Skip to Content

DOCIRENA 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Docirena - Package Insert - UK (Bordon)

2. What you need to know before you use Docirena infusion

Black

D:\Europe\Docetaxel\AET\UK+Ireland\UK\Variation\Docetaxel PI - (GBR) - Bordon.cdr

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Important information about some of the ingredients of Docirena infusion.
Docirena infusion contains ethanol (alcohol)
[Docirena 20 mg/1 ml]
This medicinal product contains approximately 55 vol % ethanol (alcohol), i.e. 0.46 g
(0.57 ml) ethanol 96 % per vial of 1ml fill volume, equivalent to 12 ml beer, 5 ml wine
per vial.
[Docirena 80 mg/4 ml]
This medicinal product contains approximately 55 vol % ethanol (alcohol), i.e. up to
1.828 g (2.26 ml) ethanol 96 % per vial of 4ml fill volume, equivalent to 46 ml beer, 20
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.

RECOMMENDATIONS
FOR THE SAFE
HANDLING
Docirena infusion is an
antineoplastic agent and,
as with other potentially
toxic compounds, caution
should be exercised when
handling it and preparing
Docirena infusion
solutions. The use of
gloves is recommended.
If Docirena infusion
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
GUIDE FOR USE
WITH Docirena
20 mg/1 ml and
Docirena 80 mg/4 ml
CONCENTRATE FOR
SOLUTION FOR
INFUSION
It is important that you
read the entire contents
of this procedure prior to
the preparation of the
Docirena infusion.

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

You must not be given Docirena infusion if
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of
Docirena infusion.
• if the number of white blood cells is too low.

Pregnancy, breast-feeding and fertility
Ask your doctor for advice before being given any medicine.
Docirena 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 Docirena infusion 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 Docirena infusion
If you are a man being treated with Docirena infusion you are advised not to father a
child during and for up to 6 months after treatment and to seek advice on conservation of
sperm prior to treatment because docetaxel may alter male fertility.

Date : 16 August 2012

Version : 05

Method and route of administration
Docirena 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 Docirena 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 medicine, ask your doctor, or hospital pharmacist.
If you are given more Docirena infusion than you should
Your doctor will ensure that the correct dose for your condition is given. In cases of
suspected overdose, you should be closely monitored. Appropriate treatment should be
started if required.
If you have any further questions on the use of this product, ask your doctor or healthcare
staff.
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.
Tell your doctor immediately if you notice any of the following;
- flushing, skin reactions or itching
- chest tightness or difficulty breathing
- fever or chills
- back pain
- dizziness or feeling light-headed due to low blood pressure.
The severity of adverse events of Docirena infusion may be increased when Docirena
infusion is given in combination with other chemotherapeutic agents.
Between infusions of Docirena infusion 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)

V004/BO/UK

1. What Docirena infusion is and what it is used for
The name of this medicine is Docirena 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.
Docirena 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, Docirena 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,
Docirena infusion could be administered in combination with doxorubicin and
cyclophosphamide.
- For the treatment of lung cancer, Docirena infusion could be administered either
alone or in combination with cisplatin.
- For the treatment of prostate cancer, Docirena infusion is administered in
combination with prednisone or prednisolone.
- For the treatment of metastatic gastric cancer, Docirena infusion is administered in
combination with cisplatin and 5-fluorouracil.
- For the treatment of head and neck cancer, Docirena infusion is administered in
combination with cisplatin and 5-fluorouracil.

Other medicines and Docirena
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 Docirena infusion or the other medicine may not work as well as
expected and you may be more likely to get a side effect.

Usual dose
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.

xxxxxxxxxx

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

3. How to use Docirena infusion
Docirena infusion will be administered to you by a healthcare professional.

xxxxxx

Read all of this leaflet carefully before you start taking 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 your pharmacist.
- 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.

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.

Docirena 20 mg/1 ml
and Docirena 80 mg/4
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 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 required amount of
concentrate for
solution for infusion
with a calibrated
syringe.

The name of these medicines are Docirena 20 mg/1 ml concentrate for solution for
infusion and Docirena 80 mg/4 ml concentrate for solution for infusion, called Docirena
infusion in the rest of the leaflet.

