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DOCETAXEL MYLAN 40 MG/ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Docetaxel 40 mg/ml 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.
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 40 mg/ml concentrate and solvent for solution for infusion is
and what it is used for
2.
Before you use Docetaxel 40 mg/ml concentrate and solvent for solution for
infusion
3.
How to use Docetaxel 40 mg/ml concentrate and solvent for solution for
infusion
4.
Possible side-effects
5.
How to store Docetaxel 40 mg/ml concentrate and solvent for solution for
infusion
6.
Further information

1.

WHAT DOCETAXEL 40 MG/ML CONCENTRATE AND SOLVENT
FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR

The name of this medicine is Docetaxel 40 mg/ml concentrate and solvent for solution
for infusion. Docetaxel is a substance derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Docetaxel 40 mg/ml concentrate and solvent for solution for infusion 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 40 mg/ml concentrate
and solvent for solution for infusion 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 40 mg/ml concentrate and solvent for solution for
infusion could be administered in combination with doxorubicin and
cyclophosphamide.
For the treatment of lung cancer, Docetaxel 40 mg/ml concentrate and solvent
for solution for infusion could be administered either alone or in combination
with cisplatin.
For the treatment of prostate cancer, Docetaxel 40 mg/ml concentrate and
solvent for solution for infusion is administered in combination with prednisone
or prednisolone.

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2.

For the treatment of metastatic gastric cancer, Docetaxel 40 mg/ml concentrate
and solvent for solution for infusion is administered in combination with
cisplatin and 5-fluorouracil.
For the treatment of head and neck cancer, Docetaxel 40 mg/ml concentrate and
solvent for solution for infusion is administered in combination with cisplatin
and 5-fluorouracil.
BEFORE YOU USE DOCETAXEL 40 MG/ML CONCENTRATE AND
SOLVENT FOR SOLUTION FOR INFUSION

You must not be given Docetaxel 40 mg/ml concentrate and solvent for solution
for infusion if




you are allergic (hypersensitive) to docetaxel or any of the other ingredients of
Docetaxel 40 mg/ml concentrate and solvent for solution for infusion.
the number of white blood cells is too low.
you have a severe liver disease.

Take special care with Docetaxel 40 mg/ml concentrate and solvent for solution
for infusion
Before each treatment with Docetaxel 40 mg/ml concentrate and solvent for solution
for infusion, you will have blood tests to check that you have enough blood cells and
sufficient liver function to receive Docetaxel 40 mg/ml concentrate and solvent for
solution for infusion. 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 40 mg/ml concentrate and solvent for
solution for infusion 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 40 mg/ml concentrate and solvent for solution for infusion 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.
The 1.8 ml solvent vial contains small amounts of ethanol, less than 100mg per dose.
The 7.1 ml solvent vial contains 13 vol % ethanol (alcohol), i.e. up to 152.1 mg per
dose, equivalent to 3 ml beer, 1.3 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.
Taking 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 40 mg/ml concentrate and solvent for solution for infusion or the

other medicine may not work as well 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 40 mg/ml concentrate and solvent for solution for infusion 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 40 mg/ml
concentrate and solvent for solution for infusion 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 40 mg/ml concentrate and solvent for
solution for infusion 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 40 mg/ml concentrate
and solvent for solution for infusion.
Driving and using machines
There is no reason why you cannot drive between courses of Docetaxel 40 mg/ml
concentrate and solvent for solution for infusion except if you feel dizzy or are unsure
of yourself.

3.

HOW TO USE DOCETAXEL 40 MG/ML CONCENTRATE AND
SOLVENT FOR SOLUTION FOR INFUSION

Docetaxel 40 mg/ml concentrate and solvent for solution for infusion 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 40 mg/ml concentrate and solvent for solution for infusion 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 40 mg/ml concentrate
and solvent for solution for infusion. 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, Docetaxel 40 mg/ml concentrate and solvent for solution for
infusion 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 user in 10); common (affects 1 to 10
users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in
10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot
be estimated from the available data).
The most commonly reported adverse reactions of Docetaxel 40 mg/ml concentrate
and solvent for solution for infusion alone are: decrease in the number of red blood
cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhea and
tiredness.
The severity of adverse events of Docetaxel 40 mg/ml concentrate and solvent for
solution for infusion may be increased when Docetaxel 40 mg/ml concentrate and
solvent for solution for infusion 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 40 mg/ml concentrate and solvent for solution for
infusion 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 diarrhea, 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.
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

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 patients):






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 DOCETAXEL 40 MG/ML CONCENTRATE AND
SOLVENT FOR SOLUTION FOR INFUSION

Keep out of the reach and sight of children.
Do not use Docetaxel 40 mg/ml concentrate and solvent for solution for infusion after
the expiry date which is stated on the carton and vial labels after EXP. The expiry date
refers to the last day of that month.
Do not store above 25 °C or below 2 °C.
Keep the vial in the outer carton, in order to protect from light.
The premix solution should be used immediately after preparation. However the
chemical and physical in-use 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).
Chemical and physical in-use stability of the infusion solution has been demonstrated
for 4 hours at 2 – 8 °C and 4 hours at room temperature (below 25 °C).
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 reconstitution/dilution has taken place in controlled and validated aseptic
conditions.

