For your patients’ severe
eosinophilic asthma

Help bring
back balance

By preventing exacerbations
& by reducing daily OCS dose

NUCALA is indicated for the add-on maintenance treatment of adult and pediatric patients 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.

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Exacerbation reduction

Trial 2 53% reduction in exacerbations vs placebo^1*
61% reduction in exacerbations requiring hospitalization/ED visit vs placebo*

Real-world study: Interim analysis at 12 months^2†
Associated with

Secondary objective. Results are descriptive.

See study limitations

View exacerbation data

OCS reduction

Trial 3: Greater percent reduction in daily OCS dose (Weeks 20-24) while maintaining asthma control vs placebo (P=0.008; Primary Endpoint.)^3‡

Reduction in daily OCS dose^3‡

Results are descriptive.
Sensitivity analysis to the primary endpoint.

See OCS reduction data

Long-term data

4.5-year open-label study:
Exacerbation rate 0.68/year (Secondary Endpoint)^4§

Associated with

Results are descriptive. Median duration 3.8 years.

Review long-term data

^†Real-world study: Prespecified interim analysis of a 2-year prospective, observational cohort study (N=368). Secondary objective (shown above): Post-exposure NUCALA 0.27/year vs baseline 1.14/year; rate ratio 0.23 (95% CI: 0.18, 0.30). Primary objective (Exacerbations/year): Post-exposure NUCALA 1.43 vs baseline 4.63 (69% reduction; rate ratio 0.31; 95% CI: 0.27, 0.35). Results are descriptive. Study limitations: May not reflect final results. Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.²

^§4.5-year open-label study: Assessed safety, immunogenicity, and efficacy of NUCALA (N=347). Secondary endpoint: Mean exacerbations/year: 0.68 (95% CI: 0.60, 0.78) with NUCALA + asthma controller in all patients; based on exacerbations reported from the time a patient enrolled until study withdrawal (median duration 3.8 years). Rate prior to study start was 1.74.⁴ Results are descriptive.

^*Trial 2: 32-week placebo controlled study (N=576) Primary endpoint: Frequency of exacerbations. NUCALA+SOC 0.83/year, placebo+SOC 1.74/year, P<0.001. Secondary endpoint: Frequency of exacerbations requiring hospitalization and/or ED visit. NUCALA+SOC 0.08/year, placebo+SOC 0.20/year, P=0.02.^{1

‡}Trial 3: 24-week placebo-controlled study (N=135); Sensitivity analysis to the primary endpoint. NUCALA+SOC 95% CI: 20.0, 75.0; placebo+SOC 95% CI: -20, 33.3.³ Results are descriptive.

View full study design and primary endpoint results

The targeted therapy for 4 eosinophil-driven diseases

NUCALA is for the:

add-on maintenance treatment of patients 6 years and older with severe eosinophilic asthma (SEA). NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults 18 years and older with inadequate response to nasal corticosteroids.
treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
treatment of patients aged 12+ with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

See Important Safety Info

Get your patients started with NUCALA

Steps for accessing NUCALA and other helpful resources for your SEA patients and practice

See patient access & support

Administering NUCALA

NUCALA gives appropriate patients the option to self-administer at home.

See SEA dosing & administration

CI=confidence interval; ED=emergency department; IL=interleukin; MOA=mechanism of action; OCS=oral corticosteroid; SOC=standard of care.

Next: Eosinophils and MOA in SEA

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Who is the NUCALA SEA patient?

Convert SEA patient lab results with the Eosinophil Calculator

Indications

Important Safety Information

Indications & Important Safety Info

NUCALA is indicated for the:

add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.

NUCALA is indicated for the:

add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.

NUCALA is indicated for the:

add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.
treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

Important Safety Information

CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (ie, days). If a hypersensitivity reaction occurs, discontinue NUCALA.

Acute Asthma Symptoms or Deteriorating Disease
NUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster
Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.

Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.

ADVERSE REACTIONS

Most common adverse reactions (≥5%) in patients receiving NUCALA:

Severe asthma trials: headache, injection site reaction, back pain, fatigue
CRSwNP trial: oropharyngeal pain, arthralgia
EGPA and HES trials (300 mg of NUCALA): no additional adverse reactions were identified to those reported in severe asthma clinical trials

Systemic reactions, including hypersensitivity, occurred in clinical trials in patients receiving NUCALA. Manifestations included rash, pruritus, headache, myalgia, flushing, urticaria, erythema, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, angioedema, and multifocal skin reaction. A majority of systemic reactions were experienced the day of dosing.

USE IN SPECIFIC POPULATIONS
A pregnancy exposure registry monitors pregnancy outcomes in women with asthma exposed to NUCALA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/asthma.

The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

Please see full Prescribing Information and Patient Information for NUCALA.

MPLWCNT210074 August 2021.

References

Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207.
Harrison T, Canonica GW, Chupp G, et al. Real-world mepolizumab in the prospective severe asthma REALITI-A study—initial analysis. [published online ahead of print, August 13, 2020]. Eur Respir J. doi: 10.1183/13993003.00151-2020.
Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-1197.
Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-1751.e7.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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MPLWCNT210080 August 2021
Produced in USA.

Help bring back balance

Exacerbation reduction

OCS reduction

Long-term data

The targeted therapy for 4 eosinophil-driven diseases

Get your patients started with NUCALA

Administering NUCALA

References

Help bring
back balance