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PEDIATRIC USE (AGES 6-11)
The FIRST and ONLY severe eosinophilic asthma biologic indicated down to age 6
Identifying Appropriate Pediatric Patients
Patients aged 6 to 11 years with severe asthma and:
- 2+ controller therapies, including medium- to high-dose* inhaled corticosteroids
- 2+ exacerbations (OCS bursts, hospitalizations, and/or visits) in the previous 12 months
- Baseline blood eosinophils ≥150 cells/μL, which is predictive of efficacy for NUCALA1
The safety and efficacy of NUCALA for severe eosinophilic asthma have been established in patients aged 6 years and older.
*Medium- to high-dose ICS defined as >200 μg/day fluticasone propionate dry powder inhaler [DPI] or equivalent daily.1
Dosing
The recommended dose of NUCALA in children aged 6 to 11 years is 40-mg subcutaneous (SC) administered once every 4 weeks.
Administration of 40-mg dose
NUCALA lyophilized powder should be reconstituted and administered by a healthcare professional. Follow the instructions in the Prescribing Information for reconstitution.
Remove 0.4 mL of reconstituted NUCALA (equivalent to 40 mg of mepolizumab) and administer SC injection into the upper arm, thigh, or abdomen. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended.
Each vial of NUCALA contains 100 mg/mL of reconstituted solution. Any residual should be discarded. Each vial should be used for a single patient.
DosingThe recommended dose of NUCALA in children aged 6 to 11 years is 40 mg subcutaneous (SC), administered once every 4 weeks. Administration of 40-mg doseNUCALA lyophilized powder should be reconstituted and administered by a healthcare professional. Follow the instructions in the Prescribing Information for reconstitution. Remove 0.4 mL of reconstituted NUCALA (equivalent to 40 mg of mepolizumab) and administer SC injection into the upper arm, thigh, or abdomen. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended. Each vial of NUCALA contains 100 mg/mL of reconstituted solution. Any residual should be discarded. Each vial should be used for a single patient. |
REFERENCE:
- Wagener AH, de Nijs SB, Lutter R, et al. External validation of blood eosinophils, FeNO and serum periostin as surrogates for sputum eosinophils in asthma. Thorax. 2015;70(2):115-120.
- Gupta A, Ikeda M, Gang B, et al. Long-term safety and pharmacodynamics of mepolizumab in children with severe asthma with an eosinophilic phenotype [published online ahead of print, August 16, 2019]. J Allergy Clin Immun. https://doi.org/10.1016/j.jaci.2019.08.005.
