Taxotere

Italy

Brand name Taxotere

Form solution for infusion, concentrate

Active substance / Dosage

DOCETAXEL

Prescription type Restricted prescription – hospital or equivalent facility use only

ATC code

L01CD02

Registration number 032391

Manufacturer SANOFI WINTHROP INDUSTRIE

Taxotere solution for infusion, concentrate

Table of Contents

Package leaflet: Information for the patient
TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion
1. What TAXOTERE is and what it is used for
2. What you should know before using TAXOTERE
3. How to use TAXOTERE
4. Possible side effects
5. How to store TAXOTERE
6. Package contents and other information
1. COMPOSITION
2. PRESENTATION
3. RECOMMENDATIONS FOR SAFE HANDLING
4. PREPARATION FOR INTRAVENOUS ADMINISTRATION
5. DISPOSAL INSTRUCTIONS
Patient information leaflet
TAXOTERE 80 mg/2 ml concentrate and solvent for infusion solution
1. What TAXOTERE is and what it is used for
2. What you should know before using TAXOTERE
3. How to use TAXOTERE
4. Possible side effects
5. How to store TAXOTERE
6. Package contents and other information
1. COMPOSITION
2. PRESENTATION
3. RECOMMENDATIONS FOR SAFE HANDLING
4. PREPARATION FOR INTRAVENOUS ADMINISTRATION
5. DISPOSAL METHOD
Patient information leaflet: information for the patient
TAXOTERE 20 mg/1 ml concentrate for solution for infusion
1. What TAXOTERE is and what it is used for
2. What you must know before using TAXOTERE
3. How to use TAXOTERE
4. Possible side effects
5. How to store TAXOTERE
6. Package Contents and Other Information
Patient Information Leaflet
TAXOTERE 80 mg/4 ml concentrate for solution for infusion
1. What TAXOTERE is and what it is used for
2. What you should know before using TAXOTERE
3. How to use TAXOTERE
4. Possible side effects
5. How to store TAXOTERE
6. Package Contents and Other Information
Patient information leaflet: information for the patient
TAXOTERE 160 mg/8 ml concentrate for solution for infusion
1. What TAXOTERE is and what it is used for
2. What you should know before using TAXOTERE
3. How to use TAXOTERE
4. Possible side effects
5. How to store TAXOTERE
6. Package contents and other information

Package leaflet: Information for the patient

TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion

docetaxel
Read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, hospital pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, hospital pharmacist, or nurse. (See section 4). Contents of this leaflet:
1. What TAXOTERE is and what it is used for
2. What you need to know before using TAXOTERE
3. How to use TAXOTERE
4. Possible side effects
5. How to store TAXOTERE
6. Contents of the pack and other information

1. What TAXOTERE is and what it is used for

The name of this medicine is TAXOTERE. The name of the active substance is docetaxel.
Docetaxel is a substance derived from the needle-like leaves of the yew tree and belongs to a group of anticancer agents known as taxanes.
TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, stomach adenocarcinoma, or head and neck cancer:

for the treatment of advanced breast cancer, TAXOTERE may be given alone or in combination with doxorubicin, trastuzumab, or capecitabine.
for the treatment of early-stage breast cancer with or without lymph node involvement, TAXOTERE may be given in combination with doxorubicin and cyclophosphamide.
for the treatment of lung cancer, TAXOTERE may be given alone or in combination with cisplatin.
for the treatment of prostate cancer, TAXOTERE is given in combination with prednisone or prednisolone.
for the treatment of metastatic stomach adenocarcinoma, TAXOTERE is given in combination with cisplatin and 5-fluorouracil.
for the treatment of head and neck cancer, TAXOTERE is given in combination with cisplatin and 5-fluorouracil.

2. What you should know before using TAXOTERE

Do not take TAXOTERE:

if you are allergic (hypersensitive) to docetaxel or to any of the excipients in TAXOTERE (listed in section 6);
if your white blood cell count is too low;
if you have severe liver problems.

