The Sites have been designed to provide general information about Corcept and its products. These Sites are not intended to provide investment advice.
Corcept is not a healthcare provider. It does not render medical advice or services. The information and Site Content (as defined below) provided on the Sites is for general company and product information and educational purposes only. As such, the Sites and any Site Content are neither medical nor health care advice for any individual problem, should not be relied upon as an exclusive source of information, and are not intended to be a source or substitute for professional medical advice, diagnosis or treatment from a qualified healthcare provider familiar with your personal medical history. Use of the Sites does not create a doctor-patient relationship. In particular, you should not rely on the content contained on the Sites for diagnosing a health problem or disease. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding our products or any medical condition you or your family might have, and before stopping, starting or modifying any treatment or medication. Never disregard professional medical advice or delay in seeking it because of something you have read on the Sites. In the case of a medical emergency, seek immediate assistance from appropriate emergency personnel.
Medical treatment and knowledge are frequently changing, and the Sites should not be considered to be error free or a comprehensive source of information on any topic. Corcept does not guarantee the accuracy, completeness, or usefulness of any information accessed on the Sites and neither does Corcept adopt nor endorse, nor is Corcept responsible for, the accuracy or reliability of any opinion, advice, or statement made by parties other than Corcept. Under no circumstances will Corcept be responsible for any errors or omissions on the Sites or any loss or damage resulting from anyone's reliance on information or other Site Content. You assume the entire risk of loss in using the Sites and any Site Content.
"Corcept" "Korlym" and other Corcept graphics, logos, designs, page headers, button icons, scripts, service names, product names, and other trademarks, whether or not appearing in large print or with the trademark symbol, are the trademarks or trade dress of Corcept in the US and other countries. You may not use Corcept’s trademarks and trade dress, including as part of trademarks and/or as part of domain names, in connection with any product or service in any manner that is likely to cause confusion or create the impression that Corcept endorses any product or service. You may not reproduce or use Corcept’s trademarks or trade dress without the prior written permission of Corcept.
You should assume that any communication or information you transmit through, to or in connection with the Sites ("User Content") will not be private. You authorize Corcept to treat any User Content as non-confidential and non-proprietary, and you grant to Corcept an irrevocable, perpetual, non-exclusive, transferable, fully paid, worldwide license (with the right to sublicense) to use, reproduce, publicly perform, publicly display, publish, distribute, modify, translate, excerpt (in whole or in part), and create derivative works of such User Content for any purpose whatsoever, including but not limited to research, development, manufacture, use, or sale of any products or ingredients incorporating or relying on such information. You agree that such submission constitutes a "work for hire," under US copyright law. You agree to assign all rights in and to your submission to Corcept. Corcept shall have no obligation of any kind (such as compensation) with respect to the submission or any materials that accompany it. By submitting User Content, you represent and warrant that: (i) you have all rights necessary to transmit such User Content and grant the licenses thereto specified herein; (ii) such User Content will not violate or infringe upon the rights of any third party; and (iii) such User Content will not contain libelous, defamatory or otherwise unlawful material.
The Sites may contain links to other websites (“Third Party Sites”) as well as articles, photographs, text, graphics, pictures, designs, sound, video, information, trademarks and other content or items belonging to or originating from third parties (the “Third Party Content”). Such Third Party Sites and Third Party Content are not investigated, monitored or checked for accuracy, appropriateness, or completeness by us, and we are not responsible for any Third Party Sites accessed through the Sites, any User submissions or any Third Party Content posted on or available through the Sites, including the content, accuracy, offensiveness, opinions, reliability, privacy practices or other policies of or contained in the Third Party Sites or the Third Party Content. Third Party Content is used by Corcept subject to license, or subject to the fair use provisions of United States trademark and/or copyright laws and applicable provisions in other jurisdictions. Inclusion of, linking to, or permitting the use of any Third Party Site or any Third Party Content does not imply approval or endorsement thereof by Corcept. If you decide to leave the Sites and access the Third Party Sites or to access or use any Third Party Content, you do so at your own risk and you should be aware that our terms and policies no longer govern. You should review the applicable terms and policies, including privacy and data gathering practices, of any site to which you navigate from the Sites or relating to any applications you use or install from the Sites.
If you believe that your work has been copied in a way that constitutes copyright or moral rights infringement, please provide Corcept with the following information. Please be advised that to be effective, notification must include ALL of the following:
Send notices by mail to:
Attn: Compliance Officer
149 Commonwealth Drive
Menlo Park, California 94025
United States of America
The Sites may be unavailable from time to time for maintenance or other reasons. Corcept shall have no responsibility for any interruption, delay in operation or transmission, theft or destruction of, unauthorized access to, or alteration of, any content made available via the Sites. Under no circumstances will Corcept be responsible for any personal injury or death resulting from the use of the Sites, any Site Content or Third Party Content. We make no representations regarding the amount of time any content or information will be preserved.
