PACKAGE LEAFLET: INFORMATION FOR THE USER

Docetaxel CT 20 mg/0.5 ml concentrate and solvent for solution for infusion Docetaxel CT 80 mg/2 ml concentrate and solvent for solution for infusion

docetaxel

Read all of this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your your doctor or your hospital pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their

symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your your doctor or your hospital pharmacist.

In this leaflet:

1.    What Docetaxel CT is and what it is used for

2.    Before you use Docetaxel CT

3.    How to use Docetaxel CT

4.    Possible side effects

5.    How to store Docetaxel CT

6.    Further information

1.    WHAT DOCETAXEL CT IS AND WHAT IT IS USED FOR

The name of this medicine is Docetaxel CT. 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.

Docetaxel CT 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 CT could be administered either alone or in combination with doxorubicin, or capecitabine.

-    For the treatment of early breast cancer with lymph node involvement, Docetaxel CT could be administered

in combination with doxorubicin and cyclophosphamide.

-    For the treatment of lung cancer, Docetaxel CT could be administered either alone or in combination with

cisplatin.

-    For the treatment of prostate cancer, Docetaxel CT is administered in combination with prednisone or

prednisolone.

-    For the treatment of metastatic gastric cancer, Docetaxel CT is administered in combination with cisplatin

and 5-fluorouracil.

-    For the treatment of head and neck cancer, Docetaxel CT is administered in combination with cisplatin and

5-fluorouracil.

2.    BEFORE YOU TAKE/USE DOCETAXEL CT

You must not be given Docetaxel CT if

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

•    the number of white blood cells is too low.

•    you have a severe liver disease.

Take special care with Docetaxel CT

Before each treatment with Docetaxel CT, you will have blood tests to check that you have enough blood

cells and sufficient liver function to receive Docetaxel CT. 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 CT 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 CT 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.

Taking 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 CT or the other medicine

may not work as well as expected and you may be more likely to get a side effect.

Pregnancy

Ask your doctor for advice before being given any medicine.

Docetaxel CT 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 CT 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 CT 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 CT.

Driving and using machines

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

unsure of yourself.

Important information about some of the ingredients of Docetaxel CT

This medicinal product contains alcohol (up to 1.6 g per dose, equivalent to 40 ml beer or 17 ml wine).

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.

3.    HOW TO USE DOCETAXEL CT

Docetaxel CT 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 CT will be given by infusion into one of your veins (intravenous route). 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 CT. 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 medicines, Docetaxel CT 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 CT 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 CT may be increased when Docetaxel CT 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 CT 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 diarrhea, 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 DOCETAXEL CT

Keep out of the reach and sight of children.

Docetaxel CT 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 25°C. The premix solution is for single use only.

The infusion solution should be used within 4 hours below 25°C.

6. FURTHER INFORMATION What Docetaxel CT contains

-    The active substance is docetaxel. Each ml of docetaxel solution contains 40 mg of docetaxel anhydrous.

One vial contains 20 mg/0.5 ml or 80 mg/2 ml of docetaxel.

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

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

What Docetaxel CT looks like and contents of the pack

Docetaxel CT concentrate for solution for infusion is a clear, yellow solution.

The solvent is a clear, colourless solution.

Each pack contains

Docetaxel CT 20 mg/0.5 ml or 80 mg/2 ml

•    one single dose vial of concentrate and,

•    one single dose vial of solvent

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany

Manufacturer:

CT Arzneimittel GmbH, Graf-Arco-StraBe 3, 89079 Ulm or

Merckle GmbH, Ludwig-Merckle-StraBe 3, 89143 Blaubeuren, Germany This leaflet was last revised in January 2012

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

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

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

FORMULATION

DOCETAXEL CT concentrate for solution for infusion is a clear, yellow solution containing 40 mg/ml

docetaxel (anhydrous).

The solvent for Docetaxel CT is a clear colourless solution containing 9.53% w/w ethanol in water for injections.

PRESENTATION

Docetaxel CT 20 mg/0.5 ml and 80 mg/2 ml is supplied as single dose vials.

Each pack contains:

•    one single dose Docetaxel CT vial of concentrate 20 mg/0.5 ml or 80 mg/2 ml

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

Docetaxel CT vials should be stored below 25 °C and protected from light.

Docetaxel CT should not be used after the expiry date shown on the carton and vials.

Docetaxel CT 20 mg/0.5 ml concentrate for solution for infusion vial

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

This vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in citric acid anhydrous, polysorbate 80 and

ethanol (fill volume: 24.4mg/0.61 ml). This fill volume has been established during the development of

Docetaxel CT 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 CT vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg per vial.

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

Solvent vial contains 1.5 ml of a 9.53% w/w solution of ethanol in water for injections (fill volume: 1.94 ml).

The addition of the entire contents of the solvent vial to the contents of the Docetaxel CT 20 mg concentrate

for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.

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

15 ml clear glass Type I vial with a red flip off cap.

This vial contains 2 ml of a 40 mg/ml solution of docetaxel in citric acid anhydrous, polysorbate 80 and

ethanol (fill volume: 94.4 mg/2.36 ml). This fill volume has been established during the development of

Docetaxel CT 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 CT vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg per vial.

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

Solvent vial contains 6 ml of 9.53% w/w solution of ethanol in water for injections (fill volume: 7.3 ml). The

addition of the entire contents of the solvent vial to the contents of the Docetaxel CT 80 mg concentrate for

solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel. RECOMMENDATIONS FOR THE SAFE HANDLING

Docetaxel CT is an antineoplastic agent and, as with other potentially toxic compounds, caution should be

exercised when handling it and preparing Docetaxel CT solutions. The use of gloves is recommended. If Docetaxel CT concentrate, premix solution or infusion solution should come into contact with skin, wash

immediately and thoroughly with soap and water. If Docetaxel CT concentrate, premix solution or infusion

solution should come into contact with mucous membranes, wash immediately and thoroughly with water.

PREPARATION FOR THE INTRAVENOUS ADMINISTRATION

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

1.    If the vials are stored under refrigeration, allow the required number of Docetaxel CT boxes to stand at

room temperature (below 25°C) for 5 minutes.

2.    Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel

CT vial by partially inverting the vial.

3.    Inject the entire contents of the syringe into the corresponding Docetaxel CT vial.

4.    Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.

Do not

shake.

5.    Allow the premix vial to stand for 5 minutes at room temperature and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the

formulation).

The premix solution contains 10 mg/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 25°C. The premix solution is for single use only.

b)    Preparation of the infusion solution

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 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted

with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.

2.    Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.

If a dose greater than 200 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.

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

The Docetaxel CT infusion solution should be used within 4 hours and should be aseptically administered as

a 1-hour infusion under room temperature (below 25 C) and normal lighting conditions.

As with all parenteral products, Docetaxel CT premix solution and infusion solution should be visually

inspected prior to use, solutions containing a precipitate should be discarded.

DISPOSAL

Any unused product or waste material should be destroyed according to hospital standard procedures applicable to cytotoxic agents with due regard to current laws related to the disposal of hazardous waste.