PEDIATRIC DOSING & ADMINISTRATION (AGES 6-11)

Pediatric patients ages 6-11 can receive NUCALA at home or in the office. The 40 mg/0.4 mL prefilled syringe can be used in either location and must be administered by a healthcare professional or patient caregiver. The patient caregiver may administer NUCALA after the healthcare provider determines it is appropriate. Children with SEA can also receive NUCALA lyophilized powder, which is reconstituted and administered in-office by a healthcare professional.

 

Once-monthly* NUCALA is a fixed-dose (independent of weight) SC injection with no loading dose. For ages 6-11, the recommended dose is 40 mg SC once monthly.*


(To see options for ages 12+, go to at-home dosing & admin or in-office dosing & admin.)

 

*Every four weeks.
SC=subcutaneous.

40 mg Prefilled Syringe for Patients Aged 6-11 Years

At-home or in-office dosing (ages 6-11) and administration with NUCALA 40 mg/0.4 mL prefilled syringe

Watch this instructional video, and read details below, including Warnings and Storage Info.

How to use the prefilled syringe

How to use the prefilled syringe | 7:34

This NUCALA 40 mg/0.4 mL single-use prefilled syringe, for ages 6-11, can be administered at home by a caretaker or in the office by a healthcare professional.

 

40 mg/0.4 mL prefilled syringe full Instructions for Use picture_as_pdf

 

See Warnings & Storage info below keyboard_arrow_down

For NUCALA 40 mg/0.4 mL prefilled syringe

 

DOSING & ADMINISTRATION

  • Recommended NUCALA dose for ages 6-11 is 40 mg (independent of weight)
  • Intended for use with guidance by a healthcare professional
  • SC injection every 4 weeks by healthcare professional or caregiver into the thigh, abdomen, or upper arm
  • Each single-use prefilled syringe is for 1 patient only 
  • In line with clinical practice, monitoring of patients after administration of biologic agents is recommended

 

Keep NUCALA and all medicines away from children.

 

WARNINGS

  • Do not use any prefilled syringe more than 1 time
  • Do not share the prefilled syringe with other people
  • Do not use the prefilled syringe if it was dropped or looks damaged

 

STORAGE INFO

  • Store in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • Keep in the original carton until time of use to protect from light
  • Do not freeze
  • Do not shake
  • Keep away from heat
  • If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days
  • Do not use the prefilled syringe if it has been left out of the carton for more than 8 hours
Lyophilized powder bottle

In-office dosing (ages 6-11), reconstitution, and administration of NUCALA lyophilized powder

NUCALA lyophilized powder should be reconstituted and administered by a healthcare professional.

 

(For the other pediatric [ages 6-11] administration option, 40 mg/0.4 mL prefilled syringe, see info above.)

 

  • Recommended NUCALA dose for ages 6-11 is 40 mg (independent of weight)
  • Reconstitute* NUCALA in the vial 
  • Remove and administer 0.4 mL of the reconstituted solution (equivalent to 40 mg of mepolizumab)   
  • Because each NUCALA vial should only be used for 1 patient, discard the remaining solution
  • SC injection every 4 weeks into the thigh, abdomen, or upper arm
  • In line with clinical practice, monitoring of patients after administration of biologic agents is recommended
  • Store below 30°C (86°F)
    • Does not require refrigeration if stored below 30°C (86°F)
  • Do not freeze
  • Discard if not used within 8 hours of reconstitution

 

*See reconstitution instructions on the In-office dosing & administration page.

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INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

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. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
  • 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. NUCALA is not indicated for the relief of acute bronchospasm.
  • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
  • 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. 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Known hypersensitivity to mepolizumab or excipients.

 

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.

 

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.

 

USE IN SPECIFIC POPULATIONS

The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

 

Please see full Prescribing Information and Patient Information for NUCALA.

PMUS-MPLWCNT240085 May 2025

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.