COSMEX: Most frequent on-treatment AEs and SEAs (N=339)
AEs occurring in ≥10% of the population, SEAs occurring in > 1 subject
*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.
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 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