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DOCETAXEL BEACON 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL ANHYDROUS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Docetaxel Beacon 20 mg/1 ml
[Docetaxel Beacon 80 mg/4 ml]
concentrate for solution for infusion
docetaxel
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your 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 pharmacist.
In this leaflet:
1. What Docetaxel Beacon is and what it is used for
2. Before you take Docetaxel Beacon
3. How to take Docetaxel Beacon
4. Possible side effects
5. How to store Docetaxel Beacon
6. Further information

1. WHAT DOCETAXEL BEACON IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Beacon. 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 Beacon 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 Beacon 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 Beacon could be administered in combination with doxorubicin and
cyclophosphamide.
- For the treatment of lung cancer, Docetaxel Beacon could be administered either
alone or in combination with cisplatin.
- For the treatment of prostate cancer, Docetaxel Beacon is administered in
combination with prednisone or prednisolone.
- For the treatment of metastatic gastric cancer, Docetaxel Beacon is administered
in combination with cisplatin and 5-fluorouracil.
- For the treatment of head and neck cancer, Docetaxel Beacon is administered in
combination with cisplatin and 5-fluorouracil.
2. BEFORE YOU USE DOCETAXEL BEACON
You must not be given Docetaxel Beacon if

you are allergic (hypersensitive) to docetaxel or any of the other ingredients of
Docetaxel Beacon.

the number of white blood cells is too low.

you have a severe liver disease.
Take special care with Docetaxel Beacon
Before each treatment with Docetaxel Beacon, you will have blood tests to check that
you have enough blood cells and sufficient liver function to receive Docetaxel Beacon. In
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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 Beacon 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 Beacon 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 Beacon contains alcohol. Discuss with your doctor if you suffer from alcohol
dependency or liver impairment. See also section “Important information about some of
the ingredients of Docetaxel Beacon” below.
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 Beacon 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 Beacon 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 Beacon 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 Beacon 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 Beacon
.
Driving and using machines
There is no reason why you cannot drive between courses of Docetaxel Beacon except
if you feel dizzy or are unsure of yourself.
Important information about some of the ingredients of Docetaxel Beacon.
[Docetaxel Beacon 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 1 ml fill volume, equivalent to 12 ml beer, 5 ml wine
per vial.
[Docetaxel Beacon 80 mg/4 ml]
This medicinal product contains approximately 55 vol % ethanol (alcohol), i.e. up to 1.83
g (2.26 ml) ethanol 96 % per vial of 4 ml 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 breast feeding women, in
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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 medicine may impair your ability to drive or use machines.

3. HOW TO USE DOCETAXEL BEACON
Docetaxel Beacon will be administered to you by a healthcare professional.
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.
Method and route of administration
Docetaxel Beacon 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 Beacon. 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 Docetaxel Beacon 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, Docetaxel Beacon 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 Beacon 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 Beacon may be increased when Docetaxel
Beacon 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
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• 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 Beacon the following may occur, and the frequency
may vary with the combinations of medicines that are received:
Very common (affects more than 1 user in 10):
• 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
• 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.
Common (affects 1 to 10 users in 100):
• oral thrush
• dehydration
• dizziness
• hearing impaired
• decrease in blood pressure; irregular or rapid heart beat
• heart failure
• inflammation of the gullet (oesophagitis)
• dry mouth
• difficulty or painful swallowing
• severe bleeding (haemorrhage)
• raised liver enzymes (hence the need for regular blood tests).
Uncommon (affects 1 to 10 users in 1,000):
• fainting
• at the injection site, skin reactions, inflammation of the vein (phlebitis) or swelling
• inflammation of the colon, small intestine; intestinal perforation
• blood clots.
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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 pharmacist.
5. HOW TO STORE DOCETAXEL BEACON
Keep out of the reach and sight of children.
Do not use Docetaxel Beacon after the expiry date which is stated on 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).
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 immediately the medicine 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 may crystallize over time. If
crystals appear, the solution must no longer be used and shall be discarded.
Dispose any unused product or waste material in accordance with local requirements.

6. FURTHER INFORMATION
What Docetaxel Beacon contains
-

The active substance is docetaxel.

[Docetaxel Beacon 20 mg/1 ml]
One ml docetaxel concentrate contains 20 mg docetaxel.
One vial of 1 ml of concentrate contains 20 mg docetaxel
[Docetaxel Beacon 80 mg/4 ml]
One ml docetaxel concentrate contains 20 mg docetaxel.
One vial of 4 ml of concentrate contains 80 mg docetaxel
The other ingredients are polysorbate 80, ethanol 96% and citric acid
monohydrate.
What Docetaxel Beacon looks like and contents of the pack
Docetaxel Beacon concentrate for solution for infusion is a clear viscous, colourless to
brownish-yellow sterile solution.
[Docetaxel Beacon 20 mg/1 ml]
The concentrate is supplied in a 2 ml colourless glass vial with a green flip-off closure.
Each box contains one vial of 1 ml concentrate (20 mg docetaxel).

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[Docetaxel Beacon 80 mg/4 ml]
The concentrate is supplied in a 4 ml colourless glass vial with a red flip-off closure.
Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Marketing Authorisation Holder
[to be completed nationally]
Manufacturer
[to be completed nationally]

This leaflet was last approved in
11 May 2011

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---------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals
only:
PREPARATION GUIDE FOR USE WITH Docetaxel Beacon 20 mg/1 ml [Docetaxel
Beacon 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 Docetaxel Beacon infusion solution.
RECOMMENDATIONS FOR THE SAFE HANDLING
Docetaxel Beacon is an antineoplastic agent and, as with other potentially toxic
compounds, caution should be exercised when handling and preparing Docetaxel Beacon
solutions. The use of gloves is recommended.
If Docetaxel Beacon 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 OF THE INTRAVENOUS ADMINISTRATION
Preparation of the infusion solution
DO NOT use other docetaxel medicinal products consisting of several vials
(concentrate and solvent) with this medicinal product (Docetaxel Beacon 20
mg/1 ml [Docetaxel Beacon 80 mg/4 ml] concentrate for solution for infusion,
which contains only 1 vial).
Docetaxel Beacon 20 mg/1 ml [Docetaxel Beacon 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.
In Docetaxel Beacon 20 mg/1 ml [Docetaxel Beacon 80 mg/4 ml] vial the
concentration of docetaxel is 20 mg/ml.
• Then, 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 microbiological point of view the the infusion solution should be used
immediately. 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 below 25°C
including the one hour infusion to the patient.
• As with all parenteral products, 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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