WHO SHOULD NOT TAKE ABRAXANE?

ABRAXANE should not be given to patients with dangerously low white blood cell counts.

HOW IS ABRAXANE® GIVEN?

ABRAXANE is injected into a vein [intravenous (I.V.) infusion] over 30 minutes.

WHAT PREMEDICATION IS REQUIRED WITH ABRAXANE?

While reactions can occur to any medication, severe allergic reactions to ABRAXANE are uncommon and premedication is not required. However, you should make your doctor aware of any allergies you may have so he/she can determine the course of action required.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ABRAXANE?

Most patients taking ABRAXANE will experience side effects, although it is not always possible to tell whether such effects are caused by ABRAXANE, another medicine they may be taking, or the cancer itself. Important side effects are described below; however, some patients may experience other side effects that are less common. Report any unusual symptoms to your doctor.

Important side effects observed in studies of patients taking ABRAXANE were as follows:

Hair Loss: Complete hair loss, or alopecia, almost always occurs with ABRAXANE. This usually involves the loss of eyebrows, eyelashes, and pubic hair, as well as scalp hair. It can occur suddenly after treatment has begun, but usually happens 14 to 21 days after treatment. Hair generally grows back after you've finished your ABRAXANE treatment.

Infections Due to Low White Blood Cell Count: Among the body's defenses against bacterial infections are white blood cells. Between your ABRAXANE treatment cycles, you will often have blood tests to check your white blood cell counts. ABRAXANE usually causes a brief drop in white blood cells. If you have a fever (temperature above 100.4°F) or other sign of infection, tell your doctor right away. Sometimes serious infections develop that require treatment in the hospital with antibiotics. Serious illness or death could result if such infections are not treated when white blood cell counts are low.

Numbness, Tingling, or Burning in the Hands and/or Feet (Neuropathy): These symptoms occur often with ABRAXANE® and usually get better or go away without medication within three weeks of interrupting treatment. Be sure to tell your doctor about any numbness, tingling or burning that you have in your hands or feet so that he/she can decide the best approach for relief of your symptoms. Sometimes it is necessary to interrupt treatment with ABRAXANE until these symptoms improve. After improvement, treatment can be restarted at a lower dose.

Fatigue and Weakness: ABRAXANE may cause asthenia, fatigue, weakness, lethargy and malaise. These side effects are usually self-limited and do not require dose modification or interruption.

Low Red Blood Cell Count: Red blood cells deliver oxygen to tissues throughout all parts of the body and take carbon dioxide from the tissues by using a protein called hemoglobin. A lowering of the volume of red blood cells may occur following ABRAXANE treatment causing anemia. Some patients may need a blood transfusion to treat the anemia. Patients can feel tired, tire easily, appear pale, and become short of breath. Contact your doctor if you experience any of these symptoms following ABRAXANE treatment.

Mouth or Lip Sores (Mucositis): Some patients develop redness and/or sores in the mouth or on the l