Administration of Korlym® requires careful and gradual titration and potassium monitoring1
Finding the right dose
- The recommended starting dose of Korlym is 300 mg/day1
- The dose may be increased by 300 mg (to a maximum of 1200 mg daily) every 2 to 4 weeks as needed. Dose should not exceed 20 mg/kg per day1
- Decisions about dose increases should be based on a clinical assessment of tolerability and the degree of improvement in Cushing syndrome manifestations1
Doses at which FIRST improvements were observed in the Korlym phase 3 pivotal trial2*†:
*Clinical response based on improvement in metabolic, physical, neurologic, and social assessments compared with baseline.2
Dosing considerations
- Obtain a negative pregnancy test in females of reproductive potential prior to initiating treatment with Korlym or if treatment is interrupted for more than 14 days1
- Administer once daily orally with a meal. Patients should swallow the tablet whole. Do not split, crush, or chew Korlym tablets1
- Renal impairment: Do not exceed 600 mg once daily1
- Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment1
- Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone1
- For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg/day and titrate to a maximum of 900 mg/day if clinically indicated1
- When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: For patients receiving a daily dose of 600 mg, reduce the daily dose to 300 mg. Titrate to a maximum of 600 mg per day if clinically indicated. For patients receiving a daily dose of 900 mg, reduce the daily dose to 600 mg. Titrate to a maximum of 900 mg per day if clinically indicated. For patients receiving a daily dose of 1200 mg, reduce the daily dose to 900 mg1
- The number of serious adverse events (AEs) did not increase with dose increases over time2
- The frequency of the 4 most commonly reported AEs (nausea, fatigue, headache, and hypokalemia) did not increase over time1,2
For additional information see AEs and Important Prescribing Considerations.
Determining the effective dose of Korlym for your patient
Evaluating patient response
- To evaluate response in patients treated with Korlym, assess improvements in areas such as insulin sensitivity, weight loss, and mental status1
- Improvements may be observed within the first 6 weeks of therapy
- Measurement of serum cortisol levels is not an effective measure of response1
- If adequate improvement is not observed, further dose increases should be considered1
Monitoring to help guide dose changes
Initial dose changes within the first 6 weeks of therapy | Dose changes beyond 2 months of therapy |
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Important treatment considerations
MR overstimulation—suspected hypokalemia | Excess GR antagonism—suspected adrenal insufficiency | |
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How to manage it: |
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Background: |
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