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Important Legal Information
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Celgene provides the services described in the website (the "Services"), subject to the following Conditions for Use ("Conditions"), which may be updated by Celgene from time to time without notice to you. You are bound by any such revisions and therefore should review the Conditions each time you visit the website for changes. Your use of the website is subject to, and constitutes acceptance of, the then-current Conditions.
1. Forward-Looking Statements
This website contains "Forward-Looking Statements" as defined in the Private Securities Litigation Reform Act of 1995. Such statements are identified by the use of words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such statements are based on management's current expectations and are subject to certain factors, risks and uncertainties that may cause actual results, events and performance to differ materially from those referred to or implied in such statements. These risks are identified in our filings with the Securities and Exchange Commission, which are available through Internet links contained in the Investor Relations section of the Celgene Corporate website. The information presented in this website is believed to be current as of the date of original publication. We do not intend to update any of the forward-looking statements after such date to conform these statements to actual results or to changes in our expectations, except as required by law.
2. Celgene Privacy Policy
All personal data provided by you to Celgene, whether via one of the website's forms or by participation in one or more of the Services is subject to our Privacy Policy, which is incorporated into these Conditions by reference. You can find the full Privacy Policy at http://www.celgene.com/utility/privacy.aspx. It is located on our website’s home page, bottom right, by clicking on the words "Privacy Policy."
Celgene will only collect personal data you voluntarily provide to us, including “sensitive” personal data (e.g. relating to your racial or ethnic origin, religious beliefs, sexual life, physical or mental health or civil or criminal offences). In particular, you consent to the disclosure of such personal data to third parties in order to enable us to provide information and the Services to you that you have requested. Celgene will use the personal data you provide for the specific limited purposes about which we inform you when we ask for such information. Celgene keeps your data only for as long as is reasonably needed for such purposes and in accordance with any applicable legal or ethical reporting or documentation retention requirements.
You agree to inform us promptly should you become aware that any personal data held by us about you is inaccurate and/or out of date. Accordingly, we do not accept liability for any loss, costs, damages, or distress caused to any person arising out of our reasonable reliance upon the accuracy of personal data that you provide to us. If you have submitted personal information through this website and wish us to cease using it for the purposes submitted, please contact 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 please contact IR@celgene.com. For all other inquiries please e-mail us at Privacy@celgene.com.
Unless we agree otherwise in writing, we require you to use any personal information that we supply to you about members of our staff and/or third parties only for the purposes for which such information is disclosed to you.
3. Warranties
You hereby warrant that you will not use the website to:
- upload, post, e-mail, or otherwise transmit any information, data, software, sound, text, photographs, graphics, video, messages, and any other material ("Content") that is unlawful, harmful, threatening, abusive, harassing, tortuous, defamatory, vulgar, obscene, libelous, invasive of another's privacy, hateful, or racially, ethnically, or otherwise objectionable;
- upload, post, e-mail, or otherwise transmit personal data about anyone other than yourself without that person's consent;
- upload, post, e-mail, or otherwise transmit any Content that infringes any patent, trademark, trade secret, copyright, or other proprietary rights of any party;
- violate any applicable law or regulation in relation to your use of the website including, but not limited to, regulations promulgated by any securities exchange; or
- collect or store personal data about other users.
4. Indemnity
You hereby agree to indemnify Celgene for any loss or damage of any kind incurred as a result of a breach of any of the warranties described in paragraph 3, above.
5. Links
The Services may provide, or third parties may provide, links to other websites or resources. Because Celgene does not have control over such sites and resources, you acknowledge and agree that Celgene is not responsible for the availability of such external sites or resources, and does not endorse and is not responsible or liable for any content, advertising, products, or other materials on or available from such sites or resources.
You further acknowledge and agree that Celgene shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such content, goods, or services available on or through any such site or resource.
6. Proprietary Rights
You acknowledge and agree that the website Materials, Services, and any information presented to you through the website or the Services contain proprietary information that is protected by copyrights, trademarks, service marks or other proprietary rights and laws, applicable intellectual property, and other laws. Except as expressly authorized by Celgene or relevant third parties, you agree not to modify, rent, lease, loan, sell, distribute or create derivative works based on the website Materials or the Services in whole or in part.
7. Copyright
Without prejudicing the generality of the foregoing, you further acknowledge and agree that all responses received in response to queries sent through the "contact us e-mail form" are copyrighted and proprietary and may not be copied or reproduced for any commercial purpose.
8. Disclaimers
Your use of the Services is at your sole risk. The Services are provided on an "as is" and "as available" basis. To the fullest extent permitted by applicable law, Celgene expressly disclaims all warranties, conditions and other terms of any kind, whether express or implied, including, but not limited to any implied term of merchantability, satisfactory quality, fitness for a particular purpose, and any term as to the provision of Services to a standard of reasonable care and skill or as to non-infringement of any intellectual property right.
Celgene makes no warranty or representation that (i) the service will meet your requirements, (ii) the service will be uninterrupted, timely, secure, or error-free, (iii) the results that may be obtained from the use of the service will be accurate or reliable, and (iv) the quality of any services, information, or other material obtained by you through the Service will meet your expectations.
No advice or information, whether oral or written, obtained by you from Celgene or through or from the Services shall create any warranty or other obligation not expressly stated in the Conditions.
9. Limitation of Liability
To the fullest extent permitted by applicable laws, and except in respect of death or personal injury arising from Celgene's negligence as determined by a court of law, Celgene hereby excludes liability for any claims, loss, demands, or damages of any kind whatsoever with respect to the Services, and any information, content, advertisements, or products provided or distributed through the Services including, without limitation, direct, indirect, incidental or consequential loss, or otherwise and whether or not the possibility of such loss has been notified to Celgene. The foregoing will apply whether such claims, loss, or damages arise in tort, contract, negligence, under statute, or otherwise. If you are a consumer your statutory rights, if any, are not limited.
10. Exclusions and Limitations
Some jurisdictions do not allow the exclusion of certain warranties or the limitation or exclusion of liability for incidental or consequential damages. Accordingly, some of the above limitations of paragraph 8 and 9 above may not apply to you.
In particular, nothing in these Conditions shall affect the legal rights of any consumer or exclude or restrict any liability for death or personal injury arising from the negligence or fraud of Celgene as determined by a court of law.
11. General Information
These Conditions (including the guides and rules referred to herein) constitute the entire agreement between you and Celgene and govern your use of the Services, superseding any prior agreements between you and Celgene. The Conditions and the relationship between you and Celgene shall be governed by the laws of New Jersey USA. You and Celgene agree to submit to the exclusive jurisdiction of the New Jersey courts.
Any failure by Celgene to exercise or enforce any right or provision of the Conditions shall not constitute a waiver of such right or provision. If any provision of the Conditions is found by a court of competent jurisdiction to be invalid, the parties nevertheless agree that the court should endeavor to give effect to the parties' intentions as reflected in the provision, and the other provisions of the Conditions remain in full force and effect.
12. Violations
We recommend users who find inappropriate content to contact us immediately at Privacy@celgene.com. In addition, we reserve the right to remove all material that we consider inappropriate. This includes pornographic, offensive, defamatory, undocumented, illegal material(s) that is/are in any way contrary to accepted morality and behavior.
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.
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