Korlym

Indications
Dosage
How Supplied

INDICATIONS

Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

Limitations of use

Korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome.

DOSAGE AND ADMINISTRATION

Adult Dosage

The recommended starting dose is 300 mg orally once daily. Korlym must be given as a single daily dose. Korlym should always be taken with a meal. Patients should swallow the tablet whole. Do not split, crush, or chew tablets.

Dosing and titration

The daily dose of Korlym may be increased in 300 mg increments. The dose of Korlym may be increased to a maximum of 1200 mg once daily but should not exceed 20 mg/kg per day. Increases in dose should not occur more frequently than once every 2-4 weeks. Decisions about dose increases should be based on a clinical assessment of tolerability and degree of improvement in Cushing's syndrome manifestations. Changes in glucose control, antidiabetic medication requirements, insulin levels, and psychiatric symptoms may provide an early assessment of response (within 6 weeks) and may help guide early dose titration. Improvements in cushingoid appearance, acne, hirsutism, striae, and body weight occur over a longer period of time and, along with measures of glucose control, may be used to determine dose changes beyond the first 2 months of therapy. Careful and gradual titration of Korlym accompanied by monitoring for recognized adverse reactions (See WARNINGS AND PRECAUTIONS may reduce the risk of severe adverse reactions. Dose reduction or even dose discontinuation may be needed in some clinical situations. If Korlym treatment is interrupted, it should be reinitiated at the lowest dose (300 mg). If treatment was interrupted because of adverse reactions, the titration should aim for a dose lower than the one that resulted in treatment interruption.

Dosing In Renal Impairment

No change in initial dose of Korlym is required in renal impairment. The maximum dose should be limited to 600 mg. [See Renal Impairment and CLINICAL PHARMACOLOGY]

Dosing In Hepatic Impairment

No change in the initial dose of Korlym is required in mild to moderate hepatic impairment. The maximum dose should be limited to 600 mg. Korlym should not be used in severe hepatic impairment. [See Hepatic Impairment and CLINICAL PHARMACOLOGY]

HOW SUPPLIED

Dosage Forms And Strengths

Korlym is supplied as a light yellow to yellow oval-shaped tablet debossed with “Corcept” on one side and “300” on the other. Each tablet contains 300 mg of mifepristone. The tablets are not scored.

Storage And Handling

Korlym is supplied as a light yellow to yellow, film-coated, oval-shaped tablet debossed with “Corcept” on one side and “300” on the other. Each tablet contains 300 mg of mifepristone. Korlym tablets are available in bottles of 28 tablets (NDC 76346-073-01) and bottles of 280 tablets (NDC 76346-073-02).

Store at controlled room temperature, 25 °C (77 °F); excursions permitted to 15 to 30 °C (59 – 86 °F). [See USP Controlled Room Temperature]

Manufactured for: Corcept Therapeutics Incorporated, Menlo Park, CA 94025. Revised: June 2013

Last reviewed on RxList: 11/24/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.