Contact Us

Phone: 1-866-61-EISAI (1-866-61-34724)

Fax: 1-866-57-EISAI (1-866-57-34724)

Monday - Friday 8AM - 8PM ET




Legal Notice

Conditions of Use

Eisai Inc. provides this site for your personal information. You may browse or download content on this site for your personal, non-commercial use only, but thereafter such content may not be recopied, reproduced or otherwise redistributed or used. The content of this site is owned or controlled by Eisai Inc. and is protected under applicable copyright and trademark laws. All copyright and other proprietary notices contained in downloaded materials must be retained. Through your access to and use of this site, you accept, without limitation or qualification, all terms and conditions of use described throughout this site.

Jurisdiction

Although it is accessible worldwide, this site and its content are intended only for residents of the United States. Nothing in this site should be interpreted as a promotion or solicitation for any product or of any nature that is not authorized by the laws and regulations of the country where you are located.

Medical Information

This site may contain information relating to various medical conditions and their treatment. Such information is provided for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare professional. You should not use this information for diagnosing or treating a health problem or disease. In order for you to make intelligent healthcare decisions, you should always consult with your physician or other healthcare provider for your personal medical needs.

Some areas of this site may ask you to submit personally identifiable information in order for you to benefit from the specified features (such as newsletter subscriptions, tips/pointers, order processing, or resume submission) or to participate in a particular activity (such as sweepstakes or other promotions). You will be informed what information is required and what information is optional.

Privacy

Any "personally identifiable" information in electronic communications to this site is governed by and subject to the site's Privacy Policy. By "personally identifiable" information, we mean data that are unique to an individual, such as a name, address, social security number or telephone number.

Unsolicited Submissions

Under no circumstances should you use this site or any of the fax or mailing addresses listed on this site to send Eisai Inc. confidential or proprietary information. Your unsolicited communications to us, including any ideas, inventions, concepts, techniques, know-how, proposals, data, questions, comments or similar such materials and information, other than the personal information described above, will be treated as non-confidential and non-proprietary information. Eisai reserve the right to use any such communications, including without limitation any ideas, inventions, concepts, know-how, processes or techniques disclosed therein for any purpose whatsoever, including by reproducing, disclosing and distributing such information or otherwise using such information in connection with the development, manufacture and marketing of products or services. You shall be responsible for the content and information contained in any communications sent or submitted by you to this site or otherwise to the owners of this site, including for the truthfulness and accuracy of such content and information.

Links to Other Sites

As a convenience, from time to time www.EisaiReimbursement.com may contain certain links or references to other sites that we think may be useful or of interest to you. Eisai does not control, endorses, promote or has any affiliation with any other site unless expressly stated herein or on such site. The owners of this site therefore have no responsibility for the content, accuracy or any other aspect of the information contained on such linked sites. Eisai will not be liable for any damages or injury arising from your access to such sites or content. The trademarks, service marks, trade names, trade dress and products in this site are protected in the United States and internationally. Nothing contained in this site shall be construed as conferring on you any license or right under any copyright, patent, trademark or trade name or under any other proprietary rights of Eisai Inc. or any third party, whether by implication, estoppel or otherwise. No use may be made by you of any of these without the prior written authorization of the owners of this site or of the respective proprietary rights, as applicable, except to identify products or services of the owners.

Warranties

Eisai does not make any representations or warranties as to the timeliness, availability, accuracy or completeness of any information contained in this site. Like any printed materials, the information provided in this site may become outdated over time. Eisai undertake no obligation to correct or update any content or information on this site. Eisai may make improvements and/or changes in the products and/or services described in this content and information at any time without notice and reserve the right to alter or delete content and information in the site at any time. All information on this site is provided "AS IS," without any warranties, including but not limited to IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT, ALL OF WHICH ARE EXPRESSLY DISCLAIMED. All visitors to www.EisaiReimbursement.com agree that all access to and use of this site and its content are at their own risk. None of Eisai any affiliate of either of them, or any party involved in creating, producing or delivering this site will be liable for any injury or any direct, indirect, special, exemplary, incidental, consequential, punitive or other damages arising out of access to, use of or inability to use www.EisaiReimbursement.com or any errors or omissions in the content thereof or from reliance on any information on this site, even if Eisai is informed of the possibility of such damages.

Trademarks

All product names, trademarks, logos and service marks (collectively referred to as "Trademarks") displayed on this site are the property of Eisai their respective affiliates, related companies, licensors or business partners. The use or misuse of these Trademarks or any other materials, except as permitted herein, is expressly prohibited and may be in violation of the laws of copyright, trademark, privacy, publicity, slander, libel and communications. Please be advised that each of Eisai (and their respective affiliates) actively and aggressively enforces its intellectual property rights to the fullest extent of the law.

Images of people or places displayed on this site are either the property of, or used with permission by, Eisai. The use of these images by you is prohibited unless specifically permitted by the terms and conditions of this site. Unauthorized use of the images may violate the laws of copyright, trademark, privacy, publicity and communications.

Indication

Important Safety Information:

Treatment with DACOGEN® is associated with neutropenia and thrombocytopenia. Complete blood and platelet counts should be performed as needed to monitor response and toxicity but at a minimum prior to each dosing cycle. Clinicians should consider the need for early institution of growth factors and/or antimicrobial agents for the prevention or treatment of infections in patients with MDS.

DACOGEN® may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with DACOGEN® and for 1 month following completion of treatment. Men should be advised not to father a child while receiving treatment with DACOGEN® and for 2 months following completion of treatment.

In the phase 3 clinical trial, the highest incidences of Grade 3 or Grade 4 adverse events in the DACOGEN® arm were neutropenia (87%), thrombocytopenia (85%), febrile neutropenia (23%), and leukopenia (22%). Bone marrow suppression was the most frequent cause of dose reduction, delay, and discontinuation. Six patients had fatal events associated with their underlying disease and myelosuppression (anemia, neutropenia, and thrombocytopenia) that were considered at least possibly related to drug treatment. Of the 83 DACOGEN®-treated patients, 8 permanently discontinued therapy for adverse events compared to 1 of 81 patients in the supportive care arm.

In the single-arm study, the highest incidence of Grade 3 or Grade 4 adverse events was neutropenia (37%), thrombocytopenia (24%), and anemia (22%). Seventy-eight percent of patients had dose delays. Hematologic toxicities and infections were the most frequent causes of dose delays and discontinuation. Eight patients had fatal events due to infection and/or bleeding that were considered at least possibly related to drug treatment. Nineteen of 99 patients permanently discontinued therapy for adverse events.

Other commonly occurring reactions include fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

If hematologic recovery from a previous DACOGEN® treatment cycle requires more than 6 weeks when administering the 3-day dosing, then the next DACOGEN® cycle should be delayed and dosing temporarily reduced. When administering the 5-day dosing, the DACOGEN® cycle should be delayed until there is hematologic recovery. If the following nonhematologic toxicities are present, DACOGEN® treatment should not be restarted until the toxicity is resolved: (1) serum creatinine ≥2 mg/dL; (2) SGPT, total bilirubin ≥2 × ULN; and (3) active or uncontrolled infection.

Because there are no data on use of DACOGEN® in patients with renal or hepatic dysfunction, DACOGEN® should be used with caution in these patients.

For more information about DACOGEN® please see full Prescribing Information.



Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.

This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries.

DACOGEN® is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc., Dublin, CA, U.S.A.

Distributed and marketed by Eisai Inc. CORP74BR6 ©2012 Eisai Inc. All rights reserved.

This site was last modified on : December 19, 2011 at 5:45pm ET