Taxotere 20 mg


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Taxotere 20 mg


Taxotere 20 mg concentrate and solvent for solution for infusion


TAXOTERE 20 mg concentrate and solvent for solution for infusion


Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your hospital pharmacist. If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist. In this leaflet: 1. What Taxotere is and what it is used for 2. Before you use Taxotere 3. How to use Taxotere 4. Possible side-effects 5. How to store Taxotere 6. Further information What Taxotere Is And What It Is Used For

The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.

Docetaxel belongs to the group of anti-cancer medicines called taxoids.

TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:

For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. For the treatment of early breast cancer with lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide. For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin. For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone. For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil. For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil. Before You Use Taxotere

You should not be given TAXOTERE if:

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. Take special care with TAXOTERE:

Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE. In case of white blood cell disturbances, you may experience associated fever or infections.

You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE administration and to continue for one or two days after it in order to minimise certain undesirable 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).

During treatment, you may be given medication to maintain the number of your blood cells.

Taking/using other medicines:

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription. This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.

Pregnancy and 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.

Driving and using machines:

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

How To Use Taxotere

TAXOTERE will be administered to you by a healthcare professional.

Usual dosage

The dose will depend on your weight and your general condition. Your doctor will calculate your body surface area in square meters (m2) and will determine the dose you should receive.

Method and route of administration

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

Frequency of administration

You should usually receive your infusion once every 3 weeks.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE. In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give him/her results of your blood tests. Such information will allow him/her to decide whether a dose reduction is needed. If you have any further questions on the use of this product, ask your doctor or hospital pharmacist.

Possible Side Effects

Like all other anticancer medicines, TAXOTERE can cause side effects, although not everybody gets them.

Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

The most commonly reported adverse reactions of TAXOTERE alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.

The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.

During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) may occur:

flushing, skin reactions, itching chest tightness; difficulty in breathing fever or chills back pain low blood pressure

More severe reactions may occur.

The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.

Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of drugs that are received:

Very Common: (experienced in more than 1 in 10 patients)

infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets, fever: if this happens you must tell your doctor immediately allergic reactions as described above loss of appetite (anorexia) insomnia feeling of numbness or pins and needles or pain in the joints of muscles headache alteration in sense of taste inflammation of the eye or increased tearing of the eyes swelling caused by faulty lymphatic drainage shortness of breath nasal drainage; inflammation of the throat and nose; cough bleeding from the nose sores in the mouth stomach upsets including nausea, vomiting and diarrhea, constipation abdominal pain indigestion short term hair loss (in most cases normal hair growth should return) redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) change in the color of your nails, which may detach muscle aches and pains; back pain or bone pain change or absence of menstrual period swelling of the hands, feet, legs tiredness; or flu-like symptoms weight gain or loss

Common (experienced in less than 1 in 10 but more than 1 in 100 patients)

oral candidiasis dehydration dizziness hearing impaired decrease in blood pressure; irregular or rapid heart beat heart failure oesophagitis dry mouth difficulty or painful swallowing haemorrhage raised liver enzymes (hence the need for regular blood tests)

Uncommon: (experienced in more than 1 in 1,000 but less than 1 in 100)

fainting at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling inflammation of the colon, small intestine; intestinal perforation

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.

How To Store Taxotere

Keep out of the reach and sight of children.

TAXOTERE should not be used after the expiry date shown on the pack.

Do not store above 25°C or below 2°C.

Store in the original package in order to protect from light.

The premix solution should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature.

The infusion solution should be used within 4 hours at room temperature.

Further Information What TAXOTERE contains: The active substance is docetaxel. Each ml of docetaxel solution contains 40 mg of docetaxel anhydrous. One vial contains 20 mg docetaxel. The other ingredient is polysorbate 80. What TAXOTERE looks like and contents of the pack:

TAXOTERE 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80.

Each blister carton of TAXOTERE 20 mg concentrate and solvent for solution for infusion contains:

one single-dose TAXOTERE vial and, one single-dose solvent for TAXOTERE vial Marketing Authorisation Holder: Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex France Manufacturer: Aventis Pharma Dagenham Rainham Road South Dagenham Essex RM10 7XS United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom sanofi-aventis Tel:+44 (0) 1483 505 515

This leaflet was last updated in January 2007

Taxotere 20 mg

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