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IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

WARNING: HEPATOTOXICITY AND QT PROLONGATION

Cases of hepatotoxicity with fatal outcome or requiring liver transplantation have been reported with oral ketoconazole. Some patients had no obvious risk factors for liver disease. RECORLEV is associated with serious hepatotoxicity. Evaluate liver enzymes prior to and during treatment
RECORLEV is associated with dose-related QT interval prolongation. QT interval prolongation may result in life-threatening ventricular dysrhythmias such as torsades de pointes. Perform ECG and correct hypokalemia and hypomagnesemia prior to and during treatment

RECORLEV is contraindicated in patients:
- With cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT >3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug-induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease
- Taking drugs that cause QT prolongation associated with ventricular arrhythmias, including torsades de pointes
- With prolonged QTcF interval >470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome
- With hypersensitivity to levoketoconazole, ketoconazole, or any excipient in RECORLEV
- Taking certain drugs that are sensitive substrates of CYP3A4 or CYP3A4 and P-gp
RECORLEV may lead to hypocortisolism with a potential for life-threatening adrenal insufficiency. Dosage reduction or interruption may be necessary
Hypersensitivity to RECORLEV has been reported. Anaphylaxis has been reported with oral ketoconazole
RECORLEV may lower serum testosterone in men and women. Inform patients to report associated symptoms
Most common adverse reactions are nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, abnormal uterine bleeding, erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper respiratory infection, myalgia, arrhythmia, back pain, insomnia/sleep disturbances, and peripheral edema
Avoid use of strong CYP3A4 inhibitors and inducers 2 weeks before and during RECORLEV treatment. Consult approved product labeling for drugs that are substrates of CYP3A4, P-gp, OCT2, and MATE prior to initiating RECORLEV. For atorvastatin, metformin, and gastric acid modulators, see full Prescribing Information for recommendations regarding concomitant use with RECORLEV
Breastfeeding is not recommended during treatment and for one day after final dose

Please see full Prescribing Information, including Boxed Warning, for RECORLEV.

INDICATION

RECORLEV (levoketoconazole) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.

Limitations of Use: RECORLEV is not approved for the treatment of fungal infections.

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Copyright © 2026 Xeris Pharmaceuticals, Inc. All rights reserved. US-REC-25-00006 (v2) 01/26

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