HEALTHCARE PROFESSIONALS

For some patients, surgery is a step - not a final solution - in managing their Cushing's.

What is KORLYM?

KORLYM is a prescription medicine used to treat high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or cannot have surgery.

KORLYM is not for people who have type 2 diabetes mellitus not caused by Cushing's syndrome.

It is not known if KORLYM is safe and effective in children.


Please scroll to see the Medication Guide for Korlym

What is the most important information I should know about KORLYM?

KORLYM can cause serious side effects, including:

  • Loss of a pregnancy. Women who can become pregnant must:
    • have a negative pregnancy test before starting KORLYM
    • have a negative pregnancy test before restarting KORLYM if you stop taking it for more than 14 days
    • use a non-hormonal form of birth control while taking KORLYM and for 1 month after stopping KORLYM. Talk to your doctor about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.

Do not take KORLYM if you:

  • are pregnant. See "What is the most important information I should know about KORLYM?"
  • are taking:
    • simvastatin (Zocor®, Vytorin®, Juvisync®, Simcor®)
    • lovastatin (Mevacor®, Altoprev®, Advicor®)
    • cyclosporine (Gengraf®, Neoral®, Restasis®, Sandimmune®)
    • dihydroergotamine (Migranal®)
    • ergotamine (Ergomar®, Migergot®)
    • fentanyl (Abstral®, Actiq®, Duragesic®, Fentora®, Lazanda®, Onsolis®, Sublimaze Preservative Free®, Subsys®)
    • pimozide (Orap®)
    • quinidine (Neudexta®)
    • sirolimus (Rapamune®, Torisel®)
    • tacrolimus (Prograf®, Protopic®)
  • must take corticosteroid medicines for other serious medical problems
  • are a woman who still has her uterus (womb) and have:
    • unexplained bleeding from your vagina
    • changes in the cells lining your uterus (endometrial hyperplasia) or cancer of the lining of your uterus (endometrial cancer)
  • are allergic to mifepristone or any of the ingredients in KORLYM. See the end of this Medication Guide for a complete list of ingredients in KORLYM.

Talk to your doctor before taking KORLYM if you have any of these conditions.

What should I tell my doctor before taking KORLYM?

Before taking KORLYM, tell your doctor if you:

  • have low potassium in your blood (hypokalemia)
  • have or have had a bleeding problem or are taking medicines to thin your blood
  • have or have had heart problems
  • have had an organ transplant
  • have been taking medicines called corticosteroids (cortisone, dexamethasone, methylprednisolone, prednisolone, prednisone)
  • are breastfeeding or plan to breastfeed. KORLYM passes into your breast milk and may harm your baby. You and your doctor should decide if you will take KORLYM or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Using KORLYM with certain other medicines can affect each other. Using KORLYM with other medicines can cause serious side effects.

Especially tell your doctor if you take:

  • medicines to treat:
    • fungal infections (such as ketoconazole)
    • depression
    • HIV infection
    • Hepatitis C infection
    • certain bacterial infections
    • high blood pressure
  • steroid medicines such as prednisone
  • thyroid hormones

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist.

How should I take KORLYM?

  • Take KORLYM exactly as your doctor tells you.
  • Your doctor may change your dose if needed.
  • KORLYM is usually taken 1 time each day.
  • Take KORLYM with food.
  • Swallow KORLYM whole. Do not split, crush or chew KORLYM tablets. If you cannot swallow KORLYM tablets whole, tell your doctor.

What should I avoid while taking KORLYM?

You should not drink grapefruit juice while you take KORLYM. Grapefruit juice may increase the amount of KORLYM in your blood and increase your chance of having side effects.

What are the possible side effects of KORLYM?

