Mepolizumab

Brands

DEA Class; Rx

Common Brand Names; Nucala

  • Interleukin Inhibitors; 
  • Monoclonal Antibodies, Anti-asthmatics

Subcutaneous humanized monoclonal antibody directed against interleukin (IL)-5
Used for maintenance therapy in severe asthma (eosinophilic phenotype) in patients 6 years and older; adults with eosinophilic granulomatosis with polyangiitis (EGPA), also known as Churg-Strauss syndrome; hypereosinophilic syndrome in patients 12 years and older; and as add-on maintenance for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults 18 and older with inadequate response to nasal steroids
Reduces severe exacerbations of asthma and may allow more time in remission and lower frequency of relapse for EGPA, which may allow for oral corticosteroid dose reduction for both indications

Indicated for asthma maintenance add-on therapy in patients with severe asthma (eosinophilic phenotype).

For the treatment of eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) .
For the treatment of hypereosinophilic syndrome (HES) present for at least 6 months without an identifiable non-hematologic secondary cause.
For add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRwNP).

Hypersensitivity

Asthma

  • Headache (19%)

  • Injection site reactions (8%)

  • Back pain (5%)

  • Fatigue (5%)

  • Influenza (3%)

  • Urinary tract infection (3%)

  • Upper abdominal pain (3%)

  • Pruritus (3%)

  • Eczema (3%)

  • Muscle spasms (3%)

  • Abdominal pain (≥3%)

  • Allergic rhinitis (≥3%)

  • Asthenia (≥3%)

  • Bronchitis (≥3%)

  • Cystitis (≥3%)

  • Dizziness (≥3%)

  • Dyspnea (≥3%)

  • Ear infection (≥3%)

  • Gastroenteritis (≥3%)

  • Lower respiratory tract infection (≥3%)

  • Musculoskeletal pain (≥3%)

  • Nasal congestion (≥3%)

  • Nasopharyngitis (≥3%)

  • Toothache (≥3%)

  • Viral infection (≥3%)

  • Viral respiratory tract infection (≥3%)

  • Systemic nonallergic reactions (2%)

  • Systemic allergic/hypersensitivity reactions (1%)

CRSwNP

  • Oropharyngeal pain (8%)

  • Arthralgia (6%)

  • Upper abdominal pain (3%)

  • Diarrhea (3%)

  • Nasal dryness (3%)

  • Rash (3%)

  • Injection site reactions (2%)

EGPA

  • Systemic allergic/hypersensitivity reactions (4%)

  • Systemic nonallergic reactions (1%)

HES

  • Injection site reaction (7%)

  • Other systemic reactions (ie, multifocal skin reaction) (2%)

Hypersensitivity reactions (eg, angioedema, bronchospasm, hypotension, urticaria, rash) reported; these reactions generally occur within hours of administration, but in some instances can have a delayed onset (ie, days); discontinue drug in the event of a hypersensitivity reaction

Not for treatment of acute asthma symptoms or acute exacerbations; do not use to treat acute bronchospasm or status asthmaticus; instruct patients to seek immediate medical advice if their asthma remains uncontrolled or worsens after initiating mepolizumab

In clinical trials, 2 serious adverse reactions of herpes zoster occurred during treatment compared with none in placebo; consider varicella vaccination if medically appropriate before initiating treatment

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation mepolizumab; reductions in corticosteroid dose, if appropriate, should be gradual and performed 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

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 trimesters of pregnancy

Unknown if distributed in human breast milk

Adults

100 mg subcutaneously every 4 weeks for severe asthma and chronic rhinosinusitis with nasal polyps (CRwNP); 300 mg subcutaneously every 4 weeks for eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.

Geriatric

100 mg subcutaneously every 4 weeks for severe asthma and chronic rhinosinusitis with nasal polyps (CRwNP); 300 mg subcutaneously every 4 weeks for eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.

Adolescents

100 mg subcutaneously every 4 weeks for severe asthma; 300 mg subcutaneously every 4 weeks for hypereosinophilic syndrome; safety and efficacy have not been established for eosinophilic granulomatosis with polyangiitis.

Children

1 to 5 years: Safety and efficacy have not been established.6 to 11 years: 40 mg subcutaneously every 4 weeks for asthma; safety and efficacy for other indications have not been established.12 years: 100 mg subcutaneously every 4 weeks for asthma; 300 mg subcutaneously every 4 weeks for hypereosinophilic syndrome; safety and efficacy have not been established for eosinophilic granulomatosis with polyangiitis.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mepolizumab 

injection, lyophilized powder for reconstitution

  • 100mg/vial

injection, solution

  • 100mg/mL
  • Available as single-dose prefilled autoinjector or syringe
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