Xeomin Label Expanded for Pediatric Upper Limb Spasticity Associated With Cerebral Palsy
KEY TAKEAWAYS
- The FDA approved a label update expanding Xeomin’s indication to children and adolescents with cerebral palsy.
- The updated label applies to patients aged 2 years and older with upper limb spasticity associated with cerebral palsy.
- Cerebral palsy–related spasticity can affect upper limb function and interfere with daily activities such as dressing, writing, and handling objects.
The Food and Drug Administration (FDA) approved an update to the Prescribing Information for Xeomin (incobotulinumtoxinA; Merz Therapeutics, Raleigh, NC), expanding its indication to include children and adolescents aged 2 years and older with upper limb spasticity associated with cerebral palsy (CP). Xeomin was initially approved in 2010 for the treatment of cervical dystonia and blepharospasm, and its label was first expanded to adult upper limb spasticity in 2015. Xeomin is a form of botulinum toxin that is administered via intramuscular or intraglandular injection.
CP affects approximately 1 in 345 children in the United States, and spasticity is a common motor manifestation that can limit upper limb function. In children with CP, upper limb spasticity may affect comfort, independence, and participation in daily activities, including dressing, writing, and handling objects.
Expanded Label Update
- The FDA label update expands Xeomin use to include pediatric patients with upper limb spasticity caused by CP.
- The indication applies to children and adolescents aged 2 years and older.
- The update broadens a therapeutic option for long-term spasticity management in pediatric patients with CP.
The label for Xeomin includes a Boxed Warning for distant spread of toxin effect.
Source
Merz Therapeutics. Xeomin approved for expanded indication in pediatric upper limb spasticity patients with cerebral palsy following FDA label update. Published June 26, 2026. Accessed June 29, 2026. https://merztherapeutics.com/us/xeomin-approved-for-expanded-indication-in-pediatric-upper-limb-spasticity-patients-with-cerebral-palsy-following-fda-label-update/
Stewart J. Xeomin FDA approval history. Drugs.com. Last updated, July 23, 2024. Acessed June 29, 2026. https://www.drugs.com/history/xeomin.html