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DOCETAXEL 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL

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Package leaflet: Information for the patient
Docetaxel 20 mg/ml concentrate for solution for infusion
docetaxel

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, hospital pharmacist or nurse.
If you get any side effects, talk to your doctor, hospital pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Docetaxel is and what it is used for
2. What you need to know before you use Docetaxel
3. How to use Docetaxel
4. Possible side effects
5. How to store Docetaxel
6. Contents of the pack and other 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 cancer or head
and neck cancer:

For the treatment of advanced breast cancer, Docetaxel could be administered either
alone or in combination with doxorubicin, or trastuzumab, or capecitabine.

For the treatment of early breast cancer with or without lymph node involvement,
Docetaxel could be administered in combination with doxorubicin and cyclophosphamide.

For the treatment of lung cancer, Docetaxel could be administered either alone or in
combination with cisplatin.

For the treatment of prostate cancer, Docetaxel is administered in combination with
prednisone or prednisolone.

For the treatment of metastatic gastric cancer, Docetaxel is administered in
combination with cisplatin and 5-fluorouracil.

For the treatment of head and neck cancer, Docetaxel is administered in combination
with cisplatin and 5-fluorouracil.

2. What you need to know before you use Docetaxel
YOU MUST NOT be given Docetaxel

if you are allergic to docetaxel or any of the other ingredients of this medicine (listed in
section 6).

if the number of white blood cells is too low.

if you have a severe liver disease.
Warnings and precautions
Talk to your doctor, hospital pharmacist or nurse before you are given Docetaxel.
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Before each treatment with Docetaxel, you will have blood tests to check that you have
enough blood cells and sufficient liver function to receive Docetaxel. In case of white blood
cells disturbances, you may experience associated fever or infections.
Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision
problems, in particular blurred vision, you should immediately have your eyes and vision
examined.
If you develop acute or worsening problems with your lungs (fever, shortness of breath or
cough), please tell your doctor, hospital pharmacist or nurse immediately.
Your doctor may stop your treatment immediately.
You will be asked to take premedication consisting of an oral corticosteroid such as
dexamethasone, one day prior to Docetaxel 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 Docetaxel in particular allergic reactions and fluid retention (swelling of the hands,
feet, legs or weight gain).
During treatment, you may be given other medicines to maintain the number of your blood
cells.
Docetaxel contains alcohol. Discuss with your doctor if you suffer from alcohol dependency
or liver impairment. See also section Docetaxel contains ethanol (alcohol) below.
Other medicines and Docetaxel
Tell your doctor or hospital pharmacist if you are taking, have recently taken or might take
any other medicine. This is because Docetaxel or the other medicine may not work as well
as expected and you may be more likely to get a side effect.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or hospital pharmacist for advice before being given this medicine.
Docetaxel must NOT be administered if you are pregnant unless clearly indicated by your
doctor.
You must not become pregnant during treatment with this medicine and must use an
effective method of contraceptive during therapy, because /…/ may be harmful for the unborn
baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.
You must not breast-feed while you are treated with Docetaxel.
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.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Docetaxel contains ethanol (alcohol)
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 400 mg (0.5 ml) per ml
concentrate, equivalent to 10 ml of beer or 4 ml of wine per ml concentrate.
Harmful for those suffering from alcoholism.
To be taken into account if you are pregnant or if you are a breast-feeding woman, in
children and in high-risk groups such as patients with liver disease or epilepsy.

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The amount of alcohol in this medicinal product may alter the effects of other medicines.
The amount of alcohol in this medicine may impair your ability to drive or use machines.

3. How to use Docetaxel
Docetaxel 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
Docetaxel will be given by infusion into one of your veins (intravenous use). 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 Docetaxel. In particular, please inform your
doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles,
fever and give her/him results of your blood tests. Such information will allow her/him 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.
4. Possible side effects
Like all medicines, Docetaxelthis medicine 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 Docetaxel 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 Docetaxel may be increased when Docetaxel is given in
combination with other chemotherapeutic agents.
During the infusion at the hospital the following allergic reactions (may affect more than 1 in
10 people) 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.

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Between infusions of Docetaxel the following may occur, and the frequency may vary with
the combinations of drugs that are received:
Very common (may affect more than 1 in 10 people):

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 diarrhoea, constipation

abdominal pain

indigestion

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; or flu-like symptoms

weight gain or loss
Common (may affect up to 1 in 10 people):

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

fainting

at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling

inflammation of the colon, small intestine; intestinal perforation

blood clots
Frequency unknown:

interstitial lung disease (inflammation of the lungs causing coughing and difficulty
breathing. Inflammation of the lungs can also develop when docetaxel therapy is used
with radiotherapy)

pneumonia (infection of the lungs)

pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

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blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
decrease of the sodium in your blood

