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DOCETAXEL DR REDDYS 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL ANHYDROUS

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Docetaxel 20 mg/1 ml, 80 mg/4 ml, 160 mg/8 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, hospital pharmacist or nurse.

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.

Other medicines and Docetaxel

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

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.

1. What Docetaxel is and what it is used for

Pregnancy, breastfeeding and fertility

Ask your doctor for advice before being given any
medicine.

Docetaxel is a substance derived from the needles of yew
trees. Docetaxel belongs to the group of anti-cancer
medicines called taxoids.

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.

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.

You must not breastfeed 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. The amount of alcohol in
this medicine may impair your ability to drive or use
machines (see below).

Docetaxel concentrate contains ethanol
(alcohol)

Docetaxel 20 mg/1 ml contains 50 vol % ethanol
anhydrous (alcohol), i.e. up to 395 mg Ethanol per vial,
equivalent to 10 ml of beer or 4 ml wine per vial.
Docetaxel 80 mg/4 ml contains 50 vol % ethanol
anhydrous (alcohol), i.e. up to 1.58 g Ethanol per vial,
equivalent to 40 ml of beer or 17 ml wine per vial.
Docetaxel 160 mg/8 ml contains 50 vol % ethanol
anhydrous (alcohol), i.e. up to 3.16 g Ethanol per vial,
equivalent to 80 ml of beer or 33 ml wine per vial.

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 concentrate
if the number of white blood cells is too low
if you have a severe liver disease.

Harmful for those suffering from alcoholism.
To be taken into account if you are pregnant or if you are
breastfeeding, in children and high-risk groups such as
patients with liver disease, or epilepsy.

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.

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).
The amount of alcohol in this medicinal product may alter
the effects of other medicines.

Tell your doctor, hospital pharmacist or nurse if you have
vision problems. In case of vision problems, in particular
blurred vision, you should immediately have your eyes
and vision examined.

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

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.

Usual dose

The dose will depend on your weight and your general
condition. Your doctor will calculate your body surface
area in square metres (m2) and will determine the dose
you should receive.

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).

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

During treatment, you may be given other medicines to
maintain the number of your blood cells.

You should usually receive your infusion once every
3 weeks.

Docetaxel concentrate contains alcohol. Discuss with your
doctor if you suffer from alcohol dependency, epilepsy or
liver impairment. See also section “Docetaxel concentrate
contains ethanol (alcohol)” below.

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.

Docetaxel concentrate for solution for infusion requires NO prior
dilution with an accompanying solvent before addition to and
dilution in infusion solutions.
• 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 fitted with a 21G needle.

DO NOT use other docetaxel medicinal products consisting of
2 vials (concentrate and solvent) with this medicinal product
(Docetaxel concentrate for solution for infusion, which contains
only 1 vial).

Preparation of the infusion solution

Preparation of the intravenous administration

If Docetaxel 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.

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.

Recommendations for the safe handling

It is important that you read the entire contents of this guide prior to the
preparation of the Docetaxel infusion solution.

PREPARATION GUIDE FOR USE WITH DOCETAXEL
CONCENTRATE FOR SOLUTION FOR INFUSION

The following information is intended for healthcare professionals only:

If you have any further questions on the use of this
medicine, ask your doctor, or hospital pharmacist.
The amount of alcohol in this medicine may impair your
ability to drive or use machines.

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, hair loss (alopecia), nausea,
vomiting, sores in the mouth, diarrhoea and tiredness.
The severity of adverse events of Docetaxel may be
increased when it 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):
• 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 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 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 (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)
• 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, hospital
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, website:
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 on the label of the vial after
EXP. The expiry date refers to the last day of that month.
Docetaxel 20 mg/ml and 80 mg/4 ml: Do not store above
25°C. Do not freeze. Store in the original package in order
to protect from light.
Docetaxel 160 mg/8 ml: Do not store above 25°C. Do not
freeze.
Use the vials immediately after opening. If not used
immediately, in-use storage times and conditions are the
responsibility of the user.
Chemical and physical in-use stability has been
demonstrated in non-PVC bags for 6 hours at 25°C and
for 48 hours at 2° to 8°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.
Docetaxel infusion solution is supersaturated, therefore
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.

6. Contents of the pack and other
information
What Docetaxel concentrate contains

The active substance is docetaxel. Each ml of concentrate
for solution for infusion contains 20 mg docetaxel
(anhydrous).
One vial of 20 mg/1 ml concentrate contains 20 mg
docetaxel.
One vial of 80 mg/4 ml concentrate contains 80 mg
docetaxel.
One vial of 160 mg/8 ml concentrate contains 160 mg
docetaxel.
The other ingredients are polysorbate 80, ethanol
anhydrous (see section 2) and citric acid anhydrous.

What Docetaxel concentrate looks like and
contents of the pack

Docetaxel concentrate for solution for infusion is a pale
yellow to brownish-yellow solution.
The 20 mg/1 ml concentrate is supplied in a 2 ml glass vial
with a rubber stopper and a green flip-off seal. Each vial
contains 1 ml concentrate.
The 80 mg/4 ml concentrate is supplied in a 5 ml glass vial
with a rubber stopper and a pink flip-off seal. Each vial
contains 4 ml concentrate.
The 160 mg/8 ml concentrate is supplied in a 10 ml glass
vial with a rubber stopper and a blue flip-off seal. Each vial
contains 8 ml concentrate.
Each box contains 1 vial.

Marketing Authorisation Holder and
Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 12/2015

In Docetaxel, the concentration of docetaxel is 20 mg/ml.
• 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.
• Chemical and physical in-use stability has been demonstrated in nonPVC bags for 6 hours at 25°C and for 48 hours at 2° to 8°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.
• 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, 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.

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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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