In this article, we will discuss Vismodegib (Pediatric Use). So, let’s get started.
Vismodegib (Pediatric Use)
The safety and effectiveness of Vismodegib capsule have not been established in pediatric patients. In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at 50 mg/kg/day (approximately 0.4 times the systemic exposure (AUC) in patients at the recommended human dose). Abnormalities in growing incisor teeth (including degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at 15 mg/kg/day (approximately 0.2 times the AUC in patients at the recommended human dose).