Privacy Policy | VIDAZA.com

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

Indication

VIDAZA is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

IMPORTANT SAFETY INFORMATION

VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors.
In Studies 1 and 2, the most commonly occurring adverse reactions by SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%), and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%). In Study 3, the most common adverse reactions by IV route also included petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia (31.3%).
In Study 4, the most commonly occurring adverse reactions were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%) and febrile neutropenia (12.6%).
Because treatment with VIDAZA is associated with anemia, neutropenia and thrombocytopenia, complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle.
Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease. In addition, azacitidine and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
VIDAZA may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be apprised of the potential hazard to the fetus. Men should be advised not to father a child while receiving VIDAZA.
Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

Please see full Prescribing Information.