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Docetaxel Concentrate and Solvent for Solution for Infusion

Docetaxel 20mg/0.5ml and 80mg/2ml Concentrate and Solvent for Solution for Infusion

Docetaxel Concentrate and Solvent for Solution for Infusion1. What Docetaxel is and what it is used for

The name of this medicine 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 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 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.

2. Before you use

Do not use Docetaxel if

•  you are allergic (hypersensitive) to docetaxel or any other ingredients of Docetaxel

•  the number of white blood cells is too low.

•  you have a severe liver disease.

Take special care with Docetaxel

Before each treatment with Docetaxel, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel. 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 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 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.

  • Using 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 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

Ask your doctor for advice before being given any medicine.

Docetaxel 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.

If you are a man being treated with Docetaxel 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.

  • Driving and using machines

The amount of alcohol in this medicinal product may impair your ability to drive or use machines.

There is no reason why you cannot drive between courses of Docetaxel except if you feel dizzy or are unsure of yourself.

Important information about one of the ingredients of Docetaxel

This medicinal product contains ethanol. Harmful for those suffering from alcoholism. To be taken into account in children and high risk groups such as patients with liver disease or epilepsy.

Docetaxel Concentrate and Solvent for Solution for Infusion3.How to use

Docetaxel 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

Docetaxel will be given by infusion into one of your veins. Docetaxel comes in 2 parts, a single vial of concentrate and a single vial of solvent. The infusion is made by diluting the contents of the concentrate vial with the contents of the solvent vial and then the resultant’premix’ solution is diluted with an appropriate infusion solution before being administered.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.

The following information is intended for medical or healthcare professionals only:

PREPARATION GUIDE FOR USE WITH DOCETAXEL CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT

It is important to read the entire contents of this procedure prior to the preparation of either the Docetaxel premix solution or the Docetaxel infusion solution

1. FORMULATION

Docetaxel 20mg/0.5ml

Each blister pack contains:

•  one single dose Docetaxel vial of concentrate 20mg/0.5ml

•  one single dose solvent for Docetaxel vial of concentrate 1.5ml

Docetaxel 80mg/2ml

Each blister pack contains:

•  one single dose Docetaxel vial of concentrate 80mg/2ml

•  one single dose solvent for Docetaxel vial of concentrate 6ml

2. PRESENTATION

2.1  Docetaxel 20mg/0.5ml vial

Docetaxel20mg/0.5ml concentrate for solution for infusion vial

8ml clear glass Type I vial with a flip-off cap. This vial contains 0.5ml of a 40mg/ml solution of docetaxel in citric acid anhydrous, polysorbate 80 and ethanol absolute (fill volume: 25.2mg/0.63ml). This fill volume has been established during the development of Docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and “dead-volume”.This overfill ensures that after dilution with the entire contents of the accompanying solvent for Docetaxel vial, there is a minimal extractable premix volume of 2ml containing lOmg/ml docetaxel which corresponds to the labelled amount of 20mg/0.5ml per vial.

2.2 Solvent for Docetaxel 20mg/0.5ml vial

Solvent vial: 8ml clear glass Type I vial with a flip-off cap.

Solvent vial contains 1.5ml of a 9.53% w/w solution of ethanol absolute in water for injections (fill volume: 2.0ml). The addition of the entire contents of the solvent vial to the contents of the Docetaxel 20mg/0.5ml concentrate for solution for infusion vial ensures a premix concentration of lOmg/ml docetaxel.

2.1 Docetaxel 80mg/2ml vial

Docetaxel 80mg/2ml concentrate for solution for infusion vial:

15ml clear glass Type I vial with a flip-off cap. This vial contains 2ml of a 40mg/ml solution of docetaxel in citric acid anhydrous, polysorbate 80 and ethanol absolute (fill volume: 92.0mg/2.3ml). This fill volume has been established during the development of Docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and “dead-volume”. This overfill ensures that after dilution with the entire contents of the accompanying solvent for Docetaxel vial, there is a minimal extractable premix volume of 8ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80mg/2ml per vial.

2.2 Solvent for Docetaxel 80mg/2ml vial

Solvent vial: 15ml clear glass Type I vial with a flip-off cap.

Solvent vial contains 6ml of a 9.53% w/w solution of ethanol absolute in water for injections (fill volume: 7.04ml). The addition of the entire contents of the solvent vial to the contents of the Docetaxel 80mg/2ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.

3. RECOMMENDATIONS FORTHE SAFE HANDLING

Docetaxel is an antineoplastic agent and as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel solutions.The use of gloves is recommended. If Docetaxel concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.

4. PREPARATION FOR THE INTRAVENOUS ADMINISTRATION

4.1 Preparation of the Docetaxel premix solution (10 mg docetaxel/ml)

4.1.1. If the vials are stored under refrigeration, allow the required number of Docetaxel boxes to stand at room temperature for 5 minutes.

4.1.2. Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel vial by partially inverting the vial.

Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and you response to Docetaxel. 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 informatior 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.

4.1.3. Inject the entire contents of the syringe into the corresponding Docetaxel vial.

4.1.4. Remove the syringe and needle and mix manually by repeated inversions for at least 120 seconds. Do not shake.

4.1.5. Allow the premix vial to stand for 3 minutes at room temperature and then check that the solution is homogenous and clear (foaming is normal even after 3 minutes due to the presence of polysorbate 80 in the formulation).

4.2.3. Mix the infusion bag or bottle manually using a rocking motion.

4.2.4The Docetaxel infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature and normal lighting conditions.

4.2.5 As with all parenteral products, Docetaxel premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

The premix solution contains lOmg/ml docetaxel and should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).

4.2 Preparation of the infusion solution

4.2.1. More than one premix vial may be necessary to obtain the required dose for the patient. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10mg/ ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle. For example, a dose of 140mg docetaxel would require 14ml docetaxel premix solution.

4.2.2. Inject the required premix volume into a 250ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution. If a dose greater than 200mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74mg/ml docetaxel is not exceeded.

5. SHELF LIFE

•  Premix solution: The premix solution contains lOmg/ml docetaxel and should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C). The premix solution is for single use only.

•  Infusion solution: Chemical and physical in-use stability has been demonstrated for 4 hours at about 25°C at normal lighting conditions, and 4 hours at

5°C ± 3°C protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6. DISPOSAL

Any unused product or waste material should be disposed of in accordance with local requirements.

4. Possible side effects

Like all other anticancer medicines, Docetaxel 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, diarrhoea 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 (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 Docetaxel the following may occur, and the frequency ma; 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

•  short term 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 color 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

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.

5. How to store

Keep out of the reach and sight of children. Docetaxel should not be used after the expiry date shown on the carton and vials. Do not store above 25°C. Store in the original package in order to protect from light.

The premix solution should be used immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).

The infusion solution should be used within 4 hours at room temperature (below 25°C).

6. Further information

What Docetaxel contains

•  The active substance is docetaxel. Each ml of docetaxel solution contains 40mg of docetaxel anhydrous. One vial contains 20mg/0.5ml or 80mg/2ml of docetaxel.

•  The other ingredients are citric acid anhydrous, ethanol absolute and polysorbate 80.

The solvent vial contains 9.53% w/w ethanol absolute in water for injections.

What Docetaxel looks like and contents of the pack

Docetaxel concentrate for solution for infusion is a clear, oily, yellow solution. The solvent is a clear, colourless solution.

Each carton contains Docetaxel 20mg/0.5ml

•  one single dose vial of concentrate and

•  one single dose vial of solvent

Docetaxel 80mg/2ml

•  one single dose vial of concentrate and

•  one single dose vial of solvent

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