Package leaflet: Information for the user

DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion

docetaxel
Please read all of this leaflet carefully before you are given this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, hospital pharmacist, or nurse.
If you get any side effects, talk to your doctor, hospital pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What DOCETAXEL KABI is and what it is used for
What you need to know before you are given DOCETAXEL KABI
How to use DOCETAXEL KABI
Possible side effects
How to store DOCETAXEL KABI
Contents of the pack and other information

1. What DOCETAXEL KABI is and what it is used for
The name of this medicine is DOCETAXEL KABI. The active substance is docetaxel.
Docetaxel is a substance derived from the needle-like leaves of the yew tree and belongs to a group of anticancer medicines called taxoids.
DOCETAXEL KABI has been prescribed by your doctor for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, stomach adenocarcinoma, or head and neck cancer:

For the treatment of advanced breast cancer, DOCETAXEL KABI may be given alone or in combination with doxorubicin, trastuzumab, or capecitabine.
For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL KABI may be given in combination with doxorubicin and cyclophosphamide.
For the treatment of lung cancer, DOCETAXEL KABI may be given alone or in combination with cisplatin.
For the treatment of prostate cancer, DOCETAXEL KABI is given in combination with prednisone or prednisolone.
For the treatment of metastatic stomach adenocarcinoma, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.
For the treatment of head and neck cancer, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.

2. What you need to know before using DOCETAXEL KABI

Do not use DOCETAXEL KABI:

if you are allergic (hypersensitive) to docetaxel or to any of the excipients of DOCETAXEL KABI (listed in section 6);
if your white blood cell count is too low;
if you have severe liver problems.

Warnings and precautions
Before each treatment with DOCETAXEL KABI, you will undergo blood tests to determine whether your blood cells are sufficiently numerous and whether your liver function is adequate for receiving DOCETAXEL KABI.
If abnormalities in white blood cells occur, you may also experience fever or infections.
Immediately inform your doctor, hospital pharmacist, or nurse if you have abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stools, or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor will take immediate action.
Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience visual disturbances, particularly blurred vision, you must immediately have your eyes and vision checked.
Inform your doctor, hospital pharmacist, or nurse if you have previously had an allergic reaction to paclitaxel therapy.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If you develop acute lung problems or if pre-existing symptoms worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue treatment.
You will be asked to take preventive oral corticosteroid treatment, such as dexamethasone, one day before administration of DOCETAXEL KABI and to continue for one or two days afterwards, in order to reduce certain adverse effects that may occur following infusion of DOCETAXEL KABI, particularly allergic reactions and fluid retention (swelling of the hands, feet, legs, or weight gain).
During treatment, you may need medications to maintain your blood cell counts.
Severe skin reactions have been reported with DOCETAXEL KABI, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP).

Symptoms of SJS/TEN may include blisters, peeling or bleeding of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also simultaneously experience flu-like symptoms such as fever, chills, or muscle pain.
Symptoms of AGEP may include a widespread scaly and red rash with swollen bumps under the skin (including skin folds, trunk, and upper extremities), accompanied by blisters and fever. If you develop severe skin reactions or any of the reactions listed above, contact your doctor or a healthcare professional immediately.

Other medicines and DOCETAXEL KABI:
The amount of alcohol in this medicine may alter the effects of other medicines. Inform your doctor or pharmacist if you are taking other medicines.
Inform your doctor or hospital pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because DOCETAXEL KABI or the other medicines may not work as expected, and you may be more likely to experience adverse effects.

Pregnancy, breastfeeding and fertility
Ask your doctor for advice before taking any medicine.
DOCETAXEL KABI must NOT be administered during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment and for 2 months after the end of treatment with this medicine. You must use adequate contraception during treatment and for 2 months after the end of treatment, because DOCETAXEL KABI can be harmful to the unborn child. If you become pregnant during treatment, inform your doctor immediately.
You must not breastfeed during treatment with DOCETAXEL KABI.
If you are a man receiving treatment with DOCETAXEL KABI, you must not father a child and must use adequate contraception during treatment and for 4 months after the end of treatment with this medicine. It is recommended that you seek advice about sperm preservation before starting treatment, as docetaxel may impair male fertility.

