THE NUCALA PATIENT

Meredith: EGPA with vasculitic features*

EGPA patient Meredith in studio holding paintbrush and palette

MEREDITH’S EGPA WITH VASCULITIC FEATURES* RESULTS IN RELAPSES, DESPITE DAILY OCS AND IMMUNOSUPPRESSANTS.

Age: 49

EOS: 250 cells/μL (4% of WBC) with historic counts of 1500 cells/μL

ANCA status: positive

BVAS†: 6

Medical history:

  • Experienced a relapse 12 months ago that involved increased difficulty with hand grip and numbness in feet
  • Increased joint pain in past 2 weeks and purpuric rash on arms and legs in past month
  • Peripheral neuropathy present for 3 years; adult-onset asthma treated with maintenance OCS for 6 years
  • Current medications: prednisone 15 mg/day; methotrexate‡ 20 mg weekly; high-dose ICS/LABA

See how NUCALA can help patients like Meredith

REVIEW RELAPSE DATA
  • *

    This represents one potential EGPA patient, but EGPA can show up differently and impact many organ systems.1-3

  • †

    BVAS is typically used to assess vasculitis activity in clinical trials, but is not routinely used in clinical practice.4

  • ‡

    Note that methotrexate is not FDA-approved for EGPA, but it is included in the 2021 ACR/VF Guideline recommendations.5

Ken: EGPA with respiratory features*

EGPA patient Ken gardening with his wife

KEN CONTINUES TO EXPERIENCE DIFFICULTY BREATHING AND WHEEZING DESPITE TAKING HIGH-DOSE ICS/LABA. HE IS CONCERNED ABOUT THE LONG-TERM EFFECTS OF DAILY OCS USE.

Age: 53

EOS: 350 cells/µL (with historic counts of 1250 cells/µL off of prednisone)

ANCA status: negative

BVAS†: 5

Medical history:

  • Abnormal chest X-ray showing patchy, non-fixed infiltrates
  • Attempts to taper from high-dose ICS/LABA resulted in worsening asthma
  • Short history of peripheral neuropathy 1 year ago
  • Comorbid conditions: CRSwNP with anosmia for 3 years; asthma for 10 years
  • Current medications: prednisone 5 mg/day; high-dose ICS/LABA; intranasal steroid

See how NUCALA can help patients like Ken

VIEW OCS DATA
  • *

    This represents one potential EGPA patient, but EGPA can show up differently and impact many organ systems.1-3

  • †

    BVAS is typically used to assess vasculitis activity in clinical trials, but is not routinely used in clinical practice.4

Hear from a peer about NUCALA

EGPA vs HES | 9:06

An expert in immunology describes how to differentiate two diseases related to peripheral blood eosinophilia: eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).

EGPA patient Meredith painting in her studio

Start your patient on NUCALA

Begin with the enrollment form. See the resources that MyNUCALA offers to eligible patients, such as:

  • Savings & access options
  • 1-on-1 support team assistance
  • Text reminders & more
GO TO ACCESS & SUPPORT

ACR=American College of Rheumatology; ANCA=antineutrophil cytoplasmic antibody; BVAS=Birmingham Vasculitis Activity Score; ICS=inhaled corticosteroid; ICU=intensive care unit; LABA=long-acting beta2-agonist; OCS=oral corticosteroid; VF=Vasculitis Foundation; WBC=white blood cell.

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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. Moosig F, Bremer JP, Hellmich B, et al. A vasculitis centre based management strategy leads to improved outcome in eosinophilic granulomatosis and polyangiitis (Churg-Strauss, EGPA): monocentric experiences in 150 patients. Ann Rheum Dis. 2013;72(6):1011-1017.
  2. Baldini C, Talarico R, Della Rossa A, Bombardieri S. Clinical manifestations and treatment of Churg-Strauss syndrome. Rheum Dis Clin North Am. 2010;36(3):527-543.
  3. Noth I, Strek ME, Leff AR. Churg-Strauss syndrome. Lancet. 2003;361(9357):587-594.
  4. Mukhtyar C, Lee R, Brown D, et al. Modification and validation of the Birmingham Vasculitis Activity Score (version 3). Ann Rheum Dis. 2009;68(12):1827-1832.
  5. Chung SA, Langford CA, Maz M, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumatol. 2021;73(8):1366-1383.