Terms and Conditions
Sanofi Genzyme Corporation, a subsidiary of Sanofi, is pleased to provide you with this website (“website”) and its content for general informational purposes. Please carefully read these Terms and Conditions relating to the use of our website. By using our website, you agree to these Terms and Conditions without limitation or qualification. If you do not agree to these Terms and Conditions, please do not use our website. We reserve the right to revise these Terms and Conditions or any portion of them at any time without notice by updating this posting. You are bound by any revisions and should periodically visit this page to review the current Terms and Conditions that apply to your use of our website. If you violate any of these Terms, your permission to use our website and any content or materials downloadable, printable or otherwise available from this website (the “materials”) automatically terminates and you must immediately destroy any copies you have made of the materials.
The entire contents of this website are subject to copyright protection. You may not copy the contents of this website other than for non-commercial individual reference with all copyright or other proprietary notices retained, and thereafter the contents may not be recopied, reproduced or otherwise redistributed. Except as expressly provided above, you may not otherwise copy, display, download, distribute, modify, reproduce, republish or retransmit any information, text or documents contained in this website or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such images, text or documents, without the express written consent of Sanofi Genzyme. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent or trademark of Sanofi Genzyme, its affiliates or any third party. Sanofi Genzyme prohibits the use of any Sanofi Genzyme trademark, or any related graphic, as a "hot link" to any website unless approved by Sanofi Genzyme.
All product names, whether or not appearing in large print or with the trademark symbol, are trademarks of Sanofi Genzyme, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted. The use or misuse of these trademarks or any other materials, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law, the law of slander and libel, the law of privacy and publicity, and communications regulations and statutes. Please be advised that Sanofi Genzyme actively and aggressively enforces its intellectual property rights to the fullest extent of the law.
This website does not provide medical advice.
This website and the materials are intended for educational purposes only. They are not a substitute for actual medical care. Persons requiring diagnosis or treatment, or who have specific questions related to their condition or care, are urged to contact their health care provider.
In an effort to assist patients in identifying medical resources, we have contracted with certain health care institutions that consider themselves to have expertise in the research, diagnosis and treatment of particular diseases or health conditions. These third parties may be mentioned on this website and this website may provide a link to those third party websites. Sanofi Genzyme makes no warranties or representations, and expressly disclaims any responsibility for, the information or treatment that you may receive from any listed health care provider.
With respect to prescription drugs and other medications and therapies, the doctor prescribing such drug is advised to check the product information sheet accompanying each drug to verify conditions of use and identify any changes in dosage schedule or contraindications, particularly if the agent to be administered is new, infrequently used or has a narrow therapeutic range. The materials do not constitute medical advice and website users are urged to consult their doctors with any drug or health related questions they may have.
We have provided links to certain third party websites as a courtesy. By providing these links, we are not endorsing, adopting or agreeing with any of the content of the linked sites or the products or services of that third party. We do not review or control the content of third party sites and that content is not part of our website. We expressly disclaim any responsibility for the content of any third party sites linked to our website or the products or services of that third party. We do not make any representations regarding the content or accuracy of materials on third party websites or the products or services of third parties. We urge you to use discretion when you access any third party sites linked to our website.
Our website contains forward looking statements, including statements regarding Sanofi Genzyme’s future performance and strategy. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, our ability to successfully complete preclinical and clinical development of our products and services; the content and timing of submissions to and decisions made by the FDA, the EMEA and other regulatory agencies; the accuracy of our estimates of the size and characteristics of the markets to be addressed by our products and services; market acceptance of our products and services; the availability and amount of reimbursement for our products and services from third-party payors; our ability to expand the use of current products in existing and new indications and to otherwise effectively manage our growth; our ability to manufacture sufficient amounts of our products and to do so in a timely and cost-effective manner; our ability to establish and maintain strategic license, collaboration and distribution arrangements and to manage our relationships with collaborators, distributors and partners; and the other factors described under the headings “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s most recent public filing made with the U.S Securities and Exchange Commission or the AMF (Autorité des marchés financiers). Forward-looking statements speak only as of the date first made, unless another date is indicated. We caution you not to place substantial reliance on the forward-looking statements and we undertake no obligation to update or revise the statements.
The materials may contain inaccuracies or typographical errors. Sanofi Genzyme makes no representations about the accuracy, reliability, completeness, or timeliness of the materials or about the results to be obtained from using this website or the materials. Although we make a good faith effort to update the materials periodically, we do not have any duty to update the materials, and we will not be liable for any failure to update such materials. Your use of the website and the materials is at your own risk. Changes can and will be made to the website and materials and at any time. It is your responsibility to monitor such changes.
Sanofi Genzyme makes no claims that the materials are appropriate or may be downloaded outside of the United States. Access to the materials may not be legal by certain persons or in certain countries. If you access the website from outside of the United States, you do so at your own risk and are responsible for compliance with the laws of your jurisdiction.
Sanofi Genzyme does not warrant that the website will operate error-free or that the website and its server are free of computer viruses and other harmful goods. If your use of the website or the materials results in the need for servicing or replacing equipment or data, Sanofi Genzyme is not responsible for those costs.
The website and materials are provided on an 'as is' basis without any express or implied warranties of any kind. Sanofi Genzyme and its suppliers, to the fullest extent permitted by law, disclaim all express and implied warranties, including the warranty of merchantability, non-infringement of third parties rights, and fitness for a particular purpose. Sanofi Genzyme and its suppliers make no warranties about the accuracy, reliability, completeness, or timeliness of the materials, services, software text, graphics, and links.
