Docetaxel Mylan
docetaxel
Package Leaflet: Information for the user
Docetaxel
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or hospital pharmacist.
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 Mylan 20 mg/1 ml is and what it is used for
What you need to know before you use Docetaxel Mylan 20 mg/1 ml
How to use Docetaxel Mylan 20 mg/1 ml
Possible side effects
How to store Docetaxel Mylan 20 mg/1 ml
Contents of the pack and other information
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 Mylan 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 5-fluorouracil.
You must not be given Docetaxel Mylan
if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Mylan
if the number of white blood cells is too low.
if you have a severe liver disease.
Before each treatment with Docetaxel Mylan, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Mylan. 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 Mylan 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 Mylan 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 Mylan contains alcohol. Discuss with your doctor if you suffer from alcohol dependency or liver impairment. See also section “Docetaxel Mylan contains ethanol” below.
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 Mylan or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Medicinal product no longer authorised
Ask your doctor for advice before being given any medicine.
Docetaxel Mylan 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 Mylan 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 Mylan.
If you are a man being treated with Docetaxel Mylan 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.
This medicine contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial equivalent to 10 ml of beer or 4 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 high- risk 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.
Docetaxel Mylan 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 Mylan 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 Mylan. 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.
Medicinal product no longer authorised
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 Mylan alone are: decrease in the number of red blood cells or white blood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan 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 Mylan 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
Medicinal product no longer authorised
swelling of the hands, feet, legs
tiredness; or flu-like symptoms
weight gain or loss.
fungal infection of the mouth (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).
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.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
Use the vial immediately after its opening. If not used immediately, in-use storage times and conditions are the responsibility of the user.
From a microbiological point of view, dilution must take place in controlled and aseptic conditions. Use immediately the medicine once added into the non-PVC infusion bag. If not used immediately, in-
use storage times and conditions are the responsibility of the user and would normally not be longer
Medicinal product no longer authorised
than 6 hours below 25°C including the one hour infusion.
Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall 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.
The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).
One vial contains 20 mg of docetaxel.
The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.
Docetaxel Mylan concentrate for solution for infusion is a pale yellow to brownish-yellow solution. The concentrate is supplied in a clear colourless glass vial with a rubber stopper and a plastic flip-off cap.
Each vial contains 1 ml of concentrate. Each box contains 1 or 5 vials.
Mylan S.A.S.
117 allée des parcs 69800 Saint Priest France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Mylan bvba/sprl
Tél/Tel: + 0032 2 658 61 00
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mylan bvba/sprl
Tél/Tel: + 0032 2 658 61 00 (Belgium)
Mylan Kft
Tel: 36 1 8026993
Mylan ApS
Tlf: + 45 3694 4568
George Borg Barthet Ltd Tel: +356 21244205
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Mylan dura GmbH
Tel: + 49-(0) 6151 9512 0
Mylan B.V
Tel: + 31 (0)33 2997080
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mylan AB
Tlf: + 46 8-555 227 50 (Sverige)
Generics Pharma Hellas ΕΠΕ Τηλ: +30 210 9936410
Arcana Arzneimittel GmbH Tel: +43 1 416 24 18
Mylan Pharmaceuticals, S.L tel: + 34 93 3786400
Mylan Sp.z.o.o
Tel: +48 22 5466400
Mylan SAS
Tel: +33 4 37 25 75 00
Mylan, Lda.
Phone: + 00351 21 412 7200
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mc Dermott Laboratories Ltd Tel: + 1800 272 272
Allphar +353 1 4041600
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Mylan AB
Tel: + 46 8-555 227 50
Mylan sr.o
Tel: +421 2 32 604 901
Mylan S.p.A
Tel: + +39/02-61246921
Mylan OY
Puh/Tel: + 358 9-46 60 03
Pharmaceutical Trading Co Ltd Τηλ: +35 7 24656165
Mylan AB
Tel: + 46 8-555 227 50
Mylan SAS
Tel: +33 4 37 25 75 00 (France)
Generics [UK] Ltd t/a Mylan Tel: +44 1707 853000
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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 the Docetaxel Mylan 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 Mylan 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
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.
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, dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately. If not used immediately, in- use storage times and conditions are the responsibility of the user.
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. It should be used within 6 hours (including the one hour infusion intravenous administration).
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
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:
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.