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pre filled pen

Nucala (mepolizumab)

The only anti-IL-5 indicated for severe refractory eosinophilic asthma to demonstrate powerful and lasting reduction in exacerbations and OCS dose for up to 4.5 years* 1-5

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Nucala

*Range: 4 weeks to 4.5 years
ED, emergency department; ICS, inhaled corticosteroid; IL-5, interleukin-5; OCS, oral corticosteroid

Nucala is generally well tolerated. Very commonly or commonly reported adverse reactions in clinical trials included: headache; back pain; local injection site reactions; systemic administration-related and hypersensitivity reactions (which can occur after a long duration of treatment); LRTI; UTI; pharyngitis; nasal congestion; upper abdominal pain; eczema and pyrexia. 7

MENSA was a 32-week exacerbation study comparing Nucala 100mg SC (n=194) vs placebo (n=191) in patients with severe eosinophilic asthma.

††SIRIUS was a 24-week glucocorticoid-sparing effect study comparing Nucala SC (100mg) with placebo added to SoC in 135 patients with severe eosinophilic asthma6

†††Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. The recommended dose of Nucala is 100mg 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 40mg SC regardless of weight and available in lyophilised powder. 7

The pre-filled formulations are not indicated in 6-11 year olds.

References

  1. Ortega H et al. N Engl J Med 2014; 371:1198–1207
  2. Chupp GL et al. Lancet Respir Med 2017; 5:390–400
  3. Lugogo N et al. Clin Ther 2016; 38:2058–2070
  4. Khurana S et al. Clin Ther 2019; 41 (10):2041-2056
  5. Khatri et al. 2019; J Allergy Clin Immunol; 143 (5): 1742-1751
  6. Bel EH et al. N Engl J Med 2014; 371:1189–1197
  7. Nucala Summary of Product Characteristics. Available at www.medicines.ie. Last Accessed December 2020
  8. http://www.ncpe.ie/drugs/mepolizumab-nucala/ Last accessed: December 2020

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Copyright © 2020 GlaxoSmithKline Group of Companies. All rights reserved.
Nucala is a registered trademark of the GlaxoSmithKline Group of Companies.