Camitotic 20mg/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 or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

-    The full name of the product is Camitotic 20mg/ml Concentrate for Solution for Infusion but within the leaflet it will be referred to as Camitotic.

What is in this leaflet:

1.    What Camitotic is and what it is used for

2.    What you need to know before you use Camitotic

3.    How to use Camitotic

4.    Possible side effects

5.    How to store Camitotic

6.    Contents of the pack and other information

1.    What Camitotic is and what it is used for

The name of this medicine is Camitotic. 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.

Camitotic 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, Camitotic 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, Camitotic could be administered in combination with doxorubicin and cyclophosphamide.

•    For the treatment of lung cancer, Camitotic could be administered either alone or in combination with cisplatin.

•    For the treatment of prostate cancer, Camitotic is administered in combination with prednisone or prednisolone.

•    For the treatment of metastatic gastric cancer, Camitotic is administered in combination with cisplatin and 5-fluorouracil.

•    For the treatment of head and neck cancer, Camitotic is administered in combination with cisplatin and 5-fluorouracil.

2.    What you need to know before you use Camitotic Do not use Camitotic:

•    if you are allergic to docetaxel or any of the other ingredients of this medicine (listed in section 6).

•    if the number of white blood cells is too low.

•    if you have a severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before using Camitotic

Before each treatment with Camitotic, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Camitotic. 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 problem with your lungs (fever, shortness of breath or cough), please tell your doctor, 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 Camitotic 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 Camitotic in particular 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 your blood cells.

Docetaxel contains alcohol. Discuss with your doctor if you suffer from alcohol dependency or liver impairment. See also section “Docetaxel contains ethanol (alcohol)” below.

Other medicines and Camitotic

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This is because Camitotic 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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Camitotic 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 Camitotic may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

Breast-feeding

You must NOT breast-feed while you are treated with Camitotic.

Fertility

If you are a man being treated with Camitotic 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 effects on the ability to drive and use machines have been performed.

There is no reason why you cannot drive between courses of Camitotic 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.

Camitotic contains ethanol (alcohol)

1 ml vial: This medicinal product contains 51 vol % ethanol (alcohol), i.e. equivalent to 10 ml of beer or 4,16 ml wine per vial.

4 ml vial: This medicinal product contains 51 vol % ethanol (alcohol), i.e. equivalent to 40.4 ml of beer or 16.83 ml wine per vial.

7    ml vial: This medicinal product contains 51 vol % ethanol (alcohol), i.e. equivalent to 70.8 ml of beer or 29.6 ml wine per vial.

8    ml vial: This medicinal product contains 51 vol % ethanol (alcohol), i.e. equivalent to 81.1 ml of beer or 33.8 ml wine per vial.

Harmful for those suffering from alcoholism.

To be taken into account if you are pregnant or if you are a breast-feeding woman, in 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 medicine may impair your ability to drive or use machines.

3. How to use Camitotic

Camitotic 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

Camitotic 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 Camitotic. 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 pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 Camitotic 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 Camitotic may be increased when Camitotic 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, 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 Camitotic the following may occur, and the frequency may vary with the combinations of medicines that are received:

Very Common (may affect more than 1 in 10 people):

•    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 or 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 (may affect up to 1 in 10 people):

•    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 (may affect up to 1 in 100 people):

•    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)

•    pneumonia (infection of the lungs)

•    pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

•    burn like appearance at the injection site may appear several days after the last dose.

•    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 Camitotic

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated 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.

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.

Once added to the infusion bag:

The diluted solution should be used immediately after preparation. If not used immedialtely the in-use storage times and conditions are the responsibility of the user and would not normally be longer than 3 days when stored between 2-8°C protected from light or 8 hours at room temperature (below 25°C) including the one hour infusion.

Dispose any unused product or waste material in accordance with local requirements.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Camitotic 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 Camitotic looks like and contents of the pack

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

Pack sizes:

1 x 1ml single dose vial 1 x 4ml single dose vial 1 x 7ml single dose vial

I    x 8 ml single dose vial

Not all pack sizes may be marketed

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavikurvegur 76-78,

220 Hafnarfjordur Iceland

Manufacturer

S. C. Sindan-Pharma S.R.L

II    Ion Mihalache Blvd,

011171 Bucharest, Romania

Actavis Italy S.p.A.

Via Pasteur 10,

20014 Nerviano (MI),

Italy

This leaflet was last revised in May 2016

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

Camitotic 20mg/ml Concentrate for Solution for Infusion

Instructions on use

Camitotic is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Camitotic 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 Camitotic concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Camitotic 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 Camitotic 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 140 mg docetaxel would require 7ml of Camitotic 20mg/ml Concentrate for Solution for Infusion.

For doses below 192 mg of docetaxel, inject the required volume of Camitotic 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 opening

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

From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, in non-PVC bags, is stable for 8 hours. It should be used within 8 hours (including the one hour infusion intravenous administration).

In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated for 3 days when stored between 2 to 8°C protected from light.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

Disposal

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

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