TAXOTERE. 80 mg. / 4 ml.1 vials
The name of this medicine is TAXOTERE. The 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.
TAXOTERE. 80 mg. / 4 ml.1 vials
What TAXOTERE and what it is used
The name of this medicine is TAXOTERE. The 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 .
TAXOTERE 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 cancer of the head and neck :
For the treatment of advanced breast cancer , TAXOTERE can be administered alone or in combination with doxorubicin, or trastuzumab, or capecitabine;
For treatment of early breast cancer with or without lymph node involvement , TAXOTERE can be administered in combination with doxorubicin and cyclophosphamide ;
For the treatment of lung cancer , TAXOTERE can be administered alone or in combination with cisplatin ;
For the treatment of prostate cancer , TAXOTERE is administered in combination with prednisone or prednisolone ;
For the treatment of metastatic gastric cancer , TAXOTERE is administered in combination with cisplatin and 5- fluorouracil ;
For the treatment of cancer, head and neck cancer , TAXOTERE is administered in combination with cisplatin and 5- fluorouracil .
2 . What you should know before using TAXOTERE
You should not apply TAXOTERE if:
you are allergic ( hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE;
the number of white blood cells is too low ;
you have severe liver disease.
Warnings and Precautions
Before each treatment with TAXOTERE, you will be given a blood test to determine whether you have enough blood cells and sufficient liver function to receive TAXOTERE. In case you have a disorder of white blood cells may experience associated fever or infections.
Tell your doctor , hospital pharmacist or nurse if you have vision problems . In the case of vision problems , especially blurred vision, you should immediately take stock of the eyes and vision.
If you have signs of acute or worsening lung problems (fever , shortness of breath or cough) , tell your doctor , hospital pharmacist or nurse. 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 TAXOTERE and one or two days afterwards, in order to reduce some of the side effects that may occur after the infusion of TAXOTERE, especially 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 blood cells.
TAXOTERE contains alcohol . Discuss with your doctor if you suffer from alcohol dependence or liver disorder . See also section "TAXOTERE contains ethanol ( alcohol ) " below .
Other medicines, TAXOTERE
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines , including medicines obtained without a prescription. This is because TAXOTERE or the other drug may not work as expected and there may be more likely to have an adverse reaction.
Pregnancy, lactation and fertility
Ask your doctor before taking any medicine .
TAXOTERE must NOT apply if you are pregnant, unless specifically directed by your doctor.
Should not become pregnant during treatment with this medicine and must use an effective method of contraception during treatment as TAXOTERE can harm your baby. If during pregnancy occurs , you should inform your doctor immediately.
You should not breastfeed while being treated with TAXOTERE.
If you are a man being treated with TAXOTERE, 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 impair male fertility.
Driving and using machines
No studies on the effects on ability to drive and use machines.
TAXOTERE contains ethanol ( alcohol )
This product contains 50 % by volume of ethanol ( alcohol ), i.e. to 1.58 g ( 2 ml) of the vial , equivalent to 40 ml of beer or wine , 17 ml per vial.
Harmful for those suffering from alcoholism.
To take into account if you are pregnant or breast-feeding, 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 drugs.
The amount of alcohol in this medicinal product may impair your ability to drive and use machines.
3 . How to use TAXOTERE
TAXOTERE will be administered 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.
Route of administration and route of administration
TAXOTERE will be given by infusion into one of your veins ( intravenous ) . 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 TAXOTERE. Please tell your doctor , especially in the case of diarrhea, mouth ulcers , feeling of numbness or tingling , fever and give her / him the results of your blood tests . Such information will allow her / him to decide whether a dose reduction . 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 this with you and will explain the potential risks and benefits of treatment.
The most commonly reported side effects of TAXOTERE alone are: decrease the number of red blood cells or white blood cells, alopecia , nausea, vomiting , mouth sores , diarrhea and tiredness .
The severity of adverse reactions to TAXOTERE may be increased when TAXOTERE 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, pruritus ;
chest tightness, difficulty in breathing ;
fever or chills ;
low blood pressure .
May experience more severe reactions.
Your condition will be closely monitored by hospital staff during treatment . Tell them immediately if you experience any of these reactions .
Between infusions of TAXOTERE may arise the following side effects and frequency may vary depending on the combinations of medicines which are applied :
Very common ( may affect more than 1 in 10 people):
infections, decrease the number of red (anemia ), or white blood cells ( important in fighting infection) and platelets ;
fever : if this happens, immediately contact your doctor ;
allergic reactions, as described above ;
loss of appetite ( anorexia ) ;
feeling of numbness, tingling or pain in the joints or muscles ;
change in taste ;
inflammation of the eye or increased tearing of the eyes ;
swelling due to impaired lymphatic drainage ;
difficulty breathing ;
nasal discharge , inflammation of the nose and throat, cough;
ulcers in the mouth ;
stomach upsets including nausea , vomiting and diarrhea , constipation ;
abdominal pain ;
hair loss (in most cases normal hair growth should return) ;
redness and swelling of the hands or soles of the feet , which can cause your skin to peel (this may also occur on the arms , face, or body) ;
discoloration of the nail, which can then fall down ;
muscle pain , back pain or bone ;
change or absence of menstrual period ;
swelling of the hands, feet, legs ;
fatigue , or flu-like symptoms ;
gain or loss of weight.