THE SITES, INCLUDING ALL CONTENT THEREIN, ARE PROVIDED “AS IS”, "AS-AVAILABLE", AND "WITH ALL FAULTS." TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW, CORCEPT, ITS DIRECTORS, OFFICERS, EMPLOYEES, CONSULTANTS, SUBSIDIARIES AND AFFILIATES DISCLAIM ANY AND ALL REPRESENTATIONS AND WARRANTIES WITH RESPECT TO THE SITES, WHETHER EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF TITLE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. CORCEPT CANNOT GUARANTEE AND DOES NOT PROMISE ANY SPECIFIC RESULTS FROM USE OF THE SITES. CORCEPT DOES NOT REPRESENT OR WARRANT THAT THE CONTENT OR MATERIALS ON THE SITES ARE ACCURATE, COMPLETE, RELIABLE, CURRENT OR ERROR-FREE OR THAT THE SITES OR THEIR SERVERS, ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. CORCEPT DISCLAIMS ANY RESPONSIBILITY TO UPDATE SUCH INFORMATION. CORCEPT HAS NOT REVIEWED THE THIRD PARTY WEBSITES THAT MAY BE LINKED TO ANY OF OUR SITES AND DOES NOT ENDORSE AND IS NOT RESPONSIBLE FOR THE CONTENT OF ANY OFF-SITE PAGES OR ANY THIRD PARTY WEBSITES LINKED TO ANY OF OUR SITES. THEREFORE, WITHOUT LIMITING THE FOREGOING, YOU UNDERSTAND AND AGREE THAT YOU DOWNLOAD OR OTHERWISE OBTAIN CONTENT, MATERIAL OR DATA FROM OR THROUGH THE SITES AT YOUR OWN DISCRETION AND RISK AND THAT YOU WILL BE SOLELY RESPONSIBLE FOR YOUR USE THEREOF AND ANY DAMAGES, LOSS OF DATA OR OTHER HARM OF ANY KIND THAT MAY RESULT.
CORCEPT DISCLAIMS RESPONSIBILITY FOR ANY DAMAGES WHATSOEVER THAT RESULT FROM MISTAKES, OMISSIONS, INTERRUPTIONS, DELETION OF FILES, ERRORS, DEFECTS, DELAYS IN OPERATION OR TRANSMISSION, OR ANY FAILURE OF PERFORMANCE RELATING TO OUR SITES WHETHER OR NOT CAUSED BY EVENTS BEYOND OUR REASONABLE CONTROL INCLUDING, WITHOUT LIMITATION, ACTS OF ANY OF OUR THIRD PARTY VENDORS, ACTS OF GOD, COMMUNICATIONS LINE FAILURE, THEFT, DESTRUCTION OR UNAUTHORIZED ACCESS TO THE SITES' RECORDS, PROGRAMS OR SERVICES. IN NO EVENT SHALL CORCEPT'S TOTAL LIABILITY FOR ALL DAMAGES, LOSSES AND CAUSES OF ACTION EXCEED FIVE DOLLARS ($5.00). SOME JURISDICTIONS DO NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. AS A RESULT, THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. ANY CLAIMS ARISING IN CONNECTION WITH YOUR USE OF THE SITES OR ANY CONTENT (INCLUDING, WITHOUT LIMITATION, ANY PRODUCT OR SERVICE) MUST BE BROUGHT WITHIN ONE (1) YEAR OF THE DATE OF THE EVENT GIVING RISE TO SUCH ACTION.
If any of the above exclusions of warranties is unenforceable in your jurisdiction, the other exclusions listed above will still be given effect to the full extent permitted by that jurisdiction’s law.
Please note that if and when they are available or become available, the products and services referred to on any of our Sites are, or will be, available in the United States. They may not be available in other countries. The information provided on our Sites is intended for use only by persons in the United States. Corcept makes no representations that the information on our Sites is appropriate for visitors in countries other than the United States, which countries may have different legal or regulatory requirements, or indications for, or restrictions on, the sale or use of pharmaceutical products or information. Nothing herein should be considered a solicitation or promotion for any product or an indication for any product that is not permitted by the laws or regulations of the country where a User resides. The Sites may include links to other sites, some of which may be outside the United States. Those websites may have information that is appropriate only to that particular originating country.
Should you become employed by Corcept, none of the information or materials on any of our Sites shall constitute or be considered part of an employment contract or an employee manual or handbook. Nothing stated or represented on any of our Sites shall affect the employment relationships between Corcept and its current, former, or future employees.
All statements included or incorporated by reference in these Sites, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and projections about our industry, management’s beliefs, and certain assumptions made by us, including statements regarding financial condition, the success of Corcept’s collaboration with partners, timing, design and results of clinical trials and drug development programs and the timing and likelihood of the commercialization of product candidates. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” similar expressions, and variations or negatives of these words. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements speak only as of the date they are made and are based upon the information available to us at that time. Such information is subject to change, and we will not necessarily inform you of such changes. These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement due to risks and uncertainties, including risks relating to the continued safety and efficacy of pharmaceutical products in clinical development, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters. Our Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, recent Current Reports on Form 8-K, and other Securities and Exchange Commission filings discuss the foregoing risks as well as other important risk factors that could contribute to such differences or otherwise affect our business, results of operations and financial condition. We undertake no obligation to revise or update publicly any forward-looking statement for any reason.
Under California Civil Code Section 1789.3, California users of the Sites receive the following specific consumer rights notice: The Complaint Assistance Unit of the Division of Consumer Services of the California Department of Consumer Affairs may be contacted in writing at 1625 North Market Blvd., Suite N 112, Sacramento, California 95834, or by telephone at 1–800–952–5210.
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.