In no event shall Sanofi Genzyme, its affiliates, suppliers, or any third parties mentioned at this website be liable for any damages whatsoever (including, without limitation, incidental and consequential damages, lost profits, or damages resulting from lost data or business interruption) resulting from the use or inability to use the website and the materials, whether based on warranty, contract, tort, or any other legal theory, and whether or not Sanofi Genzyme is advised of the possibility of such damages. In no event shall Sanofi Genzyme’s total liability to you for all damages, losses, and causes of action (whether in contract, tort, including without limitation negligence, or otherwise) exceed the amount paid by you, if any, for accessing this site.
Third party websites may link to a Sanofi Genzyme website provided that they do not imply any false sponsorship, affiliation or association with Sanofi Genzyme. A Sanofi Genzyme website may not appear as a frame within the linking website. Sanofi Genzyme reserves the right to revoke its consent to a link at any time and in its sole discretion.
The order, purchase, and/or sale of any products from Sanofi Genzyme, its affiliates, and/or their suppliers are subject to the terms and conditions contained in the applicable purchase order or written agreement between the parties.
You agree to defend, indemnify, and hold harmless Sanofi Genzyme, its affiliates, officers, directors, employees and agents, from and against any claims, actions or demands, including without limitation reasonable legal and accounting fees, alleging or resulting from your use of the materials (including software) or your breach of these Terms and Conditions of Use. Sanofi Genzyme shall provide notice to you promptly of any such claim, suit, or proceeding and shall assist you, at your expense, in defending any such claim, suit or proceeding.
As a user of this website, you are liable for the accuracy of the information that you provide to us, including, but not limited to, your state license number and your professional representation. Registration and the use of a password may be required to access some features of this site. You are responsible for maintaining the confidentiality of your password.
This website and its contents are intended to comply with the laws and regulations in the U.S. Although the information on this web site is accessible to users outside of the U.S., the information on the web site pertaining to Sanofi Genzyme products and services is intended for use only by residents of the U.S. Other countries may have laws, regulatory requirements and medical practices that differ from those in the U.S. This site links to other sites produced by Sanofi Genzyme's various operating divisions and subsidiaries, some of which are outside the U.S. Those sites may have information that is appropriate only to that particular originating country. Sanofi Genzyme reserves the right to limit provision of our products or services to any person, geographic region or jurisdiction and/or to limit the quantities or any products or services we provide. Any offer for any product or service made on this website is void where prohibited.
Our website is operated from our offices in the Commonwealth of Massachusetts, U.S.A. These Terms and Conditions of Use shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts without regard to any conflict of law provisions thereof. Any action related to these Terms and Conditions of Use shall be brought only in the state courts of and federal courts in the Commonwealth of Massachusetts and all parties waive any objection to the personal jurisdiction of and venue in such courts.
If any provision of these Terms and Conditions of Use is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of these Terms and Conditions of Use shall remain in full force and effect. Any provision of these Terms and Conditions of Use held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable. The parties further agree to replace such invalid or unenforceable provision of these Terms and Conditions of Use with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable provision.
These Terms and Conditions of Use represent the entire agreement between you and Sanofi Genzyme relating to the subject matter herein and shall not be modified except by Sanofi Genzyme as provided herein or through a written document signed by both parties.
If you have any question regarding these Terms and Conditions of Use, please contact us.
These Terms and Conditions were last updated: 9/21/2011
CERDELGA (eliglustat) capsules is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
Limitations of Use:
CERDELGA is contraindicated in EMs or IMs taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and in IMs or PMs taking a strong CYP3A inhibitor due to the risk of significantly increased eliglustat blood concentration, which may result in prolongation of cardiac intervals that could result in cardiac arrhythmias.
Your doctor will perform a test to help determine if CERDELGA is right for you.
CERDELGA can affect the way other medicines work and other medicines can affect how CERDELGA works. Using CERDELGA with other medicines or herbal supplements (including St. John’s Wort) may cause an increased risk of side effects, including ECG changes and irregular heart beat. Especially tell your doctor if you take medicines for fungal infections, tuberculosis, seizures, heart rhythm and rate problems, high blood pressure, or depression or other mental health problems. Your doctor may need to prescribe a different medicine, change your dose of other medicines, or change your dose of CERDELGA. Tell your doctor about any new medicines before you start taking them.
Before taking CERDELGA, tell your doctor about all of your medical conditions, including kidney or liver problems, history of heart attacks, or heart rhythm problems (including long QT syndrome). If you are pregnant or plan to become pregnant or breastfeed, talk to your physician. It is not known if CERDELGA will harm your unborn baby.
It is not known if CERDELGA is safe and effective in children.
Swallow the capsule whole, preferably with water. If you miss a dose of CERDELGA, take the next dose at the usual time. Do not take two doses of CERDELGA at the same time. Avoid eating or drinking grapefruit products while taking CERDELGA. Grapefruit products can increase the amount of CERDELGA in your body.
The most common adverse reactions (≥10%) for CERDELGA are: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. Call your doctor for medical advice about adverse effects.
You may report adverse effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If you would like more information, talk with your doctor. You may also go to www.cerdelga.com for the Full Prescribing Information, including the Patient Medication Guide, or call Sanofi Genzyme at 1-800-745-4447.