Celgene Corporation Privacy and Data Protection Policy
Celgene Corporation recognizes the importance of protecting the privacy of information we collect from visitors to our websites. To this end, we are committed to using our best efforts to respect our visitors’ privacy. While the security of information in transit over the Internet cannot be assured, our privacy practices are designed to give customers choices and control over personally identifiable information and to ensure that we use information we receive in ways compatible with the purposes for which it has been collected by the individual. We have established this privacy policy for the Celgene Corporation global network of websites and are posting it here so that you can understand the care with which we intend to treat your information.
What information do we collect and how do we use it?
Some of the information we keep on our Web server is information that site visitors volunteer to provide through forms and some is collected automatically. We only collect personally identifiable data, such as your name or e-mail address or geographic location, when it is voluntarily submitted to us.
Our server automatically collects information in aggregate form to track the total number of visitors to our site, the number of visitors to each page of our site, and the domain names of our visitors' Internet service providers. No personally identifiable information is collected automatically. We use this aggregate information to help us better understand site visitors’ needs and to improve our products and services.
In some places on our site, Celgene uses a technology called cookies. A cookie is a token that a server gives to your browser when you access a Web page. Cookies help provide additional functionality, making a visit to our websites more efficient for the visitor. The use of cookies allows us to collect more accurate information regarding aggregate use of our websites. In order to provide the highest possible level of customer service, cookies allow us to track paths through the site to identify users’ unmet information needs. We do not collect personally identifiable data through cookies.
Celgene offers site visitors the option of submitting a resume for employment consideration. Resumes submitted through our website are shared only internally or with vendors Celgene has engaged to assist us with our Human Resource processes. Any vendors or service organizations Celgene engages to assist us are also required to follow this
Privacy Policy.
Visitors to our website may e-mail us from time to time with requests for information. The information provided in these e-mail messages is used to respond to your request.
Celgene websites are not intended or designed for children under the age of 13. We do not collect personally identifiable data from any person we know to be under the age of 13.
With whom do we share the information we collect?
We do not share information we collect from our websites with other organizations except for members of the Celgene group of companies in the United States, the European Union, and elsewhere, vendors or service organizations we have engaged to assist us with completing a service (a CME organization to award continuing medical education credits for example), or unless required by law (reporting safety information to regulatory authorities for example). Any vendor or service organization to which we provide such information is also required to follow this Privacy Policy. We do not sell or rent personal information to other organizations for their commercial use. We do not partner with or have special relationships with any ad server companies.
Some users of our websites are invited to participate in nonpublic, secure (password-protected) sites. Members who choose to participate in these sites also have access to their own and other members’ profile information, including personal contact information.
How can site visitors view, change, or delete their information?
You may have access to your personal information at any time to revise, correct, or delete it by contacting us. For previous submissions related to Medical Services please contact Medinfo@celgene.com. For previous submissions related to Career and Employment please contact Careersnj@celgene.com. For previous submissions related to Investor Relations requests please contact IR@celgene.com. For previous submissions related to Patient Support contact Patientsupport@celgene.com. For all other inquiries please e-mail us at Privacy@celgene.com.
How is personal information secured and protected?
Personally identifiable data are stored in secure databases relevant for the purposes for which it was collected that are accessible only to authorized Celgene employees and contracted vendors.
What is the policy related to third-party sites?
Celgene provides links to third-party sites as a convenience to our site visitors. Links to third-party sites do not constitute an endorsement or a warranty of any kind. Celgene is not responsible for the privacy practices or the content of such websites. We suggest contacting these sites directly for information on their data collection and distribution policies.
What if this Privacy Policy changes?
From time to time, we may use website visitor information for new, unanticipated uses not previously disclosed in our Privacy Policy. Any changes to our Privacy Policy will be promptly communicated on this page. We will also send visitors for whom we have a valid e-mail address a notice through e-mail with a link to this page and provide an option to opt out of new uses.
How can I contact you to get more information?
If you have questions about this Privacy Policy, the practices of this site, or your dealings with this website, please contact us. We will address any issue to the best of our ability. You can contact us via e-mail at Privacy@celgene.com or by phone at +1-908-673-9000, or by postal mail at:
Celgene Corporate Headquarters
Attn: Privacy Matters
86 Morris Avenue
Summit, NJ 07901
Last Updated December 14, 2009
ISTODAX® (romidepsin) for injection is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
This indication is based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.
Important Safety Information
WARNINGS AND PRECAUTIONS:
- Treatment with ISTODAX has been associated with thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, monitor these hematological parameters during treatment with ISTODAX and modify the dose as necessary
- Serious and sometimes fatal infections have been reported during treatment and within 30 days after treatment with ISTODAX and the risk of life threatening infections may be higher in patients with a history of extensive or intensive chemotherapy
- Electrocardiographic (ECG) changes have been observed with ISTODAX
- In patients with congenital long QT syndrome, a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, appropriate cardiovascular monitoring precautions should be considered, such as monitoring electrolytes and ECGs at baseline and periodically during treatment
- Ensure that potassium and magnesium are within the normal range before administration of ISTODAX
- Tumor lysis syndrome has been reported during treatment with ISTODAX. Patients with advanced stage disease and/or high tumor burden should be closely monitored and appropriate precautions taken, and treatment should be instituted as appropriate
- ISTODAX may cause fetal harm when administered to a pregnant woman. Advise women to avoid pregnancy while receiving ISTODAX. If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus (Pregnancy Category D)
ADVERSE REACTIONS:
Cutaneous T-Cell Lymphoma
The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 1 (N=102) were infections (11%) and asthenia/fatigue (8%), and in Study 2 (N=83) were lymphopenia (37%), infections (33%), neutropenia (27%), leukopenia (22%), anemia (16%), asthenia/fatigue (14%), thrombocytopenia (14%), hypophosphatemia (10%), vomiting (10%), dermatitis/exfoliative dermatitis (8%), hypermagnesemia (8%), hyperuricemia (8%), hypocalcemia (6%), nausea (6%), and pruritus (6%).
Infections were the most common type of serious adverse event reported in both Study 1 (N=102) and Study 2 (N=83) with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection.
The most common adverse reactions regardless of causality in Study 1 (N=102) were nausea (56%), asthenia/fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%) and in Study 2 (N=83) were nausea (86%), asthenia/fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG ST-T wave changes (63%), neutropenia (57%), lymphopenia (57%), infections (54%), anorexia (54%), vomiting (52%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), leukopenia (46%), dysgeusia (40%), and constipation (39%).
DRUG INTERACTIONS:
- ISTODAX is metabolized by CYP3A4. Avoid concomitant use with strong CYP3A4 inhibitors and potent CYP3A4 inducers if possible
- Caution should also be exercised with concomitant use of moderate CYP3A4 inhibitors and P-glycoprotein (P-gp, ABCB1) inhibitors
- Physicians should carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients concurrently administered ISTODAX and warfarin sodium derivatives
USE IN SPECIFIC POPULATIONS:
- Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ISTODAX, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
- Patients with moderate and severe hepatic impairment and/or patients with end-stage renal disease should be treated with caution
Please see full Prescribing Information, including, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.
ISTODAX® is a registered trademark of Celgene Corperation.
Celgene Patient Support® is a registered trademark of Celgene Corporation.
©2009 year of origin. ©2011 date of revision. Celgene Corporation, www.celgene.com.
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