Warnings and precautions
Before each treatment with TAXOTERE, blood tests must be performed to determine whether blood cells are sufficiently numerous and whether liver function is adequate. If abnormalities in white blood cells occur, fever or infections may also develop.
Immediately inform your doctor, hospital pharmacist, or nurse if you experience abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stools, or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor will address this immediately.
Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience vision problems, particularly blurred vision, you must have your eyes and vision checked immediately.
Inform your doctor, hospital pharmacist, or nurse if you have previously had an allergic reaction to paclitaxel therapy.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If you develop acute lung problems or if pre-existing symptoms worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may discontinue treatment immediately.
You will be asked to take a preventive treatment with oral corticosteroids such as dexamethasone one day before administration of TAXOTERE and to continue for one or two days afterwards in order to reduce certain adverse effects that may occur following infusion of TAXOTERE, particularly allergic reactions and fluid retention (swelling of hands, feet, legs, or weight gain).
During treatment, you may need medication to maintain your blood cell count.
Severe skin reactions have been reported with TAXOTERE, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP).

Symptoms of SJS/TEN may include blisters, peeling or bleeding of the skin in any area (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also experience flu-like symptoms such as fever, chills, or muscle pain at the same time.
Symptoms of AGEP may include a widespread scaly and red rash with swollen bumps under the skin (including skin folds, trunk, and upper extremities), accompanied by blisters and fever. If you develop severe skin reactions or any of the reactions listed above, contact your doctor or a healthcare professional immediately. Before starting TAXOTERE, inform your doctor, hospital pharmacist, or nurse if you have kidney problems or high levels of uric acid in your blood. TAXOTERE contains alcohol. Inform your doctor if you suffer from alcohol dependence, epilepsy, or liver impairment. See also the section “TAXOTERE contains ethanol (alcohol)” below. Other medicines and TAXOTERE Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. This is because TAXOTERE or other medicines may not work as expected and you may be more likely to experience adverse effects.

The amount of alcohol in this medicine may alter the effects of other medicines.
Pregnancy, breastfeeding and fertility
Ask your doctor for advice before taking any medicine.
TAXOTERE must not be administered during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment and for 2 months after the end of treatment with this medicine. You must use adequate contraception during treatment and for 2 months after the end of treatment because TAXOTERE may be harmful to the unborn child. If you become pregnant during treatment, inform your doctor immediately.
You must not breastfeed during treatment with TAXOTERE.
If you are a man receiving treatment with TAXOTERE, you must not father a child and must use adequate contraception during treatment and for 4 months after the end of treatment with this medicine. It is recommended that you seek information about sperm preservation before starting treatment, as docetaxel may impair male fertility.
Driving and using machines:
The amount of alcohol in this medicine may impair your ability to drive or use machinery.
You may experience adverse effects from this medicine that could impair your ability to drive, or use equipment or machinery (see section 4 Possible side effects). If this occurs, do not drive and do not use any equipment or machinery until you have discussed it with your doctor, nurse, or hospital pharmacist.
TAXOTERE contains ethanol (alcohol)
This medicine contains 13% (p/p) of 95% v/v ethanol (alcohol), i.e. up to 252 mg of 95% v/v ethanol per solvent vial, equivalent to 6 ml of beer or 2.6 ml of wine.
Harmful for individuals suffering from alcoholism.
The presence of ethanol should also be considered during pregnancy or breastfeeding, in the treatment of children, and in high-risk populations such as patients with liver disease or epilepsy.
The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

3. How to use TAXOTERE

TAXOTERE will be administered to you by a healthcare professional.
Usual dose:
The dose will depend on your body weight and general health condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
Method and route of administration:
TAXOTERE will be administered by intravenous infusion (for intravenous use only). The infusion will last approximately 1 hour and will be given in a hospital setting.
Frequency of administration:
The infusion is normally given once every 3 weeks.
Your doctor may adjust the dose and frequency based on blood test results, your general condition, and your response to TAXOTERE. In particular, inform your doctor if you experience diarrhoea, mouth inflammation, numbness, tingling, or fever, and show them your blood test results. This information will help the doctor decide whether a dose reduction is necessary. If you have any doubts about the use of this medicine, consult your doctor or hospital pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss this with you and explain the potential risks and benefits of treatment.
The most commonly reported adverse reactions with TAXOTERE alone are: reduction in the number of red or white blood cells, hair loss, nausea, vomiting, mouth inflammation, diarrhoea, and fatigue.
If you are given TAXOTERE in combination with other chemotherapeutic agents, the severity of side effects may increase.

During the infusion in hospital, the following allergic reactions may occur (may affect more than 1 in 10 people):

hot flushes, skin reactions, itching
tightness in the chest, difficulty breathing
fever or chills
back pain
low blood pressure

More severe reactions may occur. If you have previously had a hypersensitivity reaction to paclitaxel, you may develop a hypersensitivity reaction to docetaxel, which could be more severe. Your condition will be closely monitored by hospital staff during treatment. Inform hospital staff immediately if you notice any of these effects.

