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| prescribing information | important safety information |
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ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable
suspension) is indicated for the treatment of breast cancer after failure of combination
chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Prior therapy should have included an anthracycline unless clinically contraindicated.
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Privacy Policy
Abraxis BioScience, Inc.
Privacy Policy
US Residents Only
General
This Policy applies to residents of the United States.
This Privacy Policy explains how we handle the personal information that you provide to us on web sites controlled by Abraxis BioScience, Inc. which link to this Privacy Policy (referred to as "Abraxis web sites"). This Privacy Policy does not apply to personal information collected from you offline, to Abraxis web sites that do not link to this Privacy Policy, to residents of countries other than the United States, or to third-party web sites to which Abraxis web sites may link. Your use of Abraxis web sites which link to this Privacy Policy is subject to this Privacy Policy and the Terms of Use.
Please read this Privacy Policy before using Abraxis web sites or submitting personal information to us.
How does this Privacy Policy define "personal information"?
"Personal information" means information that identifies you or could reasonably be used to identify you and which is submitted to and/or collected by Abraxis web sites and maintained by Abraxis in an accessible form. Examples of personal information include your name, your postal address and your telephone number. Data that are not personal, such as questions, comments, ideas and suggestions excluding personal information, shall be deemed to be non-confidential, and Abraxis shall be free to disclose and use the same, without any obligation whatsoever to you, for any purpose and through any means.
How does Abraxis collect information online?
Abraxis collects information in two ways:
Personal Information You Submit:
Abraxis collects personal information that you enter into data fields on Abraxis web sites. For example, you may submit your name, postal address, e-mail address, and/or other information in order to receive information about various subjects, register for Abraxis programs, contact Abraxis customer service, or respond to Abraxis surveys. To protect your privacy, you should not provide Abraxis with any information that is not specifically requested, such as your medical history.
Passive Collection of Unidentifiable Information:
Abraxis web sites may collect information about your visits to Abraxis web sites without you actively submitting such information. Unidentifiable information may be collected using various technologies, such as cookies, Internet tags, and web beacons. Your Internet browser automatically transmits to Abraxis web sites some of this unidentifiable information, such as the URL of the web site you just visited and the browser version your computer is operating. Passive information collection technologies can make your use of Abraxis web sites easier by allowing Abraxis to provide better service, customize sites based on consumer preference, compile statistics, analyze trends, and otherwise administer and improve Abraxis web sites. Certain features of Abraxis web sites may not work without use of passive information collection technologies. Information collected by these technologies cannot be used to identify you without additional identifiable information.
In what circumstances might Abraxis collect and use personal information?
Abraxis will use the personal information you provide through Abraxis web sites to respond to your questions and to provide you with efficient customer service. After you have entered personal information into a form or data field on an Abraxis web site, Abraxis may use certain identifying technologies, referred to as "cookies," to allow that web site to "remember" your personal preferences, such as sections of that web site that you visit frequently and, if you choose, your user ID. We may also use this personal information for other business purposes, such as to offer you the opportunity to receive notices regarding Abraxis products or services, to invite you to participate in surveys about our products, or to notify you about special promotions.
Does Abraxis consolidate personal information?
Abraxis may consolidate the personal information of customers who use Abraxis web sites. We use this information to help us better design Abraxis web sites and Abraxis products, to communicate information to you, to enhance our marketing and research activities, and to facilitate other business functions.
What choices do I have about how Abraxis collects and uses personal information about me?
You can access and use much of this web site without telling us who you are or revealing any personal information. Some areas of the site, however, do allow you to contact us to ask questions or provide comments. You may always limit the amount and type of personal information that Abraxis receives about you by choosing not to enter any personal information into forms or data fields on Abraxis web sites; however, some of our online services can only be provided to you if you provide us with appropriate personal information. Other parts of Abraxis web sites may ask whether you wish to opt out or opt into our contact lists for offers, promotions and additional services that may be of interest to you.
You may also be provided with preference questions or preference boxes allowing you to indicate that you do not want Abraxis web sites to use tracking technologies, such as cookies, to "remember" your personal information, such as user IDs or mailing addresses, on return visits. However, Abraxis web sites that use tracking technologies to collect unidentifiable information do not generally provide you with the ability to opt out of the tracking technologies. Some Internet browsers allow you to limit or disable the use of tracking technologies that collect unidentifiable information, erase cookies from your computer's hard drive, block all cookies, or even receive a warning before a cookie is placed on your system. Refer to your browser instructions or help button to learn more about tracking technologies and cookies.
Who will have access to personal information about me?
Personal information can be accessed by a restricted number of Abraxis employees, by certain companies with which Abraxis may conduct joint programs, and by individuals and entities with whom Abraxis contracts to carry out business activities for Abraxis. We train our employees about the importance of privacy and how to handle and manage customer data appropriately and securely. Also, it is Abraxis's practice to notify you if you are registering for a program which is conducted in conjunction with another company that may require access to your personal information. In addition, Abraxis's practice is to require its contractors to keep your personal information confidential and to use personal information only to perform functions for Abraxis.
Does Abraxis share personal information with third parties?