Driving and using machines:
The amount of alcohol in this medicine may impair your ability to drive or operate machinery.
You may experience adverse effects from this medicine that could impair your ability to drive, use equipment, or operate machinery (see section 4 Possible side effects). If this occurs, do not drive and do not use any equipment or machinery until you have discussed it with your doctor, nurse, or hospital pharmacist.

DOCETAXEL KABI contains ethanol (alcohol).
This medicine contains 395 mg of alcohol (ethanol) per ml, equivalent to 39.5% p/v.
The amount in a 9 ml dose is equivalent to 88.9 ml of beer or 35.6 ml of wine.
The alcohol contained in this preparation may affect children. These effects may include drowsiness and mood swings. It may also impair the ability to concentrate and to perform physical activities.
If you have epilepsy or liver problems, speak with your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, speak with your doctor or pharmacist before taking this medicine.

3. How to use DOCETAXEL KABI

DOCETAXEL KABI will be administered to you by a healthcare professional.
Usual dosage:
The dosage will depend on your body weight and general health condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
Method and route of administration:
DOCETAXEL KABI will be administered by intravenous infusion (for intravenous use only).
The infusion will last approximately 1 hour and will be given in a hospital setting.
Frequency of administration:
The infusion is normally administered once every 3 weeks.
Your doctor may adjust the dose and frequency of administration based on blood test results, your general condition, and your response to DOCETAXEL KABI. In particular, inform your doctor if you experience diarrhea, mouth inflammation, numbness, tingling, fever, and show the results of your blood tests. This information will help the doctor decide whether a dose reduction is necessary. If you have any doubts about how to use this medicine, consult your doctor or hospital pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Your doctor will discuss this with you and explain the potential risks and benefits of the treatment.
The most commonly reported adverse reactions with DOCETAXEL KABI alone are: decrease in red or white blood cells, hair loss, nausea, vomiting, mouth inflammation, diarrhoea, and fatigue.
If you are given DOCETAXEL KABI in combination with other chemotherapy medicines, the severity of side effects may increase.
During the infusion in hospital, the following allergic reactions may occur (may affect more than 1 in 10 people):

hot flushes, skin reactions, itching
tightness in the chest, difficulty breathing
fever or chills
back pain
low blood pressure

More severe reactions may occur. If you have previously had a hypersensitivity reaction to paclitaxel, you may also develop a hypersensitivity reaction to docetaxel, which could be more severe.

Your condition will be closely monitored by hospital staff during treatment.
Inform hospital staff immediately if you notice any of these effects.
Between DOCETAXEL KABI infusions, the following side effects may occur, and their frequency may vary depending on the concomitant medications you are taking:
Very common (may affect more than 1 in 10 people):

infections, decreased number of red blood cells (anaemia) or white blood cells (the latter are important in fighting infections), and platelets
fever: in this case, you must inform your doctor immediately
allergic reactions as described above
loss of appetite (anorexia)
insomnia
sensation of numbness, tingling, or pain in joints or muscles
headache
altered sense of taste
eye inflammation or increased eye tearing
swelling due to insufficient lymphatic drainage
difficulty breathing
nasal mucus discharge; inflammation of throat and nose; cough
nosebleeds
mouth inflammation
stomach disorders including nausea, vomiting, diarrhoea, constipation
abdominal pain
indigestion
hair loss: in most cases, hair regrowth returns to normal. In some cases (frequency not known), permanent hair loss has been observed
redness and swelling of the palms of the hands or soles of the feet, which may lead to skin peeling (this may also occur on arms, face, or body)
changes in nail colour, which may lead to nail loss
muscle pain; back pain or bone pain
changes or absence of menstrual period
swelling of hands, feet, legs
fatigue or flu-like symptoms
weight gain or weight loss
upper respiratory tract infection

