Docetaxel

Docetaxel 20mg/ml Concentrate for Solution for Infusion

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.

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.

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 yewtrees.

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 prednisoneor 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.

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.

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.

Pregnancy

Askyour 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 contraceptive 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

There is no reason why you cannot drive between courses of Docetaxel except if you feel dizzy or are unsure of yourself. In higher doses (7.5ml concentrate (150mg) contains 3g ethanol) the amount of alcohol may impair your ability to drive or use machines.

Important information about some of the ingredients of Docetaxel

This medicinal product contains 400mg ethanol (alcohol) per ml concentrate. Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are a breastfeeding woman, in children and in high-risk groups such as patients with liver disease or epilepsy. In higher doses (7.5ml concentrate (150mg) contains 3g ethanol) the amount of alcohol may alter the effects of other medicines and impair your ability to drive or use machines.

The amount of alcohol in this medicinal product may alter the effects of the other medicines.

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 metres (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. 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. 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.

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 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
• 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 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

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 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 vial.

Store below 25°C.

Store in the original package in order to protect from light.

The diluted solution should be used immediately after preparation. If not used immediately in-use storage times and conditions are the responsibility of the user and would not normally be longer than 8 hours at room temperature (about 25°C) including the one hour infusion. Dispose any unused product or waste material accordance with local requirements.

Further information

What Docetaxel contains

• The active substance is docetaxel. Each ml of docetaxel solution contains 20mg of docetaxel anhydrous.
• The other ingredients are citric acid anhydrous, povidone, ethanol absolute and polysorbate 80.

What Docetaxel looks like and contents of the pack:

Docetaxel Concentrate for Solution for Infusion is a clear, pale yellow solution.

Pack sizes:

1 x 1ml single dose vial 1 x4ml single dose vial 1 x7ml single dose vial

Docetaxel 20mg/ml Concentrate for Solution for Infusion

Instructions on use

Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel solutions. Cytotoxic agents should be prepared for administration only by personnel who have been trained in the safe handling of such preparations. Referto local cytotoxic guidelines before commencing. The use of gloves is recommended. If Docetaxel concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel 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 Docetaxel 20mg/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 20mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a needle. For example, a dose of 140mg docetaxel would require 7ml of Docetaxel 20mg/ml concentrate for solution for infusion.

For doses below 192mg of docetaxel, inject the required volume of Docetaxel 20mg/ml concentrate for solution for infusion into a 250ml infusion bag or bottle containing either 250ml of 50mg/ ml (5%) glucose solution for infusion or 9mg/ml (0.9%) sodium chloride solution for infusion. For doses exceeding 192mg of docetaxel more than 250ml of the infusion solution is required, as the maximum concentration of docetaxel is 0.74mg per ml of infusion solution.

Mix the infusion bag or bottle manually using a rocking motion. The diluted solution should be used within 8 hours and 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 dilution

The diluted solution should be used immediately after preparation. However, the physical and chemical stability of the diluted solution (0.74mg/ml) in the recommended solutions for infusion (50mg/ml (5%) glucose solution for infusion and 9mg/ml (0.9%) sodium chloride solution for infusion) has been demonstrated for 8 hours at about 25°Cand normal lighting conditions.

Disposal

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