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DOCETAXEL ACTAVIS 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL

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Docetaxel 20mg/ml Concentrate
for Solution for Infusion
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 or pharmacist.
• This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as
yours.
• If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section
4.
• The full name of the product is
Docetaxel 20mg/ml Concentrate
for Solution for Infusion but within
the leaflet it will be referred to as
Docetaxel.

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

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 Docetaxel

Tell your doctor or 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 for advice before taking this
medicine.

Pregnancy

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 Docetaxel may be harmful
for the unborn baby. If pregnancy
occurs during your treatment, you
must immediately inform your doctor.

Breast-feeding

1 What Docetaxel is and
what it is used for
The name of this medicine is
Docetaxel. The 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:

You must NOT breast-feed while you
are treated with Docetaxel.

Fertility

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.
There is no reason why you cannot
drive between courses of Docetaxel

continued below

• F or the treatment of advanced
breast cancer, Docetaxel could be
administered either alone or in
combination with doxorubicin, or
trastuzumab, or capecitabine.
• F or the treatment of early breast
cancer with or without lymph node
involvement, Docetaxel could be
administered in combination with
doxorubicin and cyclophosphamide.
• F or the treatment of lung cancer,
Docetaxel could be administered
either alone or in combination with
cisplatin.
• F or the treatment of prostate
cancer, Docetaxel is administered
in combination with prednisone or
prednisolone.
• F or the treatment of metastatic
gastric cancer, Docetaxel is
administered in combination with
cisplatin and 5-fluorouracil.
• F or 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
Do not use Docetaxel if

• you are allergic to docetaxel or
any of the other ingredients of this
medicine (listed in section 6).
• the number of white blood cells is
too low.
• you have a severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist
before using Docetaxel
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
problem with your lungs (fever,
shortness of breath or cough), please
tell your doctor, pharmacist or nurse
immediately. Your doctor may stop
your treatment immediately.
continued below

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.

continued below

except if you feel dizzy or are unsure
of yourself. In higher doses (7.5ml
concentrate (150mg) contains 3g
ethanol) the amount of alcohol may
impair your ability to drive or use
machines.

Docetaxel contains
ethanol(alcohol)

1ml vial: This medicinal product
contains 51 vol % ethanol (alcohol),
i.e. up to 0.400g (0.5ml) per vial,
equivalent to 10ml of beer or 4.16ml
wine per vial.
4 ml vial: This medicinal product
contains 51 vol % ethanol (alcohol),
i.e. up to 1.6 g (2.02 ml) per vial,
equivalent to 40.4 ml of beer or
16.83 ml wine per vial.
7 ml vial: This medicinal product
contains 51 vol % ethanol (alcohol),
i.e. up to 2.8 g (3.54 ml) per vial,
equivalent to 70.8 ml of beer or
29.6 ml wine per vial.
8 ml vial: This medicinal product
contains 51 vol % ethanol (alcohol),
i.e. up to 3.2 g (4.1 ml) per vial,
equivalent to 81.1 ml of beer or
33.8 ml wine per vial.
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 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 medicines.
The amount of alcohol in this
medicinal product may impair your
ability to drive or use machines.

3 How to use
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 metres (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. The infusion
will last approximately one hour
during which you will be in the
hospital.

continued below

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.

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AAAI5260

The following information is intended for medical or healthcare professionals only:

Docetaxel 20mg/ml Concentrate for Solution
for Infusion
Instructions on use

Docetaxel is an antineoplastic agent
and, as with other potentially toxic
compounds, caution should be
exercised when handling it and
preparing Docetaxel 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
Docetaxel concentrate or infusion
solution should come into contact
with mucous membranes, wash
immediately and thoroughly with
water.
Preparation of the solution for
infusion
More than one vial of Docetaxel
20mg/ml concentrate for solution for
infusion may be necessary to obtain
the required dose for individual
patients. Based on the required
dose for the patient expressed
in mg, aseptically withdraw the

