Dosage and administration of levoketoconazole

Levoketoconazole is indicated for the treatment of endogenous hypercortisolism in adult patients with Cushing's syndrome in whom surgical treatment is not an option or is refractory. Levoketoconazole is not approved for the treatment of fungal infections, and its safety and effectiveness have not been established. There are strict regulations on usage and dosage. Includes the following:

1. Laboratory testing before starting the drug:

(1) Obtain baseline liver tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin). Carefully consider the risks and potential benefits of initiating recovery in patients with AST or ALT above normal but ≤3 times the upper limit of normal.

(2) Obtain a baseline electrocardiogram (ECG).

(3) Correct hypokalemia and hypomagnesemia before initiating recovery.

2. Recommended dosage, titration and efficacy monitoring

Levoketoconazole starting dose150 mg orally twice daily with or without food. Titrate the dose to 150 mg daily, based on 24-hour urinary free cortisol levels and patient tolerance, no more frequently than every 2-3 weeks. Monitor cortisol levels on at least two 24-hour urinary cortisol collections every 2-3 weeks until an adequate clinical response is achieved. The maximum recommended dose is 1200 mg per day, 600 mg twice daily. If necessary for tolerability reasons, the dose may be reduced to 150 mg once daily. Once the maintenance dose is reached, monitor cortisol levels with at least two 24-hour urine-free cortisol collections every 1-2 months or as directed.

If 24-hour urinary free cortisol levels remain above the upper limit of normal despite treatment at the maximum recommended dose of 1200 mg per day, or if the patient is unable to tolerate treatment with levketoconazole, consider discontinuing levketoconazole and switching the patient to another therapy.

Reference materials:https://www.recorlev.com/