Between TAXOTERE infusions, the following side effects may occur, and their frequency may vary depending on the concomitant medications you are taking:

Very common (may affect more than 1 in 10 people):

infections, decreased number of red blood cells (anaemia) or white blood cells (the latter are important in fighting infections) and platelets
fever: in this case, you must inform your doctor immediately
allergic reactions as described above
loss of appetite (anorexia)
insomnia
sensation of numbness, tingling, or pain in joints or muscles
headache
altered sense of taste
eye inflammation or increased eye tearing
swelling due to insufficient lymphatic drainage
difficulty breathing
nasal mucus discharge; throat and nose inflammation; cough
nosebleeds
mouth inflammation
stomach disorders including nausea, vomiting, diarrhoea, constipation
abdominal pain
indigestion
hair loss (in most cases, hair regrowth returns to normal). In some cases (frequency unknown), permanent hair loss has been observed
redness and swelling of the palms of the hands or soles of the feet, which may cause skin peeling (this may also occur on arms, face, or body)
changes in nail colour, which may lead to nail loss
muscle pain; back pain or bone pain
changes or absence of menstrual cycle
swelling of hands, feet, legs
fatigue or flu-like symptoms
weight gain or weight loss
upper respiratory tract infection

Common (may affect up to 1 in 10 people):

oral candidiasis
dehydration
dizziness
hearing disturbances
low blood pressure; irregular or rapid heartbeat
heart failure
oesophagitis
dry mouth
difficulty or pain when swallowing
haemorrhage
increased liver enzymes (requiring regular blood tests)
increased blood sugar levels (diabetes)
decreased potassium, calcium, and/or phosphate levels in the blood

Uncommon (may affect up to 1 in 100 people):

fainting
skin reactions at the injection site, phlebitis (vein inflammation), or swelling
blood clot formation
acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel in combination with certain other anticancer treatments

Rare (may affect up to 1 in 1,000 people):

inflammation of the colon or small intestine, which may be fatal (frequency unknown); intestinal perforation

Frequency not known (cannot be estimated from available data):

pulmonary interstitial disorders (lung inflammation that may cause cough and difficulty breathing. Lung inflammation may also develop when docetaxel treatment is administered concurrently with radiotherapy)
pneumonia (lung infections)
pulmonary fibrosis (scarring and thickening in the lungs causing shortness of breath)
blurred vision due to retinal swelling inside the eye (cystoid macular oedema)
decreased sodium and/or magnesium levels in the blood (electrolyte imbalance)
ventricular arrhythmia or ventricular tachycardia (manifested as rapid or irregular heartbeat, severe shortness of breath, dizziness, and/or fainting). Some of these symptoms may be serious. If this occurs, you must inform a doctor immediately
injection site reactions at the site of a previous reaction
non-Hodgkin’s lymphoma (a cancer affecting the immune system) and other tumours may occur in patients treated with docetaxel in combination with certain other anticancer treatments
Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blisters, skin peeling or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms such as fever, chills, or muscle pain)
Acute Generalized Exanthematous Pustulosis (AGEP) (widespread scaly and red rash with swollen bumps under the skin (including skin folds, trunk, and upper extremities) and blisters accompanied by fever)
Tumour lysis syndrome is a serious condition characterised by changes in blood tests such as increased levels of uric acid, potassium, and phosphate, and decreased calcium levels; it causes symptoms such as seizures, kidney failure (reduced urine output or dark urine), and disturbances in heart rhythm. In such cases, you must inform your doctor immediately
Myositis (muscle inflammation – warmth, redness, and swelling – causing muscle pain and weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TAXOTERE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister, and vial.
Do not store at temperatures above 25°C or below 2°C.
Store the medicine in the original packaging to protect it from light.
The prediluted solution should be used immediately after preparation, although chemical and physical stability of the solution has been demonstrated for up to 8 hours when stored between +2°C and +8°C or at room temperature (below 25°C).
The solution must be used within 4 hours when stored at room temperature (below 25°C).

6. Package contents and other information

What the TAXOTERE concentrate vial contains:
The active substance is docetaxel (as trihydrate). Each ml of docetaxel solution contains 40 mg of
docetaxel (anhydrous). One vial contains 20 mg/0.5 ml of docetaxel. The other components are
polysorbate 80 and citric acid.
What the solvent vial contains:
13% (p/p) ethanol 95% (see section 2) in water for injections.
Description of the appearance of TAXOTERE and package contents:
TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear, viscous solution ranging
from yellow to brownish-yellow.
Each package contains:

one single-dose vial of concentrate and
one single-dose vial of solvent.

