Metastatic Breast Cancer Treatment Drug: ABRAXANE for Injectable Suspension


 

About Breast Cancer & Chemotherapy


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.

There are many different types of breast cancer. Likewise, there are many different ways of treating breast cancer, depending on the type of cancer, how far it has progressed, and personal decisions made by women and their health care professionals. This part of ABRAXANE.com provides an overview of these topics—please talk to your doctor to learn more. You can also visit other helpful resources on the Web to further explore these topics.

Click here for a list of online resources.

To learn more about breast cancer and chemotherapy, click on the links below:

About breast cancer tumors

The body is made up of billions of cells that form tissue and organs. Cells are replaced on a regular basis, allowing each organ to continue to function normally. During this process, cells that die are replaced by new cells. Occasionally, cells are replaced by abnormal cells that grow in an uncontrolled way. As a result, there is an abnormal growth or lump of cells that form a tumor.

There are two kinds of breast tumors: noncancerous (benign) tumors and cancerous (malignant) tumors. Benign breast tumors are not cancerous and do not spread outside the breast in which they appear. Malignant breast tumors are cancerous and are made up of cells that can spread from the breast to other parts of the body.

There are several different types of breast cancer. In many cases, breast cancer starts in the ducts or lobules of the breast (where milk can be produced). In the early stages of breast cancer, breast tumors found in these ducts are called "in situ," meaning that they are in one location and are noninvasive. Invasive breast cancer means that the cancerous breast tumor has broken through the wall of the ducts or lobules and spread to other parts of the body.


Illustration courtesy of the National Cancer Institute

Treatment will vary depending on the type of breast cancer, so it is important to have a thorough medical examination to determine exactly which type is present. For more information about breast tumors, visit our Online Information page.

ABRAXANE® is used to treat tumors that have spread to other parts of the body.

ABRAXANE 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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About metastatic breast cancer

Some tumors are benign, meaning that they are not cancerous and will not spread beyond the breast into other organs. Malignant breast tumors are cancerous and are made up of cells that can spread from the breast to other parts of the body. Because of their ability to spread and grow in other organs, malignant breast tumors can interfere with normal body function and can be life-threatening.

Breast cancer cells that metastasize, or break away from the main malignant tumor, can travel to other parts of the body, such as the bones, liver, lungs, or brain. The blood and lymph are body fluids that can carry these cancer cells from the main tumor to other parts of the body.

For more information about metastatic breast cancer, visit our Online Information page.

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Learning about chemotherapy

Chemotherapy is the use of drugs to destroy cancer cells, including those that have spread to areas other than the breast.

The drugs used in chemotherapy are called cytotoxic drugs because they kill cells. The drugs circulate throughout the body in the bloodstream, killing both cancer cells and some healthy cells. Chemotherapy drugs are carefully controlled in both dosage and frequency so that cancer cells are destroyed while minimizing the risk to healthy cells. Several different types of cytotoxic agents are used to treat breast cancer.

The choice of chemotherapy is different for each person and depends on what kind of cancer a person has, how large the tumor is, and how far it has spread. You and your doctor will decide whether chemotherapy is right for you and which drugs are most appropriate given your type and stage of breast cancer.

For more information about chemotherapy, visit our Online Information page.

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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.