Common (may affect up to 1 in 10 people):

oral candidiasis
dehydration
dizziness
hearing disturbances
low blood pressure; irregular or rapid heartbeat
heart failure
oesophagitis
dry mouth
difficulty or pain when swallowing
bleeding
increased liver enzymes (requiring regular blood tests)
increased blood sugar levels (diabetes)
decreased levels of potassium, calcium, and/or phosphate in the blood

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

fainting
injection site skin reactions, phlebitis (vein inflammation), or swelling
formation of blood clots
acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel, along with certain other anticancer treatments

Rare (may affect up to 1 in 1,000 people):

inflammation of the colon or small intestine, which may be fatal (frequency not known); intestinal perforation

Frequency not known (cannot be estimated from available data):

interstitial lung disease (lung inflammation that may cause cough and difficulty breathing. Lung inflammation may also develop when docetaxel treatment is given concurrently with radiotherapy)
pneumonia (lung infections)
pulmonary fibrosis (scarring and thickening in the lungs causing shortness of breath)
blurred vision due to swelling of the retina inside the eye (cystoid macular oedema)
decreased levels of sodium and/or magnesium in the blood (electrolyte imbalance)
ventricular arrhythmia or ventricular tachycardia (manifested as rapid or irregular heartbeats, severe shortness of breath, dizziness and/or fainting). Some of these symptoms may be serious. If this occurs, you must inform a doctor immediately
injection site reactions at the site of a previous reaction
non-Hodgkin’s lymphoma (a cancer affecting the immune system) and other tumours may occur in patients treated with docetaxel, along with certain other anticancer treatments
Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blisters, skin peeling or bleeding of any skin area (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms at the same time, such as fever, chills or muscle pain)
Acute Generalized Exanthematous Pustulosis (AGEP) (widespread scaly and red rash with swollen skin bumps (including skin folds, trunk, and upper limbs) and blisters accompanied by fever)
Tumour lysis syndrome is a serious condition indicated by changes in blood tests such as increased levels of uric acid, potassium, and phosphate, and decreased calcium levels; it causes symptoms such as seizures, kidney failure (reduced urine output or dark urine), and heart rhythm disturbances. In such cases, you must inform your doctor immediately
Myositis (muscle inflammation – warmth, redness, and swelling – causing muscle pain and weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOCETAXEL KABI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the vial label after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Store the medicine in its original packaging to protect it from direct light.
Use the vial immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user.
From a microbiological standpoint, reconstitution/dilution must be carried out under controlled and aseptic conditions.
Use the medicine immediately after it has been added to the infusion bag. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally it should not be kept for longer than 6 hours at temperatures below 25°C, including a one-hour infusion.
Docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals form, the solution must no longer be used and must be discarded.
Do not dispose of any medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Other Information

What DOCETAXEL KABI Contains

The active substance is anhydrous docetaxel. Each ml of concentrate for solution for infusion contains 20 mg of docetaxel.
The excipients are polysorbate 80, anhydrous ethanol (see section 2), and citric acid (to adjust pH).

Description of the Appearance of DOCETAXEL KABI and Contents of the Package:
DOCETAXEL KABI concentrate for solution for infusion is a clear, colourless to pale yellow solution.
Clear, colourless glass vial (Type I) of 6 ml with a fluorotec rubber stopper and a blue aluminium cap containing 1 ml of concentrate.
Each package contains one vial of 1 ml concentrate (20 mg docetaxel).

Marketing Authorization Holder:
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany

Manufacturer:
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder.

This leaflet was last updated on: (MM/YYYY)

The following information is intended exclusively for healthcare professionals.

GUIDE TO THE PREPARATION OF DOCETAXEL 20 mg/1ml CONCENTRATE FOR
INFUSION SOLUTION

It is important that you read the entire content of this guide before preparing the infusion solution of DOCETAXEL KABI.

Recommendations for Safe Handling
Docetaxel is an antineoplastic agent and, as with other potentially toxic products, caution should be exercised when handling and preparing its solutions. The use of gloves is recommended.
If concentrated DOCETAXEL KABI or infusion solution comes into contact with the skin, wash immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.