Marketing Authorization Holder:
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturers:
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
65926 Frankfurt am Main
Germany

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

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 236 91 40
България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Тел.: +359 (0)2 4942 480 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Česká republika Magyarország
Sanofi s.r.o. sanofi-aventis zrt., Magyarország
Tel: +420 233 086 111 Tel.: +36 1 505 0050
Danmark Malta
Sanofi A/S sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39. 02 39394275
Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel.: 0800 52 52 010 Tel: +31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 131
Eesti Norge
Swixx Biopharma OÜ sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00
Ελλάδα Österreich
Sanofi-Aventis Μονοπρόσωπη AEBE sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0
España Polska
sanofi-aventis, S.A. sanofi-aventis Sp. z o.o.
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00
France Portugal
Sanofi Winthrop Industrie Sanofi - Produtos Farmacêuticos, Lda.
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Appel depuis l’étranger : +33 1 57 63 23 23
Hrvatska România
Swixx Biopharma d.o.o. Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40 (0) 21 317 31 36
Ireland Slovenija
sanofi-aventis Ireland Ltd. T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 235 51 00
Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600
Italia Suomi/Finland
sanofi S.r.l. Sanofi Oy
Tel: 800536389 Puh/Tel: +358 (0) 201 200 300
Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ: +357 22 741741 Tel: +46 (0)8 634 50 00
Latvija United Kingdom (Northern Ireland)
Swixx Biopharma SIA sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +371 6 616 47 50 Tel: +44 (0) 800 035 2525

This leaflet was last updated
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
The following information is intended for healthcare professionals only.
INSTRUCTIONS FOR THE PREPARATION OF TAXOTERE 20 mg/0.5 ml CONCENTRATE FOR
INFUSION SOLUTION AND ITS CORRESPONDING SOLVENT FOR TAXOTERE
It is important that you read the entire content of this guide before preparing either the
prediluted TAXOTERE solution or the infusion solution of TAXOTERE.

1. COMPOSITION

TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear, viscous solution with a yellow to yellow-brown colour, containing 40 mg/ml of docetaxel (anhydrous) in polysorbate 80 and citric acid. The solvent for TAXOTERE is a 13% (w/w) solution of 95% ethanol in water for injections.

2. PRESENTATION

TAXOTERE is supplied in single-dose vials.
Each package contains one vial of TAXOTERE (20 mg/0.5 ml) and one vial of the corresponding solvent for TAXOTERE in a blister pack.
TAXOTERE vials must be stored between +2°C and +25°C, protected from light.
TAXOTERE must not be used after the expiry date stated on the packaging, blister pack, and vial.

2.1 TAXOTERE 20 mg/0.5 ml vials:

The TAXOTERE 20 mg/0.5 ml vial has a capacity of 7 ml, is made of clear glass and has a removable green cap.
The TAXOTERE 20 mg/0.5 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
Each TAXOTERE 20 mg/0.5 ml vial contains 0.5 ml of a 40 mg/ml docetaxel solution in polysorbate 80 (fill volume: 24.4 mg/0.61 ml). This overfill was established during the development of TAXOTERE to compensate for liquid loss during the preparation of the prediluted solution (see section 4), due to foam formation, adherence to the vial walls, and "dead space". This overfill ensures that, after dilution with the entire contents of the accompanying solvent vial, the minimum extractable volume of the prediluted solution is 2 ml, containing 10 mg/ml of docetaxel, corresponding to the labeled content of 20 mg/0.5 ml per vial.

2.2 Solvent for TAXOTERE 20 mg/0.5 ml vials:

The solvent for TAXOTERE 20 mg/0.5 ml is contained in a 7 ml clear glass vial with a removable transparent cap.
The solvent for TAXOTERE 20 mg/0.5 ml consists of a 13% (w/w) solution of 95% ethanol in water for injections.
Each solvent vial for TAXOTERE 20 mg/0.5 ml contains 1.98 ml of solution. This volume has been calculated based on the actual volume of the TAXOTERE 20 mg/0.5 ml vials. Adding the entire contents of the solvent vial to the TAXOTERE 20 mg/0.5 ml vial ensures the preparation of a prediluted solution containing 10 mg/ml of docetaxel.

