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DOCETAXEL DONG-A 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL ANHYDROUS

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PACKAGE LEAFLET

Package leaflet: Information for the user
Docetaxel Dong-A 20mg / 1mL concentrate for solution for infusion
Docetaxel Dong-A 80mg / 4mL 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, 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.
What is in this leaflet:
1. What DOCETAXEL DONG-A is and what it is used for
2. What you need to know before you use DOCETAXEL DONG-A
3. How to use DOCETAXEL DONG-A
4. Possible side effects
5. How to store DOCETAXEL DONG-A
6. Contents of the pack and other information
1. What DOCETAXEL DONG-A is and what it is used for
The name of this medicine is DOCETAXEL DONG-A. Docetaxel is a substance derived from the needles
of yew trees.
Docetaxel belongs to the group of anti-cancer medicines which are called taxoids.
DOCETAXEL DONG-A 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 DONG-A 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
DONG-A could be administered in combination with doxorubicin and cyclophosphamide.
- For the treatment of lung cancer, DOCETAXEL DONG-A could be administered either alone or in
combination with cisplatin.
- For the treatment of prostate cancer, DOCETAXEL DONG-A is administered in combination with
prednisone or prednisolone.
- For the treatment of metastatic gastric cancer, DOCETAXEL DONG-A is administered in
combination with cisplatin and 5-fluorouracil.
- For the treatment of head and neck cancer, DOCETAXEL DONG-A is administered in combination
with cisplatin and 5-fluorouracil.
2. What you need to know before you use DOCETAXEL DONG-A
You must not be given DOCETAXEL DONG-A if
- you are allergic (hypersensitive) to docetaxel or any of the other ingredients of DOCETAXEL
DONG-A .
- the number of white blood cells is too low.
- you have a severe liver disease.
Warnings and precautions
Before each treatment with DOCETAXEL DONG-A, you will have blood tests to check that you have
enough blood cells and sufficient liver function to receive DOCETAXEL DONG-A. In case of white blood
cell disturbances, you may experience associated fever or infections.
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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.
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
before DOCETAXEL DONG-A is administered 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 DONG-A 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 Dong-A 20mg / 1mL contains 38.1% ethanol (alcohol), i.e. up to 0.381g per vial, equivalent to
9.6 mL of beer or 3.9 mL wine per vial.
Docetaxel Dong-A 80mg / 1mL contains 38.1% ethanol (alcohol), i.e. up to 1.52g per vial, equivalent to
38.4 mL of beer or 15.6 mL wine per vial.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as
patients with liver disease, or epilepsy.
Docetaxel is not recommended for use in children.
Other medicines and DOCETAXEL DONG-A
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 DONG-A 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 DONG-A must NOT be administered if you are pregnant unless clearly specified 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 DONG-A 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 being treated with DOCETAXEL DONG-A.
If you are a man being treated with DOCETAXEL DONG-A you are advised not to father a child during and
up to 6 months after treatment and to seek advice on conservation of sperm before 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.
3. How to use DOCETAXEL DONG-A
DOCETAXEL DONG-A 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 metres (m²) and will determine the dose you should receive.
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Method and route of administration
DOCETAXEL DONG-A 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 DONG-A. In particular, please inform your doctor if you
have diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give them the results
of your blood tests. Such information will allow them 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 DONG-A 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 DONG-A may be increased when DOCETAXEL DONG-A
is given in combination with other chemotherapeutic agents (drugs for cancer treatment).
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 DONG-A 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 tear secretion
- swelling caused by faulty fluid (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
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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 thrush (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 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 DONG-A
Keep this medicine out of the sight and reach of children.
This medicine should not be used after the expiry date shown on the carton, blister pack and vials.
Do not store above 25℃.
Store in the original package in order to protect from light.
The infusion solution should be used within 6 hours at room temperature (below 25°C).
6. Contents of the pack and other information
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What DOCETAXEL DONG-A concentrate vial contains
- The active substance is docetaxel (anhydrous). Each mL of docetaxel solution contains 20 mg of
docetaxel. One vial contains 20 mg/1 mL docetaxel.
- The active substance is docetaxel (anhydrous). Each mL of docetaxel solution contains 80 mg of
docetaxel. One vial contains 80 mg/4 mL docetaxel.
- The other ingredients are polysorbate 80, citric acid and ethanol (alcohol). Air in the vial has been
replaced by nitrogen.
What DOCETAXEL DONG-A looks like and contents of the pack
DOCETAXEL DONG-A 20 mg/1 mL concentrate for solution for infusion is a clear viscous, yellow to
brown yellow solution.
Each pack contains: One single-dose vial of 1 mL of concentrate with a light blue seal.
DOCETAXEL DONG-A 80 mg/4 mL concentrate for solution for infusion is a clear viscous, yellow to
brown yellow solution.
Each pack contains: One single-dose vial of 4 mL of concentrate with a lavender seal.
This leaflet was last revised in 06/2014

