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DOCETAXEL AQVIDA 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL

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Package leaflet: Information for the patient
Docetaxel AqVida 20 mg/ml concentrate for solution for infusion
Docetaxel
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 pharmacist.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Docetaxel AqVida is and what it is used for
2.
What you need to know before you use Docetaxel AqVida
3.
How to use Docetaxel AqVida
4.
Possible side effects
5.
How to store Docetaxel AqVida
6.
Contents of the pack and other information

1.

What Docetaxel AqVida is and what it is used for

The name of this medicine is Docetaxel AqVida. 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 AqVida 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 AqVida 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
AqVida could be administered in combination with doxorubicin and cyclophosphamide.

For the treatment of lung cancer, Docetaxel AqVida could be administered either alone or in
combination with cisplatin.

For the treatment of prostate cancer, Docetaxel AqVida is administered in combination with
prednisone or prednisolone.

For the treatment of metastatic gastric cancer, Docetaxel AqVida is administered in
combination with cisplatin and 5-fluorouracil.

For the treatment of head and neck cancer, Docetaxel AqVida is administered in combination
with cisplatin and 5-fluorouracil.

2.

What you need to know before you use Docetaxel AqVida

You must not be given Docetaxel AqVida

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

if the number of white blood cells is too low.

if you have a severe liver disease.
Warnings and precautions

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Before each treatment with Docetaxel AqVida, you will have blood tests to check that you have
enough blood cells and sufficient liver function to receive Docetaxel AqVida. In case of white blood
cells disturbances, you may experience associated fever or infections.
Tell your doctor or your pharmacist if you have vision problems. In case of vision 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 or pharmacist 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 AqVida 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 AqVida 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 AqVida contains alcohol. Discuss with your doctor if you suffer from alcohol dependency
or liver impairment. See also section “Docetaxel AqVida contains ethanol (alcohol)” below.
Other medicines and Docetaxel AqVida
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicine,
including medicines obtained without a prescription. This is because Docetaxel AqVida 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 AqVida 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 AqVida 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 AqVida.
If you are a man being treated with Docetaxel AqVida, 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 AqVida 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 AqVida contains ethanol (alcohol)
1 ml vial:
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g (0.5 ml) per vial,
equivalent to 10 ml of beer or 4 ml wine per vial.
4 ml vial:
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 1.58 g (2 ml) per vial,
equivalent to 40 ml of beer or 16 ml wine per vial.
7 ml vial:
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 2.765 g (3.5 ml) per vial,
equivalent to 70 ml of beer or 28 ml wine per vial.
8 ml vial:
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This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 3.16 g (4 ml) per vial,
equivalent to 80 ml of beer or 33 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 children and highrisk 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 AqVida

Docetaxel AqVida 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 AqVida 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 AqVida. 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 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 AqVida 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 AqVida may be increased when Docetaxel AqVida 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,
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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 AqVida 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 diarrhoea, 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)
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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)

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 or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via 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 AqVida

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.
Do not store above 25 °C.
Store in the original package in order to protect from light.
Do not freeze.
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.

6.

Contents of the pack and other information

What Docetaxel AqVida contains

The active substance is docetaxel. Each ml of concentrate for solution for infusion contains
20 mg docetaxel.

The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.
What Docetaxel AqVida looks like and contents of the pack
Docetaxel AqVida concentrate for solution for infusion is a yellow to brownish yellow clear oily
solution.
Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Each box contains one vial of 7 ml concentrate (140 mg docetaxel).
Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Not all pack sizes may be marketed.
pal (UK) Docetaxel AqVida 20 mg/ml concentrate for solution for infusion
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Marketing Authorisation Holder and Manufacturer
AqVida GmbH
Kaiser-Wilhelm-Str. 89
20355 Hamburg
Germany
This leaflet was last revised in 02/2014.
The following information is intended for healthcare professionals only:
PREPARATION GUIDE FOR USE WITH DOCETAXEL AQVIDA 20 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
It is important that you read the entire contents of thisguide prior to the preparation of the Docetaxel
AqVida infusion solution
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 its solutions. The use of gloves is recommended.
If Docetaxel AqVida 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 2 vials (concentrate and solvent)
with this medicinal product

Docetaxel AqVida 20 mg/ml concentrate for solution for infusion, which contains only
1 vial with 1 ml (20 mg/1 ml).

Docetaxel AqVida 20 mg/ml concentrate for solution for infusion, which contains only
1 vial with 4 ml (80 mg/4 ml).

Docetaxel AqVida 20 mg/ml concentrate for solution for infusion, which contains only
1 vial with 7 ml (140 mg/7 ml).

Docetaxel AqVida 20 mg/ml concentrate for solution for infusion, which contains only
1 vial with 8 ml (160 mg/8 ml).
Docetaxel AqVida 20 mg/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. From a microbiological point of view, the concentrate 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.
Chemical and physical in-use stability of the open vial has been demonstrated for 4 weeks at 2 to
8 °C.



More than one vial of concentrate for solution for infusion may be necessary to obtain the
required dose for the patient.
Aseptically withdraw the required amount of concentrate for solution for infusion with a
calibrated syringe fitted with a 21G needle.

In Docetaxel AqVida 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
In Docetaxel AqVida 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
In Docetaxel AqVida 140 mg/7 ml vial the concentration of docetaxel is 20 mg/ml.
In Docetaxel AqVida 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
pal (UK) Docetaxel AqVida 20 mg/ml concentrate for solution for infusion
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Then, inject via a single injection (one shot) 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, 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. Chemical and physical in-use stability has been demonstrated in
polyolefin bags for 72 hours at 2 to 8°C and for 8 hours at 25 °C. Although contact time is very little,
only non-PVC tubing and administration sets are recommended for use as precaution.
Docetaxel solution for infusion 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, 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. 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.

pal (UK) Docetaxel AqVida 20 mg/ml concentrate for solution for infusion
National version: 26.02.2014

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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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