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.

Choose NUCALA

Exacerbation reduction

Trial 2: 53% reduction in exacerbations vs placebo
(P<0.001; Primary Endpoint)^1*

Real-world study:

interim analysis at 1 year^2†

71%

reduction

in exacerbations

vs baseline

Primary objective.

Results are descriptive.

See study limitations^†

View exacerbation data

OCS reduction

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

Real-world study:

interim analysis at 1 year^2†

75%

reduction

in daily maintenance
OCS dose vs baseline^§

Secondary objective.

Results are descriptive.

See study limitations^†

See OCS reduction data

Long-term data

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

Associated with

61%

reduction

in annual exacerbation

rate vs baseline^4II

Results are descriptive.

Median duration 3.8 years.²

Review long-term data

^†Real-world study: Prespecified interim analysis of a 2-year prospective, observational cohort study at 1 year (N=822). Primary objective (shown above): Post-exposure NUCALA 1.23 vs baseline 4.28 (71% reduction; rate ratio 0.29; 95% CI: 0.26, 0.32). Secondary objective (shown above): Daily median maintenance OCS dose in OCS-dependent patient subgroup (n=298). Post-exposure NUCALA at Weeks 53-56 (n=222) 2.5 mg/day vs baseline 10 mg/day. 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

^§Dose assessments based on data captured from medical records or patient recall without documentation of asthma control.²

^II4.5-year open-label study: Assessed safety, immunogenicity, and efficacy of NUCALA (N=347). Select 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.^2,4 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.^‡Trial 3: 24-week placebo-controlled OCS dose reduction trial (N=135).

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

Request a Rep

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.
Data on file, GSK.
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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This website is funded and developed by GSK.
This site is intended for US healthcare professionals only.
©2021 GSK or licensor.
MPLWCNT220004 February 2022
Produced in USA.

Help bring back balance

Exacerbation reduction

Real-world study:

interim analysis at 1 year2†

71%

OCS reduction

Real-world study:

interim analysis at 1 year2†

75%

Long-term data

Associated with

61%

The targeted therapy for 4 eosinophil-driven diseases

Get your patients started with NUCALA

Administering NUCALA

References

Help bring
back balance

interim analysis at 1 year^2†

interim analysis at 1 year^2†