Metastatic Breast Cancer Treatment Drug: ABRAXANE for Injectable Suspension

ABRAXANE for Injectable Suspension
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Online Information


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.

When going through metastatic breast cancer treatment, it is important to have access to as many helpful resources as possible. Below are Web sites that provide information about breast cancer, metastatic breast cancer treatment, breast cancer therapy, breast cancer advocacy, and a range of other topics.

This list of resources is provided merely as a convenience. Abraxis and AstraZeneca take no responsibility for the content of, or services provided by, the resources and make no representations as to the accuracy or completeness of any information provided and shall have no liability for any damages or injuries of any kind arising from the information contained within these resources.

AstraZeneca and Abraxis BioScience sites

AstraZeneca
The AstraZeneca US corporate site informs people about AstraZeneca's medicines and support programs.

AstraZeneca Cancer Support Network
AZCSN is a comprehensive support network for patients and healthcare professionals. From patient assistance programs and insurance verification to finding answers to reimbursement questions regarding AstraZeneca oncology products, AZCSN provides the support to save time and effort. Support is available each step of the way by accessing information online or calling 1-888-992-9276 Monday through Friday, 8:00 am to 8:00 pm EST.

Abraxis BioScience, Inc.
Provides information about the proprietary nab™ technology of ABRAXANE.

ARIMIDEX® (anastrozole)
The official Web site for ARIMIDEX provides complete details on how ARIMIDEX works, findings from the ATAC (ARIMIDEX, Tamoxifen Alone or in Combination) clinical trial, the risk of breast cancer recurrence, maintaining breast health, and more.

FASLODEX® (fulvestrant) Injection
The official Web site for FASLODEX Injection provides complete details for women with metastatic disease on how FASLODEX works, the results of two major clinical research studies on this medication, a resource database, and more.

IN YOUR CORNER™
When battling breast cancer, it’s important to treat the whole person, not just the illness. That’s why AstraZeneca created IN YOUR CORNER, a unique support program for women currently taking or considering taking ARIMIDEX. The site was created with the help of other women who have had breast cancer and with guidance from health care professionals. Women who register for IN YOUR CORNER receive a series of free informative mailings and e-mails that coordinate with treatment stages.

 

Online support and community

BCMets
The largest online community of people living with advanced breast cancer, their families, and their friends. Enter search criteria for information and patient mailing list submissions.

CancerCare
A national nonprofit organization that offers complimentary assistance services to those affected by cancer.

Cancer Hope Network
Offers free, confidential, one-on-one support for people with cancer and their families.

Caring 4 Cancer
An online community to help provide strength to those fighting cancer.

Imaginis
An online health resource for women and those battling breast cancer.

National Coalition for Cancer Survivorship (NCCS)
The oldest survivor-led cancer advocacy organization in the country. Advocates for superior cancer care for all Americans.

Patient Advocate Foundation (PAF)
A national nonprofit organization that aims to protect patients by finding them access to care, helping to maintain their employment, and ensuring that they are financially stable.

People Living With Cancer
An award-winning patient information Web site of the American Society of Clinical Oncology (ASCO) that contains oncologist-approved cancer information.

SusanLoveMD.org
A nonprofit organization whose purpose is to advance the quality of women's health through groundbreaking research, education and advocacy.

Breast cancer organizations

BreastCancer.org
A clearinghouse of breast cancer education information on a spectrum of topics. Support resources include chat rooms, discussion boards, and online conferences.

Johns Hopkins Avon Foundation Breast Cancer Center
Offers a wealth of clinical and support services as well as unprecedented high-quality care.

Living Beyond Breast Cancer
Provides news and message boards for women with breast cancer.

National Breast Cancer Foundation
A customizable site for breast cancer patients, survivors, caregivers, and supporters.

National Comprehensive Cancer Network (NCCN)
A not-for-profit whose primary objective is to enrich the quality and resourcefulness of the oncology practice.

Susan G. Komen Breast Cancer Foundation
Provides useful information, research news, and information on how to get involved with the Komen Race for the Cure.

Y-ME National Breast Cancer Organization
Offers general cancer and lifestyle information.

General cancer resources

American Cancer Society (ACS)
Universal cancer resources, statistics, treatment information, and health news.

Association of Cancer Online Resources (ACOR)
Provides access to 159 mailing lists that offer assistance and information to people affected by cancer.

CancerLinks
A search engine that retrieves cancer-related sites.

OncoLink
Administers information about specific types of cancer and provides news about cancer treatments and research advances.

