What is it and how is it used?
The name of this medicine is Docetaxel Winthrop. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Docetaxel Winthrop 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:
What do you have to consider before using it?
You must not be given Docetaxel Winthrop
Take special care with Docetaxel Winthrop
Before each treatment with Docetaxel Winthrop, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Winthrop. In case of white blood cells disturbances, you may experience associated fever or infections.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Winthrop 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 Winthrop 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 Winthrop contains alcohol. Discuss with your doctor if you suffer from alcohol dependency or liver impairment. See also section “Important information about some of the ingredients of Docetaxel Winthrop” below.
Taking other medicines
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 Winthrop or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Pregnancy
Ask your doctor for advice before being given any medicine.
Docetaxel Winthrop 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 Winthrop may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.
If you are a man being treated with Docetaxel Winthrop 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.
Breast-feeding
You must not breast-feed while you are treated with Docetaxel Winthrop.
Driving and using machines
There is no reason why you cannot drive between courses of Docetaxel Winthrop except if you feel dizzy or are unsure of yourself.
Important information about some of the ingredients of Docetaxel Winthrop.
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g (0.5 ml) 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.
How is it used?
Docetaxel Winthrop 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 meters (m²) and will determine the dose you should receive.
Method and route of administration
Docetaxel Winthrop 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 Winthrop. 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.
What are possible side effects?
Like all medicines, Docetaxel Winthrop 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 frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot be estimated from the available data).
The most commonly reported adverse reactions of Docetaxel Winthrop 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 Winthrop may be increased when Docetaxel Winthrop is given in combination with other chemotherapeutic agents.
During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) 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 Winthrop the following may occur, and the frequency may vary with the combinations of medicines that are received
Very common (affects more than 1 user in 10):
Common (affects 1 to 10 users in 100):
Uncommon (affects 1 to 10 users in 1,000):
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Docetaxel Winthrop after the expiry date which is stated on 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, reconstitution/dilution must take place in controlled and aseptic conditions.
Use immediately the medicine once added into the infusion bag . If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer 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 to 8°C.
Docetaxel infusion solution is supersaturated, therefore may cristallize over time. If crystals appear, the solution must no longer be used and shall be discarded.
Dispose any unused product or waste material in accordance with local requirements
