hrp0089p2-p020 | Adrenals and HPA Axis P2 | ESPE2018

Long-term Follow-up of Safety and Disease Control for Hydrocortisone Granules Designed to give Age-appropriate Dosing with Taste Masking to Children with Adrenal Insufficiency

Neumann Uta , Braune Katarina , Whitaker Martin , Wiegand Susanna , Krude Heiko , Porter John , Digweed Dena , Voet Bernard , Ross Richard , Davies Madhu , Blankenstein Oliver

Context: Alkindi® (Hydrocortisone Granules, Diurnal Ltd, UK), was recently licensed for oral administration to children with adrenal insufficiency (AI) from birth to 18 years. Previously, children received compounded hydrocortisone to achieve age appropriate dosing, however almost 25% of batches were out of specification for mass and content uniformity and clinically evident under- and over-dosing was reported.Objectives: Primary: long-te...