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Recorlev
levoketoconazole
Black Box Warnings .
Hepatotoxicity
serious cases, incl. fatal or requiring liver transplant, have occurred w/ oral ketoconazole, even in pts w/o hepatic dz risk factors; serious hepatotoxicity has occurred w/ levoketoconazole; contraindicated in pts w/ cirrhosis, acute hepatic dz, poorly controlled chronic hepatic dz, recurrent symptomatic cholelithiasis, hx of drug-induced liver injury due to ketoconazole or other azole antifungal that required tx D/C, or extensive metastatic liver dz; monitor LFTs at baseline and during tx; interrupt tx immediately if signs of hepatotoxicity
QT Prolongation
levoketoconazole assoc. w/ dose-related QT prolongation, may lead to life-threatening ventricular dysrhythmias incl. torsades de pointes; contraindicated w/ drugs that prolong QT interval assoc. w/ ventricular arrhythmias, incl. torsades de pointes; contraindicated in pts w/ baseline QTc >470 msec, torsades de pointes hx, ventricular tachycardia, ventricular fibrillation, long QT syndrome or first-degree family hx; monitor ECG and correct hypokalemia and hypomagnesemia before and during tx; temporarily D/C if QTc >500 msec
Adult Dosing .
Dosage forms: TAB: 150 mg
Cushing syndrome
- [150-600 mg PO bid]
- Start: 150 mg PO bid, then may incr. dose by 150 mg/day no more frequently than q2-3wk; Max: 1200 mg/day; Info: for pts ineligible for or who have failed surgery; adjust dose based on tx response and urinary free cortisol levels; may decr. dose to 150 mg PO qd if not tolerated; see pkg insert for dose adjustments based on LFTs, QTc
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [see below]
- AST/ALT 1-3x ULN: not defined, caution advised; AST/ALT >3x ULN/cirrhosis/acute hepatic dz/chronic hepatic dz, uncontrolled: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.