Details for: ABRAXANE FOR INJECTABLE SUSPENSION

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/38°C) 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 (Neuropathy): These symptoms in the hands and/or feet occur often with ABRAXANE and usually get better or go away without medication within three weeks of interrupting treatment. Weakness or paralysis of the muscles of the face have also been reported with the use of ABRAXANE. Be sure to tell your doctor about any numbness, tingling or burning that you have in your face, 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 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 lips. These symptoms might occur a few days after the ABRAXANE treatment and usually decrease or disappear within one week. Talk with your doctor about proper mouth care and other ways to prevent or reduce your chances of developing mucositis.

Joint and Muscle Pain: You may get joint and muscle pain a few days after your ABRAXANE treatment. These symptoms usually disappear in a few days. Although pain medicine may not be necessary, tell your doctor if you are uncomfortable.

Stomach Upset and Diarrhea: Some patients experience nausea, vomiting, and/or diarrhea following ABRAXANE use. If you experience nausea or stomach upset, tell your doctor because medicines can be given that almost always reduce or eliminate these symptoms. Diarrhea will usually disappear without treatment; however, if you experience severe abdominal or stomach area pain and/or severe diarrhea, tell your doctor right away.

Heart and Blood Vessel (Cardiovascular) Effects: ABRAXANE may cause a drop in heart rate (bradycardia), low blood pressure (hypotension), irregular heartbeat, and chest pain. The patient usually does not notice these changes. You should notify your doctor if you feel dizziness, chest pain, shortness of breath, or faint during treatment with ABRAXANE.

Irritation at the Injection Site: ABRAXANE may cause irritation at the site where it enters the vein. Reactions may include discomfort, redness, swelling, inflammation (of the surrounding skin or of the vein itself), and ulceration (open sores). These reactions are usually caused by the i.v. (intravenous) fluid leaking into the surrounding area. If you notice anything unusual at the site of the injection (needle), either during or after treatment, tell your doctor right away.

Respiratory: ABRAXANE may cause shortness of breath and cough. Sometimes these symptoms are a sign of serious lung inflammation due to ABRAXANE. You should notify your doctor right away if you develop a cough and/or shortness of breath while taking ABRAXANE treatment.

Ability to Drive and Use Machines: Adverse events such as fatigue, weakness and malaise may affect your ability to drive and use machines.

Other Side Effects: ABRAXANE may cause mild allergic reactions during the infusion such as flushing. ABRAXANE may also cause vision disturbances, changes in your nails and rash. Tell your doctor if you experience blurry or decreased central vision.
Rare occurrences of severe allergic reactions have been reported with ABRAXANE. In very rare cases these reactions have been fatal. Patients who experience a severe allergic reaction to ABRAXANE should not receive ABRAXANE again.

Talk with your doctor or other healthcare professional to discuss ways to prevent or reduce some of these side effects. Because this leaflet does not include all possible side effects that can occur with ABRAXANE, it is important to talk with your doctor about other possible side effects.