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M.C. Last updated: March 2018. UK/COM/0106/15(2)

M.C. Last updated: March 2018. UK/COM/0106/15(2)

Nucala▼ (mepolizumab) packshot

Nucala is the only anti-IL-5 indicated for severe refractory eosinophilic asthma to demonstrate powerful and lasting reductions 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.

How To Use Nucala

Nucala: Power to choose

Nucala should be administered by subcutaneous injection only.
The Nucala pre-filled pen or pre-filled syringe can be self-administrated, or administered by a care giver, following training in injection technique.2
The Nucala lyophilised powder must be administered by a healthcare professional.

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.
  • Nucala pre-filled pen and pre-filled syringe
    • Store in a refrigerator (2 – 8C)
    • Do not freeze
    • Store in the original carton in order to protect from light

    If necessary, the pre-filled pen and pre-filled syringe can be removed from the refrigerator and kept in the unopened pack for up to 7 days at room temperature (up to 30C), when protected from light. The pack should be discarded if left out of the refrigerator for more than 7 days. The pre-filled pen or pre-filled syringe must be administered within 8 hours once the pack is opened. The pack should be discarded if not administered within 8 hours.

    Lyophilised powder

    If the reconstituted solution is not used immediately:

    • Store below 25 C
    • Do not freeze
    • Keep the vial in the outer carton in order to protect from light

    Chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours when stored below 30 C.

    From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

    Disposal2
    Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Could your patients be eligible for Nucala?


Summary of NICE guidance
TA431

Eligibility criteria in England and Wales8.

Blood eosinophils

Blood eosinophils ≥ 300 cells/ µl (0.3 x 10⁹/ L) in the previous 12 months

AND

≥ 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

Blood eosinophils ≥ 150 cells/ µl (0.15 x 10⁹/ L) in the previous 12 months

AND

≥ 4 exacerbations in the previous 12 months

OR

Receiving maintenance treatment with OCS

I've got severe asthma and my life back

What would be your treatment goals for patients like Jenna?

(Efficacy data)

Reduce Exacerbations

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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

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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

icon

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 choose 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

  1. GlaxoSmithKline Data on File REF-26441.
  2. Nucala Summary of Product Characteristics.
  3. Ortega HG, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371: 1198 -1207
  4. GlaxoSmithKline. Data on file: Efficacy of mepolizumab by baseline blood eosinophil count- a post hoc analysis of MUSCA study. UK/NLA/0092.18
  5. Bel EH et al. N Eng J Med 2014; 371: 1189- 1197.
  6. Lugogo N et al Clin Ther 2016; 38:2058-2070.
  1. 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
  2. NICE - National Institute for Health and Care Excellence View
  3. SMC- Scottish Medicines Consortium View
  4. Nucala SmPC, 2019.
  5. 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-190009v2 | August 2019