Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions in Cushing's syndrome (≥ 20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, endometrial hypertrophy ( 6 ).
To report suspected adverse reactions, contact Corcept Therapeutics at 1-855-844-3270 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
Safety data on the use of KORLYM are available from 50 patients with Cushing's syndrome enrolled in an uncontrolled, open-label, multi-center trial (Study 400).
Forty-three patients had Cushing's disease and all except one had previously undergone pituitary surgery.
Four patients had ectopic ACTH secretion, and three had adrenal carcinoma.
Patients were treated for up to 24 weeks.
A dose of 300 mg per day was administered for the initial 14 days;
thereafter, the dose could be escalated in increments of 300 mg per day based on assessments of tolerability and clinical response.
Doses were escalated up to 900 mg per day for patients <60 kg, or 1200 mg per day for patients >60 kg.
5 WARNINGS AND PRECAUTIONS Adrenal insufficiency : Patients should be closely monitored for signs and symptoms of adrenal insufficiency ( 5.1 ).
Hypokalemia : Hypokalemia should be corrected prior to treatment and monitored for during treatment ( 5.2 ).
Vaginal bleeding and endometrial changes : Women may experience endometrial thickening or unexpected vaginal bleeding.
Use with caution if patient also has a hemorrhagic disorder or is on anti-coagulant therapy ( 5.3 ).
QT interval prolongation : Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval ( 5.4 ).
Like all medications, Korlym can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: