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DOCETAXEL STADA 20 MG/0.5 ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

DOCETAXEL 20 mg/0.5 ml concentrate and solvent for solution for
infusion
Docetaxel
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 DOCETAXEL is and what it is used for
2. Before you use DOCETAXEL
3. How to use DOCETAXEL
4. Possible side-effects
5. How to store DOCETAXEL
6. Further information

1. WHAT DOCETAXEL IS AND WHAT IT IS USED FOR
The name of this medicine is DOCETAXEL. 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.
DOCETAXEL 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 (stomach) cancer or head and neck
cancer. DOCETAXEL is often used in combination with other anti-cancer medicines.
In particular, you may receive DOCETAXEL for the treatment of:
• advanced breast cancer, DOCETAXEL can be given either alone or in combination with
doxorubicin, or trastuzumab, or capecitabine (anti-cancer medicines).
• early breast cancer with lymph node involvement, DOCETAXEL can be given in combination
with doxorubicin and cyclophosphamide (anti-cancer medicines).
• lung cancer, DOCETAXEL can be given either alone or in combination with cisplatin (anti-cancer
medicine).
• prostate cancer, DOCETAXEL is given in combination with prednisone or prednisolone.
• metastatic gastric cancer, DOCETAXEL is given in combination with cisplatin and 5-fluorouracil
(anti-cancer medicines).
• head and neck cancer, DOCETAXEL is given in combination with cisplatin and 5-fluorouracil
(anti-cancer medicines).

2. BEFORE YOU USE DOCETAXEL
You must NOT be given DOCETAXEL if
• you are allergic (hypersensitive) to docetaxel or any of the other ingredients of DOCETAXEL (see
section 6. “Further information”).
• your number of white blood cells is too low.
• you have a severe liver disease.
Take special care with DOCETAXEL

Before each treatment with DOCETAXEL, you will have blood tests to check that you have enough
blood cells and your liver is working properly. If you have a low white blood cell level, you may
experience fever or infections.
You will be asked to take a corticosteroid orally (for example dexamethasone) one day before your
DOCETAXEL treatment and to continue for one or two days after it. This should help to reduce side
effects which may occur after the infusion of DOCETAXEL. These side effects include allergic
reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
During treatment, you may be given a medicine to maintain the number of your blood cells.
Taking other medicines
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. This is because DOCETAXEL or the
other medicine may not work as expected and you may be more likely to get a side effect.
Pregnancy

Ask your doctor for advice before being given any medicine.
DOCETAXEL must NOT be given if you are pregnant unless clearly indicated by your doctor.
You must not become pregnant during treatment with this medicine. You must use an effective
method of contraception during therapy, because DOCETAXEL may be harmful for the unborn baby.
If pregnancy occurs during your treatment, you must immediately inform your doctor.
If you are a man being treated with DOCETAXEL you are advised not to father a child during and up
to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because
docetaxel may alter male fertility.
Breast-feeding
You must not breast-feed while you are treated with DOCETAXEL.
Driving and using machines
There is no reason why you cannot drive between courses of DOCETAXEL except if you feel dizzy or
unsure about driving.
Important information about some of the ingredients of DOCETAXEL
This medicine contains 9.6 vol % ethanol (alcohol), i.e. up to 1.3 g per dose, equivalent to 26 ml beer
or 11 ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding
women, children and high-risk groups such as patients with liver disease, or epilepsy.

3. HOW TO USE DOCETAXEL
DOCETAXEL will be given to you by a nurse or a doctor.
Usual dosage
The dose will depend on your weight, your height 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
DOCETAXEL will be given slowly into one of your veins (infusion). 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.
Change of usual dosage and frequency of dosing
Your doctor may change the dose and frequency of dosing depending on your blood tests, your
general condition and your response to DOCETAXEL.
Please tell your doctor in particular if you have:
• diarrhoea
• sores in the mouth
• a feeling of numbness or pins and needles
• fever
Give your doctor the results of your blood tests. Such information will allow your doctor to decide
whether your dose needs to be reduced.
If you have any further questions about DOCETAXEL, ask your doctor or hospital pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, DOCETAXEL 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 frequency of possible side effects listed below is defined using the following convention: very
common (affects more than 1 patients in 10); common (affects 1 to 10 patients in 100); uncommon
(affects 1 to 10 patients in 1,000); rare (affects 1 to 10 patients in 10,000); very rare (affects less than 1
patients in 10,000); not known (frequency cannot be estimated from the available data).
The most commonly reported side effects of DOCETAXEL alone are:
• decrease in the number of red blood cells or white blood cells
• hair loss
• nausea (feeling sick)
• vomiting
• sores in the mouth
• diarrhoea
• tiredness
The severity of side effects of DOCETAXEL may be increased when DOCETAXEL is given together
with other anti-cancer medicines.
During the infusion at the hospital the following allergic reactions (affects more than 1 patient 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 side effects.
Between infusions of DOCETAXEL the following may occur, and the frequency may vary with the

combinations of medicines that were given:
Very common (affects more than 1 in 10 patients):
• fever: if this happens you must tell your doctor immediately
• infections
• decrease in the number of red (anaemia), or white blood cells (which are important in fighting
infection) and platelets
• allergic reactions as described above
• loss of appetite (anorexia)
• difficulty in sleeping (insomnia)
• feeling of numbness or pins and needles or pain in the joints of muscles
• headache
• change in sense of taste
• inflammation of the eye or increased tearing of the eyes
• swelling because your lymphatic system does not drain properly
• shortness of breath
• runny nose, inflammation of the throat and nose, cough
• bleeding from the nose
• sores in the mouth
• stomach upsets including nausea (feeling sick), vomiting and diarrhoea, 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 colour 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;
• flu-like symptoms
• weight gain or loss
Common (affects less than 1 in 10 but more than 1 in 100 patients):
• fungal infection in the mouth (oral candidiasis)
• loss of fluids (dehydration)
• dizziness
• hearing impaired
• decrease in blood pressure
• irregular or rapid heart beat
• heart failure
• soreness or burning of the food pipe (oesophagitis)
• dry mouth
• difficult or painful swallowing
• haemorrhage
• raised liver enzymes (hence the need for regular blood tests)
Uncommon (affects more than 1 in 1,000 but less than 1 in 100 patients):
• fainting
• at the infusion site: skin reactions, phlebitis (inflammation of the vein) or swelling
• inflammation or perforation of the bowel (colon, small intestine)
• clots in blood vessels (thrombosis)

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.

5. HOW TO STORE DOCETAXEL
Keep out of the reach and sight of children.
Do not use DOCETAXEL after the expiry date which is stated on the carton and label after EXP.
Do not store above 25°C or below 2°C.
Store in the original package in order to protect from light.
Premix solution: Chemical and physical stability of the premix solution has been demonstrated for 16
hours at 2 to 8°C or at 25°C.
Infusion solution: Chemical and physical stability of the infusion solution has been demonstrated for 4
hours at 25°C.
From a microbiological point of view, the premix and infusion solution should be used immediately. If
not used immediately, in-use storages times and conditions are the responsibility of the user, unless
preparation has taken place in controlled and validated aseptic conditions.

6. FURTHER INFORMATION
What DOCETAXEL concentrate contains
The active substance is docetaxel. Each vial contains 20 mg docetaxel (anhydrous) in 0.5 ml.
Each ml of concentrate contains 40 mg of docetaxel (anhydrous).
After reconstitution of the concentrate vial with the relevant solvent vial, each ml of the resultant
premix solution contains 10 mg docetaxel (anhydrous).
The other ingredients are: polysorbate 80, 30.6% (w/w) ethanol anhydrous, citric acid monohydrate,
sodium citrate, hydrochloric acid, water for injections.
What Solvent for DOCETAXEL concentrate contains
Polysorbate 80, 2.6% (w/w) ethanol anhydrous, water for injections.
What DOCETAXEL looks like and contents of the pack
DOCETAXEL 20 mg/0.5 ml concentrate for solution for infusion is a clear, light-yellow to brownyellow and slightly viscous solution.
The Solvent for DOCETAXEL 20 mg/0.5 ml concentrate is a clear, light-yellow to yellow solution.
Each carton contains:
1 vial of 0.5 ml DOCETAXEL 20 mg/0.5 ml concentrate
1 vial of 1.5 ml Solvent for DOCETAXEL 20 mg/0.5 ml concentrate

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Manufacturer

cell pharm GmbH
Feodor-Lynen-Str. 35
D-30625 Hannover
Germany

This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria
Docetaxel STADA 20 mg/0.5 ml Konzentrat und Lösungsmittel zur Herstellung
einer Infusionslösung
Belgium
Docetaxel EG 20 mg/0.5 ml solution à diluer et solvant pour perfusion,
Docetaxel EG 20 mg/0.5 ml concentraat en oplosmiddel voor oplossing voor
infusie,
Docetaxel EG 20 mg/0.5 ml Konzentrat und Lösungsmittel zur Herstellung
einer Infusionslösung
Czech Republic
Docetaxel STADA 20 mg/0.5 ml koncentrát a rozpouštědlo pro přípravu
infúzního roztoku
Denmark
Docetaxel “PCD”, koncentrat og solvens til infusionsvæske, opløsning
Finland
Docetaxel STADA 20 mg/0.5 ml infuusiokonsentraatti ja liuotin, liuosta varten
France
Docetaxel EG 20 mg/0.5 ml solution à diluer et solvant pour perfusion
Germany
Docetaxel cell pharm 20 mg/0.5 ml Konzentrat und Lösungsmittel zur
Herstellung einer Infusionslösung
Hungary
Docetaxel STADA 40 mg/ml koncentrátum és oldószer oldatos infúzióhoz
Italy
Docetaxel EG 20 mg/0.5 ml concentrato e solvente per soluzione per infusione
Luxembourg
Docetaxel EG 20 mg/0.5 ml solution à diluer et solvant pour perfusion
Netherlands
Docetaxel CF 40 mg/ml, concentraat en oplosmiddel voor oplossing voor
infusie, 0,5 ml
Norway
Docetaxel STADA 20 mg/0.5 ml konsentrat og væske til infusjonsvæske,
oppløsning
Poland
Docetaxel STADA
Spain
Docetaxel CICLUM 20 mg/0.5 ml concentrado y disolvente para solución para
perfusion EFG
Sweden
Docetaxel cell pharm, 20 mg/0.5 ml koncentrat och vätska till infusionsvätska,
lösning
United Kingdom
Docetaxel 20 mg/0.5 ml concentrate and solvent for solution for infusion

This leaflet was last approved in 12/2010.

The following information is intended for medical or healthcare professionals only:
PREPARATION GUIDE FOR USE WITH DOCETAXEL 20 mg/0.5 ml CONCENTRATE FOR
SOLUTION FOR INFUSION AND SOLVENT FOR DOCETAXEL

It is important that you read the entire contents of this procedure prior to the preparation of either the
DOCETAXEL STADA premix solution or the DOCETAXEL STADA infusion solution.
1. FORMULATION
DOCETAXEL STADA 20 mg/0.5 ml concentrate for solution for infusion is a clear, light-yellow to
brown-yellow and slightly viscous solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate
80, 30.6% (w/w) ethanol anhydrous, citric acid monohydrate, sodium citrate, hydrochloric acid and
water for injections.
The solvent for DOCETAXEL concentrate is a clear, light-yellow to yellow solution of polysorbate
80, 2.6% (w/w) ethanol anhydrous and water for injections.

2. PRESENTATION
Each carton contains one vial of DOCETAXEL 20 mg/0.5 ml concentrate and one corresponding vial
of solvent for DOCETAXEL 20 mg/0.5 ml concentrate.
DOCETAXEL should be stored between 2°C and 25°C and protected from light. Do not use
DOCETAXEL after the expiry date which is stated on the carton and label after EXP.
For single use only - discard unused contents appropriately.
2.1 DOCETAXEL 20 mg/0.5 ml concentrate
• The vial of DOCETAXEL 20 mg/0.5 ml concentrate is a 6 ml clear glass (type I) vial with a
fluoropolymer coated rubber stopper and a green flip-off cap.


The vial of DOCETAXEL 20 mg/0.5 ml concentrate contains 0.5 ml of a 40 mg/ml solution of
docetaxel (fill volume: 24 mg/0.60 ml). This fill volume has been established during the
development of DOCETAXEL to compensate for liquid loss during preparation of the premix (see
section 4) due to foaming, adhesion to the walls of the vial and "dead-volume". This overfill
ensures that after dilution with the entire contents of the accompanying vial of solvent for
DOCETAXEL, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml
docetaxel which corresponds to the labelled amount of 20 mg per vial.

2.2 Solvent for DOCETAXEL 20 mg/0.5 ml concentrate
• The vial of solvent for DOCETAXEL 20 mg/0.5 ml is a 6 ml clear glass (type I) vial with a
fluoropolymer coated rubber stopper and a transparent colourless flip-off cap.


The vial of solvent for DOCETAXEL 20 mg/0.5 ml contains 1.5 ml solution (fill volume: 2.03
ml). This fill volume has been established based on the fill volume of the DOCETAXEL 20
mg/0.5 ml vial. The addition of the entire contents of the solvent vial to the contents of the
DOCETAXEL 20 mg/0.5 ml vial ensures a premix concentration of 10 mg/ml docetaxel.

3. RECOMMENDATIONS FOR THE SAFE HANDLING
DOCETAXEL is an antineoplastic agent and, as with other potentially toxic compounds, caution
should be exercised when handling it and preparing DOCETAXEL solutions. The use of gloves is

recommended.
If DOCETAXEL concentrate, premix solution or infusion solution should come into contact with skin,
wash immediately and thoroughly with soap and water. If DOCETAXEL concentrate, premix solution
or infusion solution should come into contact with mucous membranes, wash immediately and
thoroughly with water.

4. PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
4.1 Preparation of the DOCETAXEL premix solution (10 mg docetaxel/ml)
4.1.1 If the vials are stored under refrigeration, allow the required
number of DOCETAXEL cartons to stand at room temperature
(below 25°C) for 5 minutes.

4.1.2 Using a syringe fitted with a needle, aseptically withdraw the
entire contents of the solvent for DOCETAXEL vial by partially
inverting the vial.

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

4.1.4 Remove the syringe and needle and mix manually by repeated
inversions for at least 45 seconds. Do not shake.

4.1.5 Allow the premix vial to stand for 5 minutes at room
temperature (below 25°C) and then check that the solution is
homogenous and clear (foaming is normal even after 5 minutes
due to the presence of polysorbate 80 in the formulation).
The premix solution contains 10 mg/ml docetaxel and should be
used immediately after preparation. Chemical and physical
stability of the premix solution has been demonstrated for 16
hours at 2 to 8°C or at 25°C.

4.2 Preparation of the infusion solution
4.2.1 More than one premix vial may be necessary to obtain the
required dose for the patient. Based on the required dose for the
patient expressed in mg, aseptically withdraw the corresponding
premix volume containing 10 mg/ml docetaxel from the
appropriate number of premix vials using graduated syringes
fitted with a needle. For example, a dose of 140 mg docetaxel
would require 14 ml docetaxel premix solution.

4.2.2 Inject the required premix volume into a 250 ml infusion bag or
bottle containing either 5% glucose solution or 0.9% sodium
chloride solution. If a dose greater than 200 mg of docetaxel is
required, use a larger volume of the infusion vehicle so that a
concentration of 0.74 mg/ml docetaxel is not exceeded.

4.2.3 Mix the infusion bag or bottle manually using a rocking motion.

4.2.4 The DOCETAXEL infusion solution should be used within 4 hours and should be aseptically
administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting
conditions.
4.2.5 As with all parenteral products, DOCETAXEL premix solution
and infusion solution should be visually inspected prior to use,
solutions containing a precipitate should be discarded.

5. DISPOSAL
Any unused product or waste material should be disposed of in accordance with local requirements.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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