Docetaxel

1. What are the general characteristics of Taxotere?

The active ingredient of Taxotere is docetaxel, a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids.

Each vial of Taxotere contains 20 mg docetaxel in 0.5 ml polysorbate 80 as an inactive ingredient.

Before use, Taxotere will be prepared with a vial of solvent containing 1.5 ml of a mixture of water and alcohol which will be added to an infusion bag before administration.

Taxotere is marketed by Rhône-Poulenc Rorer SA, 20 avenue Raymond Aron, 92165 Antony Cedex, France.

The manufacturer of Taxotere is Rhone-Poulenc Rorer Limited, Rainham Road South, Dagenham, Essex RM10 7XS.

2. What is Taxotere used for?

Taxotere has been prescribed by your doctor for the treatment of breast cancer.

3. How has the efficacy of Taxotere been studied?

Taxotere has been shown to be effective in patients who have received prior treatment for their breast cancer, however studies comparing it with other drugs are not yet completed.

4. When will you not be administered Taxotere?

• you experienced in the past a severe allergic reaction to it or to polysorbate 80 which is contained in the product.
• the number of white blood cells is too low.
• you have a severe liver disease.
• you are pregnant or breast feeding.

5. What must you do before receiving Taxotere?

You will have blood tests to check that you have enough blood cells and sufficient liver function to receive Taxotere before each administration.

You will be asked to take a steroid tablet one day prior to Taxotere administration and to continue for four days after it in order to minimise certain unwanted effects which may occur after the infusion of Taxotere in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

6. What should you know about the administration of Taxotere?

Taxotere will be given by infusion into one of your veins. The injection will last approximately one hour during which you will be in the hospital.

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square metres (m2). The usual dose of Taxotere is 100 mg/m2.

You should usually receive your infusion once every 3 weeks.

Tell your doctor if you are taking any medicine which has been prescribed for you or which you bought without a prescription.

8. May Taxotere be administered during pregnancy or while breast-feeding?

Taxotere must NOT be administered if you are pregnant or if you are planning to become pregnant. You must take adequate contraceptive precautions during therapy and for at least three months after Taxotere is no longer administered to you. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must NOT breast-feed while you are treated with Taxotere.

If you are thinking of becoming pregnant or breastfeeding discuss it with your doctor first.

9. May you drive or use machines if you have been administered with Taxotere?

There is no reason why you cannot drive between courses of Taxotere except if you feel dizzy or are unsure of yourself.

10. Does Taxotere have any side-effects?

You must be aware that as with other anti-cancer medicines, Taxotere will cause side effects. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.

During the infusion at the hospital the following may occur: allergic reactions characterised by one or more of the following: flushing, skin redness over your body, itching, chest tightness, back pain; difficulty in breathing, faintness, fever or chills, Your condition will be closely monitored during treatment.

TELL YOUR DOCTOR IMMEDIATELY IF YOU HAVE ANY OF THESE EVENTS.

• decrease in the number of red blood cells or white blood cells (which are important in fighting infections) and platelets, raised liver enzymes (hence the need for regular blood tests).
• fever (increased temperature). If you experience increased temperature, you must call your doctor immediately.
• redness and swelling of the palms of your hands or soles of your feet, which may cause your skin to peel; change in the colour of your nails which then may detach.
• swelling of the hands, feet, legs or weight gain.
• a feeling of numbness or pins and needles or pain in the joints or the muscles, weakness.
• stomach upsets including nausea, vomiting and diarrhoea, sores in the mouth.
• temporary loss of hair. After your treatment, normal hair growth should return.
• irregular or rapid heart beat, dizziness or faintness.
• pain, redness and dryness of the skin, phlebitis (inflammation of the vein) and swelling at the site of injection.
• tiredness.

You may experience one or several of these symptoms, be sure to inform your doctor if you do.

If another side effect occurs, which is not mentioned in this patient leaflet, please ask your doctor for advice.

11. How should Taxotere be stored and what is its shelf-life?

Taxotere (docetaxel) 20 mg should be stored in a refrigerator and protected from bright light. Its shelf-life under these conditions is 12 months. The expiry date is found on the box.

12. When was this patient leaflet prepared?