KORLYM can cause serious side effects including:

  • See "What is the most important information I should know about KORLYM?"
  • reduced effects of adrenal hormones (adrenal insufficiency). KORLYM stops an adrenal hormone in your body called cortisol from working. Tell your doctor right away if you have any symptoms of adrenal insufficiency. Symptoms may include:
    • unusual tiredness or weakness
    • nausea
    • fatigue
    • low blood pressure (hypotension)
    • low blood sugar (hypoglycemia)
  • low blood potassium (hypokalemia). Your doctor should check the level of potassium in your blood before you start taking KORLYM and while you take it. Tell your doctor if you have any signs of low potassium. Signs may include:
    • muscle weakness, aches, or cramps
    • abnormal or irregular heartbeats (palpitations)
  • bleeding from the vagina. KORLYM may cause the lining of your uterus to become thick and may cause your uterus to bleed. Tell your doctor right away about any bleeding from your vagina that is not normal for you.
  • problems with the electrical system of your heart (QT interval prolongation).
  • worsening of symptoms of other medical problems that are treated with corticosteroids when you take corticosteroids and KORLYM at the same time.

The most common side effects of KORLYM include:

  • nausea
  • fatigue
  • headache
  • low potassium in your blood
  • pain in your arms and legs (arthralgia)
  • vomiting
  • swelling of your arms and legs (peripheral edema)
  • high blood pressure
  • dizziness
  • decreased appetite
  • thickening of the lining of the uterus (endometrial hypertrophy)

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of KORLYM.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store KORLYM?

Store KORLYM at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep KORLYM and all medicines out of the reach of children.

General information about the safe and effective use of KORLYM

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use KORLYM for a condition for which it was not prescribed. Do not give KORLYM to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KORLYM that is written for healthcare professionals.

What are the ingredients in KORLYM?

Active ingredient: mifepristone

Inactive ingredients: silicified microcrystalline cellulose, sodium starch glycolate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide, triacetin, D&C yellow 10 aluminum lake, polysorbate 80, and FD&C yellow 6 aluminum lake.

Manufactured for: Corcept Therapeutics Incorporated, Menlo Park, CA 94025

KORLYM® is a registered trademark of Corcept Therapeutics Incorporated.

©2017 Corcept Therapeutics Incorporated. All rights reserved.

K-00003 MAY 2017

For more information, go to www.korlym.com or www.corcept.com or call 1-855-456-7596.

This Medication Guide has been approved by the US Food and Drug Administration.

Revised: 05/2017

What Is Cushing's Syndrome?

Throughout your journey with Cushing's, you've probably had a lot of questions about your condition. Because Cushing's is a rare disorder, you know how important it is to be educated about it.

Cushing's syndrome is a hormonal disorder caused by high levels of cortisol in the body. Cortisol is a hormone made in the adrenal glands that performs vital tasks such as regulating the metabolism of proteins, carbohydrates, and fats.1

However, too much cortisol in the body can lead to such problems as1,2,3:

  • Diabetes
  • Obesity
  • Depression
  • Cognitive dysfunction
  • Cushingoid appearance
  • Skin changes
  • Severe fatigue
  • Weak muscles

The production of cortisol typically follows a specific chain of events1:

causes of Cushing's syndrome

Adapted from the National Institute of Diabetes and Digestive and Kidney Diseases.

  1. First, a part of the brain called the hypothalamus sends corticotropin-releasing hormone (CRH) to the pituitary gland, which is located at the base of the brain.
  2. The pituitary gland then secretes another hormone called adrenocorticotropin hormone (ACTH).
  3. ACTH stimulates the adrenal glands, which are located on top of the kidneys, to release cortisol into the bloodstream.
  4. When there is an adequate amount of cortisol in the blood, less CRH and ACTH are released. This process ensures that the adrenal glands release just the right amount of cortisol to meet the body's needs.

However, if something goes wrong with the adrenal glands or the regulating switches in the pituitary or hypothalamus, cortisol production can go awry. This can cause excessive levels of cortisol associated with Cushing's syndrome.

Classifying Cushing's syndrome

There are two types of Cushing's syndrome.

The first type, endogenous Cushing's, occurs when tumors in the body cause the production of high levels of cortisol. These tumors are typically classified based on their location in the body1:

  • Cushing's Disease. Caused by tumors in the pituitary gland, Cushing's disease accounts for approximately 70% of all Cushing's syndrome cases.4
  • Ectopic Cushing's. Ectopic Cushing's is caused by tumors outside of the pituitary gland. These tumors can be either benign or malignant.
  • Adrenal Cushing's. Adrenal Cushing's is caused by tumors or abnormalities in the adrenal glands. These tumors can be either benign or malignant.

