Mepolizumab
NUCALA
What it isMonoclonal antibody neutralizing IL-5; severe eosinophilic asthma, eosinophilic COPD, EGPA, hypereosinophilic syndrome, and chronic rhinosinusitis with nasal polyps.
Why this oneUnlike benralizumab, it neutralizes the IL-5 ligand rather than directly depleting eosinophils through the receptor.
What limits itIt is not rescue therapy and benefit depends on an eosinophilic phenotype. Hypersensitivity and herpes zoster can interrupt use; vaccinate before starting.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Severe asthma with eosinophilic phenotype | Adults & peds ≥12 y | 100 mg SC q4wk | 100 mg SC q4wk | 100 mg SC q4wk |
| Severe asthma with eosinophilic phenotype | Peds 6–11 y | 40 mg SC q4wk | 40 mg SC q4wk | 40 mg SC q4wk |
| Chronic rhinosinusitis with nasal polyps (CRSwNP) | Adults ≥18 y | 100 mg SC q4wk | 100 mg SC q4wk | 100 mg SC q4wk |
| COPD with eosinophilic phenotype | Adults | 100 mg SC q4wk | 100 mg SC q4wk | 100 mg SC q4wk |
| Eosinophilic granulomatosis with polyangiitis (EGPA) | Adults | 300 mg SC q4wk | 300 mg SC q4wk | 300 mg SC q4wk |
| Hypereosinophilic syndrome (HES) | Adults & peds ≥12 y | 300 mg SC q4wk | 300 mg SC q4wk | 300 mg SC q4wk |
Renal No dose adjustment; not cleared renally
Hepatic No dose adjustment expected (degraded by proteolytic enzymes)
Instructions
- SC injection into upper arm, thigh, or abdomen
- 300 mg given as 3 separate 100 mg injections ≥5 cm apart
- Reconstitute lyophilized vial with 1.2 mL Sterile Water; do not shake
- If dose missed, give as soon as possible then resume usual schedule
Cautions
- Hypersensitivity reactions (anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) — discontinue if they occur
- Not for acute bronchospasm or status asthmaticus
- Herpes zoster infections — consider vaccination
- Do not stop corticosteroids abruptly on initiation; taper gradually
- Treat pre-existing helminth infections before therapy
Adverse reactions
- Headache
- Injection site reaction
- Back pain
- Fatigue
- Oropharyngeal pain
- Arthralgia (CRSwNP)
- Diarrhea, cough (COPD)
Pregnancy Insufficient data; monoclonal antibody crosses placenta (greater transfer in 2nd/3rd trimester); no fetal harm in monkeys at ~9x MRHD
Lactation No human milk data; IgG present in milk in small amounts; weigh benefits vs. risk
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Mepolizumab ballicule
