Metastatic Breast Cancer Treatment Drug: ABRAXANE for Injectable Suspension

Black Box Warning

ABRAXANE 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.

 

Privacy Policy

AstraZeneca Pharmaceuticals, LP Privacy Statement

Abraxis BioScience, LLC.
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, LLC. (including its divisions and affiliates) 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:

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 that 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’s 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 healthcare 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’s 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, LLC.
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.

 

 

Important Safety Information & Boxed Warning

You should receive ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) under the care of a doctor who is trained to use cancer drugs. Because you may have side effects from your treatment, you should get this medicine in a clinic or hospital with doctors, nurses, and pharmacists who are trained to give cancer drugs.

ABRAXANE therapy should not be given to patients with metastatic breast cancer who have low blood counts. Low blood counts, especially low white blood cell counts, may make you more likely to get an infection. In order to check for low blood counts your doctor may need to take some blood to test your blood counts.

Note: ABRAXANE is paclitaxel made with the human blood protein albumin. This makes it behave differently in the body than regular paclitaxel. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL DRUGS.

Important Safety Information

One of the more important side effects associated with chemotherapy is neutropenia, which is a decrease in the number of infection-fighting white blood cells (neutrophils). Normal levels range from approximately 1,500 cells/mm3 to 1,800 cells/mm3 (but vary according to several factors, such as age and race). If levels fall below 500 cells/mm3, your risk of developing an infection increases and treatment may be interrupted. To avoid the risk of serious infection and fever, your doctor will monitor your absolute neutrophil count (ANC) during therapy.

Women should avoid becoming pregnant while being treated with ABRAXANE. Tell your doctor if you are pregnant, if you become pregnant, or you plan to become pregnant while taking ABRAXANE. Discuss with your doctor how ABRAXANE may affect fertility. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk

The most important adverse events included lower white and red blood cell counts, infections, tingling and numbness, nausea, vomiting, diarrhea, muscle and joint aches, and mouth sores. Other adverse reactions included weakness, visual disturbances, fluid retention, hair loss, and liver and kidney dysfunction. Low platelet counts, allergic reactions (which in rare cases were severe), cardiovascular reactions, and injection site reactions were uncommon.

Sensory neuropathy (numbness, tingling, or burning in the hands and feet) can occur with ABRAXANE and other paclitaxel medications. Severe sensory neuropathy can improve with proper management, as prescribed by your doctor. You should tell your nurse or doctor if you experience numbness, tingling, or burning in your hands or feet while taking ABRAXANE.

Please talk to your doctor or nurse if you have questions regarding the potential side effects of ABRAXANE therapy. You may want to review the Product Information, including Warnings, Precautions, and Contraindications.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

The information on this site is intended for US residents only.

©2008 Abraxis BioScience, LLC.
and AstraZeneca Pharmaceuticals LP.
All Rights Reserved. AO 853/261222  4/08

ABRAXANE is marketed under a
co-promotion agreement between
Abraxis BioScience, LLC. and AstraZeneca.

Abraxis
AstraZeneca

Abraxis Oncology is a division of Abraxis
BioScience, LLC. All Abraxis BioScience,
LLC. corporate names, names of services,
and names of products referred to herein
are trade names, service marks, and/or
trademarks that are owned by or licensed
to Abraxis BioScience, its divisions or its
affiliates, unless otherwise noted.

Important Safety Information & Boxed Warning

You should receive ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) under the care of a doctor who is trained to use cancer drugs. Because you may have side effects from your treatment, you should get this medicine in a clinic or hospital with doctors, nurses, and pharmacists who are trained to give cancer drugs.

ABRAXANE therapy should not be given to patients with metastatic breast cancer who have low blood counts. Low blood counts, especially low white blood cell counts, may make you more likely to get an infection. In order to check for low blood counts your doctor may need to take some blood to test your blood counts.

Note: ABRAXANE is paclitaxel made with the human blood protein albumin. This makes it behave differently in the body than regular paclitaxel. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL DRUGS.

Important Safety Information

One of the more important side effects associated with chemotherapy is neutropenia, which is a decrease in the number of infection-fighting white blood cells (neutrophils). Normal levels range from approximately 1,500 cells/mm3 to 1,800 cells/mm3 (but vary according to several factors, such as age and race). If levels fall below 500 cells/mm3, your risk of developing an infection increases and treatment may be interrupted. To avoid the risk of serious infection and fever, your doctor will monitor your absolute neutrophil count (ANC) during therapy.

Women should avoid becoming pregnant while being treated with ABRAXANE. Tell your doctor if you are pregnant, if you become pregnant, or you plan to become pregnant while taking ABRAXANE. Discuss with your doctor how ABRAXANE may affect fertility. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk

The most important adverse events included lower white and red blood cell counts, infections, tingling and numbness, nausea, vomiting, diarrhea, muscle and joint aches, and mouth sores. Other adverse reactions included weakness, visual disturbances, fluid retention, hair loss, and liver and kidney dysfunction. Low platelet counts, allergic reactions (which in rare cases were severe), cardiovascular reactions, and injection site reactions were uncommon.

Sensory neuropathy (numbness, tingling, or burning in the hands and feet) can occur with ABRAXANE and other paclitaxel medications. Severe sensory neuropathy can improve with proper management, as prescribed by your doctor. You should tell your nurse or doctor if you experience numbness, tingling, or burning in your hands or feet while taking ABRAXANE.

Please talk to your doctor or nurse if you have questions regarding the potential side effects of ABRAXANE therapy. You may want to review the Product Information, including Warnings, Precautions, and Contraindications.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

The information on this site is intended for US residents only.

©2008 Abraxis BioScience, LLC. and AstraZeneca Pharmaceuticals LP. All Rights Reserved. AO 853/261222  4/08
(Site updated 2/07)

ABRAXANE is marketed under a co-promotion agreement between Abraxis BioScience, LLC. and AstraZeneca.

Abraxis
AstraZeneca

Abraxis Oncology is a division of Abraxis BioScience, LLC. All Abraxis BioScience, LLC. corporate names, names of services, and names of products referred to herein are trade names, service marks, and/or trademarks that are owned by or licensed to Abraxis BioScience, its divisions or its affiliates, unless otherwise noted.