Nucala is the only anti-IL-5 indicated for severe refractory eosinophilic asthma to demonstrate a powerful reduction in exacerbations and OCS dose for up to 4.5 years*1
See instructions for use videos*Range: 4 weeks to 4.5 years
What is Nucala?
Indication
Nucala is indicated as an
add-on treatment for severe
refractory eosinophilic
asthma in adults,
adolescents and children
aged 6 years and older2.
The recommended dose of
Nucala is 100mg SC once
every 4 weeks in adults and
adolescents 12 years and
older, available in pre-filled
pen, pre-filled syringe or as
a lyophilised powder. The
licensed dose of Nucala in
children aged 6–11 years is
40mg SC regardless of
weight, and is available as a
lyophilised powder2. The
pre-filled formulations are
not indicated in 6-11 year
olds.
Dosing
In adults and adolescents aged 12 years and older: fixed 100mg SC dose every 4 weeks2.
In children aged 6-11: fixed 40mg dose every 4 weeks2.
How Does Nucala Work?
Nucala is a humanised monoclonal antibody that inhibits IL-5 signalling and the production and survival of eosinophils2.
The Nucala pre-filled pen or pre-filled syringe should be used for subcutaneous injection only. For self-administration the recommended injection sites are the abdomen or thigh. A caregiver can also inject Nucala into the upper arm.2
For demonstration purposes only.
†Combined primary endpoint analysis of a 12-week, open-label study that assessed the correct use of Nucala pre-filled pen in patients with SEA following training on proper pen technique at baseline. The primary endpoint of the study was the proportion of patients who were able to successfully self-administer their observed third dose in-clinic at Week 8 and was determined using a checklist of steps based on instructions for use and visual inspection of the pen (155 of 157 attempted injections). Ease of use was measured through a patient questionnaire at the end of the study using a 5-point scale (not at, a little, moderately, very, and extremely). Of the patients who successfully self-administered at primary end-point (n= 155), 151 patients completed the questionnaire.11
For demonstration purposes only.
For demonstration purposes only.
Could your patients be eligible for Nucala?
Summary of NICE guidance
TA431
Eligibility criteria in England and Wales8.
Blood eosinophils ≥ 300 cells/ µl (0.3 x 10⁹/ L) in the previous 12 months
≥ 4 exacerbations needing systemic corticosteroids in the previous 12 months
OR
Continuous OCS equivalent to 5 mg prednisolone/ day over previous 6 months
Summary of SMC guidance
Eligibility criteria in Scotland9.
Blood eosinophils ≥ 150 cells/ µl (0.15 x 10⁹/ L) in the previous 12 months
≥ 4 exacerbations in the previous 12 months
OR
Receiving maintenance treatment with OCS
What would be your treatment goals for patients like Jenna?
(Efficacy data)
Reduce Exacerbations
MENSA demonstrated that Nucala 100mg SC significantly reduced the frequency of exacerbations vs. placebo, when both were added to standard of care (SoC)† at week 323.
†Standard of care–High dose ICS and additional maintenance treatment(s)
MUSCA demonstrated that Nucala 100mg SC significantly reduced the frequency of exacerbations vs. placebo, when both were added to standard of care (SoC)†,7.
†Standard of care–High dose ICS and additional maintenance treatment(s)
Reduce OCS use
SIRIUS + COSMOS
SIRIUS demonstrated that the odds of achieving a reduction in OCS dose was 2.39 times higher in patients receiving Nucala vs placebo*, when both were added to standard of care†,5.
COSMOS demonstrated that the effect of Nucala 100mg SC on reduction of OCS use observed in SIRIUS was durable5,6.
†Standard of care–High dose ICS and additional maintenance treatment(s)
Improve Quality of Life
MUSCA
Nucala 100mg SC significantly improved health related quality of life from baseline compared with a placebo at week 24, when both were added to standard of care†,7
†Standard of care–High dose ICS and additional maintenance treatment(s)
Safety Profile
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); URTI; UTI; pharyngitis; nasal congestion; upper abdominal pain; eczema and pyrexia2.
Why should you chose Nucala?
Powerful and lasting reduction in exacerbations for up to 4.5 years*1,2
Powerful and lasting reduction in OCS dose for up to 4.5 years*1,3
Lasting reduction in blood eosinophil levels without complete depletion for up to 4.5 years*1,4
*Range: 4 weeks to 4.5 years
References
- GlaxoSmithKline Data on File REF-26441.
- Nucala Summary of Product Characteristics.
- Ortega HG, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371: 1198 -1207
- GlaxoSmithKline. Data on file: Efficacy of mepolizumab by baseline blood eosinophil count- a post hoc analysis of MUSCA study. UK/NLA/0092.18
- Bel EH et al. N Eng J Med 2014; 371: 1189- 1197.
- Lugogo N et al Clin Ther 2016; 38:2058-2070.
- Chupp GL, Bradford ES, Albers FC et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med 2017
- NICE - National Institute for Health and Care Excellence View
- SMC- Scottish Medicines Consortium View
- Nucala SmPC, 2019.
- Bernstein, D.,et al. Usability of mepolizumab single-use prefilled autoinjector for patient self-administration. Journal of Asthma, 2019; pp.1-12.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard 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.
Nucala is a registered trademark of the GlaxoSmithKline group of companies
PM-GB-MPL-WCNT-190009 | August 2019