6.

FURTHER INFORMATION

What the Docetaxel 40 mg/ml concentrate and solvent for solution for infusion
concentrate vial contains
The active substance is docetaxel.
Each single-dose vial of Docetaxel concentrate contains 40 mg/ml docetaxel
(anhydrous).
The other ingredients are polysorbate 80 and anhydrous citric acid.
What the solvent vial contains
13% (w/w) anhydrous ethanol in water for injections.

What Docetaxel 40 mg/ml concentrate and solvent for solution for infusion looks
like and contents of the pack
Each pack contains:

one single-dose vial of concentrate

one single-dose vial of solvent
Two pack sizes are available:

carton containing a 20 mg/0.5 ml concentrate for solution for infusion vial and a
1.8 ml solvent vial.

carton containing a 80 mg/2 ml concentrate for solution for infusion vial and a
7.1 ml solvent vial.
The concentrate for solution for infusion is a clear colorless to pale yellow viscous
solution.
The solvent is a colorless solution.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Mylan,
Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Agila Specialties Polska Sp. z o.o.
10, Daniszewska Str
03-230 Warsaw
Poland
This leaflet was last revised in 02/2015

The following information is intended for medical or healthcare professionals only:
PREPARATION GUIDE FOR USE WITH DOCETAXEL 40 MG/ML
CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

It is important that you read the entire contents of this procedure prior to the
preparation of either the Docetaxel 40 mg/ml concentrate premix solution or the
Docetaxel 40 mg/ml concentrate infusion solution
1.

FORMULATION

Docetaxel concentrate for solution for infusion is a clear colorless to pale yellow
viscous solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80. The
solvent for Docetaxel 40 mg/ml is a 13% w/w solution of anhydrous ethanol in water
for injections.
2.

PRESENTATION

Docetaxel 40 mg/ml concentrate and solvent for solution for infusion is supplied as
single-dose vials.
Two pack sizes are available:

A box containing one concentrate vial (20 mg) and one corresponding solvent
vial.

A box containing one concentrate vial (80 mg) and one corresponding solvent
vial.
Docetaxel 40 mg/ml concentrate and solvent for solution for infusion vials should be
stored between 2 °C and 25 °C and protected from light.
Docetaxel 40 mg/ml concentrate and solvent for solution for infusion should not be
used after the expiry date shown on the carton, blister pack and vials.
2.1

Docetaxel 40 mg/ml concentrate vials

20 mg/0.5 ml concentrate for solution for infusion vial

5 ml clear glass vial with a violet flip-off aluminium seal.


Each vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80
(fill volume:26.8 mg/0.67 ml). This volume has been established during the
development 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 solvent , there is a minimal extractable premix volume of 2 ml
containing 10 mg/ml docetaxel which corresponds to 20 mg per vial.

80 mg/2 ml concentrate for solution for infusion vial

10 ml clear glass vial with a violet flip-off aluminium seal.


Each vial contains 2 ml of a 40 mg/ml solution of docetaxel in polysorbate 80
(fill volume:96 mg/2.4 ml). This volume has been established during the
development 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 solvent , there is a minimal extractable premix volume of 8 ml
containing 10 mg/ml docetaxel which corresponds to 80 mg per vial.

2.2

Solvent for Docetaxel 40mg/ml

The solvent is a 13% w/w solution of anhydrous ethanol in water for injections.
1.8 ml solvent vial

The solvent vial is a 5 ml clear glass vial with a green flip-off aluminium seal.


Each solvent vial contains 1.8 ml (fill volume 2.0 ml). This volume has been
established based on the fill volume of the concentrate vial. The addition of the
entire contents of the solvent vial to the contents of the Docetaxel 40 mg/ml
concentrate vial ensures a premix concentration of 10 mg/ml docetaxel.

7.1 ml solvent vial

The solvent for Docetaxel 40 mg/ml is a 10 ml clear glass vial with a green flipoff aluminium seal.


Each solvent vial contains 7.1 ml (fill volume 7.5 ml). This volume has been
established based on the fill volume of the concentrate vial. The addition of the
entire contents of the solvent vial to the contents of the Docetaxel 40 mg/ml
concentrate 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 40 mg/ml
concentrate and solvent for solution for infusion
boxes 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 vial
by partially inverting the vial.

4.1.3 Inject the entire contents of the syringe into the
corresponding Docetaxel 40 mg/ml concentrate
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.
However the chemical and physical in-use
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 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, the docetaxel
premix solution and infusion solution should be
visually inspected prior to use, solutions
containing a precipitate should be discarded.

5.

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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