ABRAXANE is a prescription medicine for breast cancer that has spread to other parts of the body. ABRAXANE is used after treatment with combination chemotherapy has stopped working, including anthracyclines, if appropriate, or when the cancer has come back within 6 months of treatment after surgery.

Important Safety Information About ABRAXANE^®

• ABRAXANE has not been studied in people with kidney problems
• If you are pregnant, or become pregnant, ABRAXANE can cause harm to your unborn baby. You should avoid becoming pregnant while taking ABRAXANE
• Men should not father a child while being treated with ABRAXANE
• If you have a very low white blood cell count, you should not take ABRAXANE. If your white blood cell count goes down while taking ABRAXANE, you should stop taking it until your white blood cell count returns to normal. If your white blood cell count drops very low, your doctor will lower your dose of ABRAXANE
• It is not known whether ABRAXANE interacts with other drugs, so be sure to tell your doctor about any medicines you are taking
• People treated with ABRAXANE often have a side effect called sensory neuropathy, a numbness, tingling, or burning in the hands, feet, and ankles. If you get mild sensory neuropathy, you will probably not have to lower your dose of ABRAXANE. If sensory neuropathy becomes severe, you may have to stop taking ABRAXANE until it improves, and then continue treatment at a lower dose
• Treatment with ABRAXANE can make liver problems worse. If you have liver problems, your starting dose of ABRAXANE should be lowered
• Treatment with ABRAXANE can cause irritation where the medicine is injected (injection site reactions). When taking ABRAXANE, you should be monitored by your doctor or nurse to make sure no problems occur at the injection site
• Since it is not known if ABRAXANE passes into human milk, you should stop nursing if you are taking ABRAXANE
• You should not drive a car when you are being treated with ABRAXANE. Side effects such as feeling very tired (fatigue), having no energy (lethargy), or feeling sick (malaise) can affect your ability to drive or use machinery
• In a clinical trial, severe heart and blood vessel side effects occurred in approximately 3% of women taking ABRAXANE. Side effects included chest pain, heart attack, fluid under the skin, blood clots in the veins or lungs, and high blood pressure. Stroke and heart failure were rare
• The most important side effects during treatment with ABRAXANE included hair loss, low white blood cell count, sensory neuropathy, weakness, muscle or joint pain, low red blood cell count (anemia), nausea, diarrhea, infection, vomiting, and sores in the mouth or on the lips (mucositis)
• Other side effects included vision problems, kidney problems, fluid retention, liver problems, and allergic reactions, and a decrease in blood clotting cells (platelets). Dehydration and fever were common

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.