Pooled safety data for hepatic injury and other liver-related adverse reactions and elevations in AST or ALT: at least one liver-related adverse reaction (27%), liver enzyme elevation* (20%), and AST or ALT > ULN† (45%).
ALT=alanine aminotransferase; AST=aspartate aminotransferase; TEAE=treatment-emergent adverse event; ULN=upper limit of normal.
References: 1. Recorlev. Prescribing Information. Xeris Pharmaceuticals, Inc; 2021. 2. US National Library of Medicine. Open-label treatment in Cushing’s syndrome (OPTICS). Accessed December 23, 2021. https://clinicaltrials.gov/ct2/show/NCT03621280. 3. Data on file. Xeris Pharmaceuticals, Inc. 2021. 4. Fleseriu M, Pivonello R, Elenkova A, et al. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing’s syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial [published correction appears in Lancet Diabetes Endocrinol. 2019;7(11):e22]. Lancet Diabetes Endocrinol. 2019;7(11):855-865.