Marketing Authorisation
Holder
Dong-A Pharmaceutical UK
Limited
London Gas Museum
Twelvetrees Crescent
Bromley by Bow
London E3 3JH
UK

Manufacturer

Batch Release site in EU

Dr. Reddy's Laboratories
Limited,
FTO-7
Plot No. P1 to P9. Phase- III.
Duvvada, VSEZ,
Visakhapatnam
Andhra Pradesh 530 046.
India

Melbourn Scientific Ltd
Saxon Way,
Melbourn,
Royston, SG8 6DN
UK

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The following information is intended for healthcare professionals only:

PREPARATION GUIDE FOR USE WITH DOCETAXEL DONG-A 20 mg/1 mL and
80 mg/4 mL CONCENTRATE FOR SOLUTION FOR INFUSION.
_________________________________________________________________________
It is important that you read the entire contents of this guide before the preparation of Docetaxel Dong-A
infusion solution. The use of docetaxel should be confined to units specialised in the administration of
cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in
the use of anticancer chemotherapy. Docetaxel Dong-A Concentrate for Solution for Infusion must be
diluted before administration.
1. FORMULATION
Docetaxel Dong-A 20 mg/1 mL Concentrate for Solution for Infusion
Docetaxel Dong-A 80 mg/4 mL Concentrate for Solution for Infusion
Docetaxel Dong-A 20 mg/1 mL or 80 mg/4 mL Concentrate for Solution for Infusion is a clear, pale yellow
solution containing 20 mg/mL docetaxel (anhydrous) in polysorbate 80, citric acid and ethanol.
2. PRESENTATION
Docetaxel Dong-A is supplied as single-dose vials.
Each carton contains one vial of Docetaxel Dong-A (20 mg/1 mL or 80 mg/4 mL).
Docetaxel Dong-A vials should be stored below 25°C and protected from light.
Docetaxel Dong-A should not be used after the expiry date shown on the carton or vial.
2.1 Docetaxel Dong-A 20 mg/1 mL vial
• The Docetaxel Dong-A 20 mg/1 mL vial is a 5 mL clear glass vial with an aluminium light blue flipoff cap.
2.2 Docetaxel Dong-A 80 mg/4 mL
• The Docetaxel Dong-A 80 mg/4 mL vial is a 5 mL clear glass vial with an aluminium lavender flipoff cap.
3. RECOMMENDATIONS FOR SAFE HANDLING
Docetaxel Dong-A is an antineoplastic agent and, as with other potentially toxic compounds, caution should
be exercised when handling it and preparing Docetaxel Dong-A solutions. The use of gloves is
recommended.
If Docetaxel Dong-A concentrate or infusion solution should come into contact with skin, wash immediately
and thoroughly with soap and water. If Docetaxel Dong-A concentrate or infusion solution should come
into contact with mucous membranes, wash immediately and thoroughly with water and seek medical
attention.
4. PREPARATION OF THE INFUSION SOLUTION FOR INTRAVENOUS ADMINISTRATION
4.1 More than one vial of Docetaxel Dong-A 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 new, dry, graduated syringes, each fitted with a needle.
For example, a dose of 140 mg docetaxel would require 7 mL of Docetaxel Dong-A 20 mg/mL Concentrate
for Solution for Infusion.
4.2 Inject the required concentrate for solution volume into a 250 mL infusion bag containing either 5%
glucose solution or sodium chloride 9 mg/mL (0.9%) solution for infusion. If a dose greater than 200 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.
4.3 Mix the infusion bag or bottle manually using a rocking motion.
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4.4 The Docetaxel Dong-A infusion solution should be used within 6 hours and should be administered
aseptically as a 1-hour infusion at room temperature (below 25°C) and normal lighting conditions.
4.5 As with all parenteral products, Docetaxel Dong-A concentrate for solution and infusion solution should
be inspected visually before use, solutions containing a precipitate should be discarded.
5. DISPOSAL
All materials that have been used for dilution and administration should be disposed of according to
standard procedures. Do not throw away any medicines via wastewater. Ask your pharmacist how you may
throw away medicines no longer needed for use. These measures will help to 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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