Alkindi® Sprinkle (hydrocortisone oral granules; Eton Pharmaceuticals) is now available as replacement therapy in pediatric patients with adrenocortical insufficiency.
Alkindi Sprinkle contains immediate-release oral hydrocortisone granules designed for the dosing needs of pediatric patients with adrenocortical insufficiency; most of these patients require significantly lower doses than the currently available 5mg tablet formulation of hydrocortisone. The approval of Alkindi Sprinkle is supported by use in pediatric patients for adrenocortical insufficiency with another hydrocortisone product, along with supportive pharmacokinetic and safety data in 24 pediatric patients with adrenocortical insufficiency.
Alkindi Sprinkle is available exclusively through AnovoRx specialty pharmacy in 4 dosage strengths: 0.5mg, 1mg, 2mg, and 5mg. The oral granules are contained within capsules that should be opened and administered to the patient either directly on the tongue or by pouring the granules onto a spoon and placing it in the patient’s mouth.
Alternatively, the granules may be mixed with cold or room temperature soft food and subsequently swallowed within 5 minutes to avoid a bitter taste. The Alkindi Sprinkle capsules should not be swallowed. Additionally, the granules should not be administered via nasogastric or gastric tubes as they may cause tube blockage.
“Alkindi Sprinkle is a very welcome treatment option for children who, for over 60 years, were forced to rely on adult-strength hydrocortisone to treat adrenocortical insufficiency,” said Mitchell Geffner MD, co-director, Congenital Adrenal Hyperplasia (CAH) Comprehensive Care Clinic and Professor of Pediatrics, Keck School of Medicine of University of Southern California. “Low-dose options, as low as 0.5mg, allow for more accurate and individualized dosing for patients.”
AnovoRx will administer the Eton Cares Program in partnership with Eton Pharmaceuticals to assist patients in gaining access to the treatment. To enroll patients in the program and prescribe Alkindi Sprinkle, clinicians will need to complete a patient referral form.
For more information visit alkindisprinkle.com.
1. Eton Pharmaceuticals announces availability of orphan drug Alkindi® Sprinkle (hydrocortisone) in the United States. [press release]. Deer Park, IL: Eton Pharmaceuticals; November 24, 2020.
2. Alkindi® Sprinkle [package insert]. Deer Park, IL: Eton Pharmaceuticals; 2020.
This article originally appeared on MPR