NUCALA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Learn more about the established safety profile of NUCALA in EGPA.

Pivotal trial (MIRRA): 52-week placebo-controlled study (N=136). NUCALA and placebo were administered in addition to SOC.1†

Co-primary endpoints: NUCALA patients spent significantly more time in remission* vs placebo over 52 weeks (OR: 5.9, 95% Cl: 2.7, 13.0; P<0.001). Significantly more NUCALA patients were in remission* at both Week 36 and Week 48 vs placebo; 32% vs 3% (OR: 16.7, 95% CI: 3.6, 77.6; P<0.001). Secondary endpoint: Significantly more NUCALA patients achieved a lower daily steroid dose during the last 4 weeks of treatment (OR: 0.20, 95% Cl: 0.09, 0.41; P<0.001).1

*Remission was defined as Birmingham Vasculitis Activity Score (BVAS)=0 (no active vasculitis) plus prednisolone or prednisone dose ≤4 mg/day.

†SOC was defined as OCS +/– immunosuppressants. After Week 4, OCS (prednisolone or prednisone) dose could be tapered, per physician judgment or a suggested protocol.

Pivotal study designkeyboard_arrow_right

NUCALA for EGPA: what you need to know

THE ONLY EGPA BIOLOGIC WITH SAFETY DATA UP TO 7.4 YEARS2

See data supporting the established safety profile of NUCALA.

VIEW LONG-TERM SAFETY DATA

GETTING PATIENTS STARTED ON NUCALA

Help patients start and stay on NUCALA with resources for enrollment and access to treatment. Are you a biologic coordinator? These resources are for you.

VISIT NUCALA ACCESS & SUPPORT

Hear from a peer about NUCALA

EGPA vs HES | 9:06

An expert in allergy and immunology describes how to differentiate two diseases related to peripheral blood eosinophilia: eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).

ACR/VF recommendations include NUCALA‡ as a treatment for appropriate patients with EGPA3

‡NUCALA is conditionally recommended as an add-on treatment option for appropriate patients with EGPA in the 2021 ACR/VF Guideline for the Management of ANCA-Associated Vasculitis. All EGPA recommendations in the Guideline are conditional due in part to the lack of multiple randomized controlled trials and/or low-quality evidence supporting the recommendations.3

SEE CLASSIFICATION CRITERIA
EGPA patient Ken gardening with his wife

PATIENT TYPES WHO MAY BENEFIT FROM NUCALA

In your practice, you may know these types of patients with eosinophilic granulomatosis with polyangiitis (EGPA).

SEE NUCALA PATIENT PROFILES
Three NUCALA Autoinjectors

ONCE-MONTHLY§ DOSING

Fixed dosing, independent of weight. See all the options for at-home or in-office administration. Watch “how-to” videos and download the full Instructions for Use.

§Every 4 weeks.

GET DETAILS ABOUT DOSING

Make NUCALA your first-choice biologic to treat 5 chronic inflammatory diseases

NUCALA is for SEA, CRSwNP, COPD, EGPA, or HES.

EXPLORE INDICATIONS

ACR=American College of Rheumatology; ANCA=antineutrophil cytoplasmic antibody; CI=confidence interval; IL-5=interleukin-5; OCS=oral corticosteroid; OR=odds ratio; SOC=standard of care; VF=Vasculitis Foundation.

INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

NUCALA is indicated for the: 

  • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
  • 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 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-MPLWCNT240087 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. Wechsler ME, Akuthota P, Jayne D, et al; for the EGPA Mepolizumab Study Team. Mepolizumab or placebo for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2017;376(20):1921-1932.

  2. Data on file, GSK.

  3. Chung SA, Langford CA, Maz M, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody‑Associated Vasculitis. Arthritis Rheumatol. 2021;73(8):1366‑1383.