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
- HALAVEN® is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Important Safety Information
Neutropenia
- Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days.
- Severe neutropenia (ANC < 500/mm3) lasting more than one week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes > 3 x ULN and bilirubin > 1.5 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia. Two patients died from complications of febrile neutropenia.
Peripheral Neuropathy
- Patients should be monitored closely for signs of peripheral motor and sensory neuropathy.
- Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received HALAVEN®. Delay administration of HALAVEN® until resolution to Grade 2 or less.
- Neuropathy lasting more than one year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation.
Pregnancy Category D
- HALAVEN® is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks.
QT Prolongation
- In an uncontrolled ECG study in 26 patients, QT prolongation was observed on day 8, with no prolongation on day 1. ECG monitoring is recommended for patients with congestive heart failure, bradyarrhythmias, concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics and electrolyte abnormalities.
- Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN® and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
Most Common Adverse Reactions
- Most common adverse reactions (≥25%) reported in patients receiving HALAVEN® were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%).
- The most common serious adverse reactions reported were febrile neutropenia (4%) and neutropenia (2%).
Please see the HALAVEN® full prescribing information.
