HEALTHCARE PROFESSIONALS

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.

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.

Who should not take Korlym?

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
  • 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. For more information, ask your doctor or pharmacist.

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.

This Medication Guide summarizes the most important information about Korlym. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Korlym that is written for healthcare professionals.

For more information, call 1-855-4Korlym (1-855-456-7596) or visit www.korlym.com or www.corcept.com.

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.

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

Manufactured for:
Corcept Therapeutics Incorporated
Menlo Park, CA 94025

K-00003 JUN 2013

PRIVACY POLICY

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Your California Privacy Rights

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The Information We Collect

When you visit the Sites you may provide us with two types of information: (i) information regarding your use of the Sites automatically collected by us as you interact with the Sites, even if you do nothing during your visit but browse the Sites, and (ii) information you submit voluntarily via the Sites.

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Children; Parental Consent Policy

The Children's Online Privacy Protection Act imposes certain requirements on websites directed toward children under 13 that collect information on those children, or on websites that know they are collecting Personal Information from children under the age of 13. The Sites are not intended for children under the age of 13, and it currently is our policy not to collect Personal Information from any person under 13, and we request that children under the age of 13 not submit any Personal Information to us via the Sites. If we learn that we have inadvertently gathered Personal Information from children under 13, we will use reasonable efforts to notify such child's parent or guardian and erase such information from our records, unless the child's parent or guardian consents to our maintaining such information.

Use of Information Obtained by Corcept

Information collected automatically when you access the Sites is used to administer the Sites and to analyze trends and gather statistical information for aggregate use. We may disclose any such information for our legitimate business purposes.

In general, Personal Information you provide to us is used to respond to requests that you make (For example, we may use your Personal Information to process an employment application, should you submit one to us. Any information regarding your gender and ethnicity collected via our employment application, however, is used for statistical purposes only and is not used to process your employment application); and for our internal records, tracking and business purposes. We may use your contact information to send you information regarding new products or services offered by Corcept that we think you may find valuable. This includes information and services you have requested, or as otherwise disclosed to you in this Privacy Policy or on the web page where you submitted your Personal Information to us. Corcept may also send you service-related announcements from time to time through the general operation of the Sites. Generally, you may opt out of such communications, although Corcept reserves the right to send you service-related notices even if you opt out of all voluntary notifications.

Policy on Use of Social Security Numbers

Corcept has a policy which provides for the proper use and protection of Social Security numbers obtained in the course of doing business by Corcept. Such policy protects the confidentiality of Social Security numbers, prohibits unlawful disclosure of Social Security numbers, and limits access to Social Security numbers. This policy applies to all methods of collection of Social Security numbers, including Social Security numbers obtained by oral, written and electronic means. However, we cannot and do not guarantee that breaches of our or your security will never occur, as outlined below. Note to Healthcare Professionals and Business Partners If you have a business or professional relationship with Corcept, we may use your Personal Information, including Personal Information we may collect about you from other sources, to develop our business relationship with you and your organization.

Sharing Your Information with Third Parties

You may choose to provide information about you and your company or organization to other users and to the public by providing such information on public areas of the Sites ("Public Information"). Public information does not include information you submit to us but do not post on areas of the Sites accessible by other users or the public ("Non-Public Information"). Non-Public Information may include Personal Information.

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Corcept may share your Personal Information with parties described in this section who are (i) located in other countries, and (ii) subject to other applicable laws, rules and regulations relating to your Personal Information, that do not offer the same protections as the country in which your Personal Information was collected. In particular, your Personal Information may be processed in the United States and subject to applicable US laws, rules and regulations. For more information about how Corcept is committed to protecting your Personal Information, see the "Security" section of this Privacy Policy.

Note: We do not share any of your Personal Information with third parties for their own direct marketing purposes unless you explicitly give us permission to do so.

Corcept Sites may contain links to other websites which may collect information directly from you. Each of the websites linked to the Sites may have separate privacy and data collection practices, independent of Corcept. Once you link to another site from ours, you are subject to the Privacy Policy and Terms of Use of the new site, and Corcept has no responsibility or liability for these independent policies or actions and is not responsible for the privacy practices or the content of such websites, nor does Corcept endorse or make any warranties or representations about the contents, products or services offered on such websites or the security of any information you provide to them. If you have any questions about how these other sites use your information, you should contact them directly. This Privacy Policy applies solely to information collected by Corcept via the Sites.

Security

Although we use reasonable efforts to safeguard the security of your Personal Information, transmissions made on or through the Internet are inherently vulnerable to attack and cannot be guaranteed to be secure. Consequently, we cannot and do not guarantee that unauthorized access, hacking, data loss, or other breaches will never occur. In addition, submissions made via email are not protected by encryption and are vulnerable to interception during transmission. You are solely responsible for safeguarding and maintaining the secrecy of your Personal Information. Please be careful and responsible whenever you are online. We urge you to take steps to keep your Personal Information safe. Our hosting provider's computer systems employ software to monitor network traffic in order to identify unauthorized attempts to upload or change information, or otherwise cause damage. Unauthorized attempts to upload information or change information on the Sites are strictly prohibited and may be punishable under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act.

Protecting Yourself; Updating Your Information.

You can learn more about Internet privacy from government websites such as www.ftc.gov/privacy/. In addition, it is important to keep us updated with your most current contact information. You can review and make changes to the information we have on file about you by emailing us your updated information. To the extent we maintain your email address or other information about you, you may ask us via email at compliance@corcept.com to have such information deleted, updated or corrected, and/or to request us to cease collecting Personal Information about you in the future.

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Changes to Our Policy

This Privacy Policy is effective with respect to any information collected on or after the date below. Corcept reserves the right to modify or supplement this Privacy Policy at any time. If we make any changes, we will update the Sites and Privacy Policy to include such change and notice thereof. Please review this Privacy Policy often to review any changes that may affect your use of the Sites. Your continued use of the Sites once the revised Privacy Policy has been posted on any of the Sites with the updated date affirms your agreement to such changes. If you do not agree to abide by this Privacy Policy, do not use or access (or continue to use or access) the Sites.

Contacting Corcept

If you have any questions about this Privacy Policy or Corcept's privacy practices in general, or if you need help accessing your Personal Information or changing your preferences, please contact us at:

Corcept Compliance Officer
Phone: 650–327–3270
Fax: 650–327–3218
Email: compliance@corcept.com

You may also contact us by mail at Corcept Therapeutics, Attn: Compliance Officer, 149 Commonwealth Drive, Menlo Park, CA 94025. Or, you can visit our Contact Us section at www.corcept.com/contact for more information.

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Last revised on July 25, 2013