Docetaxel Dong-A 20 Mg/1 Ml Concentrate For Solution For Infusion
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.
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.
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 X.
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
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
Dr. Reddy's Laboratories Limited,
FTO-7
Plot No. P1 to P9. Phase- III. Duvvada, VSEZ, Visakhapatnam Andhra Pradesh 530 046. India
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 flip-
off 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 flip-
off 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.
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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