Preparation for Intravenous Administration
Preparation of the Infusion Solution

Do not use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Kabi 20 mg/1ml concentrate for solution for infusion which contains only 1 vial).
DOCETAXEL KABI 20 mg/1ml concentrate for solution for infusion does NOT require dilution with a solvent prior to use and is ready to be added directly to the infusion solution.

Each vial is for single use only and must be used immediately after opening. If not used immediately, the storage times and conditions during use are the responsibility of the user. More than one vial of concentrate for infusion solution may be required to achieve the required patient dose. For example, a 140 mg dose of docetaxel requires 7 ml of docetaxel concentrate for infusion solution.
Aseptically withdraw the required amount of concentrate for infusion solution using a graduated syringe.

Each vial of DOCETAXEL KABI 20 mg/1ml contains a docetaxel concentration of 20 mg/ml.

Inject in a single injection into an infusion bag or bottle of 250 ml containing either 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. If a docetaxel dose exceeding 190 mg is required, use a larger volume of diluent to ensure that the final concentration of docetaxel does not exceed 0.74 mg/ml.
Mix the bag or bottle manually by gentle rotation.
From a microbiological standpoint, reconstitution/dilution must be performed under controlled, aseptic conditions, and the infusion solution should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user. Once added as recommended to the infusion bag, the docetaxel infusion solution is stable for 6 hours when stored below 25°C. It must be used within 6 hours (including the approximately 1 hour required for intravenous infusion). The docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals appear, the solution must no longer be used and must be discarded.
As with all parenteral products, the infusion solution must be visually inspected before use; solutions containing precipitates must be discarded.

Disposal
All materials used for dilution and administration must be disposed of in accordance with standard procedures. Do not dispose of any medicinal product via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Package leaflet: Information for the user

DOCETAXEL KABI 80mg/4 ml concentrate for solution for infusion

docetaxel
Please read this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, hospital pharmacist, or nurse.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, hospital pharmacist, or nurse. See section 4.

Contents of this leaflet:

What DOCETAXEL KABI is and what it is used for
What you need to know before using DOCETAXEL KABI
How to use DOCETAXEL KABI
Possible side effects
How to store DOCETAXEL KABI
Contents of the pack and other information

1. What DOCETAXEL KABI is and what it is used for
The name of this medicine is DOCETAXEL KABI. The active substance is docetaxel.
Docetaxel is a substance derived from the needle-like leaves of the yew tree and belongs to a group of anticancer agents called taxoids.
DOCETAXEL KABI has been prescribed by your doctor for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, stomach adenocarcinoma, or head and neck cancer:

For the treatment of advanced breast cancer, DOCETAXEL KABI may be given alone or in combination with doxorubicin, trastuzumab, or capecitabine.
For the treatment of early-stage breast cancer, with or without lymph node involvement, DOCETAXEL KABI may be given in combination with doxorubicin and cyclophosphamide.
For the treatment of lung cancer, DOCETAXEL KABI may be given alone or in combination with cisplatin.
For the treatment of prostate cancer, DOCETAXEL KABI is given in combination with prednisone or prednisolone.
For the treatment of metastatic stomach adenocarcinoma, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.
For the treatment of head and neck cancer, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.

2. What you should know before using DOCETAXEL KABI

Do not take DOCETAXEL KABI: if you are allergic (hypersensitive) to docetaxel or to any of the excipients of DOCETAXEL KABI
(listed in section 6);

if your white blood cell count is too low;
if you have severe liver problems.

Warnings and precautions
Before each treatment with DOCETAXEL KABI, you will undergo blood tests to determine whether
your blood cells are sufficiently numerous and whether your liver function is adequate for receiving
DOCETAXEL KABI.
If abnormalities in white blood cells occur, you may also experience fever or infections.
Immediately inform your doctor, hospital pharmacist, or nurse if you experience abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stools, or fever. These symptoms
may be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor will address this immediately.
Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience vision problems, particularly blurred vision, you must have your eyes and vision examined immediately.
Inform your doctor, hospital pharmacist, or nurse if you have previously had an allergic reaction to paclitaxel therapy.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If you develop acute lung problems or if pre-existing symptoms worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue treatment.
You will be asked to take preventive treatment with oral corticosteroids such as dexamethasone one day before administration of DOCETAXEL KABI and to continue for one or two days afterwards in order to reduce certain adverse effects that may occur following infusion of DOCETAXEL KABI, particularly allergic reactions and fluid retention (swelling of the hands, feet, legs, or weight gain).
During treatment, you may require medications to maintain your blood cell counts.
Severe skin reactions have been reported with DOCETAXEL KABI, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP).

