The U.S.Food and Drug Management (FDA) has given the green light to an oral solution of hydrocortisone (Khindivi) for children aged 5 years and older who have adrenocortical insufficiency.According to the manufacturer, this is the first hydrocortisone oral solution to receive FDA approval.

khindivi is available in a 1-mg/ml strength, designed to eliminate the need for tablet splitting or crushing, and allows for precise, individualized dosing. The ready-to-use solution requires no refrigeration, mixing, or shaking, making it a convenient option for children who have difficulty swallowing tablets or have specific administration needs.

“Managing adrenal insufficiency in pediatric patients requires precise and consistent hydrocortisone dosing that can be carefully titrated to small increments that address the individualized pharmacokinetic needs of each child,” said Kyriakie Sarafoglou, MD, professor, Division of Pediatric Endocrinology & Division of Pediatric Genetics & metabolism, University of Minnesota, in a news release. “The availability of an FDA-approved oral hydrocortisone liquid solution offers physicians a new tool to dose patients accurately, which is important to clinical outcomes during this dynamic period of growth and development.”

Benefits of Oral Hydrocortisone for Children

The newly approved oral solution offers several advantages over traditional hydrocortisone tablets.Its liquid form allows for more accurate dosing, which is particularly important in pediatric patients where small adjustments can considerably impact treatment outcomes. The convenience of a ready-to-use solution that doesn’t require refrigeration or mixing also improves adherence to the prescribed regimen.

“The availability of an FDA-approved oral hydrocortisone liquid solution offers physicians a new tool to dose patients accurately…”

Understanding Adrenal Insufficiency

Adrenal insufficiency, also known as Addison’s disease, is a rare endocrine disorder in which the adrenal glands do not produce enough cortisol and aldosterone National Institute of Diabetes and Digestive and Kidney Diseases, Mayo Clinic. Cortisol helps regulate metabolism, blood pressure, and the immune system, while aldosterone helps control sodium and potassium levels in the blood.