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DOCETAXEL 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Docetaxel 10 mg/ml concentrate for
solution for infusion

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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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, 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 10 mg/ml Concentrate for
Solution for Infusion. 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

Do not use Docetaxel if
• you are allergic to docetaxel or any
of the other ingredients of this
medicine.
• the number of white blood cells is
too low.
• you have a severe liver disease.

Warnings and precautions
Before each treatment with Docetaxel
10 mg/ml Concentrate for Solution for
Infusion, 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 and ethanol (alcohol)”
below.
Other medicines and Docetaxel
Tell your doctor, nurse or hospital

pharmacist if you are taking or have
recently taken any other medicine,
including medicines obtained without
a prescription.
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
Ask your doctor for advice before
being given any 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
contraception during therapy, because
Docetaxel 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
75 vol % ethanol (alcohol), i.e. up to
4.7 g (6 ml) per 80 mg vial, equivalent
to 120 ml of beer or 48 ml wine per
80 mg vial.
Harmful for those suffering from
alcoholism.
To be taken into account if you are
pregnant or if you are breast-feeding,
in childen and high risk groups such
as patients with liver disease, or
epilepsy.
The amount of alcohol in this
medicinal product may alter the
effects of other medicinal products.
The amount of alcohol in this
medicinal product may impair the
patient's 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 1 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 pharmacist.

Docetaxel 10 mg/ml Concentrate for Solution for Infusion

The following information is intended for healthcare professionals only:
Instructions for use
CYTOSTATIC

FORMULATION
Docetaxel is a concentrate for solution for infusion which can directly be used to
prepare 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 are the responsibility of the user.
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 for solution for infusion or infusion solution should
come into contact with skin, wash immediately and thoroughly with soap and
water. If Docetaxel concentrate for solution for infusion or infusion solution
should come into contact with mucous membranes, wash immediately and
thoroughly with water.

PREPARATION FOR THE INFUSION SOLUTION
More than one 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 concentrate for solution for infusion volume
containing 10 mg/ml docetaxel from the appropriate number of vials using
graduated syringes fitted with a needle.

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4

Possible side effects

Like all medicines, this 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, loss of hair,
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 medical staff will monitor your
condition closely during treatment. Tell
them immediately if you notice any of
these effects.
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 or
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)
• blurred vision due to swelling of the
retina within the eye (cystoid
macular oedema)
• decrease of the sodium in your
blood.

You can also report side effects
directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). 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
label and on the carton. The expiry
date refers to the last day of that
month.
Do not store above 25°C or below
2°C. Do not freeze.

After first opening, before dilution:
Use the vial immediately after its
opening. If not used immediately,
in-use storage times and conditions
are the responsibility of the user.

From a microbiological point of view,
dilution must take place in controlled
and aseptic conditions.
After dilution:
Use the medicine immediately once
added into the infusion bag. If not
used immediately, in-use storage
times and conditions are the
responsibility of the user and should
not be longer than 48 hours below
25°C (including the one hour
infusion).
Docetaxel infusion solution is
supersaturated, therefore may
crystallise 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 10 mg/ml
Concentrate for Solution for
Infusion contains
The active substance is docetaxel.
1 ml concentrate for solution for
infusion contains 10 mg docetaxel
(anhydrous).
The other ingredients are ethanol
anhydrous, citric acid anhydrous,
polysorbate 80.

What Docetaxel 10 mg/ml
Concentrate for Solution for
Infusion looks like and contents of
the pack
Docetaxel 10 mg/ml Concentrate for
Solution for Infusion is a clear pale
yellow solution.

The medicinal product is supplied in a
glass container called a vial with a
bromobutyl-rubber stopper.
20 mg vial: each vial contains 2 ml
concentrate for solution for infusion.
80 mg vial: each vial contains 8 ml
concentrate for solution for infusion.
160 mg vial: each vial contains 16 ml
concentrate for solution for infusion.
Pack sizes:
1 vial

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179 Barleben, Germany
or

Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana,
Slovenia
or

EBEWE Pharma Ges.m.b.H. Nfg.KG,
Mondseestrasse 11, 4866 Unterach,
Austria.
This leaflet was last revised in
12/2014.

Reporting of side effects
If you get any side effects, talk to your
doctor. This includes any possible
side effects not listed in this leaflet.

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For example, a dose of 140 mg docetaxel would require 14 ml docetaxel
concentrate for solution for infusion.

Inject the required concentrate for solution for infusion 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. To prevent multiple piercing of the infusion bag or
bottle during the preparation of the infusion solution, the correct volume of
concentrate in accordance with the required dose must be measured and
transferred to the infusion bag or bottle as a single injection only.
Mix the infusion bag or bottle manually using a rocking motion.

From a microbiological point of view, dilution must take place in controlled and
aseptic conditions and the infusion solution should be used immediately. If not
used immediately, in-use storage times and conditions are the responsibility of
the user.
Once added as recommended into the infusion bag, the docetaxel infusion
solution, if stored below 25°C, is stable for 48 hours. It should be used within
48 hours (including the one hour infusion IV administration).
As with all parenteral products, Docetaxel concentrate for solution for infusion
and infusion solution should be visually inspected prior to use, 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.

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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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