Symptoms of SJS/TEN may include blisters, peeling or bleeding of the skin in any area (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also simultaneously experience flu-like symptoms such as fever, chills, or muscle pain.
Symptoms of AGEP may include a widespread scaly and red rash with swollen bumps under the skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever. If you develop severe skin reactions or any of the reactions listed above, contact your doctor or a healthcare professional immediately.

Before starting DOCETAXEL KABI, inform your doctor, hospital pharmacist, or nurse if you have kidney problems or elevated levels of uric acid in the blood.
DOCETAXEL KABI contains alcohol. Inform your doctor if you suffer from alcohol dependence, epilepsy, or liver impairment. See also the section “DOCETAXEL KABI contains ethanol (alcohol)” below.
Other medicines and DOCETAXEL KABI:
The amount of alcohol in this medicine may alter the effects of other medicines. Inform your doctor or pharmacist if you are taking other medicines.
Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. This is because DOCETAXEL KABI or the other medicines may not work as expected and you may be more susceptible to adverse effects.
Pregnancy, breastfeeding and fertility
Ask your doctor for advice before taking any medicine.
DOCETAXEL KABI must NOT be administered during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment and for 2 months after the end of treatment with this medicine. You must use adequate contraceptive measures during treatment and for 2 months after the end of treatment, because DOCETAXEL KABI may be harmful to the unborn child.
If you become pregnant during treatment, inform your doctor immediately.
You must not breastfeed during treatment with DOCETAXEL KABI.
If you are a man receiving treatment with DOCETAXEL KABI, you must not father a child and must use adequate contraceptive measures during treatment and for 4 months after the end of treatment with this medicine. It is recommended that you seek information about sperm preservation before treatment, as docetaxel may impair male fertility.
Driving and using machines:
The amount of alcohol in this medicine may impair your ability to drive or operate machinery.
You may experience adverse effects from this medicine that could impair your ability to drive, use equipment, or operate machinery (see section 4 Possible side effects).
If this occurs, do not drive and do not use any equipment or machinery until you have discussed it with your doctor, nurse, or hospital pharmacist.
DOCETAXEL KABI contains ethanol (alcohol).
This medicine contains 1.58 g of alcohol (ethanol) in each 4 ml, equivalent to 39.5% w/v.
The amount in a 9 ml dose is equivalent to 88.9 ml of beer or 35.6 ml of wine.
The alcohol contained in this preparation may affect children. These effects may include drowsiness and mood swings. It may also impair the ability to concentrate and to perform physical activity.
If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, talk to your doctor or pharmacist before taking this medicine.

3. How to use DOCETAXEL KABI

DOCETAXEL KABI will be administered to you by a healthcare professional.
Recommended dose:
The dose will depend on your body weight and your general health condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
Method and route of administration:
DOCETAXEL KABI will be given by intravenous infusion (for intravenous use only).
The infusion will last approximately 1 hour and will be administered in a hospital setting.
Frequency of administration:
The infusion is normally given once every 3 weeks.
Your doctor may adjust the dose and frequency based on blood test results, your general condition, and your response to DOCETAXEL KABI. In particular, inform your doctor if you experience diarrhea, mouth inflammation, numbness, tingling, or fever, and show them the results of your blood tests. This information will help the doctor decide whether a dose reduction is necessary. If you have any doubts about how to use this medicine, consult your doctor or hospital pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss this with you and explain the potential risks and benefits of treatment.
The most commonly reported adverse reactions with DOCETAXEL KABI alone are: decreased number of red or white blood cells, hair loss, nausea, vomiting, mouth inflammation, diarrhoea, and fatigue.
If you are given DOCETAXEL KABI in combination with other chemotherapy medicines, the severity of side effects may increase.
During the infusion in hospital, the following allergic reactions may occur (may affect more than 1 in 10 people):

hot flushes, skin reactions, itching
tightness in the chest, difficulty breathing
fever or chills
back pain
low blood pressure

More severe reactions may occur. If you have previously had a hypersensitivity reaction to paclitaxel, you may also develop a hypersensitivity reaction to docetaxel, which may be more severe.

