Corcept Therapeutics is a leader in the discovery and development of drugs that regulate the effects of cortisol.

There are many diseases in which modulating cortisol activity may benefit patients. Corcept’s scientific expertise surrounding the regulation of cortisol has led to the discovery of an extensive library of novel compounds that may ultimately address numerous important diseases.

Corcept’s drug Korlym™ (Mifepristone) 300 mg Tablets has been approved to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have diabetes mellitus type 2 or glucose intolerance and have failed surgery or are not candidates for surgery. For more information, including important safety information, see www.korlym.com. Corcept is committed to ensuring that every patient who needs it can have access to Korlym.

IMPORTANT SAFETY INFORMATION

Contraindications

• Pregnancy
• Use of simvastatin or lovastatin and CYP 3A substrates with narrow therapeutic range
• Concurrent long-term corticosteroid use
• Women with history of unexplained vaginal bleeding
• Women with endometrial hyperplasia with atypia or endometrial carcinoma

Warnings and Precautions

• Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency.
• Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment.
• 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.
• QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval.
• Use of Strong CYP3A Inhibitors: Concomitant use can increase plasma levels significantly. Use only when necessary and limit dose to 300 mg.

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.

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.

Drug Interactions

• Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym
• CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Limit mifepristone dose to 300 mg per day when used with strong CYP3A inhibitors.
• CYP3A inducers: Do not use Korlym with CYP3A inducers.
• Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym.
• Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz.
• Hormonal contraceptives: Do not use with Korlym.

Use in Specific Populations

• Nursing mothers: Discontinue drug or discontinue nursing.

Please see the accompanying full Prescribing Information including boxed warning at www.corcept.com/prescribinginfo.pdf

Please see the accompanying Medication Guide at www.corcept.com/medicationguide.pdf