Smith Farm Center for the Healing Arts
Healing resources and words of encouragement for those living with cancer, their families, and their health care professionals.

WebMD
Provides health information through portals, publications, and an online community with expert-led and peer-to-peer message boards.

Medical associations and government agencies

ClinicalTrials.gov
Information about federally and privately supported clinical research.

National Cancer Institute (NCI)
Contains invaluable cancer information for the general public, patients, and health care professionals.

NCI Alliance for Nanotechnology in Cancer
Provides up-to-date information on nanotech oncology.

NIH Roadmap
Offers a guide to finding information on medical research.

 

 

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.

Important Information About ARIMIDEX

ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is also approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following tamoxifen therapy. Patients with estrogen receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

Important Safety Information About ARIMIDEX

Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child.

In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include hot flashes, joint symptoms, weakness, mood changes, pain, sore throat, nausea and vomiting, depression, high blood pressure, osteoporosis, swelling of arms/legs, and headache. Fractures (including fractures of the spine, hip, and wrist) occurred more frequently with ARIMIDEX than with tamoxifen (10% vs 7%).

In advanced breast cancer trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, bone pain, and increased cough. Joint pain/stiffness has been reported in association with the use of ARIMIDEX.

ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies.

Please see full Prescribing Information. For more information, see your doctor.

Important Information About FASLODEX Injection

FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women whose disease has returned or progressed following antiestrogen therapy.

Important Safety Information About FASLODEX

Only postmenopausal women should take FASLODEX. Do not take FASLODEX if you are pregnant and do not become pregnant while taking FASLODEX, because it may harm your unborn child. (See WARNINGS and CONTRAINDICATIONS sections of full Prescribing Information.)

Because FASLODEX is administered intramuscularly, it should not be used in patients with certain blood disorders or in patients receiving anticoagulants (sometimes called blood thinners, for example, warfarin).

In clinical studies, the most commonly reported side effects were nausea, vomiting, constipation, diarrhea, abdominal pain, headache, back pain, hot flashes, sore throat, and injection site reactions with mild, transient pain and inflammation.

Please see full Prescribing Information. For more information, see your doctor.

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

©2008 Abraxis BioScience, Inc.
and AstraZeneca Pharmaceuticals LP.
All Rights Reserved. AO 711/256325  2/08

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

Abraxis
AstraZeneca

Abraxis Oncology is a division of Abraxis
BioScience, Inc. All Abraxis BioScience,
Inc. 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.

ARIMIDEX and FASLODEX are registered trademarks of AstraZeneca Pharmaceuticals LP.

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.

Important Information About ARIMIDEX

ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is also approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following tamoxifen therapy. Patients with estrogen receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

Important Safety Information About ARIMIDEX

Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child.

In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include hot flashes, joint symptoms, weakness, mood changes, pain, sore throat, nausea and vomiting, depression, high blood pressure, osteoporosis, swelling of arms/legs, and headache. Fractures (including fractures of the spine, hip, and wrist) occurred more frequently with ARIMIDEX than with tamoxifen (10% vs 7%).

In advanced breast cancer trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, bone pain, and increased cough. Joint pain/stiffness has been reported in association with the use of ARIMIDEX.

ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies.

Please see full Prescribing Information. For more information, see your doctor.

Important Information About FASLODEX Injection

FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women whose disease has returned or progressed following antiestrogen therapy.

Important Safety Information About FASLODEX

Only postmenopausal women should take FASLODEX. Do not take FASLODEX if you are pregnant and do not become pregnant while taking FASLODEX, because it may harm your unborn child. (See WARNINGS and CONTRAINDICATIONS sections of full Prescribing Information.)

Because FASLODEX is administered intramuscularly, it should not be used in patients with certain blood disorders or in patients receiving anticoagulants (sometimes called blood thinners, for example, warfarin).

In clinical studies, the most commonly reported side effects were nausea, vomiting, constipation, diarrhea, abdominal pain, headache, back pain, hot flashes, sore throat, and injection site reactions with mild, transient pain and inflammation.

Please see full Prescribing Information. For more information, see your doctor.

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

©2008 Abraxis BioScience, Inc. and AstraZeneca Pharmaceuticals LP. All Rights Reserved. AO 711/256325  2/08
(Site updated 2/07)

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

Abraxis
AstraZeneca

Abraxis Oncology is a division of Abraxis BioScience, Inc. All Abraxis BioScience, Inc. 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.

ARIMIDEX and FASLODEX are registered trademarks of AstraZeneca Pharmaceuticals LP.