GSK's NUCALA (Mepolizumab) Monograph

Published: August 15, 2025

NUCALA (mepolizumab) is GSK’s targeted biologic treatment that has been approved by the U.S. Food and Drug Administration (FDA) for five conditions: Eosinophilic chronic obstructive pulmonary disease (COPD), severe eosinophilic asthma (SEA), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).

Medication Overview:

Brand Name: Nucala
Generic Name: Mepolizumab
Treatment for: COPD
Manufacturer: GSK

Indicated Condition	Indication	Age	Year Approved
COPD	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.	Adults	2025
SEA	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.	Patients 6 and Older	2019
CRSwNP	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	Adults 18 and older	2021
EGPA	Treatment of adult patients with eosinophilic granulomatosis with polyangiitis	Adults	2017
HES	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.	Patients 12 and Older	2020

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.

Dosage and Administration:

The monthly, in-office SC injection or at-home Autoinjector dose is 100 mg for SEA patients 12 years and older. No loading dose.
The monthly, in-office SC injection or at-home Autoinjector dose is 100 mg for CRSwNP patients. No loading dose.
The monthly, in-office SC injection or at-home Autoinjector dose is 100 mg for COPD patients. No loading dose.
The monthly, in-office SC injection or at-home Autoinjector dose is 300 mg for EGPA patients; each autoinjector or prefilled syringe delivers 100 mg of mepolizumab; use 3 Autoinjectors or prefilled syringes for a 300 mg dose; Administer 1 mL of the reconstituted solution for each 100-mg injection; use 3 vials for a 300-mg dose. No loading dose.
The monthly, in-office SC injection or at-home Autoinjector dose is 300 mg for HES patients; each Autoinjector or prefilled syringe delivers 100 mg of mepolizumab; use 3 Autoinjectors or prefilled syringes for a 300 mg dose; Administer 1 mL of the reconstituted solution for each 100-mg injection; use 3 vials for a 300-mg dose. No loading dose.

Pediatric SEA: Pediatric patients ages 6-11 can receive NUCALA at home or in the office. 40 mg/0.4 mL prefilled syringe must be administered at home or in the office by a healthcare professional or patient carefiver. The recommended dose is 40 mg SC once monthly.

Contraindications:

Known hypersensitivity to mepolizumab or excipients.

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.

Please note: This article is current as of August 14, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.