EXPLORE STUDIES IN SEA

NUCALA has a strong foundation of evidence

NUCALA has a strong foundation of evidence with over 2,600 patients enrolled collectively in clinical trials and real-world studiesNUCALA has a strong foundation of evidence with over 2,600 patients enrolled collectively in clinical trials and real-world studies

The evidence for NUCALA efficacy and safety is based on the results of numerous studies,1-7,11 including Trial 2 (pivotal exacerbation reduction trial) and Trial 3 (pivotal OCS reduction trial).

Trial 2: pivotal exacerbation reduction trial1,6

    Trial 3: pivotal OCS reduction trial2

      REALITI-A: real-world study6,7

        COLUMBA: 4.5-year open-label study5,6

          COSMOS: open-label extension study3

            MUSCA: phase 3b quality of life trial4

              6.4-year open-label study: long-term access6

                Man and woman lying on picnic blanket holding yellow flowers

                WHICH OF YOUR SEA PATIENTS COULD BENEFIT FROM NUCALA?

                SEE THE NUCALA PATIENT

                NEED ABSOLUTE EOS COUNT (CELLS/μL) FOR A PATIENT?

                USE THE CALCULATOR
                Smiling man playing drums with another man playing guitar

                EXPLORE CLINICAL TRIAL DATA IN SEVERE EOSINOPHILIC ASTHMA (SEA) PATIENTS

                VIEW NUCALA EFFICACY

                INDICATIONS & IMPORTANT SAFETY INFO

                INDICATIONS

                IMPORTANT SAFETY INFORMATION

                INDICATIONS

                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 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).
                • 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. 

                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-MPLWCNT240085 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. 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.

                2. 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.

                3. Lugogo N, Domingo C, Chanez P, et al. Long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma: a multi-center, open-label, phase IIIb study. Clin Ther. 2016;38(9):2058-2070.e1.

                4. 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;5(5):390-400.

                5. 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.

                6. Data on file, GSK.

                7. Caruso C, Canonica GW, Patel M, et al. Prospective REALITI-A study: 2-year real-world benefits of mepolizumab in severe asthma. Chest Pulm. 2024;100107.

                8. Chapman KR, Albers FC, Chipps B, et al. Allergy. 2019;74(9):1716-1726.

                9. Gupta A, Pouliquen I, Austin D, et al. Subcutaneous mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma. Pediatr Pulmonol. 2019;54(12):1957-1967.

                10. Gupta A, Ikeda M, Geng B, et al. Long-term safety and pharmacodynamics of mepolizumab in children with severe asthma with an eosinophilic phenotype. J Allergy Clin Immunol. 2019;144(5):1336-1342.e7.

                11. Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380:651-659.

                12. Juniper EF, Svensson K, Mörk AC, Ståhl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005;99(5):553-558.

                13. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992:145(6):1321-1327.

                14. Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002;19(3):398-404.

                15. Khurana S, Brusselle GG, Bel EH, et al. Long-term safety and clinical benefit of mepolizumab in patients with the most severe eosinophilic asthma: the COSMEX study. Clin Ther. 2019;41(10):2041-2056.e5.

                16. Moore WC, Kornmann O, Humbert M, et al. Stopping versus continuing long-term mepolizumab treatment in severe eosinophilic asthma (COMET study). Eur Respir J. 2022;59(1):2100396.