DO NOT use other
docetaxel medicinal
products consisting of
vials (concentrate and
solvent) with this
medicinal product
Docirena 20 mg/1 ml
and Docirena 80 mg/4
ml concentrate for
solution for infusion,
which contains only 1
vial.

docetaxel

Warnings and precautions
Before each treatment with Docirena infusion, you will have blood tests to check that
you have enough blood cells and sufficient liver function to receive Docirena 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 Docirena 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 Docirena infusion 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.
Docirena infusion contains alcohol. Discuss with your doctor if you suffer from alcohol
dependency or liver impairment. See also section “Docirena contains ethanol (alcohol)”
below.

Preparation of the
infusion solution

Docirena 20 mg/1 ml concentrate for solution for infusion
Docirena 80 mg/4 ml concentrate for solution for infusion

• if you have a severe liver disease.

PREPARATION OF
THE INTRAVENOUS
ADMINISTRATION

PACKAGE LEAFLET: INFORMATION FOR THE USER

Font: Times New Roman - 9 Pt.

Dimension : 339 x 245 mm

Docirena - Package Insert - UK (Bordon)

Docirena infusion 20 mg/1 ml
One vial of 1 ml of concentrate contains 20 mg docetaxel
Docirena infusion 80 mg/4 ml
One vial of 4 ml of concentrate contains 80 mg docetaxel
- The other ingredients are polysorbate 80, ethanol 96% and citric acid monohydrate.
What Docirena infusion looks like and contents of the pack
Docirena concentrate for solution for infusion is a clear viscous, colourless to brownishyellow sterile solution.
Docirena infusion 20 mg/1 ml : The concentrate is supplied in a 2 ml colourless glass
vial with a flip-off seal consisting of an aluminium shell and a red plastic flip-off button.
Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Docirena infusion 80 mg/4 ml : The concentrate is supplied in a 4 ml colourless glass
vial with a flip-off seal consisting of an aluminium shell and a red plastic flip-off button.
Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1NT, UK
Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU35 0NF, United Kingdom

This leaflet was last revised on 08/2012

In Docirena
20 mg/1 ml and
Docirena 80 mg/4 ml
vial the concentration
of docetaxel is
20 mg/ml.
• Then, via a single
injection (one shot)
inject into a
250 ml infusion bag
or bottle containing
either 5% glucose
solution or sodium
chloride 9 mg/ml
(0.9%) 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 reconstitution
/dilution must take
place in controlled
and aseptic
conditions and the
infusion solution
should be used
immediately. If not
used immediately, inuse 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 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 in
non-PVC bags up to
48 hours when stored
between 2°C to 8°C.
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, the infusion
solution should be
visually inspected
prior to use, solutions
containing a
precipitate should be
discarded.

5. How to store Docirena infusion
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 outer carton and on
the label of the vial after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).

What Docirena infusion contains
- The active substance is docetaxel. Each ml of concentrate contains 20 mg docetaxel
anydrous.

V004/BO/UK

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.
If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes
any possible side effects noticed in this leaflet.

6. Contents of pack and other information

xxxxxxxxxx

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
• inflammation of the gullet (oesophagitis)
• oesophagitis, dry mouth
• difficulty or painful swallowing
• haemorrhage
• raised liver enzymes (hence the need for regular blood tests).

Store in the original package in order to protect from light.
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, reconstitution/dilution must take place in
controlled and aseptic conditions.
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
would normally not be longer than 8 hours in infusion bottle or 6 hours in infusion bag
below 25°C including the one hour infusion.
Physical and chemical in-use stability of the infusion solution prepared as
recommended has been demonstrated in non-PVC bags up to 48 hours when stored
between 2 to 8°C.
Docetaxel infusion solution is supersaturated, therefore it may crystallize over time. If
crystals appear, the solution must no longer be used and should 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.

xxxxxx








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
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 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.

Black

D:\Europe\Docetaxel\AET\UK+Ireland\UK\Variation\Docetaxel PI - (GBR) - Bordon.cdr

Date : 16 August 2012

Version : 05

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.

















Font: Times New Roman - 9 Pt.

Dimension : 339 x 245 mm

Expand Transcript

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.

Hide