NUCALA is indicated for the add-on treatment of patients 6+ with severe eosinophilic asthma (SEA). Not for acute bronchospasm or status asthmaticus.

 

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

 

Trial 2: 32-week placebo-controlled study (N=576)
Primary endpoint: Frequency of exacerbations. NUCALA + SOC 0.83/year, placebo + SOC 1.74/year, 53% reduction; P<0.001.1

 

Trial 2 study designkeyboard_arrow_right

SOC=standard of care.

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NUCALA efficacy & safety in SEA | 15:58

An expert in pulmonology and critical care describes how NUCALA can help patients with severe eosinophilic asthma (SEA), including an overview of safety and efficacy data.

NUCALA for SEA: what you need to know

EFFICACY & SAFETY ASSESSED IN NUMEROUS STUDIES

Review the clinical trial and real-world evidence for NUCALA.

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 SEVERE ASTHMA

Elevated eosinophils (EOS) are a key driver of asthma pathophysiology.2,3 Learn more about eosinophilic inflammation in SEA.

LEARN MORE ABOUT EOS IN SEA

Eosinophil unit conversion calculator

Convert your patient’s lab results to an absolute blood eosinophil count in cells/µL.

 

Get absolute EOS countskeyboard_arrow_right

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PATIENT TYPES WHO MAY BENEFIT FROM NUCALA

Learn more about which SEA patients in your practice may be right for NUCALA.

SEE THE NUCALA PATIENT
NUCALA Autoinjector and vial

CONVENIENT, 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 DOSING DETAILS

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 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. Varricchi G, Bagnasco D, Borriello F, Heffler E, Canonica GW. Interleukin-5 pathway inhibition in the treatment of eosinophilic respiratory disorders: evidence and unmet needs. Curr Opin Allergy Clin Immunol. 2016;16(2):186-200.
  3. Park YM, Bochner BS. Eosinophil survival and apoptosis in health and disease. Allergy Asthma Immunol Res. 2010;2(2):87-101.