Recorlev®
Drug - Recorlev® (levoketoconazole) [Xeris Pharmaceuticals Inc.]
October 2022
Therapeutic area - Cushing’s syndrome
Initial approval criteria
- Patient is at least 18 years of age AND
- Patient has a diagnosis of endogenous Cushing’s syndrome (hypercortisolemia) AND
- Patient is NOT a candidate for surgical treatment of Cushing’s syndrome or surgery has NOT been curative AND
- Patient does NOT have the following contraindicated conditions:
- Cirrhosis; acute liver disease or poorly controlled chronic liver disease, baseline aspartate transaminase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN); recurrent symptomatic cholelithiasis; history of drug induced liver injury due to any azole antifungal therapy that required discontinuation of treatment; or extensive metastatic liver disease; baseline prolonged QTcF interval > 470 msec; history of torsades de pointes, ventricular tachycardia/fibrillation, or long QT syndrome AND
- Hypersensitivity to any component of the product or ketoconazole AND
- Patient is NOT currently taking a drug that cause QT prolongation associated with ventricular arrhythmias (e.g., bosutinib, cisapride, clarithromycin, cobimetinib, crizotinib, disopyramide, dofetilide, dronedarone, eliglustat [in patients that are poor or ntermediate metabolizers of CYP2D6 and in patients taking strong or moderate CYP2D6 inhibitors], ivabradine, methadone, midostaurin, nicardipine, pimozide, quinidine, and ranolazine) AND
- Patient is NOT currently taking certain drugs that are sensitive CYP3A4 and/or P-gp substrates (e.g., alfentanil, avanafil, buspirone, conivaptan, dabigatran etexilate, darifenacin, darunavir, digoxin, ebastine, everolimus, fexofenadine, ibrutinib, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, triazolam, vardenafil) AND
- Patient will avoid excessive alcohol consumption AND
- Physician has assessed baseline potassium and magnesium and corrected hypokalemia and hypomagnesemia, as needed, prior to initiating levoketoconazole therapy
Renewal criteria
- Patient must continue to meet the above criteria AND
- Patient must have disease improvement from baseline and/or stabilization (e.g., normalization of mean urine free cortisol [mUFC]) AND
- 24-hour urine free cortisol (UFC) does not exceed the upper limit of normal (ULN); AND Patient has not experienced any reatment-restricting adverse effects (e.g., hypersensitivity reaction, hepatotoxicity [elevated AST or ALT, QT prolongation, hypocortisolism)
Quantity limits
Background
Recorlev is not approved for the treatment of fungal infections. The safety and effectiveness of Recorlev for the treatment of fungal infections have not been established.
Questions
MHCP Provider Resource Center 651-431-2700 or 800-366-5411