The second type of Cushing's, exogenous Cushing's, occurs when steroid medications such as prednisone are given at high doses for prolonged periods of time for the treatment of another disease, such as asthma or rheumatoid arthritis.1,2 Korlym would not be used to treat exogenous Cushing's syndrome.

Managing your Cushing's

Managing Cushing's syndrome, as you know, can pose both challenges and frustrations. First of all, it may have taken a while for your Cushing's to be accurately diagnosed. Along the way, you may have struggled with many of the physical, cognitive, and emotional symptoms associated with Cushing's.

While a number of people with Cushing's have found success through surgical removal of their tumors, not every person with Cushing's is a candidate for surgery. Still others may have undergone surgery only to find that their symptoms eventually returned.

There is hope for many patients in a medication called Korlym® (mifepristone), an approved treatment for patients with endogenous Cushing's syndrome. Korlym blocks the activity of cortisol and has been proven in clinical studies to control high blood sugar, a key symptom of Cushing's syndrome.5 During your treatment with Korlym, your doctor will also look for improvements in other Cushing's symptoms to determine whether to adjust your dose of Korlym.

1. US Department of Health and Human Services. National Institute of Diabetes and Digestive and Kidney Diseases. Cushing's Syndrome. Available at: http://endocrine.niddk.nih.gov/pubs/cushings/cushings.aspx. Accessed February 16, 2012.

2. The Endocrine Society's Clinical Guidelines. The diagnosis of Cushing's syndrome: an Endocrine Society Clinical Practice Guideline. Available at: http://www.endo-society.org/guidelines/final/upload/Cushings_Guideline.pdf. Accessed February 27, 2012.

3. National Institute of Diabetes and Digestive and Kidney Diseases: National Endocrine and Metabolic Diseases Information Service. Cushing's syndrome. Available at: http://www.endocrine.niddk.nih.gov/pubs/cushings/cushings.aspx#symptoms. Accessed March 20, 2012.

4. Nieman LK, Ilias I. Evaluation and treatment of Cushing's syndrome. Am J Med. 2005;118(12):1340-1346.

5. Korlym full Prescribing Information. Corcept Therapeutics Incorporated; 2013.

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What is KORLYM?

KORLYM is a prescription medicine used to treat high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or cannot have surgery.

KORLYM is not for people who have type 2 diabetes mellitus not caused by Cushing's syndrome.

It is not known if KORLYM is safe and effective in children.


Please scroll to see the Medication Guide for Korlym

What is the most important information I should know about KORLYM?

KORLYM can cause serious side effects, including:

  • Loss of a pregnancy. Women who can become pregnant must:
    • have a negative pregnancy test before starting KORLYM
    • have a negative pregnancy test before restarting KORLYM if you stop taking it for more than 14 days
    • use a non-hormonal form of birth control while taking KORLYM and for 1 month after stopping KORLYM. Talk to your doctor about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.

Do not take KORLYM if you:

  • are pregnant. See "What is the most important information I should know about KORLYM?"
  • are taking:
    • simvastatin (Zocor®, Vytorin®, Juvisync®, Simcor®)
    • lovastatin (Mevacor®, Altoprev®, Advicor®)
    • cyclosporine (Gengraf®, Neoral®, Restasis®, Sandimmune®)
    • dihydroergotamine (Migranal®)
    • ergotamine (Ergomar®, Migergot®)
    • fentanyl (Abstral®, Actiq®, Duragesic®, Fentora®, Lazanda®, Onsolis®, Sublimaze Preservative Free®, Subsys®)
    • pimozide (Orap®)
    • quinidine (Neudexta®)
    • sirolimus (Rapamune®, Torisel®)
    • tacrolimus (Prograf®, Protopic®)
  • must take corticosteroid medicines for other serious medical problems
  • are a woman who still has her uterus (womb) and have:
    • unexplained bleeding from your vagina
    • changes in the cells lining your uterus (endometrial hyperplasia) or cancer of the lining of your uterus (endometrial cancer)
  • are allergic to mifepristone or any of the ingredients in KORLYM. See the end of this Medication Guide for a complete list of ingredients in KORLYM.

