Indicated for:

Maintenance Treatment of Severe Asthma:

• 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.

Maintenance Treatment of Chronic Rhinosinusitis with Nasal Polyps:

• Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Eosinophilic Granulomatosis with Polyangiitis:

• The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Hypereosinophilic Syndrome:

• The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

NUCALA is for subcutaneous use only.

NUCALA should not be used to treat acute asthma symptoms or acute exacerbations. 

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA.

Herpes zoster has occurred in subjects receiving NUCALA 100 mg.

Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with NUCALA. Reductions in corticosteroid dosage, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Eosinophils may be involved in the immunological response to some helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving treatment with NUCALA and do not respond to anti-helminth treatment, discontinue treatment with NUCALA until infection resolves.

The data on pregnancy exposure are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy.

There is no information regarding the presence of mepolizumab in human milk, the effects on the breastfed infant, or the effects on milk production. However, mepolizumab is a humanized monoclonal antibody (IgG1 kappa), and immunoglobulin G (IgG) is present in human milk in small amounts.

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• Use in patients under 12 years of age with hypereosinophilic syndrome. GoToSource

• Use in patients under 18 years of age with eosinophilic granulomatosis with polyangiitis. GoToSource

• Use in patients under 6 years of age with severe asthma. GoToSource

• Bilateral nasal polyps. GoToSource

• Chronic spontaneous urticaria. GoToSource

• Chronic obstructive pulmonary disease. GoToSource

Nasopharyngitis (inflammation of nasal passages and back throat), upper respiratory infections, sinusitis, bronchitis and increased risk of malignancies. GoToSource

Hypersensitivity reactions (eg, angioedema, bronchospasm, hypotension, rash, urticaria) and herpes zoster adverse reactions. GoToSource

No major injury lawsuits reported.