There is important information that more than 155,000 women in the United States currently living with metastatic breast cancer and potentially receiving treatment should know.
Metastatic breast cancer is the most advanced stage of breast cancer. Women who are diagnosed with this disease have seen their cancer spread from the breast into other parts of their body. There are various treatment options available today for women with this disease, including chemotherapy, which continues to play a central role in the treatment of metastatic breast cancer.
However, certain chemotherapy treatments-most notably taxanes, which are one of the most commonly used types of chemotherapy for breast cancer-must be combined with chemical solvents to be delivered into the patient’s body. As a result, it can take a long time (in some cases up to three hours) for a patient to receive her chemotherapy. Additionally, chemical solvents can cause serious side effects such as allergic reactions, low blood pressure, rash and shortness of breath, among others. In turn, this could prevent patients from completing their treatment.
Offering a Different Approach
Science has yielded a different approach to treating metastatic breast cancer with a taxane chemotherapy that is free of solvents. Abraxane? for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound), the only solvent-free taxane chemotherapy, uses a unique technology to enable the delivery of the anti-cancer drug paclitaxel. This unique technology is based on a human protein called albumin, which is a natural carrier of nutrients throughout the body.
“Women diagnosed with metastatic breast cancer may not know that they have options regarding which chemotherapy they receive,” commented Virginia Kaklamani, M.D., DSc, assistant professor Division of Hematology/ Oncology, Northwestern University. “It is important that women with this disease speak with their doctor about their treatment options, which may include solvent-free taxane chemotherapy.”
The U.S. Food & Drug Administration approved Abraxane in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
“Abraxane is the only solvent-free taxane chemotherapy approved by the FDA for the treatment of metastatic breast cancer. Abraxane provides an important option for patients with this disease,” added Dr. Kaklamani.
The most serious adverse events associated with Abraxane in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting, and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis, and renal dysfunction.
Science has yielded a different approach to treating metastatic breast cancer, with a taxane chemotherapy that is free of chemical solvents.
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 white blood cell counts, which may make you more likely to get an infection. Your doctor will schedule frequent blood tests for you in order to check for low 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.
In the randomized metastatic breast cancer study, 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.
Abraxane is marketed under a copromotion agreement between Abraxis BioScience, Inc. and 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.