As a general rule, Abraxis does not share your personal information with third parties, unless it is necessary to conduct a joint program or to carry out a program or activity through a contractor. Where required by law, Abraxis will not disclose your personal information to third parties for those third parties' marketing purposes, unless you have been provided with an opportunity to opt out of this disclosure. However, if Abraxis sells one of its product lines or divisions, your personal information may be transferred to the buyer so that the buyer can continue to provide you with information and services. If Abraxis provides your personal information to individuals and entities which assist us with our business activities, it is Abraxis's practice to require those individuals and entities to keep your personal information confidential and to use your personal information only to perform functions for Abraxis. Abraxis reserves the right to disclose your personal information to respond to authorized information requests from government authorities, to address national security situations, or when otherwise required by law.
Does Abraxis share personal information with Regulatory or Law Enforcement Authorities?
If you contact Abraxis regarding your experience in using one of Abraxis' products, Abraxis may use the information you provide in submitting reports to the U.S. Food and Drug Administration, other regulatory authorities, and as otherwise required of us by law. Abraxis also may use the information to contact the prescribing physician to follow up regarding an unexpected event involving use of our product. By submitting such information, you agree that Abraxis may not be permitted to comply with your request to amend or remove personal identifiable information that was provided to Abraxis by a health care professional or a consumer regarding an adverse drug event. Additionally, Abraxis may be required by court orders or other laws to divulge information about you to law enforcement authorities or the courts. Abraxis will cooperate in responding to such requests, in accordance with the law, and will take appropriate measures to ensure that the requester understands the sensitive nature of the health-related personal information that they may receive.
How does Abraxis secure personal information?
It is Abraxis' practice to secure each web page that collects personal information; however, the confidentiality of personal information transmitted over the Internet cannot be guaranteed. We urge you to exercise caution when transmitting personal information over the Internet, especially personal information related to your health. Abraxis cannot guarantee that unauthorized third parties will not gain access to your personal information; therefore, when submitting personal information to Abraxis web sites, you must weigh both the benefits and the risks. In addition, Abraxis web sites covered by this Privacy Policy will display a warning whenever you link to a web site that is not controlled by Abraxis; you should check the privacy policies of such third-party web sites before submitting personal information.
How does Abraxis protect the privacy of children?
Abraxis does not knowingly collect or use any personal information from children (we define "children" as minors younger than 18) on Abraxis web sites. We do not knowingly allow children to order our products, communicate with us, or use any of our online services. If you are a parent and become aware that your child has provided us with information, please contact us using one of the methods specified below, and we will work with you to address this issue.
How may I correct personal information or delete it from current customer records?
You may request to remove your personal information from our current customer records or to amend your personal information. Please notify us of your wishes by contacting us in one of the ways specified below. For our record keeping purposes, we will retain certain personal information you submit in conjunction with commercial transactions.
How can I contact Abraxis?
If you have questions about the use, amendment, or deletion of personal information that you have provided to us, or if you would like to opt out of future communications from an Abraxis business or a particular Abraxis program, please contact us by clicking on the "Contact Us" link on the web site you are visiting or by e-mailing us at abraxisbiocontact @abraxisbio.com. Alternatively, you may send a letter to the following address:
Abraxis Pharmaceutical Products, a division of Abraxis BioScience, Inc.
Attention: IT Department
1501 East Woodfield Drive
Suite 300 East
Schaumburg, IL 60173
In all communications to Abraxis, please include the e-mail address used for registration (if applicable), the web site address on which you provided any personal information about which you have questions or concerns (e.g., www.abraxisbio.com), and a detailed explanation of your request. If you would like to delete or amend your personal information and are contacting us by e-mail, please put "Deletion Request" or "Amendment Request", as applicable, in the subject line of the e-mail. We will do our best to respond to all reasonable requests in a timely manner.
How will I know whether Abraxis has updated this policy?
Abraxis reserves the right to amend this Privacy Policy without prior notice to reflect technological advancements, legal and regulatory changes and good business practices. If Abraxis changes its privacy practices, a new Privacy Policy will reflect those changes and the effective date of the revised Privacy Policy will be set forth in this paragraph. This Privacy Policy was last updated on April 18, 2006 and is effective as of that date.
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WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE.
Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.
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IMPORTANT SAFETY INFORMATION
In the randomized metastatic breast cancer study, the most important adverse events included neutropenia (all cases 80%; severe 9%), anemia (all 33%; severe 1%), infections (24%), sensory neuropathy (any symptoms 71%; severe 10%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), myalgia/arthralgia (any 44%; severe 8%), and mucositis (any 7%; severe <1%). Other adverse reactions included asthenia (any 47%; severe 8%), ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), alopecia (90%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), and renal dysfunction (any 11%; severe 1%). Thrombocytopenia (any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (<1%) were uncommon. During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.
WARNINGS, PRECAUTIONS, AND CONTRAINDICATIONS
The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.
ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.
Men should be advised to not father a child while receiving treatment with ABRAXANE.
ABRAXANE contains albumin (human), a derivative of human blood.
Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.
ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3.
In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended.
Sensory neuropathy occurs frequently with ABRAXANE. The occurrence of grade 1 or 2 sensory neuropathy does not generally require dose modification. If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE.
It is recommended that nursing be discontinued when receiving ABRAXANE therapy.
Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism, and hypertension.
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