A proven safety and tolerability profile

Recorlev® was studied in patients for more than 3 years1,2

  • Up to 35 weeks in LOGICS
  • Up to 73 weeks in SONICS
  • More than 155 weeks in OPTICS

Adverse reactions occurring in ≥20% of Cushing's syndrome patients treated with Recorlev in LOGICS and SONICS1

LOGICS
LOGICS adverse reaction type Nausea/Vomiting, Hypokalemia, Systemic hypertension, Hemorrhage/Contusion, Headache, Abnormal uterine bleeding
LOGICS adverse reaction type Nausea/Vomiting, Hypokalemia, Systemic hypertension, Hemorrhage/Contusion, Headache, Abnormal uterine bleeding
  • aHemorrhage/contusion includes blood urine present, epistaxis, eye hemorrhage, gingival bleeding, hematoma, hematuria, hemorrhoidal hemorrhage, melena, and scleral hemorrhage.
SONICS
SONICS adverse reaction type Erythema, Hemorrhage/Contusion, Fatigue, Headache, Nausea/Vomiting, Abdominal pain/dyspepsia, Arthritis, Upper respiratory infection, Myalgia, Abnormal uterine bleeding, Arrhythmia, Back pain, Insomnia/Sleep disturbances, Peripheral edema, Systemic hypertension
SONICS adverse reaction type Erythema, Hemorrhage/Contusion, Fatigue, Headache, Nausea/Vomiting, Abdominal pain/dyspepsia, Arthritis, Upper respiratory infection, Myalgia, Abnormal uterine bleeding, Arrhythmia, Back pain, Insomnia/Sleep disturbances, Peripheral edema, Systemic hypertension
  • aErythema includes flushing.
  • bHemorrhage/Contusion includes blood urine present, conjunctival hemorrhage, ecchymosis, epistaxis, hematoma, hyphemia, and red blood cells urine.
  • cAbdominal pain/dyspepsia includes abdominal discomfort, abdominal distension, dyspepsia, gastritis, and other related terms.
  • dArrhythmia includes bradycardia, carotid pulse increased, defect conduction intraventricular, electrocardiogram QT prolonged, electrocardiogram T wave abnormal, heart rate increased, palpitations, and sinus bradycardia.

Pooled safety data (N=166) 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%).

  • *Liver enzyme elevation refers to elevation in AST, ALT, alkaline phosphatase, or gamma-glutamyl transferase.
  • †N=155; Not all elevations in liver enzymes were reported as adverse reactions during the studies.

Treatment discontinuation

  • In the LOGICS study, 15/84 patients (18%) discontinued Recorlev due to a TEAE; the most common TEAE leading to discontinuation was nausea in 3/84 patients (4%)3
  • In the SONICS study, 16/94 patients (17%) discontinued Recorlev due to an adverse reaction;4,5 the most common adverse reactions leading to discontinuation were liver-related (6/94)4

ALT=alanine aminotransferase; AST=aspartate aminotransferase; TEAE=treatment-emergent adverse event; ULN=upper limit of normal.

References: 1. Recorlev [prescribing information]. Chicago, IL; Xeris Pharmaceuticals, Inc. 2. Open-label treatment in Cushing's Syndrome (OPTICS). ClinicalTrials.gov identifier:NCT03621280. Updated May 10, 2023. Accessed January 5, 2025. https://clinicaltrials.gov/study/NCT03621280. 3. Pivonello R, Zacharieva S, Elenkova A, et al. Levoketoconazole in the treatment of patients with endogenous Cushing's syndrome: a double-blind, placebo-controlled, randomized withdrawal study (LOGICS). Pituitary. 2022;25(6):911-926. 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. 5. Fleseriu M, Auchus RJ, Greenman Y, et al. Levoketoconazole treatment in endogenous Cushing's syndrome: extended evaluation of clinical, biochemical, and radiologic outcomes. Eur J Endocrinol. 2022;187(6):859-871.

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