3. RECOMMENDATIONS FOR SAFE HANDLING

TAXOTERE is an antineoplastic drug and, as with other potentially toxic products, caution should be exercised when handling and preparing solutions. The use of gloves is recommended.
If concentrated, prediluted, or infusion solution of TAXOTERE comes into contact with the skin, immediately and thoroughly wash with water and soap. If concentrated, prediluted, or infusion solution of TAXOTERE comes into contact with mucous membranes, immediately and thoroughly rinse with water.

4. PREPARATION FOR INTRAVENOUS ADMINISTRATION

4.1 Preparation of the pre-diluted TAXOTERE solution (10 mg of docetaxel/ml)

Stylized blue drawing of two medicine vials placed side by side with a clock above indicating the

4.1.1 If vials have been refrigerated, allow the required number of TAXOTERE cartons to reach room temperature (below 25°C) for 5 minutes.

Technical blue drawing of a needle piercing through the rubber stopper of a medicine vial for dose preparation

4.1.2 Using a graduated syringe with a needle, under aseptic conditions, draw up the entire contents of the TAXOTERE solvent vial by inverting the vial slightly.

Technical blue drawing of two glass vials with rubber stoppers and a dropper pouring liquid into the foreground vial

4.1.3 Inject the entire contents of the syringe into the corresponding TAXOTERE vial.

Blue technical drawing of a glass vial with a curved arrow indicating rotational movement of the cap for

4.1.4 Remove the syringe and needle and mix the solution manually by repeated inversion for 45 seconds. Do not shake.

Blue technical drawing of a glass vial with a screw cap and small granules of powder at the bottom of the container

4.1.5 Allow the pre-diluted solution vial to stand for 5 minutes at room temperature (below 25°C), then check that the solution is clear and homogeneous (foam formation is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
The pre-diluted solution contains 10 mg/ml of docetaxel and must be used immediately after preparation, although chemical and physical stability of this solution has been demonstrated for up to 8 hours when stored between +2°C and +8°C or at room temperature (below 25°C).

4.2 Preparation of the infusion solution

4.2.1 Several vials of pre-diluted solution may be required to achieve the patient's required dose. Based on the patient's dose expressed in mg, aseptically withdraw the corresponding volume of pre-diluted solution containing 10 mg/ml of docetaxel from an appropriate number of vials using a graduated syringe with a needle. For example, for a docetaxel dose of 140 mg, 14 ml of pre-diluted docetaxel solution should be withdrawn.

Stylized blue drawing of a syringe with needle next to a human torso silhouette showing abdomen and legs

4.2.2 Inject the required volume of pre-diluted solution into a 250 ml bag or bottle containing 5% glucose solution or 9 mg/ml sodium chloride (0.9%) infusion solution. If a docetaxel dose exceeding 200 mg is required, use a larger volume of infusion solution so that the docetaxel concentration does not exceed 0.74 mg/ml.

Blue stylized drawing of a medicine package with a curved arrow indicating a rotational movement around the package

4.2.3 Mix the bag or bottle manually by gentle rotation.
4.2.4 The TAXOTERE infusion solution must be used within 4 hours and should be administered as a 1-hour infusion under aseptic conditions, at room temperature (below 25°C), and under normal lighting conditions.

Blue stylized drawing of a human torso with a circular prohibition sign and diagonal bar superimposed on the

4.2.5 As with all parenteral products, the pre-diluted solution and the TAXOTERE infusion solution should be inspected visually prior to use; any solutions containing particulate matter or precipitates must be discarded.

5. DISPOSAL INSTRUCTIONS

All devices used for diluting or administering TAXOTERE must be handled in accordance with standard procedures. Do not dispose of any medicinal product via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Patient information leaflet

TAXOTERE 80 mg/2 ml concentrate and solvent for infusion solution

docetaxel
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, hospital pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, hospital pharmacist, or nurse. (See section 4). Contents of this leaflet:
1. What TAXOTERE is and what it is used for
2. What you need to know before using TAXOTERE
3. How to use TAXOTERE
4. Possible side effects
5. How to store TAXOTERE
6. Contents of the pack and other information

