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mechanism of action is Interleukin-5 Antagonists [MoA]

Nucala

(Mepolizumab)

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Dosage & Administration

* •Severe asthma in patients aged 12 years and older: 100 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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	*
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)
* •Severe asthma in patients aged 6 to 11 years: 40 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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	*
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)
* •CRSwNP: 100 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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	*
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)
* •COPD: 100 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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	*
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)
* •EGPA: 300 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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	*
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)
* •HES: 300 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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	*
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)

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Nucala Prescribing Information

Indications and Usage, Maintenance Treatment of Chronic Obstructive Pulmonary Disease (

1.3 Maintenance Treatment of Chronic Obstructive Pulmonary Disease

NUCALA is indicated for the add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Limitations of Use

NUCALA is not indicated for the relief of acute bronchospasm

[see Warnings and Precautions (

5.2

)].

)

5/2025

Dosage and Administration, Recommended Dosage (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)

5/2025

Warnings and Precautions, Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Acute Deteriorating Disease (

5.2 Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Acute Deteriorating Disease

NUCALA should not be used to treat acute symptoms or acute exacerbations of asthma or COPD. Do not use NUCALA to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of treatment with NUCALA.

)

5/2025

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 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 , Clinical Studies ]
.
Limitations of Use
NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus
[see Warnings and Precautions ]
.
)
•Add-on maintenance treatment of adult patients aged 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). (
1.2 Maintenance Treatment of Chronic Rhinosinusitis with Nasal Polyps
NUCALA is indicated for the 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.
)
•Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (
1.3 Maintenance Treatment of Chronic Obstructive Pulmonary Disease
NUCALA is indicated for the add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
Limitations of Use
NUCALA is not indicated for the relief of acute bronchospasm
[see Warnings and Precautions (
5.2
)].
)
•The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (
1.4 Eosinophilic Granulomatosis with Polyangiitis
NUCALA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
)
•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 Hypereosinophilic Syndrome
NUCALA is indicated for 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.
)

Limitations of use:

Not for relief of acute bronchospasm or status asthmaticus. (

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 , Clinical Studies ]

Limitations of Use

NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus

[see Warnings and Precautions ]

1.3 Maintenance Treatment of Chronic Obstructive Pulmonary Disease

NUCALA is indicated for the add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Limitations of Use

NUCALA is not indicated for the relief of acute bronchospasm

[see Warnings and Precautions (

5.2

)].

)

•Severe asthma in patients aged 12 years and older: 100 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)

•Severe asthma in patients aged 6 to 11 years: 40 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)

•CRSwNP: 100 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)

•COPD: 100 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)

•EGPA: 300 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)

•HES: 300 mg administered subcutaneously once every 4 weeks. (

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

12 to 17 years of age:

100 mg every 4 weeks

6 to 11 years of age:

40 mg every 4 weeks

•
^a300 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
Chronic rhinosinusitis with nasal polyps	100 mg every 4 weeks	Not applicable
Chronic obstructive pulmonary disease	100 mg every 4 weeks	Not applicable
Eosinophilic granulomatosis with polyangiitis	300 mg^aevery 4 weeks	Not applicable
Hypereosinophilic syndrome	300 mg^aevery 4 weeks	12 to 17 years of age: 300 mg^aevery 4 weeks

)

For Injection

•100 mg white to off-white lyophilized powder in a single-dose vial for reconstitution.

Injection

•100 mg/mL as a clear to opalescent, colorless to pale yellow to pale brown solution in a single-dose prefilled autoinjector.
•100 mg/mL as a clear to opalescent, colorless to pale yellow to pale brown solution in a single-dose prefilled glass syringe.
•40 mg/0.4 mL as a clear to opalescent, colorless to pale yellow to pale brown solution in a single-dose prefilled glass syringe.

Risk Summary

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. In a prenatal and postnatal development study conducted in cynomolgus monkeys, there was no evidence of fetal harm with intravenous administration of mepolizumab throughout pregnancy at doses that produced exposures up to approximately 9 times the exposure at the maximum recommended human dose (MRHD) of 300 mg subcutaneous

(see Data)

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryofetal Risk:

In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

Data

Animal Data:

In a prenatal and postnatal development study, pregnant cynomolgus monkeys received mepolizumab from gestation Days 20 to 140 at doses that produced exposures up to approximately 9 times that achieved with the MRHD (on an AUC basis with maternal intravenous doses up to 100 mg/kg once every 4 weeks). Mepolizumab did not elicit adverse effects on fetal or neonatal growth (including immune function) up to 9 months after birth. Examinations for internal or skeletal malformations were not performed. Mepolizumab crossed the placenta in cynomolgus monkeys. Concentrations of mepolizumab were approximately 2.4 times higher in infants than in mothers up to Day 178 postpartum. Levels of mepolizumab in milk were ≤0.5% of maternal serum concentration.

In a fertility, early embryonic, and embryofetal development study, pregnant CD-1 mice received an analogous antibody, which inhibits the activity of murine interleukin-5 (IL-5), at an intravenous dose of 50 mg/kg once per week throughout gestation. The analogous antibody was not teratogenic in mice. Embryofetal development of IL-5–deficient mice has been reported to be generally unaffected relative to wild-type mice.

NUCALA is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation

[see Warnings and Precautions (

5.1 Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of NUCALA. These reactions generally occur within hours of administration, but in some instances can have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, NUCALA should be discontinued

[see Contraindications ]

), Description (

11 DESCRIPTION

Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Mepolizumab has a molecular weight of approximately 149 kDa.

NUCALA for injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial for subcutaneous injection after reconstitution. Upon reconstitution with 1.2 mL of Sterile Water for Injection, USP, the resulting concentration is 100 mg/mL and delivers 1 mL

[see Dosage and Administration ]

. Each vial delivers 100 mg of mepolizumab, polysorbate 80 (0.67 mg), sodium phosphate dibasic heptahydrate (7.14 mg), and sucrose (160 mg), with a pH of 7.0.

The vial stopper is not made with natural rubber latex.

NUCALA injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brown solution for subcutaneous use.

NUCALA injection is supplied in a single-dose, 1-mL, prefilled autoinjector with a fixed 29‑gauge, half-inch needle and in a single-dose, 1-mL, prefilled syringe with a fixed 29‑gauge, half-inch needle with a needle guard. Each 1 mL delivers 100 mg mepolizumab, citric acid monohydrate (0.95 mg), EDTA disodium dihydrate (0.019 mg), polysorbate 80 (0.20 mg), sodium phosphate dibasic heptahydrate (4.16 mg), and sucrose (120 mg), with a pH of 6.3.

NUCALA injection is supplied in a single-dose, 0.4-mL, prefilled syringe with a fixed 29-gauge, half-inch needle with a needle guard. Each 0.4 mL delivers 40 mg mepolizumab, citric acid monohydrate (0.38 mg), EDTA disodium dihydrate (0.0074 mg), polysorbate 80 (0.08 mg), sodium phosphate dibasic heptahydrate (1.66 mg), and sucrose (48 mg), with a pH of 6.3.

The prefilled autoinjector and prefilled syringe are not made with natural rubber latex.

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