NUCALA ACHIEVED AND MAINTAINED NORMAL EOSINOPHIL LEVELS

The reduction in blood eosinophils observed at Week 8 in the NUCALA group was maintained overall through Week 321,2

BLOOD EOSINOPHIL COUNT RATIO TO BASELINE

Blood eosinophil count ratio to baselineBlood eosinophil count ratio to baseline
Baseline: 1460 cells/µL: 92 percent reduction in eosinophils at Week 32 vs placebo (Week 32: 70 cells/µL)Baseline: 1460 cells/µL: 92 percent reduction in eosinophils at Week 32 vs placebo (Week 32: 70 cells/µL)

All results are descriptive.
The clinical significance of these pharmacodynamic data is unknown.

Note: Mean normal blood eosinophil levels in a general population of subjects without confounding factors have been reported as 100 cells/µL (range: 34-257) and 107 cells/µL (5th, 95th percentile: 30, 395); levels vary based on age, sex, environmental exposures and comorbid conditions.3,4

*Placebo, 870 cells/µL at Week 32 (1350 cells/µL at baseline). Counts given as geometric mean.

Pivotal study designkeyboard_arrow_right

How NUCALA targets eosinophils

Diagram showing how NUCALA (mepolizumab) targets eosinophils

The mechanism of action of mepolizumab in HES has not been definitively established.

    What role do blood eosinophils play?

    Eosinophils play a role in maintaining health, which includes regulating the immune system, regenerating and repairing tissue, and host protection (eg, defending the body against parasitic infections).5 In HES, hypereosinophilia is associated with organ dysfunction or damage.6

    AT-HOME OR IN-OFFICE DOSING & ADMINISTRATION

    EXPLORE DOSING

    DISCOVER OUR SAFETY PROFILE IN HES

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    HES patient looking at children

    ACCESS YOUR TOGETHER WITH NUCALA ENROLLMENT FORM

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    INDICATIONS & IMPORTANT SAFETY INFO

    INDICATIONS

    IMPORTANT SAFETY INFORMATION

    INDICATIONS

    NUCALA is indicated for the: 

    • treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause.
    • 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 aged 18 years and older with inadequate response to nasal corticosteroids.
    • add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm.
    • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    Known hypersensitivity to mepolizumab or excipients.

     

    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). Discontinue if a hypersensitivity reaction occurs.

     

    Acute Symptoms of Asthma or COPD or Acute Deteriorating Disease

    NUCALA should not be used to treat acute symptoms or acute exacerbations of asthma or COPD, 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%):

    • Severe asthma trials: headache, injection site reaction, back pain, fatigue
    • CRSwNP trial: oropharyngeal pain, arthralgia
    • COPD trials: back pain, diarrhea, cough
    • EGPA and HES trials (300 mg of NUCALA): most common adverse reactions were similar to severe asthma

    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

    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.

    PMUS-MPLWCNT240088 May 2025

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

    References

    1. Data on file, GSK.
    2. Roufosse F, Kahn J-E, Rothenburg M, et al. Efficacy and safety of mepolizumab in hypereosinophilic syndrome: A phase III, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020;146(6):1397-1405.
    3. Felarca AB, Lowell FC. The total eosinophil count in a nonatopic population. J Allergy. 1967;40(1):16-20.
    4. Hartl S, Breyer MK, Burghuber OC, et al. Blood eosinophil count in the general population: typical values and potential confounders. Eur Respir J. 2020;55(5):1901874.
    5. Weller PF, Spencer LA. Functions of tissue-resident eosinophils. Nat Rev Immunol. 2017;17:746-757.
    6. Valent P, Klion AD, Horny H-P, et al. Contemporary consensus proposal on criteria and classification of eosinophilic disorders and related syndromes. J Allergy Clin Immunol. 2012;130(3):607-612.e9.