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

Active substance: DOCETAXEL

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Docetaxel 20mg/0.5ml
and 80mg/2ml Concentrate and
Solvent for Solution for Infusion
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.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• 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 your
hospital pharmacist.
• The full name of this medicine is
Docetaxel 20mg/0.5ml and 80mg/2ml
concentrate and solvent for solution for
infusion but within the leaflet it will be
referred to as Docetaxel.
In this leaflet:
1 What Docetaxel is and what it is used for
2 Before you use
3 How to use
4 Possible side effects
5 How to store
6 Further information

1. What Docetaxel is and what it
is used for
The name of this medicine is Docetaxel.
Docetaxel is a substance derived from the
needles of yew trees.
Docetaxel belongs to the group of anticancer 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 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 5fluorouracil.

2. Before you use
Do not use Docetaxel if

• you are allergic (hypersensitive) to
docetaxel or any other ingredients of
Docetaxel (See section 6).
• the 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 sufficient
liver function to receive Docetaxel. In case
of white blood cells disturbances, you may
experience associated fever or infections.
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
medication to maintain the number of your
blood cells.

Using other medicines

Please tell your doctor 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.
The amount of alcohol in this medicinal
product may alter the effects of other
medicines.

Pregnancy

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.
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

The amount of alcohol in this medicinal
product may impair your ability to drive or
use machines.
There is no reason why you cannot drive
between courses of Docetaxel except if you
feel dizzy or are unsure of yourself.

Important information about one of
the ingredients of Docetaxel

This medicinal product contains ethanol.
Harmful for those suffering from alcoholism.
To be taken into account in children and
high risk groups such as patients with liver
disease or epilepsy.

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
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. Docetaxel comes in 2 parts, a
single vial of concentrate and a single vial
of solvent. The infusion is made by diluting
the contents of the concentrate vial with
the contents of the solvent vial and then
the resultant ‘premix’ solution is diluted
with an appropriate infusion solution before
being administered. 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.

Continued

L18974SIN-30

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

PREPARATION GUIDE FOR USE WITH DOCETAXEL CONCENTRATE FOR
SOLUTION FOR INFUSION AND SOLVENT
It is important to read the entire contents of this procedure prior to the preparation of either the
Docetaxel premix solution or the Docetaxel infusion solution

1. FORMULATION
Docetaxel 20mg/0.5ml

Each blister pack contains:
• one single dose Docetaxel vial of
concentrate 20mg/0.5ml
• one single dose solvent for Docetaxel vial
of concentrate 1.5ml

Docetaxel 80mg/2ml

Each blister pack contains:
• one single dose Docetaxel vial of
concentrate 80mg/2ml
• one single dose solvent for Docetaxel vial
of concentrate 6ml

2. PRESENTATION
2.1 Docetaxel 20mg/0.5ml vial
Docetaxel 20mg/0.5ml concentrate for
solution for infusion vial
8ml clear glass Type I vial with a flip-off cap.
This vial contains 0.5ml of a 40mg/ml
solution of docetaxel in citric acid anhydrous,
polysorbate 80 and ethanol absolute (fill
volume: 25.2mg/0.63ml). This fill volume has
been established during the development
of Docetaxel to compensate for liquid loss
during preparation of the premix 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 solvent for Docetaxel vial,
there is a minimal extractable premix volume
of 2ml containing 10mg/ml docetaxel which
corresponds to the labelled amount of
20mg/0.5ml per vial.

2.2 Solvent for Docetaxel 20mg/0.5ml
vial
Solvent vial: 8ml clear glass Type I vial with a
flip-off cap.
Solvent vial contains 1.5ml of a 9.53% w/w
solution of ethanol absolute in water for
injections (fill volume: 2.0ml). The addition
of the entire contents of the solvent vial to
the contents of the Docetaxel 20mg/0.5ml
concentrate for solution for infusion vial
ensures a premix concentration of 10mg/ml
docetaxel.

of Docetaxel to compensate for liquid loss
during preparation of the premix 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 solvent for Docetaxel vial,
there is a minimal extractable premix volume
of 8ml containing 10mg/ml docetaxel which
corresponds to the labelled amount of
80mg/2ml per vial.

2.2 Solvent for Docetaxel 80mg/2ml
vial

Solvent vial: 15ml clear glass Type I vial with
a flip-off cap.
Solvent vial contains 6ml of a 9.53% w/w
solution of ethanol absolute in water for
injections (fill volume: 7.04ml). The addition
of the entire contents of the solvent vial to
the contents of the Docetaxel 80mg/2ml
concentrate for solution for infusion vial
ensures a premix concentration of 10mg/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
(10mg docetaxel/ml)

2.1 Docetaxel 80mg/2ml vial

4.1.1. If the vials are stored
under refrigeration, allow
the required number of
Docetaxel boxes to stand
at room temperature for 5
minutes.