Common ( may affect up to 1 in 10 people):
candidiasis of the mouth ;
decrease in blood pressure, irregular or rapid heartbeat ;
heart failure ;
dry mouth ;
difficult or painful swallowing;
elevated liver enzymes ( hence the need for regular blood tests) .
Uncommon ( may affect up to 1 in 100 people):
injection site , skin reactions, phlebitis ( inflammation of the vein ) or swelling ;
inflammation of the colon , small intestine , intestinal perforation ;
interstitial lung disease ( inflammation of the lungs , causing coughing and wheezing . lung inflammation can develop also when the treatment is administered with docetaxel in combination with radiation ) ;
pneumonia ( lung infection ) ;
pulmonary fibrosis ( scarring and thickening of the lung with dyspnea) ;
blurred vision due to swelling of the retina in the eye ( cystoid macular edema ) ;
reducing the sodium in the blood.
Adverse event reporting
If you get any side effects, tell your doctor , hospital pharmacist or nurse. This includes all listed in this leaflet . You can also report side effects directly through the National Reporting System . As reported side effects , you can do your bit to get more information on the safety of this medicine.
5 . How to store TAXOTERE
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial label after " EXP " or "EXP". The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Store in the original package to protect from light.
Use the vial immediately after opening. If not used immediately, storage times and conditions during use are the responsibility of the user.
From a microbiological point of view, reconstitution / dilution must be done in controlled and validated aseptic conditions.
Use the medicine immediately after its addition to the infusion bag. If not used immediately, storage times and conditions during use are the responsibility of the user and would normally not be longer than 6 hours below 25 ° C, including infusion time of 1 hour.
Furthermore, the physical and chemical stability during the use of the infusion solution prepared according to the guidance shown in the bags , which are not of PVC, is up to 48 hours when stored between 2 to 8 ° C.
Docetaxel infusion solution is supersaturated , therefore may crystallize over time. If crystals appear , the solution should not be used and should be discarded .
Do not dispose of medications in the sewer. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does TAXOTERE
The active substance is docetaxel ( as trihydrate ) . Each ml concentrate for solution for infusion contains 20 mg docetaxel .
The other ingredients are polysorbate 80 , anhydrous ethanol and citric acid .
TAXOTERE looks like and contents of the pack
TAXOTERE concentrate for solution for infusion is a pale yellow to brownish solution. The concentrate is supplied in 7 ml clear glass vial with a purple aluminum seal and plastic flip purple cap.
Each box contains one vial of 4 ml concentrate ( 80 mg docetaxel) .
Marketing Authorisation Holder:
Aventis Pharma S.A., France.
Aventis Pharma, Dagenham, UK ;
Sanofi-Aventis Deutschland GmbH, Germany ;
Sanofi-Aventis Zrt., Hungary.
The following information is intended for healthcare professionals
INSTRUCTIONS FOR USE OF TAXOTERE 80 mg / 4 ml concentrate for solution for infusion
It is important to read the successive stages of this manual before preparing TAXOTERE infusion.
Recommendations for safe handling
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling and preparing of its solutions . The use of gloves.
If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If you come into contact with mucous membranes, wash immediately and thoroughly with water.
Preparation for intravenous administration
Preparation of Infusion Solution
Do not use other medicines with docetaxel , consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 80 mg / 4 ml concentrate for solution for infusion , which contains only 1 vial) .
TAXOTERE 80 mg / 4 ml 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 only and should be used immediately after opening. If not used immediately, storage times and conditions during use are the responsibility of the user. It may require more than one vial of concentrate for solution to obtain the required dose for the patient . For example, a dose of 140 mg is necessary dotsetaktsel 7 ml docetaxel concentrate for solution for infusion ;
Aseptically withdraw the required amount of concentrate for solution for infusion with a graduated syringe with needle 21G.
In TAXOTERE 80 mg / 4 ml vial , the concentration of docetaxel is 20 mg / ml.
Then injected with a single injection (one injection ) in 250 ml infusion bag or bottle containing either 5% glucose solution or infusion of sodium chloride 9 mg / ml (0,9%). If a dose greater than 190 mg of docetaxel , use a larger volume of the infusion medium so as not to exceed the concentration of docetaxel 0,74 mg / ml;
Mix the infusion bag or bottle manually using a rocking motion ;
From a microbiological point of view, reconstitution / dilution must be done in controlled and aseptic conditions and the product should be used immediately. If not used immediately, storage times and conditions during use are the responsibility of the user. Once added as recommended into the infusion bag , docetaxel infusion solution is stable for 6 hours when stored below 25 ° C. It should be used within 6 hours ( including a one-hour intravenous infusion). Furthermore, the physical and chemical stability during the use of the infusion solution prepared according to the guidance shown in the bags , which are not made of PVC is 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 not be used and should be discarded ;
As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
All materials used for dilution and administration should be disposed of in accordance with standard procedures. Do not dispose of medications in the sewer. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.