Tevadocel 20mg/Ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER Tevadocel 20 mg/ml concentrate for solution for infusion
docetaxel
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- 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 of the 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 is in this leaflet:
1. What Tevadocel is and what it is used for
2. What you need to know before you use Tevadocel
3. How to use Tevadocel
4. Possible side effects
5. How to store Tevadocel
6. Contents of the pack and other information
1. WHAT TEVADOCEL IS AND WHAT IT IS USED FOR
The name of this medicine is Tevadocel. 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.
Tevadocel 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, Tevadocel 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, Tevadocel could be administered in combination with doxorubicin and cyclophosphamide.
- For the treatment of lung cancer, Tevadocel could be administered either alone or in combination with cisplatin.
- For the treatment of prostate cancer, Tevadocel is administered in combination with prednisone or prednisolone.
- For the treatment of metastatic gastric cancer, Tevadocel is administered in combination with cisplatin and 5-fluorouracil.
- For the treatment of head and neck cancer, Tevadocel is administered in combination with cisplatin and 5-fluorouracil.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEVADOCEL You must NOT be given Tevadocel if
• you are allergic (hypersensitive) to docetaxel or any of the-other ingredients of Tevadocel.
• the number of white blood cells is too low.
• you have a severe liver disease.
Warnings and precautions
Before each treatment with Tevadocel, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Tevadocel. 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 Tevadocel 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 Tevadocel in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
During treatment, you may be given medication to maintain the number of your blood cells.
This medicinal product contains alcohol and may be harmful for those suffering from alcoholism and should be taken into account in high-risk groups such as patients with liver disease or epilepsy. In case any of the above conditions apply to you, discuss it with your doctor before the medicinal product is given to you.
Other medicines and Tevadocel
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 Tevadocel or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Pregnancy, breast-feeding and fertility
Ask your doctor for advice before being given any medicine.
Tevadocel 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 contraceptive during therapy, because Tevadocel 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 Tevadocel.
If you are a man being treated with Tevadocel 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
No studies on the effect on the ability to drive and use machines have been performed.
Important information about some of the ingredients of Tevadocel
This medicinal product contains 51 vol % ethanol (alcohol). i.e. up to
- 400 mg per (1 ml) vial, equivalent to 10 ml of beer or 4 ml wine per vial.
- 1600 mg per (4 ml) vial, equivalent to 40 ml of beer or 16 ml wine per vial.
- 2800 mg per (7 ml) vial, equivalent to 70 ml of beer or 28 ml wine per vial.
- 3200 mg per (8 ml) vial, equivalent to 80 ml of beer or 32 ml wine per vial.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, 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 medicinal product may impair your ability to drive or use machines.
3. HOW TO USE TEVADOCEL
Tevadocel will be administered to you by a healthcare professional.
Usual dosage
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
Tevadocel 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 Tevadocel. 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 product, ask your doctor, or hospital pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all other anticancer medicines, Tevadocel 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 Tevadocel 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 Tevadocel may be increased when Tevadocel 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:
• 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 Tevadocel the following may occur, and the frequency may vary with the combinations of drugs that are received:
Very Common: (experienced in more than 1 in 10 patients)
• 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 of 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
Common (experienced in less than 1 in 10 but more than 1 in 100 patients)
• 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)
Uncommon: (experienced in more than 1 in 1,000 but less than 1 in 100)
• fainting
• at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
• inflammation of the colon, small intestine; intestinal perforation
• blood clots
Frequency unknown:
• 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)
• pneumonis (infection of the lungs)
• pulmonary fibroses (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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE TEVADOCEL
Keep out of the sight and and reach of children.
Tevadocel should not be used after the expiry date shown on the carton and vial.
Store below 25°C.
Store in the original package in order to protect from light.
Do not refrigerate or freeze.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Tevadocel contains
- The active substance is docetaxel. Each ml of docetaxel solution contains 20 mg of docetaxel anhydrous.
- The other ingredients are citric acid anhydrous, povidone, ethanol absolute and polysorbate 80.
What Tevadocel looks like and contents of the pack:
Tevadocel concentrate for solution for infusion is a clear, pale yellow solution.
Pack sizes:
1 x 1 ml single dose vial 1 x 4 ml single dose vial 1 x 7 ml single dose vial 1 x 8 ml single dose vial
Not all pack sizes may be marketed
Marketing Authorisation Holder
TEVA UK Limited
Eastbourne BN22 9AG
Manufacturer
S. C. Sindan-Pharma S.R.L 11 Ion Mihalache Blvd,
011171 Bucharest, Romania
Actavis Italy S.p.A. - Nerviano Plant Viale Pasteur 10 20014 Nerviano (MI)
Italy
Merckle GmbH Ludwig-Merckle-StraBe 3 89143 Blaubeuren-Weiler Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Docetaxel ratiopharm 20 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Belgium: Tevadocel 20 mg/ml concentraat voor oplossing voor infusie
Germany: Docetaxel-ratiopharm 20 mg/ml Konzentrat zur Herstellung einer Infusionslosung
Spain: Docetaxel ratiopharm 20 mg/ml concentrado para solucion para perfusion
Italy: Docetaxel ratiopharm Italia 20 mg/ml concentrato per soluzione per infusione
Netherlands: Tevadocel 20 mg/ml concentraat voor oplossing voor infusie
United Kingdom: Tevadocel 20 mg/ml concentrate for solution for infusion
This leaflet was last revised in March 2014.
PL 00289/1764
The following information is intended for medical or healthcare professionals only:
Tevadocel 20 mg/ml concentrate for solution for infusion Instructions on use
Tevadocel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Tevadocel solutions. Cytotoxic agents should be prepared for administration only by personnel who have been trained in the safe handling of such preparations. Refer to local cytotoxic guidelines before commencing. The use of gloves is recommended. If Tevadocel concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Tevadocel concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Preparation of the solution for infusion
More than one vial of Tevadocel 20 mg/ml concentrate for solution for infusion may be necessary to obtain the required dose for individual patients. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 7 ml of Tevadocel 20 mg/ml concentrate for solution for infusion.
For doses below 192 mg of docetaxel, inject the required volume of Tevadocel 20 mg/ml concentrate for solution for infusion into a 250 ml infusion bag or bottle containing either 250 ml of 50 mg/ml (5%) glucose solution for infusion or 9 mg/ml (0.9%) sodium chloride solution for infusion. For doses exceeding 192 mg of docetaxel more than 250 ml of the infusion solution is required, as the maximum concentration of docetaxel is 0.74 mg per ml of infusion solution.
Mix the infusion bag or bottle manually using a rocking motion. The diluted solution should be aseptically administered as a 1-hour infusion at room temperature and normal lighting conditions.
As with all parenteral products, this medicinal product should be visually inspected prior to use and solutions containing a precipitate should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements. Storage after opening
The solution should be used immediately after opening of the vial. 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.
Storage after dilution
The diluted solution should be used immediately after preparation. If not used immediately the in-use storage times and conditions are the responsibility of the user and would not normally be longer than 3 days in non-PVC bags when stored between 2-8°C protected from light or 8 hours at room temperature (about 25°C) including the one hour infusion.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.