corresponding volume of 20mg/
ml docetaxel from the appropriate
number of vials using graduated
syringes fitted with a needle. For
example, a dose of 140mg docetaxel
would require 7ml of Docetaxel
20mg/ml concentrate for solution for
infusion.
For doses below 192mg of docetaxel,
inject the required volume of
Docetaxel 20mg/ml concentrate for
solution for infusion into a 250ml
infusion bag or bottle containing
either 250ml of 50mg/ml (5%)
glucose solution for infusion or 9mg/
ml (0.9%) sodium chloride solution
for infusion. For doses exceeding
192mg of docetaxel more than 250ml
of the infusion solution is required,
as the maximum concentration of
docetaxel is 0.74mg per ml of infusion
solution.
Mix the infusion bag or bottle
manually using a rocking motion.
The diluted solution should be
used within 8 hours and should be
aseptically administered as a 1-hour
infusion at room temperature and
normal lighting conditions.
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AAAI5260

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Docetaxel 20mg/ml Concentrate for Solution for Infusion PIL - UK
item no: AAAI5260

dimensions: 124 x 700

print proof no: 2

pharmacode:

origination date: 20.11.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 02.12.15

Technical Approval

revised by: S.Anson

date sent: 20.11.15

supplier: Actavis Nerviano

technically app. date: 20.11.15

Non Printing Colours
1.
2.
3.

4 Possible side effects

5 How to store

Like other medicines, this medicine
can cause side effects, although not
everybody gets them.

Keep this medicine out of the sight
and reach of children.

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
occur
(may affect more than 1 in 10 people):
• 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 Docetaxel
the following may occur, and
the frequency may vary with the
combinations of medicines 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

Do not use this medicine after the
expiry date which is stated on the
carton and vial.
Store below 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:
The diluted solution should be used
immediately after preparation. If
not used immediately the in-use
storage times and conditions are the
responsibility of the user and would
not normally be longer than 3 days
when stored between 2-8°C
protected from light or 8 hours at
room temperature (below 25°C)
including the one hour infusion.
Dispose any unused product or waste
material in accordance with local
requirements.
Do not throw away any medicines
via wastewater or household waste.
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 20mg 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.
Pack sizes:
1 x 1ml single dose vial
1 x 4ml single dose vial
1 x 7ml single dose vial
1 x 8 ml single dose vial

Marketing Authorisation
Holder
Actavis Group PTC ehf
Reykjavíkurvegur 76-78,
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Italy S.p.A.
Via Pasteur 10,
20014 Nerviano (MI),
Italy
This leaflet was last revised in
November 2015

If you would like a
leaflet with larger
text, please contact
01271 385257.

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)
•p
 neumonia (infection of the lungs)
•p
 ulmonary fibrosis (scarring
and thickening in the lungs with
shortness of breath)
•b
 urn like appearance at the injection
site may appear several days after
the last dose
•b
 lurred vision due to swelling of
the retina within the eye (cystoid
macular oedema)
•d
 ecrease of sodium in your blood.

Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the
safety of this medicine.

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As with all parenteral products, this
medicinal product should be visually
inspected prior to use and solutions
containing a precipitate should be
discarded.
Any unused product or waste
material should be disposed of in
accordance with local requirements.
Storage after opening
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.
Storage after dilution
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.

Actavis, Barnstaple, EX32 8NS, UK
AAAI5260

In addition, physical and chemical inuse 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.
Disposal
Any unused product or waste
material should be disposed of in
accordance with local requirements.

Once added as recommended into
the infusion bag, the docetaxel
infusion solution, if stored below
25°C, in non-PVC bags, is stable for
8 hours. It should be used within
8 hours (including the one hour
infusion intravenous administration).

continued on top of next column

Actavis, Barnstaple, EX32 8NS, UK
AAAI5260

Docetaxel 20mg/ml Concentrate for Solution for Infusion PIL - UK
item no: AAAI5260

dimensions: 124 x 700

print proof no: 2

pharmacode:

origination date: 20.11.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 02.12.15

Technical Approval

revised by: S.Anson

date sent: 20.11.15

supplier: Actavis Nerviano

technically app. date: 20.11.15

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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