NUCALA HAS A WELL-ESTABLISHED SAFETY PROFILE WITH LONG-TERM DATA IN SEA

A total of 1327 patients ≥12 years of age with severe asthma were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks’ duration: Trial 1,* Trial 2, and Trial 3. Approximately 2% of patients receiving NUCALA withdrew from these clinical trials due to adverse events vs 3% of patients receiving placebo.

 

*Trial 1: 52-week dose-ranging exacerbation study.

NUCALA safety data in severe eosinophilic asthma (SEA)

ADVERSE REACTIONS (SIDE EFFECTS) ≥3% (AND MORE COMMON THAN PLACEBO) IN THE FIRST 24 WEEKS OF TRIAL 2 AND TRIAL 3

NUCALA safety data in severe eosinophilic asthma (SEA)

 

Patients aged 6 to 11 years: Adverse reaction profile similar to trials in patients aged ≥12 years.

 

Serious adverse events (SAE): One SAE occurred in >1 patient and more frequently with NUCALA than placebo: herpes zoster (2 vs 0 patients).

 

Systemic reactions: In the 3 clinical trials, NUCALA 3% and placebo 5%.

  • Manifestations included rash, flushing, pruritus, headache, and myalgia. A majority were experienced on the day of dosing.

 

Immunogenicity: Across clinical trials in patients aged ≥6 years receiving NUCALA, 6% developed anti-mepolizumab antibodies and 1 patient had neutralizing antibodies detected. The clinical relevance of anti-mepolizumab antibodies is not known.

 

NUCALA was also evaluated in a 4.5-year open-label safety and efficacy study.1

 

See long-term datakeyboard_arrow_right

NUCALA is the only biologic for SEA with an open-label study up to 6.4 years2

There were no unexpected safety findings in this long-term access study of patients aged ≥6 years.*

OPEN-LABEL, LONG-TERM ACCESS STUDY: SAFETY RESULTS (%)

Open-label, long-term access study: safety results (%)

 

Median exposure to NUCALA: 15.5 months (1-77 months)

 

Serious AEs

  • Reported in >1% of patients: worsening of asthma (3%)

 

Non-serious AEs

  • Reported in ≥10% of patients: worsening of asthma (30%), lower respiratory tract infection (11%), and headache (10%)

 

*Add-on NUCALA every 4 weeks 100 mg SC for patients aged ≥12 years; 40 mg SC for patients aged 6-11 years.

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

‡As determined by the investigator.

§Non-serious AE population included patients who received ≥1 NUCALA dose and were required per protocol to report non-serious AEs (select non-US countries and pediatric study).

 

See 6.4-year, open-label study designkeyboard_arrow_right

 

AE=adverse event; SC=subcutaneous.

BLOOD EOSINOPHIL UNIT CONVERSION CALCULATOR

In asthma, an elevated EOS count is a sign that your patient may have eosinophilic asthma. Obtain an absolute eosinophil count in cells/µL from lab results to help decide if NUCALA is right for your patient.

GET EOSINOPHIL COUNTS

GATEWAY TO NUCALA ENROLLMENT FORM

For biologic coordinators and other HCPs who help patients manage their NUCALA injection therapy: get resources right now to help them start and stay on NUCALA.

GO TO ACCESS & SUPPORT

EXPLORE LONG-TERM DATA IN 4.5-YEAR OPEN-LABEL STUDY

In patients with severe eosinophilic asthma (SEA), NUCALA was evaluated in a 4.5-year open-label safety and efficacy study.1,2

GO TO LONG-TERM DATA

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. Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-1751.e7.

  2. Data on file, GSK.