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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, known as "premedications," that are given to you before the paclitaxel infusion.

These premedications often include dexamethasone (a steroid), diphenhydramine (an antihistamine), and cimetidine or rantidine (a different type of histamine blocker).

Heart and Blood Vessel (Cardiovascular) Effects
Paclitaxel may cause a drop in heart rate (bradycardia) and low blood pressure (hypotension). The patient usually does not notice these changes. These changes usually do not require treatment. Your heart function, including blood pressure and pulse, will be monitored while you are receiving the medicine. You should notify your doctor if you have a history of heart disease.

Infections due to Low White Blood Cell Count
Among the body’s defenses against bacterial infections are white blood cells. Between your paclitaxel treatment cycles, you will often have blood tests to check your white blood cell counts. Paclitaxel 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.

Hair Loss
Complete hair loss, or alopecia, almost always occurs with paclitaxel. 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 paclitaxel treatment.

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

Irritation at the Injection Site
Paclitaxel sometimes causes 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 IV (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.

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 paclitaxel 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 paclitaxel 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 paclitaxel 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.

Numbness, Tingling, or Burning in the Hands and/or Feet (Neuropathy)
These symptoms occur often with paclitaxel and usually get better or go away without medication within several months of completing treatment. However, if you are uncomfortable, tell you doctor so that he/she can decide the best approach for relief of your symptoms.

Stomach Upset and Diarrhea
Some patients experience nausea, vomiting, and/or diarrhea following paclitaxel use. If you experience nausea or stomach upset, tell your doctor. 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.

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

Pregnancy/Breast-feeding During Chemotherapy
ONXOL™ can cause fetal harm when given to a pregnant woman. Women should avoid becoming pregnant while they are undergoing treatment with paclitaxel. Tell your doctor if you become pregnant or plan to become pregnant while taking ONXOL™. Because studies have shown paclitaxel to be present in the breast milk of animals receiving the drug, it may be present in human breast milk as well. Therefore, breast-feeding a baby while taking paclitaxel is NOT recommended.

Premedication
All patients should be premedicated before given ONXOL™ to prevent severe allergic reactions. Such premedication may consist of dexamethasone (given by mouth approximately 12 and 6 hours before ONXOL™), diphenhydramine (or its equivalent), and cimetidine or ranitidine IV (intravenous) given 30 to 60 minutes before paclitaxel. It is important to the take the premedication exactly as scheduled. An allergic reaction may occur if you forget to take the dexamethasone or take it the wrong time. Notify your nurse and/or doctor if you did not take the premedication as scheduled.

ONXOL™ Information

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L5099, Issue date: 08/00 (L5127 09/01)
This Patient Information Leaflet has been approved by the U.S. Food and Drug Administration

Please, contact your doctor, nurse, or other healthcare provider if you have any other questions about this medicine. This medicine was prescribed for your particular condition. This summary does not include everything there is to know about paclitaxel. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. If you have questions or concerns, or want more information about paclitaxel, your doctor or pharmacist have the complete prescribing information upon which this guide is based. You may want to read it and discuss it with your doctor.

Remember, no written summary can replace careful discussion with your doctor.