What Onkotaxel is and what it is used for?
The name of this medicine is Onkotaxel. 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.
Onkotaxel 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:
Before you take Onkotaxel
Do not take Onkotaxel
Warnings and precautions
Before each treatment with Onkotaxel, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Onkotaxel. In case of white blood cells disturbances, you may experience associated fever or infections.
Tell your doctor, hospital pharmacist, or nurse immediately if you have abdominal pain or tenderness, diarrhea, rectal hemorrhage, blood in stool or fever. These symptoms may be the first signs of a serious gastrointestinal toxicity, which could be fatal. Your doctor should address them immediately.
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.
Tell your doctor, hospital pharmacist or nurse if you have experienced an allergic reaction to previous paclitaxel therapy.
Tell your doctor, hospital pharmacist or nurse if you have heart problems.
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 Onkotaxel 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 Onkotaxel 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.
Onkotaxel contains alcohol. Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Other medicines and Onkotaxel
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 Onkotaxel or the other medicine may not work as well as expected and you may be more likely to get a side effect.
The amount of alcohol in this medicinal product may alter the effects of other medicines.
Pregnancy, breast-feeding and fertility
Onkotaxel 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 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.
If you are a man being treated with Onkotaxel 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.
Driving and using machines
The amount of alcohol in this medicinal product may impair your ability to drive or use machines. You may experience side effects of this medicine that may impair your ability to drive, use tools or operate machines. If this happens, do not drive or use any tools or machines before discussing with your doctor, nurse or hospital pharmacist.
Onkotaxel contains alcohol (Ethanol)
Onkotaxel contains 50 vol % dehydrated alcohol (Ethanol).
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding, in children and high-risk groups such as patients with liver disease, or epilepsy.
The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
How to take Onkotaxel?
Onkotaxel 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.
Onkotaxel 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 Onkotaxel. In particular, please inform your doctor in case of diarrhea, sores in the mouth, feeling of numbness or pins and needles, fever. Such information will allow your doctor to decide whether a dose reduction is needed.
Onkotaxel concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to 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.
In Onkotaxel vial the concentration of docetaxel is 20 mg/ml.
Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle. Then, inject via a single injection (one shot) 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 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 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.
If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.
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 alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhea and tiredness.
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):
More severe reactions may occur.
If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe. The hospital staff will monitor your condition closely during treatment. Tell them immediately if you notice any of these effects.
Between infusions of docetaxel the following may occur, and the frequency may vary with the combinations of medicines that are received.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Not known side effects (frequency cannot be estimated from the available data):
How to store Onkotaxel?
Keep out of the reach of children.
Store between 2°C to 25°C. Keep vial in outer carton in order to protect from light.
Protect from freezing.
The diluted solution should be used immediately.
Do not use this medicine after the expiry date which is stated on the label and carton.
For single-used only. Discard unused portion.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Onkotaxel contains?
The active substance is docetaxel (as trihydrate). Each ml of solution contains 20 mg docetaxel (as trihydrate).
The other ingredients are polysorbate 80, dehydrated alcohol (Ethanol).
What Onkotaxel looks like and contents of the pack?
Onkotaxel is clear brownish yellow to pale yellow color solution.
It is supplied in packs containing:
1 x 20 mg/1 ml vial
1 x 80 mg/4 ml vial
1 x 160 mg/8 ml vial