Interleukin-5 AntagonistPrescription OnlyPregnancy Cat. Not classifiedFDA Yes

Nucala

MEPOLIZUMAB

1 INDICATIONS AND USAGE NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: • Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. ( 1.1 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) • Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive...

Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians · May 2026

Brand names:Nucala

Rx Only

NucalaMedication

Quick Reference

Medicine ClassInterleukin-5 Antagonist

FDA ApprovedYes

PregnancyCategory Not classified

Check Interactions Dosage Details

Quick Facts

Active ingredient: MEPOLIZUMAB
Medicine class: Interleukin-5 Antagonist
Brand names: Nucala
Availability: Prescription only (Rx)
Pregnancy category: Not classified
Half-life: half-life (t 1/2 ) ranged from 16 to 22 days
FDA approved: Yes

Nucala (MEPOLIZUMAB) medication overview

What Is Nucala?

Nucala (MEPOLIZUMAB) belongs to the Interleukin-5 Antagonist class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.

Key Safety Information

•Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
•Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
•Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
•Avoid or limit alcohol while taking Nucala. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
•Take Nucala with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
•Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.

This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.

Uses & Indications

Nucala is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.

( 1.1 ) • Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).

( 1.2 ) • Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

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

( 1.4 ) • The 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.

( 1.5 ) Limitations of use: Not for relief of acute bronchospasm or status asthmaticus.

( 1.1 , 1.3 ) 1.1 Maintenance Treatment of Severe Asthma 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 [see Use in Specific Populations ( 8.4 ), Clinical Studies ( 14.1 )] .

Limitations of Use NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] .

Dosage Guide

The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.

Adult Dosage

2 DOSAGE AND ADMINISTRATION • Severe asthma in patients aged 12 years and older: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • Severe asthma in patients aged 6 to 11 years: 40 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • CRSwNP: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • COPD: 100 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • EGPA: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) • HES: 300 mg administered subcutaneously once every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage NUCALA is for subcutaneous use only, and should be injected into the upper arm, thigh, or abdomen [see Dosage and Administration ( 2.2 , 2.3 )]. Table 1. Recommended Dosage of NUCALA a 300 mg dose is administered as 3 separate 100 mg dose injections administered at least 5 cm (approximately 2 inches) apart. Indication Adults Pediatric Patients Severe asthma 100 mg every 4 weeks • 12 to 17 years of age: 100 mg every 4 weeks • 6 to 11 y

Available Forms

Available Strengths

View Complete Dosage Guide

Side Effects

Common

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] • Opportunistic infections: herpes zoster [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence ≥5%): • Asthma: Headache, injection site reaction, back pain, and fatigue.
( 6.1 ) • CRSwNP: Oropharyngeal pain and arthralgia.
( 6.1 ) • COPD: Back pain, diarrhea, and cough.
( 6.1 ) • EGPA and HES: Most common adverse reactions are similar to asthma.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Adult and Adolescent Patients Aged 12 Years and Older with Severe Asthma A total of 1,327 patients with severe asthma were evaluated in 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks’ duration (Severe Asthma Trials DREAM, MENSA, and SIRIUS).

Serious

5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA.
Discontinue NUCALA in the event of a hypersensitivity reaction.
( 5.1 ) • Herpes zoster infections have occurred in patients receiving NUCALA.
Consider vaccination if medically appropriate.
( 5.3 ) • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA.

Rare

View All Side Effects

Medicine Interactions

Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.

MajorModerateMinor

View All 0 Interactions

Warnings & Contraindications

5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of NUCALA. Discontinue NUCALA in the event of a hypersensitivity reaction. ( 5.1 ) • Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate. ( 5.3 ) • Do not discontinue sys

How Nucala Works

12.1 Mechanism of Action Mepolizumab is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Inflammation is an important component in the pathogenesis of asthma, CRSwNP, COPD, EGPA, and HES. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. Mepolizumab, by inhibiting IL-5 signaling, reduces the production and survival of eosinophils

Pharmacokinetics

Absorption

Absorption Following 100-mg subcutaneous administration in the upper arm of adult and adolescent subjects with asthma, the bioavailability of mepolizumab was estimated to be approximately 80%

Half-Life

half-life (t 1/2 ) ranged from 16 to 22 days

Metabolism

Metabolism: Mepolizumab is a humanized IgG1 monoclonal antibody that is degraded by the proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue

Pregnancy & Breastfeeding Safety

Not classified

FDA Pregnancy Category Not classified

Consult your healthcare provider.

Full Pregnancy Information

Breastfeeding

Many medications pass into breast milk in varying amounts. Before using Nucalawhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.

Storage & Handling

Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.

Frequently Asked Questions

Sources & References

• FDA Prescribing Information — Official labeling and package insert for Nucala
• U.S. National Library of Medicine — MedlinePlus drug information
• American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
• PubMed / MEDLINE — View clinical studies

Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy

Medical Disclaimer

The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.