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DOCETAXEL TEVA 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Docetaxel 20 mg/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 your hospital 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. See section 4.

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

1.

What Docetaxel is and what it is used for

The name of this medicine is Docetaxel. 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 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 or without 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.

What you need to know before you use Docetaxel

You must not be given Docetaxel if
• you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel.
• the number of white blood cells is too low.
• you have a severe liver disease.
Warnings and precautions
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
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problems, in particular blurred vision, you should immediately have your eyes and vision examined.
If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough),
please tell your doctor, hospital pharmacist or nurse immediately. Your doctor may stop your
treatment immediately.
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.
Docetaxel contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or
liver impairment. See also section “Docetaxel contains ethanol (alcohol)” below.
Other medicines and Docetaxel
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.
Pregnancy, breast-feeding and fertility
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.
You must not breast-feed while you are treated with Docetaxel.
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.
Docetaxel contains ethanol (alcohol)
This medicinal product contains 40 % (w/w) ethanol (alcohol). i.e. up to
- 400 mg per (1 ml) vial, equivalent to 10 ml of beer or 4 ml wine per vial.
- 1600 mg per (4 ml) vial, equivalent to 40 ml of beer or 16 ml wine per vial.
- 2800 mg per (7 ml) vial, equivalent to 70 ml of beer or 28 ml wine per vial.
- 3200 mg per (8 ml) vial, equivalent to 80 ml of beer or 32 ml wine per vial.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, in children and in high-risk groups such as
patients with liver disease, or epilepsy.
The amount of alcohol in this medicinal product may have effects on the central nervous system (the part of
the nervous system that includes the brain and spinal cord).

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The amount of alcohol in this medicine 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

Docetaxel 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 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. 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.

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.
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, diarrhea 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 affect more than 1 in 10 people)
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.

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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 diarrhea, 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 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 (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)
• pneumonia (infection of the lungs)
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
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• blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
• decrease of the 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.
5.

How to store Docetaxel

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 the vial. The expiry
date refers to the last day of that month.

Store below 25°C.
Store in the original package in order to protect from light.
Do not refrigerate or freeze.

6.

Contents of the pack and other information

What Docetaxel contains
- The active substance is docetaxel. Each ml of docetaxel solution contains 20 mg of docetaxel anhydrous.
- The other ingredients are citric acid anhydrous, povidone, ethanol absolute (see section 2) and polysorbate
80.
What Docetaxel looks like and contents of the pack:
Docetaxel concentrate for solution for infusion is a clear, oily, pale yellow solution.
Pack sizes:
1 x 1 ml single dose vial
1 x 4 ml single dose vial
1 x 7 ml single dose vial
1 x 8 ml single dose vial
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

S.C. Sindan- Pharma S.R.L, 11 Ion Mihalache Blvd, 011171 Bucharest, Romania
*OR

Actavis Italy S.p.A., Via Pasteur 10, 20014 Nerviano (MI), Italy
This leaflet was last revised in 03/2016.

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PL 00289/1825
* Only the actual site of batch release will appear on the printed version of the leaflet

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

Docetaxel 20 mg/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 20 mg/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 20 mg/ml docetaxel from the appropriate number of vials
using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 7 ml
of Docetaxel 20 mg/ml concentrate for solution for infusion.
For doses below 192 mg of docetaxel, inject the required volume of Docetaxel 20 mg/ml concentrate for
solution for infusion into a 250 ml infusion bag or bottle containing either 250 ml of 50 mg/ml (5%) glucose
solution for infusion or 9 mg/ml (0.9%) sodium chloride solution for infusion. For doses exceeding 192 mg
of docetaxel more than 250 ml of the infusion solution is required, as the maximum concentration of
docetaxel is 0.74 mg per ml of infusion solution.
Mix the infusion bag or bottle manually using a rocking motion. The diluted solution should be aseptically
administered as a 1-hour infusion at room temperature and normal lighting conditions.
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
The solution should be used immediately after opening of the vial.
Storage after dilution
Chemical and physical in use stability of the diluted solution (0.74 mg/ ml) in the recommended solutions
for infusion (50 mg/ml (5%) glucose solution for infusion or 9 mg/ml (0.9%) sodium chloride solution for
infusion) has been demonstrated 3 days when stored at 2-8°C protected from light and for 8 hours in nonPVC bags when stored below 25°C under normal lighting conditions.
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are responsibility of the user and would normally not be longer
than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

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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.

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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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