The Food and Drug Administration (FDA) has approved a new 40mg prefilled syringe for Nucala (mepolizumab) as add-on maintenance treatment for children 6 to 11 years of age with severe asthma and with an eosinophilic phenotype. Previously, children received a 40mg dose using a solution that was reconstituted and administered in a physician’s office.

The new 40mg prefilled syringe may be used to administer Nucala to children 6 to 11 years of age every 4 weeks at home or in the physician’s office. Caregivers may administer the medication at home if it is determined to be appropriate by the healthcare provider. Nucala injection is supplied as a 40mg/0.4mL solution in a single-dose prefilled syringe for subcutaneous injection.

“For many, going to the doctor’s office to receive a biologic can be challenging, so having the possibility for children to receive Nucala at home, provides a bit more flexibility for the child’s and caregiver’s lives,” said Tonya Winders, CEO & President, Allergy and Asthma Network and President of Global Allergy and Airways Patient Platform.

Nucala is also supplied in 100mg single-dose vials for reconstitution and in 100mg/mL single-dose prefilled autoinjectors and prefilled syringes; the prefilled autoinjector and syringe are only for use in adults and adolescents aged 12 years and older.

References

  1. FDA approves Nucala (mepolizumab) 40mg prefilled syringe for children with severe eosinophilic asthma. News release. GlaxoSmithKline plc. Accessed January 24, 2022. https://us.gsk.com/en-us/media/press-releases/fda-approves-nucala-mepolizumab-40-mg-prefilled-syringe-for-children-with-severe-eosinophilic-asthma/
  2. Nucala. Package insert. GlaxoSmithKline plc; 2021. Accessed January 24, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF