Nucala is the only anti-IL-5 with up to 4.8 years of clinical trial safety data*†¹ in severe eosinophilic asthma

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.²

The maximum exposure duration of mepolizumab in the phase 3 and open label extension studies was 4.8 years. A patient withdrawal range of 4 weeks to 4.8 years was observed in MENSA, SIRIUS, COSMOS and COSMEX.

The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials ³ ⁴

Number of Nucala prescriptions in the UK

COSMEX: Most frequent on-treatment AEs and SEAs (N=339)

On-treatment AEs, n(%)  
143 (42)
Asthma 77 (23)
Bronchitis 64 (19)
Upper RTI 64 (19)
Sinusitis 62 (18)
Headache 57 (17)
Influenza 44 (13)
Back pain 42 (12)
On-treatment SAEs, n(%)  
34 (10)
Pneumonia 6 (2)
Nasal polyps 4 (1)
Respiratory tract infection (RTI)
3 (0.9)
Foot fracture 3 (0.9)
Lower RTI 3 (0.9)
Osteonecrosis 2 (0.6)
Diverticulitis 2 (0.6)
Fracture 2 (0.6)
Gastroesophageal reflux disease 2 (0.6)
Hyponatraemia 2 (0.6)
2 (0.6)

AEs occurring in ≥10% of the population, SEAs occurring in > 1 subject

Explore efficacy data


*Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within the first 3 injections.²

†The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.¹

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. These limitations are important when interpreting results: lack of comparator arm, differences in patient populations and data collection vs. randomised controlled trials.⁷

The recommended dose of Nucala is 100 mg SC once every 4 weeks in adults and adolescents 12 years and older, available in a pre-filled pen, pre-filled syringe or lyophilised powder. The licensed dose of Nucala in children aged 6–11 years is 40 mg SC regardless of weight and available in lyophilised powder. The pre-filled formulations are not indicated in 6-11 year olds.²

AE, Adverse event; SAE, Serious adverse event; SC, subcutaneous.

  1. Khurana S et al. Clin Ther 2019; 41:2041–2056
  2. Nucala SmPC, 2020
  3. Ortega HG et al. N Engl J Med 2014; 371:1198–1207
  4. Khatri S, et al. J Allergy Clin Immunol 2019; 143:1742-1751.e7
  5. GlaxoSmithKline data on file. REF-88009
  6. GlaxoSmithKline data on file. REF-74585
  7. Leather DA et al. Adv Ther 2020; 1–21

Adverse events should be reported. Reporting forms and information can be found at or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441

© 2020 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

PM-GB-MPL-WCNT-200031 | November 2020