1. What TAXOTERE is and what it is used for

The name of this medicine is TAXOTERE. The name of the active substance is docetaxel.
Docetaxel is a substance derived from the needle-like leaves of the yew plant and belongs to a group
of anticancer agents called taxanes.
TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, certain types of
lung cancer (non-small cell lung cancer), prostate cancer, gastric adenocarcinoma, or head and neck cancer:

for the treatment of advanced breast cancer, TAXOTERE may be given alone or in combination with doxorubicin, trastuzumab, or capecitabine.
for the treatment of early breast cancer with or without lymph node involvement, TAXOTERE may be given in combination with doxorubicin and cyclophosphamide.
for the treatment of lung cancer, TAXOTERE may be given alone or in combination with cisplatin.
for the treatment of prostate cancer, TAXOTERE is given in combination with prednisone or prednisolone.
for the treatment of metastatic gastric adenocarcinoma, TAXOTERE is given in combination with cisplatin and 5-fluorouracil.
for the treatment of head and neck cancer, TAXOTERE is given in combination with cisplatin and 5-fluorouracil.

2. What you should know before using TAXOTERE

Do not take TAXOTERE:

if you are allergic (hypersensitive) to docetaxel or to any of the excipients of TAXOTERE (listed in section 6);
if your white blood cell count is too low;
if you have severe liver problems.

Warnings and precautions
Before each treatment with TAXOTERE, blood tests must be performed to determine whether blood cells are sufficiently numerous and whether liver function is adequate. If white blood cell counts are abnormal, you may experience fever or infections.
Immediately inform your doctor, hospital pharmacist, or nurse if you have abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stools, or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which may be fatal. Your doctor will address this immediately.
Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience vision problems, particularly blurred vision, you must have your eyes and vision examined immediately.
Inform your doctor, hospital pharmacist, or nurse if you have previously had an allergic reaction to paclitaxel therapy.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If you develop acute lung problems or if pre-existing symptoms worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue treatment.
You will be asked to take a preventive treatment with oral corticosteroids, such as dexamethasone, one day before administration of TAXOTERE and to continue for one or two days afterwards, in order to reduce certain adverse effects that may occur following infusion of TAXOTERE, particularly allergic reactions and fluid retention (swelling of the hands, feet, legs, or weight gain).
During treatment, you may need medication to maintain the number of blood cells.
Severe skin reactions have been reported with TAXOTERE, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP).

Symptoms of SJS/TEN may include blisters, peeling or bleeding of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms such as fever, chills, or muscle pain at the same time.
Symptoms of AGEP may include a generalized scaly and red rash with swollen bumps under the skin (including skin folds, trunk, and upper extremities) and blisters accompanied by fever. If you develop severe skin reactions or any of the reactions listed above, contact your doctor or a healthcare professional immediately. Before starting TAXOTERE, inform your doctor, hospital pharmacist, or nurse if you have kidney problems or high levels of uric acid in the blood. TAXOTERE contains alcohol. Inform your doctor if you suffer from alcohol dependence, epilepsy, or liver insufficiency. See also the section “TAXOTERE contains ethanol (alcohol)” below. Other medicines and TAXOTERE Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. This is because TAXOTERE or other medicines may not work as expected and you may be more likely to experience adverse effects.

The amount of alcohol in this medicine may alter the effects of other medicines.
Pregnancy, breastfeeding and fertility
Ask your doctor for advice before taking any medicine.
TAXOTERE must not be administered during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment and for 2 months after the end of treatment with this medicine. You must use adequate contraceptive measures during treatment and for 2 months after the end of treatment, as TAXOTERE may be harmful to the unborn child. If you become pregnant during treatment, inform your doctor immediately.
You must not breastfeed during treatment with TAXOTERE.
If you are a man being treated with TAXOTERE, you must not father a child and must use adequate contraceptive measures during treatment and for 4 months after the end of treatment with this medicine. It is recommended that you seek advice about sperm preservation before treatment, as docetaxel may impair male fertility.
Driving and using machines:
The amount of alcohol in this medicine may impair your ability to drive or use machinery.
You may experience adverse effects from this medicine that could impair your ability to drive, use equipment or machinery (see section 4 Possible side effects). If this occurs, do not drive and do not use any equipment or machinery until you have discussed it with your doctor, nurse, or hospital pharmacist.
TAXOTERE contains ethanol (alcohol)
This medicine contains 13% (p/p) of 95% v/v ethanol (alcohol), i.e. up to 932 mg of 95% v/v ethanol per solvent vial, equivalent to 23 ml of beer or 9.5 ml of wine.
Harmful for individuals suffering from alcoholism.
The presence of ethanol should also be considered during pregnancy or breastfeeding, in the treatment of children, and in high-risk populations such as patients with liver disease or epilepsy.
The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).