SAFETY

Korlym has been prescribed for more than 10 years for the treatment of hyperglycemia secondary to hypercortisolism in patients with endogenous Cushing syndrome1

Most adverse events (AEs) were mild to moderate in severity in the Study of the Efficacy and Safety of Mifepristone in the Treatment of Endogenous Cushing Syndrome (SEISMIC) study2

  • The frequency of the 4 most commonly reported AEs did not increase over time3,4

    • Nausea

    • Fatigue

    • Headache

    • Hypokalemia

  • The number of serious AEs did not rise with dose increases over time4

    • Rates of cortisol withdrawal–related AEs did not increase as the average dose increased

    • Rates of cortisol withdrawal–related AEs declined the longer patients were receiving treatment

Commonly occurring (≥10%) AEs in patients receiving Korlym3

AE% Patients (N=50)
Nausea48%
Fatigue48%
Headache44%
Decreased blood potassium34%
Arthralgia30%
Vomiting26%
Peripheral edema26%
Hypertension24%
Dizziness22%
Decreased appetite20%
Endometrial hypertrophy38%a
Dry mouth18%
Abnormal thyroid function18%
Back pain16%
Dyspnea16%
Pain14%
Myalgia14%
Sinusitis14%
Diarrhea12%
Pain in extremity12%
Nasopharyngitis12%
Constipation10%
Somnolence10%
Anorexia10%
Anxiety10%

aBased on a denominator of 26 women who had baseline and end-of-trial transvaginal ultrasound measurements.

References:
  1. SEC.gov. The rise of the e-patient understanding social networks and online health information seeking. Pew Research Center’s Internet and the American Life Project. Published February 12, 2013. Accessed October 5, 2023. https://www.sec.gov/Archives/edgar/data/1088856/000110262413000154/corcepttherapeutics.htm#:~:text=In%202012%2C%20Corcept%3A,months%20after%20the%20drug's%20approval
  2. Fleseriu M, Biller BMK, Findling JW, et al. Mifepristone, a glucocorticoid receptor antagonist, produces clinical and metabolic benefits in patients with Cushing's syndrome. J Clin Endocrinol Metab. 2012;97(6):2039-2049. doi:10.1210/jc.2011-3350
  3. Korlym Prescribing Information. Corcept Therapeutics, Inc; 2019.
  4. Yuen KCJ, Williams G, Kushner H, Nguyen D. Association between mifepristone dose, efficacy, and tolerability in patients with Cushing syndrome. Endocr Pract. 2015;21(10):1087-1092. doi:10.4158/EP15760.OR