Docetaxel 80mg/2ml concentrate for
solution for infusion vial:
15ml clear glass Type I vial with a flip-off cap.
This vial contains 2ml of a 40mg/ml solution
of docetaxel in citric acid anhydrous,
polysorbate 80 and ethanol absolute (fill
volume: 92.0mg/2.3ml). This fill volume has
been established during the development

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.

L18974SIN-30

Continued

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 other anticancer 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 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 (experienced in
more than 1 person 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
effects.
Between infusions of Docetaxel the
following may occur, and the frequency may
vary with the combinations of drugs that
are received:
Very Common: (experienced in more than
1 in 10 patients)
• 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
• 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 color 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








heart failure
oesophagitis
dry mouth
difficulty or painful swallowing
haemorrhage
raised liver enzymes (hence the need for
regular blood tests)

Uncommon: (experienced in more than 1 in
1,000 but less than 1 in 100)
• fainting
• at the injection site, skin reactions,
phlebitis (inflammation of the vein) or
swelling
• inflammation of the colon, small intestine;
intestinal perforation
• blood clots
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
Keep out of the reach and sight of children.
Docetaxel should not be used after the
expiry date shown on the carton and vials.
Do not store above 25°C.
Store in the original package in order to
protect from light.
The premix solution should be used
immediately after preparation. However the
chemical and physical stability of the premix
solution has been demonstrated for 8 hours
when stored either between 2°C and 8°C or
at room temperature (below 25°C).
The infusion solution should be used within
4 hours at room temperature (below 25°C).

6. Further information
What Docetaxel contains

• The active substance is docetaxel. Each
ml of docetaxel solution contains 40mg
of docetaxel anhydrous. One vial contains
20mg/0.5ml or 80mg/2ml of docetaxel.
• The other ingredients are citric acid
anhydrous, ethanol absolute and
polysorbate 80.
The solvent vial contains 9.53% w/w
ethanol absolute in water for injections.

What Docetaxel looks like and
contents of the pack

Docetaxel concentrate for solution for
infusion is a clear, oily, yellow solution.
The solvent is a clear, colourless solution.
Each carton contains
Docetaxel 20mg/0.5ml
• one single dose vial of concentrate and
• one single dose vial of solvent
Docetaxel 80mg/2ml
• one single dose vial of concentrate and
• one single dose vial of solvent

Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
Hafnarfjordur
IS-220
Iceland

Manufacturer

S.C. Sindan-Pharma S.R.L
11 Ion Mihalache Blvd
011171 Bucharest
Romania
This leaflet was revised – April 2010

If you would like a
leaflet with larger
text, please contact
01271 311257.

Common (experienced in less than 1 in 10
but more than 1 in 100 patients)
• oral candidiasis
• dehydration
• dizziness
• hearing impaired
• decrease in blood pressure; irregular or
rapid heart beat
L18974SIN-30

Actavis, Barnstaple, EX32 8NS, UK

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

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

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

4.1.4. Remove the syringe
and needle and mix
manually by repeated
inversions for at least 120
seconds. Do not shake.

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 and
normal lighting conditions.

4.1.5. Allow the premix vial
to stand for 3 minutes at
room temperature and then
check that the solution is
homogenous and clear
(foaming is normal even
after 3 minutes due to the
presence of polysorbate 80
in the formulation).
The premix solution contains 10mg/ml
docetaxel and should be used immediately
after preparation. However the chemical and
physical stability of the premix solution has
been demonstrated for 8 hours when stored
either between 2°C and 8°C or at room
temperature (below 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 10mg/
ml docetaxel from the
appropriate number
of premix vials using
graduated syringes fitted
with a needle. For example,
a dose of 140mg docetaxel
would require 14ml
docetaxel premix solution.

4.2.2. Inject the required
premix volume into a
250ml infusion bag or
bottle containing either 5%
glucose solution or 0.9%
sodium chloride solution.
If a dose greater than
200mg of docetaxel is
required, use a larger
volume of the infusion
vehicle so that a
concentration of 0.74mg/ml
docetaxel is not exceeded.
L18974SIN-30

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. SHELF LIFE
• Premix solution: The premix solution
contains 10mg/ml docetaxel and should
be used immediately after preparation.
However the chemical and physical
stability of the premix solution has been
demonstrated for 8 hours when stored
either between 2°C and 8°C or at room
temperature (below 25°C). The premix
solution is for single use only.
• Infusion solution: Chemical and physical
in-use stability has been demonstrated
for 4 hours at about 25°C at normal
lighting conditions, and 4 hours at
5°C ± 3°C protected from light. From
a microbiological point of view, the
product 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
normally not be longer than 24 hours
at 2 to 8°C, unless dilution has taken
place in controlled and validated aseptic
conditions.

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

Actavis, Barnstaple, EX32 8NS, UK

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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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