Reporting of side effects
If you get any side effects, talk to your doctor or hospital pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via {to
be completed nationally: the national reporting system listed in Appendix V}. By reporting
side effects, you can help provide more information on the safety of this medicine.
5. How to store Docetaxel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial. The
expiry date refers to the last day of that month.
Do not store above 25 °C.
Store in the original package in order to protect from light. Do not refrigerate or freeze.
After opening of the vial:
Each vial is for single use and should be used immediately after opening. If not used
immediately, in-use storage times and conditions are the responsibility of the user.
Once added to the infusion bag:
From a microbiological point of view, reconstitution/dilution must take place in controlled and
aseptic conditions and the medicinal product should be used immediately. If not used
immediately, in-use storage times and conditions are the responsibility of the user.
Once added into the infusion bag containing the recommended solution for infusion (50
mg/ml (5 %) glucose solution for infusion or 9 mg/ml (0,9 %) sodium chloride solution for
infusion) the docetaxel infusion solution (0.74 mg/ml), if stored below 25°C, in non-PVC bags
(PP bag, PE bottle), is stable for 8 hours. It should be used within 8 hours (including the one
hour infusion intravenous administration).
In addition, physical and chemical in-use stability of the infusion solution prepared as
recommended has been demonstrated for 3 days when stored between 2 to 8°C protected
from light.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals
appear, the solution must no longer be used and shall be discarded.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Docetaxel contains

The active substance is docetaxel. Each ml of docetaxel solution contains 20 mg of
docetaxel anhydrous.

The other ingredients are citric acid anhydrous, povidone, ethanol absolute and
polysorbate 80.
What Docetaxel looks like and contents of the pack:
Docetaxel concentrate for solution for infusion is a clear, pale yellow solution.

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Pack sizes:
1 x 1 ml single dose vial
1 x 4 ml single dose vial
1 x 7 ml single dose vial
Not all pack sizes may be marketed
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastr. 2-18
61118 Bad Vilbel, Germany
Manufacturer
cell pharm GmbH
Feodor-Lynen Str. 35
30625 Hannover, Germany
S. C. Sindan-Pharma S.R.L
11 Ion Mihalache Blvd,
011171 Bucharest, Romania
Actavis Italy S.p.A. – Nerviano Plant
Viale Pasteur 10
20014 Nerviano (MI), Italy
This medicinal product is authorised in the Member States of the EEA under the
following names:
Belgium

Docetaxel EG 20 mg/ml concentraat voor oplossing voorinfusie
Docetaxel EG 20 mg/ml solution à diluer pour perfusion
Docetaxel EG 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Denmark
Docetaxel STADA
Finland
Docetaxel STADA 20 mg/ml infuusiokonsentraatti, liuosta varten
Germany
Docetaxel cell pharm 20 mg/ml Konzentrat zur Herstellung einer
Infusionslösung
Netherlands Docetaxel CF 20 mg/ml, concentraat voor oplossing voor infusie
United Kingdom Docetaxel 20 mg/ml concentrate for solution for infusion
This leaflet was last revised in 12/2015.

---------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Preparation guide for use with Docetaxel 20 mg/ml concentrate for solution for
infusion

It is important that you read the entire contents of this guide prior to the preparation of the
Docetaxel 20 mg/ml concentrate for solution for infusion

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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 its solutions. Cytotoxic agents should be
prepared for administration only by personnel who have been trained in the safe handling of
such preparations. Refer to local cytotoxic guidelines before commencing. The use of gloves
is recommended.
If Docetaxel concentrate or infusion solution should come into contact with skin, wash
immediately and thoroughly with soap and water. If it should come into contact with mucous
membranes, wash immediately and thoroughly with water.
Preparation of the intravenous administration
Preparation of the infusion solution
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and
solvent) with this medicinal product (Docetaxel 20 mg/ml concentrate for solution for
infusion, which contains only 1 vial).
Docetaxel 20 mg/ml concentrate for solution for infusion requires NO prior dilution
with a solvent and is ready to add to the infusion solution.

Each vial is for single use and should be used immediately after opening. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the
user. More than one vial of concentrate for solution for infusion may be necessary to
obtain the required dose for the patient. For example, a dose of 140 mg docetaxel would
require 7 ml docetaxel concentrate for solution.

Aseptically withdraw the corresponding volume of 20 mg/ml docetaxel from the
appropriate number of vials using graduated syringes fitted with a needle.
In Docetaxel 20 mg/ml vial the concentration of docetaxel is 20 mg/ml.

Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle
containing either 5 % glucose solution or 9 mg/ml (0.9 %) sodium chloride solution for
infusion. If a dose greater than 190 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.

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

From a microbiological point of view, the diluted solution should be used immediately. If
not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would not normally be longer than 24 hours at 2 to 8oC
unless dilution has taken place in controlled and validated aseptic conditions.

Chemical and physical in-use stability of the diluted solution (0.74 mg/ml) in the
recommended solutions for infusion (50 mg/ml (5 %) glucose solution for infusion or 9
mg/ml (0.9 %) sodium chloride solution for infusion) has been demonstrated for 8 hours at
25oC under normal lighting conditions in non-PVC bags (PP bag, PE bottle) and for 3 days
at 2-8oC when protected from light.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If
crystals appear, the solution must no longer be used and shall be discarded.

As with all parenteral products, this medicinal product should be visually inspected prior
to use and solutions containing a precipitate should be discarded.

Disposal
All materials that have been utilised for dilution and administration should be disposed of
according to standard procedures. Do not throw away any medicines via wastewater. Ask
your pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

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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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