During treatment, your condition will be closely monitored by hospital staff.
Inform hospital staff immediately if you notice any of these effects.
Between two infusions of DOCETAXEL KABI, the following side effects may occur, and their frequency may vary depending on the concomitant medicines you are taking:
Very common (may affect more than 1 in 10 people):

infections, decreased number of red blood cells (anaemia) or white blood cells (the latter are important in fighting infections), and platelets
fever: in this case, you must inform your doctor immediately
allergic reactions as described above
loss of appetite (anorexia)
insomnia
sensation of numbness, tingling, or pain in joints or muscles
headache
altered sense of taste
eye inflammation or increased eye tearing
swelling due to insufficient lymphatic drainage
difficulty breathing
mucus discharge from the nose; throat and nose inflammation; cough
nosebleeds
mouth inflammation
stomach disorders including nausea, vomiting, diarrhoea, constipation
abdominal pain
indigestion
hair loss: in most cases, hair regrowth returns to normal. In some cases (frequency not known), permanent hair loss has been observed
redness and swelling of the palms of the hands or soles of the feet, which may cause skin peeling (this may also occur on arms, face, or body)
changes in nail colour, which may lead to nail loss
muscle pain; back pain or bone pain
changes or absence of menstrual periods
swelling of hands, feet, legs
tiredness or flu-like symptoms
weight gain or weight loss
upper respiratory tract infection

Common (may affect up to 1 in 10 people):

oral candidiasis
dehydration
dizziness
hearing disturbances
low blood pressure; irregular or rapid heartbeat
heart failure
oesophagitis
dry mouth
difficulty or pain when swallowing
bleeding
increased liver enzymes (requiring regular blood tests)
increased blood sugar levels (diabetes)
reduced levels of potassium, calcium, and/or phosphate in the blood

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

fainting
at the injection site: skin reactions, phlebitis (vein inflammation), or swelling
blood clot formation
acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel in combination with certain other anticancer treatments

Rare (may affect up to 1 in 1,000 people):

inflammation of the colon or small intestine, which may be fatal (frequency not known); intestinal perforation

Frequency not known (cannot be estimated from the available data):

interstitial lung disease (lung inflammation that may cause cough and difficulty breathing. Lung inflammation may also develop when docetaxel treatment is administered concurrently with radiotherapy)
pneumonia (lung infections)
pulmonary fibrosis (scarring and thickening in the lungs causing shortness of breath)
blurred vision due to swelling of the retina inside the eye (cystoid macular oedema)
reduction of sodium and/or magnesium in the blood (electrolyte imbalance)
ventricular arrhythmia or ventricular tachycardia (manifested as rapid or irregular heartbeat, severe shortness of breath, dizziness and/or fainting). Some of these symptoms may be serious. If this occurs, you must inform a doctor immediately
injection site reactions at the site of a previous reaction
non-Hodgkin’s lymphoma (a tumour affecting the immune system) and other tumours may occur in patients treated with docetaxel in combination with certain other anticancer treatments
Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blisters, peeling or bleeding of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms such as fever, chills or muscle pain)
Acute Generalized Exanthematous Pustulosis (AGEP) (widespread scaly and red rash with skin swellings under the skin (including skin folds, trunk and upper limbs) and blisters accompanied by fever)
Tumour lysis syndrome is a serious condition revealed by changes in blood tests such as increased levels of uric acid, potassium, phosphorus and decreased calcium levels; and causes symptoms such as seizures, kidney failure (reduced urine output or dark urine) and heart rhythm disturbances. In such cases, it is necessary to inform a doctor immediately. Myositis (muscle inflammation – heat, redness and swelling – causing muscle pain and weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOCETAXEL KABI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the label of the
vial after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the medicine in the original packaging to protect it from direct light.
Use the vial immediately after opening. If not used immediately, the storage times and conditions during use are the responsibility of the user.
From a microbiological point of view, reconstitution/dilution must be carried out under controlled and aseptic conditions.
Use the medicine immediately after it has been added to the infusion bag. If not used immediately, the storage times and conditions during use are the responsibility of the user, and it should generally not be kept for more than 6 hours at temperatures below 25°C, including a one-hour infusion period.
Docetaxel solution for infusion is supersaturated and may therefore crystallize over time. If crystals form, the solution must no longer be used and must be discarded.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Package contents and other information

