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(i) When you enter the Sites, we may collect your browser type, your operating system (e.g., Windows 7), the domain name of your internet service provider (e.g., Comcast), the date and time of your visit, the pages viewed, the time spent at our Sites, and the websites visited just before and just after our Sites (including any third-party website that links to our Sites, if you followed a link to our Sites), and your IP address. Even when you visit areas of the Sites anonymously, we may collect IP addresses automatically. An IP address is a number that is automatically assigned to your computer whenever you begin service with an internet service provider. Each time you access the Sites and each time you request one of our pages, our server logs your IP address. Standing alone, your IP address is not necessarily personally identifiable. We may use your IP address to administer the Sites, to assist in diagnosing problems with our server, to monitor our system performance and/or to make it easier and more convenient for you to navigate and use the Sites. In addition, we store certain information from your browser using "cookies." A cookie is a piece of data stored on the user's computer tied to information about the user. We may use session ID cookies to confirm that users are logged in. Any and all of this information may be associated with your Personal Information. Most web browsers automatically accept cookies, but you can usually configure your browser to prevent this. Not accepting cookies may make certain features of the Sites unavailable to you.
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.
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.
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.
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.
We share your Non-Public Information with third parties only in limited circumstances where we believe such sharing is reasonably necessary to operate the Sites, legally required or, permitted by you. For example:
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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.
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 firstname.lastname@example.org to have such information deleted, updated or corrected, and/or to request us to cease collecting Personal Information about you in the future.
When you provide us with your Personal Information, you will be given some choices about how we use that Personal Information. You may change these preferences later. For example, if you sign up for an e-mail newsletter, you may opt out of receiving future e-mail newsletters at any time. If you opt in to receive communications from Corcept, we will always provide you with one or more of the following ways to opt out: (i) by following any opt-out instructions contained in communications you receive from Corcept, (ii) by un-subscribing at specific areas of the Site(s) where you registered, if available, or (iii) by sending a written request to the Corcept contact address immediately below.
Corcept Compliance Officer
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.
Make sure to provide the name of the Site(s) applicable to your request, and your name and contact information. If you do not provide us with this information, we may not be able to respond.
Last revised on July 25, 2013
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.
Do not use for the treatment of type 2 diabetes mellitus unrelated to endogenous Cushing's syndrome.
Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential.
Administer once daily orally with a meal. The recommended starting dose is 300 mg once daily. Renal impairment: Do not exceed 600 mg once daily. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment. Based on clinical response and tolerability, the dose may be increased in 300-mg increments to a maximum of 1200 mg once daily. Do not exceed 20 mg/kg per day.
Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 600 mg per day if clinically indicated. 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 either 900 mg or 1200 mg, reduce the daily dose to 600 mg.
Pregnancy; use of simvastatin or lovastatin and CYP3A 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.
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 the patient also has a hemorrhagic disorder or is on anticoagulant 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 increases mifepristone plasma levels. Adjust Korlym dose as described in Dosage and Administration. Use only when necessary and do not exceed a Korlym dose of 600 mg.
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.
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. Adjust Korlym dose as described in Dosage and Administration. Use only when necessary, and do not exceed a Korlym dose of 600 mg.
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.
Nursing mothers: Discontinue drug or discontinue nursing.
Please see accompanying full Prescribing Information and Medication Guide.