| s important information that more than 155,000 | | | | treating metastatic breast cancer, with a taxane |
| women in the United States currently living with | | | | chemotherapy that is free of chemical solvents. |
| metastatic breast cancer and potentially receiving | | | | Important Safety Information & Boxed Warning |
| treatment should know. | | | | You should receive Abraxane for Injectable |
| Metastatic breast cancer is the most advanced | | | | Suspension (paclitaxel protein-bound particles for |
| stage of breast cancer. Women who are | | | | injectable suspension) under the care of a doctor |
| diagnosed with this disease have seen their cancer | | | | who is trained to use cancer drugs. Because you |
| spread from the breast into other parts of their | | | | may have side effects from your treatment, you |
| body. There are various treatment options | | | | should get this medicine in a clinic or hospital with |
| available today for women with this disease, | | | | doctors, nurses and pharmacists who are trained |
| including chemotherapy, which continues to play a | | | | to give cancer drugs. |
| central role in the treatment of metastatic breast | | | | Abraxane therapy should not be given to patients |
| cancer. | | | | with metastatic breast cancer who have low |
| However, certain chemotherapy treatments-most | | | | white blood cell counts, which may make you |
| notably taxanes, which are one of the most | | | | more likely to get an infection. Your doctor will |
| commonly used types of chemotherapy for | | | | schedule frequent blood tests for you in order to |
| breast cancer-must be combined with chemical | | | | check for low blood counts. |
| solvents to be delivered into the patient's body. | | | | Note: Abraxane is paclitaxel made with the human |
| As a result, it can take a long time (in some | | | | blood protein albumin. This makes it behave |
| cases up to three hours) for a patient to receive | | | | differently in the body than regular paclitaxel. DO |
| her chemotherapy. Additionally, chemical solvents | | | | NOT SUBSTITUTE FOR OR WITH OTHER |
| can cause serious side effects such as allergic | | | | PACLITAXEL DRUGS. |
| reactions, low blood pressure, rash and shortness | | | | Important Safety Information |
| of breath, among others. In turn, this could | | | | One of the more important side effects |
| prevent patients from completing their treatment. | | | | associated with chemotherapy is neutropenia, |
| Offering a Different Approach | | | | which is a decrease in the number of |
| Science has yielded a different approach to | | | | infection-fighting white blood cells (neutrophils). |
| treating metastatic breast cancer with a taxane | | | | Normal levels range from approximately 1,500 |
| chemotherapy that is free of solvents. | | | | cells/mm3 to 1,800 cells/mm3 (but vary according |
| Abraxane® for Injectable Suspension (paclitaxel | | | | to several factors, such as age and race). If levels |
| protein-bound particles for injectable suspension) | | | | fall below 500 cells/mm3, your risk of developing |
| (albumin bound), the only solvent-free taxane | | | | an infection increases and treatment may be |
| chemotherapy, uses a unique technology to | | | | interrupted. To avoid the risk of serious infection |
| enable the delivery of the anti-cancer drug | | | | and fever, your doctor will monitor your absolute |
| paclitaxel. This unique technology is based on a | | | | neutrophil count (ANC) during therapy. |
| human protein called albumin, which is a natural | | | | Women should avoid becoming pregnant while |
| carrier of nutrients throughout the body. | | | | being treated with Abraxane. Tell your doctor if |
| "Women diagnosed with metastatic breast cancer | | | | you are pregnant, if you become pregnant, or |
| may not know that they have options regarding | | | | you plan to become pregnant while taking |
| which chemotherapy they receive," commented | | | | Abraxane. Discuss with your doctor how |
| Virginia Kaklamani, M.D., DSc, assistant professor | | | | Abraxane may affect fertility. Nursing a baby |
| Division of Hematology/ Oncology, Northwestern | | | | while taking Abraxane is not recommended |
| University. "It is important that women with this | | | | because the drug may be present in breast milk. |
| disease speak with their doctor about their | | | | In the randomized metastatic breast cancer |
| treatment options, which may include solvent-free | | | | study, the most important adverse events |
| taxane chemotherapy." | | | | included lower white and red blood cell counts, |
| The U.S. Food & Drug Administration approved | | | | infections, tingling and numbness, nausea, vomiting, |
| Abraxane in January 2005 for the treatment of | | | | diarrhea, muscle and joint aches, and mouth sores. |
| breast cancer after failure of combination | | | | Other adverse reactions included weakness, visual |
| chemotherapy for metastatic disease or relapse | | | | disturbances, fluid retention, hair loss, and liver and |
| within six months of adjuvant chemotherapy. Prior | | | | kidney dysfunction. Low platelet counts, allergic |
| therapy should have included an anthracycline | | | | reactions (which in rare cases were severe), |
| unless clinically contraindicated. | | | | cardiovascular reactions, and injection site |
| "Abraxane is the only solvent-free taxane | | | | reactions were uncommon. |
| chemotherapy approved by the FDA for the | | | | Sensory neuropathy (numbness, tingling, or |
| treatment of metastatic breast cancer. Abraxane | | | | burning in the hands and feet) can occur with |
| provides an important option for patients with this | | | | Abraxane and other paclitaxel medications. Severe |
| disease," added Dr. Kaklamani. | | | | sensory neuropathy can improve with proper |
| The most serious adverse events associated with | | | | management, as prescribed by your doctor. You |
| Abraxane in the randomized metastatic breast | | | | should tell your nurse or doctor if you experience |
| cancer study for which FDA approval was based | | | | numbness, tingling, or burning in your hands or |
| included neutropenia, anemia, infections, sensory | | | | feet while taking Abraxane. |
| neuropathy, nausea, vomiting, and myalgia | | | | Please talk to your doctor or nurse if you have |
| arthralgia. Other common adverse reactions | | | | questions regarding the potential side effects of |
| included anemia, asthenia, diarrhea, ocular/visual | | | | Abraxane therapy. |
| disturbances, fluid retention, alopecia, hepatic | | | | Abraxane is marketed under a copromotion |
| dysfunction, mucositis, and renal dysfunction. | | | | agreement between Abraxis BioScience, Inc. and |
| Science has yielded a different approach to | | | | AstraZeneca. |