serious adverse event; SC, subcutaneous.


  1. Han JK et al. Lancet Respir Med. 2021; 9:1141-1153
  2. GlaxoSmithKline. GSK Nucala (mepolizumab) filings accepted by European Medicines Agency for three additional eosinophil-drives diseases [Press release}. 29 October 2020. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-nucala-mepolizumab-filings-accepted-by-european-medicines-agency-for-three-additional-eosinophil-driven-diseases/ (Accessed June 2023).
  3. Nucala preparatomtale

Nucala is a trademark of the GSK group of companies

PM-NO-MPL-WCNT-230006 June 2023