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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▼ (mepolizumab)

The only anti-IL-5 therapy for severe eosinophilic asthma with efficacy and safety demonstrated for up to 4.5 years1

See if your patients are eligible

What is Nucala?

Indication

NUCALA is indicated for the add-on maintenance treatment of patients 6 years and older with severe asthma with an eosinophilic phenotype2.

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 should be administered2

  • By a healthcare professional
  • As a 100mg SC injection for adults or adolescents over 12,
    or 40mg for children aged 6-11
  • In the upper arm, thigh or abdomen

Preparation2

Nucala should be reconstituted with sterile water

Watch how to reconstitute Nucala

Could your patients be eligible for Nucala?


Summary of NICE guidance
TA431

Eligibility criteria in England and Wales9.

Blood eosinophils

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

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≥ 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 Scotland10.

Blood eosinophils

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

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≥ 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 327.

†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)†,8.

†Standard of care–High dose ICS and additional maintenance treatment(s)

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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)

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Improve Quality of Life

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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†,8

†Standard of care–High dose ICS and additional maintenance treatment(s)

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Safety Profile

Nucala is generally well tolerated; the most commonly reported adverse reactions were headache, injection site reaction and back pain2.

Why should you chose Nucala?

Powerful reduction in exacerbations

Consistent reduction in exacerbations of >60% in patients with ≥300 eosinophils (MENSA and MUSCA study population: post hoc analyses)3,4

Lasting reduction in daily OCS dose,

while maintaining asthma control5,6

Protection that lasts

The only anti- IL5 therapy for severe eosinophilic asthma with efficacy demonstrated for up to 4.5 years1

Nucala resources for you and your patients

Nucala Overview Booklet for Health Care Professionals

Nucala Overview Booklet for Health Care Professionals

An overview of Nucala for health care professionals including license, mode of action, clinical data and how to use.

Nucala Patient Support Booklet

Nucala Patient Support Booklet

A booklet to inform patients about their Nucala treatment, including why they are being prescribed Nucala, what it is and how it works.

Nucala Medical Appointment Card

Nucala Medical Appointment Card

Appointment card to remind patients of next Nucala appointment.

References

  1. Khatri et al. 2 0 1 8 Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma.
  2. Nucala Summary of Product Characteristics.
  3. Ortega HG et al. Lancet Respir Med 2016: 4;549-556
  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. Ortega HG, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371: 1198 -1207
  2. 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
  3. NICE - National Institute for Health and Care Excellence View
  4. SMC- Scottish Medicines Consortium View

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

Date of preparation: March 2019 Zinc code: UK/NLA/0116/18