NUCALA is indicated for the 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.

Co-primary endpoints:

Significant improvement in nasal obstruction. LS mean† change from baseline in nasal obstruction VAS score‡ at Weeks 49-52: NUCALA + SOC§ (n=206), –4.40 (baseline: 8.9) vs placebo + SOC§ (n=201), –2.54 (baseline: 9.0); P<0.001.1,2

Significant improvement in nasal polyp size. LS mean† change from baseline in total endoscopic nasal polyp score|| at Week 52: NUCALA + SOC§ (n=206), –0.87 (baseline score: 5.4) vs placebo + SOC§ (n=201), 0.06 (baseline score: 5.6); P<0.001.1,2

See more data >

Key secondary endpoint: Time to next nasal polyp surgery up to Week 52: 57% reduction in the proportion of patients who had surgery with NUCALA + SOC§ vs placebo + SOC,§ HR: 0.43; P=0.0032.1

View surgery results >

*Symptoms include nasal obstruction, nasal discharge, mucus in the throat, loss of smell.
†LS means from analysis using mixed model repeated measures.
‡Symptom severity measured on patient-reported VAS from 0 (none) to 10 (as bad as you can imagine).
§Defined as daily mometasone furoate nasal spray in addition to saline nasal irrigations and courses of systemic corticosteroids and/or antibiotics as required.
llTotal score (sum of scores for both nostrils) ranged from 0 to 8.
HR=hazard ratio; LS=least squares; SOC=standard of care; VAS=visual analog scale.

SYNAPSE study design >

Hear from a peer about NUCALA

NUCALA for chronic rhinosinusitis with nasal polyps | 12:32

An expert in otolaryngology describes how NUCALA can help patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Nasal polyps patient Marco eating takeout food with three friends

PATIENT TYPES WHO MAY BENEFIT FROM NUCALA

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

SEE NUCALA PATIENT PROFILES

COULD ONCE-MONTHLY NUCALA BE A GOOD OPTION FOR YOUR CRSwNP PATIENTS?

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 DOSING DETAILS

NUCALA for CRSwNP: what you need to know

EFFICACY & SAFETY ASSESSED IN PIVOTAL CLINICAL TRIAL

Review the clinical trial evidence for NUCALA efficacy.

EXPLORE NUCALA 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 SUPPORT & ACCESS

EOSINOPHILIC INFLAMMATION IN CRSwNP

Elevated eosinophils (EOS) are associated with eosinophilic inflammation, which can drive recurrent nasal polyps.3,4

LEARN MORE ABOUT EOS IN CRSwNP

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 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 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 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-MPLWCNT240086 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. Han JK, Bachert C, Fokkens W, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021;9(10):1141-1153.

  2. Data on file, GSK.

  3. Lou H, Meng Y, Piao Y. Cellular phenotyping of chronic rhinosinusitis with nasal polyps. Rhinol. 2016;54(2):150-159.

  4. Tosun F, Arslan HH, Karslioglu Y, Deveci MS, Durmaz A. Relationship between postoperative recurrence rate and eosinophil density of nasal polyps. Ann Otol Rhinol Laryngol. 2010;119(7):455-459.