Docetaxel Teva Pharma
docetaxel
docetaxel
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 Docetaxel Teva Pharma is and what it is used for
What you need to know before you use Docetaxel Teva Pharma
How to use Docetaxel Teva Pharma
Possible side effects
How to store Docetaxel Teva Pharma
Contents of the pack and other information
The name of this medicine is Docetaxel Teva Pharma. Docetaxel is a substance derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Medicinal product no longer authorised
Docetaxel Teva Pharma has been prescribed by your doctor for the treatment of advanced breast cancer, special forms of lung cancer (non-small cell lung cancer) and prostate cancer:
For the treatment of advanced breast cancer, Docetaxel Teva Pharma could be administered alone.
For the treatment of lung cancer, Docetaxel Teva Pharma could be administered either alone or in combination with cisplatin.
For the treatment of prostate cancer, Docetaxel Teva Pharma is administered in combination with prednisone or prednisolone.
you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Teva Pharma
the number of white blood cells is too low
you have a severe liver disease.
Before each treatment with Docetaxel Teva Pharma, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Teva Pharma. 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 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 Teva Pharma 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 Teva Pharma 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.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Docetaxel Teva Pharma or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Ask your doctor for advice before being given any medicine.
Docetaxel Teva Pharma must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Medicinal product no longer authorised
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy because Docetaxel Teva Pharma 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 Teva Pharma.
If you are a man being treated with Docetaxel Teva Pharma 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.
No studies on the effects on the ability to drive and use machines have been performed.
Docetaxel Teva Pharma will be administered to you by a healthcare professional.
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.
Docetaxel Teva Pharma 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.
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 Teva Pharma. 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.
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 Teva Pharma 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 Teva Pharma may be increased when Docetaxel Teva Pharma 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
Medicinal product no longer authorised
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 Teva Pharma the following may occur, and the frequency may vary with the combinations of medicines that are received:
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.
oral candidiasis
dehydration
dizziness
hearing impaired
decrease in blood pressure; irregular or rapid heart beat
heart failure
oesophagatis
dry mouth
difficulty or painful swallowing
haemorrhage
raised liver enzymes (hence the need for regular blood tests).
Medicinal product no longer authorised
fainting
at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
inflammation of the colon, small intestine; intestinal perforation
blood clots.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
This medicine should not be used after the expiry date which is stated on the carton and vials. Do not store above 25°C.
Do not freeze.
Store in the original package in order to protect from light.
The premix solution should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
The infusion solution should be used within 4 hours at room temperature (below 25°C).
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.
The active substance is docetaxel. Each vial of concentrate contains 20 mg of docetaxel. Each ml of concentrate contains 27.73 mg docetaxel.
The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol.
Water for injections.
Docetaxel Teva Pharma concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution.
Medicinal product no longer authorised
Each carton contains:
one 6 ml clear glass vial with a flip-off cap containing 0.72 ml concentrate and,
one 6 ml clear glass vial with a flip-off cap containing 1.28 ml of solvent.
Teva Pharma B.V. Computerweg 10
3542 DR Utrecht The Netherlands
PO Box 552
2003 RN Haarlem The Netherlands
TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82
H-2100 Gödöllő Hungary
Teva Operations Poland Sp. z.o.o. Sienkiewicza 25
99-300 Kutno Poland
Teva Czech Industries s.r.o Ostravská 29
Č.p. 305
747 70 Opava-Komárov Czech Republic
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
UAB “Sicor Biotech” Tel: +370 5 266 02 03
Тева Фармасютикълс България ЕООД
Teл: +359 2 489 95 82
Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111
Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
Teva Denmark A/S Tlf: +45 44 98 55 11
Drugsales Ltd
Τel: +356 21 419 070/1/2
Teva GmbH
Tel: +49 731 402 08
Teva Nederland B.V. Tel: +31 800 0228 400
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Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Tel: +372 661 0801
Teva Norway AS Tlf: +47 66 77 55 90
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007-0
Teva Pharma, S.L.U. Tél: +34 91 387 32 80
Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
Teva Santé
Tél: +33 1 55 91 78 00
Teva Pharma - Produtos Farmacêuticos Lda Tel: +351 21 476 75 50
Pliva Hrvatska d.o.o Tel: + 385 1 327 20 000
Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24
Teva Pharmaceuticals Ireland Tel: +353 51 321 740
Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
ratiopharm Oy
Sími: +358 20 180 5900
Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7911
Teva Italia S.r.l. Tel: +39 028917981
ratiopharm Oy
Puh/Tel: +358 20 180 5900
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
Teva Sweden AB Tel: +46 42 12 11 00
UAB Sicor Biotech filiāle Latvijā Tel: +371 67 323 666
Teva UK Limited
Tel: +44 1977 628 500
Medicinal product no longer authorised
The following information is intended for healthcare professionals only:
It is important that you read the entire contents of this guide prior to the preparation of either the Docetaxel Teva Pharma premix solution or the Docetaxel Teva Pharma infusion solution
Docetaxel Teva Pharma 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel (anhydrous) in polysorbate 80. The solvent for Docetaxel Teva Pharma is water for injections.
Docetaxel Teva Pharma is supplied as single-dose vials.
Each box contains one Docetaxel Teva Pharma vial (20 mg) and one corresponding solvent for Docetaxel Teva Pharma vial in a carton.
Docetaxel Teva Pharma vials should not be stored above 25°C and should be protected from light. Docetaxel Teva Pharma should not be used after the expiry date shown on the carton and vials.
Medicinal product no longer authorised
The Docetaxel 20 mg vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
The Docetaxel 20 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Each vial contains 20 mg/0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml). This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume". This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
The solvent for Docetaxel 20 mg vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
The solvent for Docetaxel composition is water for injections.
Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml). The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva Pharma 20mg vial ensures a premix concentration of 10 mg/ml docetaxel.
Docetaxel Teva Pharma is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Teva Pharma solutions. The use of gloves is recommended.
If Docetaxel Teva Pharma concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel Teva Pharma concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Pharma boxes to stand at room temperature (below 25°C) for 5 minutes.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva Pharma vial by partially inverting the vial.
Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. Do not shake.
Medicinal product no longer authorised
Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between +2°C and +8°C or at room temperature (below 25°C).
More than one premix vial may be necessary to obtain the required dose for the patient. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Inject the required premix volume into a 250 ml non-PVC 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.
Mix the infusion bag or bottle manually using a rocking motion.
The Docetaxel Teva Pharma infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
As with all parenteral products, Docetaxel Teva Pharma premix solution and infusion solution
should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Medicinal product no longer authorised
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.