NUCALA HAS A WELL-ESTABLISHED SAFETY PROFILE

In the 52-week MIRRA EGPA trial, no additional adverse reactions were identified to those reported in the severe asthma trials*†

ADVERSE REACTIONS (≥20% INCIDENCE AND MORE COMMON THAN PLACEBO) IN 52-WEEK MIRRA TRIAL1

Adverse reaction NUCALA 300 mg (n=68) % Placebo (n=68) %
Headache 32 18
Arthralgia 22 18
Sinusitis 21 16
Upper respiratory tract infection 21 16

IN THE EGPA TRIAL USING 300 MG OF NUCALA

  • Systemic reactions, including hypersensitivity: 6% NUCALA, 1% placebo
    • Manifestations included rash, pruritus, flushing, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, and angioedema. 2 of the 4 reactions occurred on the day of dosing
  • Injection site reactions (eg, pain, erythema, swelling): 15% NUCALA, 13% placebo
  • Serious AEs: 18% NUCALA, 26% placebo. Drug-related‡: 4% NUCALA and placebo1
  • Immunogenicity: In patients receiving NUCALA, <2% (n=1) developed anti-mepolizumab antibodies and none had neutralizing antibodies detected. The clinical relevance of anti-mepolizumab antibodies is not known
  • There were no serious adverse events of herpes zoster in patients receiving NUCALA

Severe asthma reactions (%, ≥3% incidence and more common than placebo) in patients with asthma in the first 24 weeks of Trial 2* and Trial 3† with NUCALA 100 mg (n=263) vs placebo (n=257): headache (19 vs 18); injection site reaction (8 vs 3); back pain (5 vs 4); fatigue (5 vs 4); influenza (3 vs 2); urinary tract infection (3 vs 2); abdominal pain upper (3 vs 2); pruritus (3 vs 2); eczema (3 vs <1); muscle spasms (3 vs <1).

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.

  • *

    Severe Asthma Trial 2: 32-week exacerbation reduction trial.

  • †

    Severe Asthma Trial 3: 24-week OCS reduction trial.

  • ‡

    Considered related by the investigator.1

Pivotal study design keyboard_arrow_right

The ONLY FDA-approved EGPA biologic with safety data up to 7.4 years2

In an open-label, long-term access study of NUCALA,* the safety profile of NUCALA was similar to that of MIRRA, with no new safety issues identified in EGPA patients aged ≥18 years.

Mean (range) exposure to NUCALA: 38.5 months (3.2 years) with a range of 1 to 89 months (7.4 years).

ADVERSE EVENTS IN OPEN-LABEL, LONG-TERM ACCESS STUDY (UP TO 7.4 YEARS)

NUCALA adverse events in open-label, long-term access study up to 7.4 years

    

71 percent of patients completed this study image

Patient discontinuations were due to AE (3%), lack of efficacy (4%), or other (22%).

 

Most common serious AEs (≥3%): worsening of asthma (6%), pneumonia (3%), and worsening of EGPA (3%).

 

Most common non-serious AEs (≥20%): nasopharyngitis (33%), upper respiratory tract infection (31%), worsening of asthma (30%), sinusitis (30%), bronchitis (29%), and arthralgia (20%).

*Safety population included patients who received ≥1 NUCALA dose.

†Serious AEs were those that resulted in death, were life-threatening, required hospitalization/prolongation of existing hospitalization, resulted in disability/incapacity, resulted in a congenital anomaly/birth defect, or were associated with liver injury and impaired liver function.

‡As determined by the investigator.

§Severe dyspnea, hypoxia, cardiac arrest; not considered related to study treatment.

llNon-serious AEs were any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment.

Defined as patients who remained in the open-label, long-term study and received NUCALA until the study end, which coincided with when it became commercially licensed for EGPA in the relevant country.

 

7.4-year open-label study design keyboard_arrow_right

AE=adverse event; OCS=oral corticosteroid.

See NUCALA dosing and administration

Choose to administer NUCALA in-office, or offer patients the option to self-administer at home

Lyophilized powder vials image

Lyophilized powder for in-office reconstitution and administration

Consider in-office dosing and administration for appropriate patients.

IN-OFFICE ADMINISTRATION
Three NUCALA Autoinjectors

The NUCALA Autoinjector for at-home administration

Consider at-home administration with the NUCALA Autoinjector for appropriate patients.

AT-HOME ADMINISTRATION

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.