Talk to your doctor before taking KORLYM if you have any of these conditions.

What should I tell my doctor before taking KORLYM?

Before taking KORLYM, tell your doctor if you:

  • have low potassium in your blood (hypokalemia)
  • have or have had a bleeding problem or are taking medicines to thin your blood
  • have or have had heart problems
  • have had an organ transplant
  • have been taking medicines called corticosteroids (cortisone, dexamethasone, methylprednisolone, prednisolone, prednisone)
  • are breastfeeding or plan to breastfeed. KORLYM passes into your breast milk and may harm your baby. You and your doctor should decide if you will take KORLYM or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Using KORLYM with certain other medicines can affect each other. Using KORLYM with other medicines can cause serious side effects.

Especially tell your doctor if you take:

  • medicines to treat:
    • fungal infections (such as ketoconazole)
    • depression
    • HIV infection
    • Hepatitis C infection
    • certain bacterial infections
    • high blood pressure
  • steroid medicines such as prednisone
  • thyroid hormones

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist.

How should I take KORLYM?

  • Take KORLYM exactly as your doctor tells you.
  • Your doctor may change your dose if needed.
  • KORLYM is usually taken 1 time each day.
  • Take KORLYM with food.
  • Swallow KORLYM whole. Do not split, crush or chew KORLYM tablets. If you cannot swallow KORLYM tablets whole, tell your doctor.

What should I avoid while taking KORLYM?

You should not drink grapefruit juice while you take KORLYM. Grapefruit juice may increase the amount of KORLYM in your blood and increase your chance of having side effects.

What are the possible side effects of KORLYM?

KORLYM can cause serious side effects including:

  • See "What is the most important information I should know about KORLYM?"
  • reduced effects of adrenal hormones (adrenal insufficiency). KORLYM stops an adrenal hormone in your body called cortisol from working. Tell your doctor right away if you have any symptoms of adrenal insufficiency. Symptoms may include:
    • unusual tiredness or weakness
    • nausea
    • fatigue
    • low blood pressure (hypotension)
    • low blood sugar (hypoglycemia)
  • low blood potassium (hypokalemia). Your doctor should check the level of potassium in your blood before you start taking KORLYM and while you take it. Tell your doctor if you have any signs of low potassium. Signs may include:
    • muscle weakness, aches, or cramps
    • abnormal or irregular heartbeats (palpitations)
  • bleeding from the vagina. KORLYM may cause the lining of your uterus to become thick and may cause your uterus to bleed. Tell your doctor right away about any bleeding from your vagina that is not normal for you.
  • problems with the electrical system of your heart (QT interval prolongation).
  • worsening of symptoms of other medical problems that are treated with corticosteroids when you take corticosteroids and KORLYM at the same time.

The most common side effects of KORLYM include:

  • nausea
  • fatigue
  • headache
  • low potassium in your blood
  • pain in your arms and legs (arthralgia)
  • vomiting
  • swelling of your arms and legs (peripheral edema)
  • high blood pressure
  • dizziness
  • decreased appetite
  • thickening of the lining of the uterus (endometrial hypertrophy)

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of KORLYM.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store KORLYM?

Store KORLYM at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep KORLYM and all medicines out of the reach of children.

General information about the safe and effective use of KORLYM

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use KORLYM for a condition for which it was not prescribed. Do not give KORLYM to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KORLYM that is written for healthcare professionals.

What are the ingredients in KORLYM?

Active ingredient: mifepristone

Inactive ingredients: silicified microcrystalline cellulose, sodium starch glycolate, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide, triacetin, D&C yellow 10 aluminum lake, polysorbate 80, and FD&C yellow 6 aluminum lake.

Manufactured for: Corcept Therapeutics Incorporated, Menlo Park, CA 94025

KORLYM® is a registered trademark of Corcept Therapeutics Incorporated.

©2017 Corcept Therapeutics Incorporated. All rights reserved.

K-00003 MAY 2017

For more information, go to www.korlym.com or www.corcept.com or call 1-855-456-7596.

This Medication Guide has been approved by the US Food and Drug Administration.

Revised: 05/2017