KHINDIVI™ (hydrocortisone) Oral Solution
In May 2025, the FDA approved KHINDIVI™ (hydrocortisone) Oral Solution for the treatment of adrenal insufficiency (AI) in pediatric patients ages 5 years and older. It is indicated for the treatment of AI due to any underlying cause, including congenital adrenal hyperplasia (CAH). KHINDIVI™ is the only FDA-approved oral solution of hydrocortisone and provides an alternative option for children who are unable to swallow tablets, or who require low dosages. It is a ready-to-use oral formulation created to eliminate the need to split or crush tablets, and ensures accuracy of dosing.
KHINDIVI™ is indicated for physiologic dosing only and is not approved for stress dosing. During clinical illness, an alternative form of hydrocortisone should be used.
KHINDIVI™ is produced by Eton Pharmaceuticals and is commercially available through Anovo Specialty Pharmacy.
Dosage and administration:
KHINDIVI™ is available at a concentration of 1mg/ml. It can be stored at room temperature and does not need to be mixed or shaken. The solution can be safely administered through a gastric tube.
Contraindication to use includes hypersensitivity to hydrocortisone or any ingredients in KHINDIVI oral solution. The inactive ingredients are berry flavor, butylated hydroxyanisole, ethyl maltol, glycerin, methylparaben, propylparaben, polyethylene glycol 400, propylene glycol, and sucralose.
Adverse effects:
Adverse effects are related to the inactive ingredients which are systemically absorbed. Hyperosmolality can develop secondary to polyethylene glycol 400, propylene glycol and glycerin. These ingredients increase plasma osmolarity in all pediatric patients, exacerbated in those under the age of 5 years. Metabolic acidosis, hypoglycemia, hepato-renal injury, and central nervous system (CNS) toxicity can also result due to polyethylene glycol 400 and propylene glycol. CNS toxicity may manifest as seizure or coma. Vomiting and diarrhea can occur from gastrointestinal irritation related to polyethylene glycol 400 and glycerin. Adverse effects may increase the risk of adrenal crisis. Additional adverse effects are comparable to alternative formulations of hydrocortisone.
It is recommended to monitor children for signs and symptoms consistent with hyperosmolarity, metabolic acidosis, hypoglycemia, hepato-renal injury, CNS toxicity, and gastrointestinal distress. Laboratory values should be monitored as clinically indicated.
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