Patient Types | NUCALA (mepolizumab) for HCPs

The NUCALA patient

NUCALA may help your patients 6 years and older with severe asthma and:

High-dose ICS* plus additional controller

2+ exacerbations^† in the previous 12 months and/or daily OCS

Baseline blood eosinophils ≥ 150 cells/μL, which is predictive of efficacy for NUCALA

*For patients 6-11 taking medium- to high-dose ICS + additional controller. See Pediatric Use.

^†Defined as worsening of asthma requiring: systemic corticosteroids or hospitalization or ED visit; or at least double the existing maintenance systemic corticosteroid dose for ≥3 days.

On this page:

SEA patient with frequent exacerbations

SEA patient with OCS dependence

SEA patient with comorbid nasal polyps

Pediatric SEA patient

PATIENT PROFILE

Severe eosinophilic asthma with frequent exacerbations

Reason for visit:

Follow-up after OCS burst for asthma exacerbation due to the common cold

Complaints:

Frequent asthma symptoms waking him up late at night/early morning
2 visits to the ED/urgent care requiring OCS bursts for nocturnal asthma attacks that did not improve with rescue inhaler
Increased use of rescue inhaler
Symptoms limiting exercise and social activity

Medical history:

Asthma duration: 25 years
Atopic status: positive (prior SCIT)
Allergic rhinitis

Current asthma medications:

High-dose ICS/LABA (15 years)
Albuterol as needed (currently averaging 6 puffs/day)

Spirometry results:

FEV₁58% predicted
FEV₁/FVC ratio: 0.67

Laboratory results:

Eosinophil count: 275 cells/μL
IgE concentration: 130 kU/L

See exacerbation data

From an expert: frequent exacerbations

See how NUCALA can help SEA patients with frequent exacerbations.

PATIENT PROFILE

Severe eosinophilic asthma with OCS dependence

Female with severe eosinophilic asthma OCS dependent image

Reason for visit:

Follow-up after ED visit 2 weeks prior for asthma exacerbation due to lower respiratory tract infection

Complaints:

Asthma symptoms interfering with work and limiting exercise
Expressed concern about long-term side effects of OCS
Weight gain of 10 pounds in the last year (BMI, 27.5 kg/m²)

Medical history:

Asthma duration: 15 years
Intermittent OCS bursts for 6 months with a subsequent switch to OCS maintenance therapy
Since start of OCS maintenance therapy, patient has had 2 exacerbations requiring bursts of OCS

Current asthma medications:

High-dose ICS/LABA (10 years) + LAMA (5 years)
OCS 10 mg/day
Albuterol as needed

Spirometry results:

FEV₁ 55% predicted
FEV₁/FVC ratio: 0.64

Laboratory results:

Eosinophil count: 180 cells/μL
IgE concentration: 117 kU/L

See OCS data

From an expert: SEA with OCS dependence

See how NUCALA can help OCS-dependent patients.

PATIENT PROFILE

Severe eosinophilic asthma with comorbid nasal polyps

Male with severe eosinophilic asthma comorbid nasal polyps image

Reason for visit:

Routine checkup

Complaints:

Persistent dyspnea that disrupts sleep

Medical history:

Asthma duration: 20 years
2 exacerbations in the past year, with 1 leading to hospitalization
Presence of nasal polyps
Atopic status: positive (prior SCIT)

Current asthma medications:

High-dose ICS/LABA (13 years) + LTRA (6 years)
Albuterol as needed

Spirometry results:

FEV₁ 66% predicted
FEV₁/FVC ratio: 0.69

Laboratory results:

Eosinophil count: 324 cells/μL
IgE concentration: 352 kU/L

See data in SEA patients with comorbidities

From an expert: exacerbations with comorbid nasal poylps

See how NUCALA can help SEA patients with frequent exacerbations and comorbid nasal polyps.

Pediatric Use (ages 6-11)

The ONLY severe eosinophilic asthma biologic indicated down to age 6.

NUCALA may help your patients aged 6 to 11 years with severe asthma, and:

Medium- to high-dose ICS* plus additional controller

2+ exacerbations^† in the previous 12 months

Baseline blood eosinophils ≥150 cells/μL, which is predictive of efficacy for NUCALA

*Medium- to high-dose ICS defined as >200 µg/day fluticasone propionate dry powder inhaler or equivalent daily.¹

^†Defined as worsening of asthma requiring: systemic corticosteroids or hospitalization or ED visit; or at least double the existing maintenance systemic corticosteroid dose for ≥3 days.

PATIENT PROFILE

Severe eosinophilic asthma in pediatric patients

Pediatric patient with severe eosinophilic asthma image

Reason for visit:

Mother called nurse with concern about current symptoms

Complaints:

Intermittent wheezing and dyspnea
Frequent use of rescue inhaler
Missed school due to asthma symptoms

Medical history:

Asthma duration: 4 years (diagnosed at age 4)
2 exacerbations in the past year, including a hospitalization
Atopic status: positive (prior SCIT)

Current asthma medications:

High-dose ICS/LABA (3 years)
Albuterol as needed (currently averaging 4 puffs/day)

Spirometry results:

FEV₁ 68% predicted
FEV₁/FVC ratio: 0.73

Laboratory results:

Eosinophil count: 370 cells/μL
IgE concentration: 148 kU/L

See pediatric dosing

BMI=body mass index; ED=emergency department; FEV₁=forced expiratory volume in 1 second; FVC=forced vital capacity; ICS=inhaled corticosteroid; IgE=immunoglobulin E; LABA=long-acting beta₂-agonist; LAMA=long-acting muscarinic antagonist; LTRA=leukotriene receptor antagonist; OCS=oral corticosteroid; SCIT=subcutaneous immunotherapy; SEA=severe eosinophilic asthma.

Next: Exacerbation reduction

Access & support

Use the Eosinophil Calculator to convert patient lab results

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Indication & Important Safety Info

Indication

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.

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 Asthma Symptoms or Deteriorating Disease
NUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster
In controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred with NUCALA compared to none with placebo. 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
In patients receiving NUCALA, the most common adverse reactions (≥5%) were headache, injection site reaction, back pain, and fatigue. Systemic reactions (allergic and nonallergic), including hypersensitivity, also occurred. Manifestations included rash, pruritus, headache, myalgia, and flushing; the majority 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.

MPLWCNT230011 March 2023.

REFERENCES

Gupta A, Ikeda M, Geng B, et al. Long-term safety and pharmacodynamics of mepolizumab in children with severe asthma with an eosinophilic phenotype. J Allergy Clin Immunol. 2019;144(5):1336-1342.e7.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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MPLWCNT200090 January 2021
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