NUCALA is indicated for the 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.

NUCALA HELPED:

PREVENT
EXACERBATIONS

Significant reductions in overall moderate or severe exacerbations* per year with NUCALA + SOC† vs placebo + SOC,† primary endpoints1,2:

MATINEE: 21% reduction at Weeks 52-104: NUCALA, 0.80 (n=403) vs placebo, 1.01 (n=401). (RR: 0.79; P=0.01).‡

METREX: 18% reduction at Week 52: NUCALA, 1.40 (n=233) vs placebo, 1.71 (n=229). (RR: 0.82; P=0.04).‡

EXACERBATION DATA

REDUCE
HOSPITAL VISITS§ DUE TO EXACERBATIONS1

The only biologic studied for 2 years to help reduce hospital visits§ due to exacerbations1

 

35% reduction in exacerbations requiring hospitalization and/or ED visit per year vs placebo. NUCALA, 0.13 vs placebo, 0.20 at Weeks 52-104; RR: 0.65 (95% CI: 0.43, 0.96).

 

NUCALA + SOC,† 0.13/year (n=403) vs placebo + SOC,† 0.20/year (n=401) at Weeks 52-104; RR: 0.65 (95% CI: 0.43, 0.96).

MATINEE secondary endpoint; not statistically significant due to failure earlier in the testing hierarchy.

§Hospitalizations/ED visits of any length.

SEE THE DATA

IMPLEMENT
A SIMPLE, ONCE-MONTHLY||
COPD BIOLOGIC DOSING SCHEDULE

See the options for at-home or in-office administration. Watch “how-to” videos and download the full Instructions for Use.

||Every 4 weeks.

DOSING DETAILS

*Moderate exacerbations (worsening of COPD symptoms) requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbations defined as those requiring hospitalization (≥24 hours) or resulting in death.3

†SOC=ICS + LABA + LAMA.

‡Mean rate of exacerbations in previous year: MATINEE 2.3; METREX 2.5.1,2

MATINEE/METREX study designskeyboard_arrow_right

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

COPD patient Nicholas throwing a Frisbee in an outdoor pool

PATIENT TYPES WHO MAY BENEFIT FROM NUCALA

In your practice, you may know these types of patients with COPD.

SEE NUCALA PATIENT PROFILES
COPD patient Anna holding stuffed animals with her granddaughter

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 SUPPORT & ACCESS

BEC=blood eosinophil count; CI=confidence interval; ED=emergency department; ICS=inhaled corticosteroid; LABA=long-acting beta2-agonist; LAMA=long-acting muscarinic antagonist; RR=rate ratio; SOC=standard of care.

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

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

EXPLORE INDICATIONS

INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

NUCALA is indicated for the: 

  • 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.
  • 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.
  • 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-MPLWCNT250056 June 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. Sciurba FC, Criner GJ, Christenson SA, et al. Mepolizumab to prevent exacerbations in COPD with an eosinophilic phenotype. N Engl J Med. 2025;392:1710-1720.
  2. Pavord ID, Chanez P, Criner GJ, et al. Mepolizumab for eosinophilic chronic obstructive pulmonary disease. N Engl J Med. 2017;377(17):1613-1629.
  3. Data on file, GSK.