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PATIENT INFORMATION

PACLITAXEL INJECTION

WHAT IS PACLITAXEL?

Paclitaxel is a prescription cancer medicine. It is injected into a vein and it is used to treat different types of tumors. The tumors include advanced ovary and breast cancer.

WHAT IS CANCER?

Under normal conditions, the cells in your body divide and grow in an orderly, controlled way. Cell division and growth are necessary for the human body to perform its functions and to repair itself, when necessary. Cancer cells are different from normal cells because they are not able to control their own growth. The reasons for this abnormal growth are not yet fully understood.

A tumor is a mass of unhealthy cells that are dividing and growing fast and in an uncontrolled way. When a tumor invades surrounding healthy body tissue it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original site to other parts of the body if not found and treated early.

HOW DOES PACLITAXEL INJECTION WORK?

Paclitaxel Injection is a type of medical treatment called chemotherapy. The purpose of chemotherapy is to kill cancer cells or prevent their growth.

All cells, whether they are healthy cells or cancer cells, go through several stages of growth. During one of the stages, the cell starts to divide. Paclitaxel may stop the cells from dividing and growing, so they eventually die. In addition, normal cells may also be affected by paclitaxel causing some of the side effects.  (See WHAT ARE THE POSSIBLE SIDE EFFECTS OF PACLITAXEL?)

WHO SHOULD NOT TAKE PACLITAXEL?

Patients who have a history of hypersensitivity (allergic reactions) to paclitaxel or other drugs containing Cremophor® EL* (Polyoxyl 35 castor Oil, NF), like cyclosporine or teniposide, should not be given paclitaxel.  In addition, paclitaxel should not be given to patients with dangerously low white blood cell counts.

HOW IS PACLITAXEL GIVEN?

Paclitaxel is injected into a vein [intravenous (I.V.) infusion].  Before you are given paclitaxel, you will have to take certain medicines (premedications) to prevent or reduce the chance you will have a serious allergic reaction.  Such reactions have occurred in a small number of patients while receiving paclitaxel and have been rarely fatal. (See WHAT ARE THE POSSIBLE SIDE EFFECTS OF PACLITAXEL? below.)

WHAT ARE THE POSSIBLE SIDE EFFECTS OF PACLITAXEL?

Most patients taking paclitaxel will experience side effects, although it is not always possible to tell whether such effects are caused by paclitaxel, 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 PACLITAXEL WERE AS FOLLOWS:

- Allergic reactions.  Allergic reactions can vary in degrees of severity. They may cause death in rare cases.  When a severe allergic reaction develops, it usually occurs at the time the medicine is entering the body (during paclitaxel infusion).  Allergic reactions may cause trouble breathing, very low blood pressure, sudden swelling, and/or hives or rash.  The likelihood of a serious allergic reaction is lowered by the use of several kinds of medicines that are given to you before the paclitaxel infusion.

- Heart and blood ve