What DOCETAXEL KABI contains

The active substance is anhydrous docetaxel. Each ml of concentrate for infusion solution contains 20 mg of docetaxel.
The excipients are polysorbate 80, anhydrous ethanol (see section 2), and citric acid (to adjust pH).

Description of the appearance of DOCETAXEL KABI and contents of the pack:
DOCETAXEL KABI concentrate for infusion solution is a clear, colourless to pale yellow solution.
Clear colourless glass vial (type I) of 6 ml with a Flurotec rubber stopper and a blue aluminium seal, containing 4 ml of concentrate.
Each pack contains one 4 ml vial of concentrate (80 mg of docetaxel).
Marketing Authorisation Holder:
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany
Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last updated on: (MM/YYYY)
The following information is intended exclusively for healthcare professionals.
GUIDE FOR THE PREPARATION OF DOCETAXEL 80 mg/4 ml CONCENTRATE FOR
INFUSION SOLUTION
It is important to read the entire content of this guide before preparing the infusion solution of
DOCETAXEL KABI.
Recommendations for safe handling
Docetaxel is an antineoplastic agent and, as with other potentially toxic products, caution should be exercised when handling and preparing its solutions. The use of gloves is recommended.
If concentrated DOCETAXEL KABI or infusion solution comes into contact with the skin, wash immediately and thoroughly with water and soap. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.

Preparation for intravenous administration
Preparation of the infusion solution
Do not use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Kabi 80 mg/4 ml concentrate for infusion solution, which contains only 1 vial).
DOCETAXEL KABI 80 mg/4 ml concentrate for infusion solution does NOT require
dilution with a solvent beforehand and is ready to be added directly to the infusion solution.

Each vial is for single use only and must be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for infusion solution may be required to achieve the patient's required dose. For example, a 140 mg dose of docetaxel requires 7 ml of docetaxel concentrate for infusion solution.
Aseptically withdraw the required amount of concentrate for infusion solution using a graduated syringe.

In each vial of DOCETAXEL KABI 80 mg/4 ml, the concentration of docetaxel is 20 mg/ml.

Inject in a single injection into an infusion bag or a 250 ml vial containing 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. If a dose exceeding 190 mg of docetaxel is required, use a larger volume of diluent to ensure that the docetaxel concentration does not exceed 0.74 mg/ml.
Mix the bag or vial manually using a rotational movement.
From a microbiological standpoint, reconstitution/dilution must be performed under controlled, aseptic conditions and the infusion solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Once added as recommended to the infusion bag, the docetaxel infusion solution is stable for 6 hours when stored at temperatures below 25°C. It must be used within 6 hours (including the approximately 1 hour required for intravenous infusion). The docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals appear, the solution must no longer be used and must be discarded.
As with all parenteral products, the infusion solution should be inspected visually before use; solutions containing precipitates must be discarded.

Disposal
All materials used for dilution and administration must be disposed of in accordance with standard procedures. Do not dispose of any medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Package leaflet: Information for the user

DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion

docetaxel
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, hospital pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, hospital pharmacist, or nurse. See section 4.

Contents of this leaflet:

What DOCETAXEL KABI is and what it is used for
What you need to know before using DOCETAXEL KABI
How to use DOCETAXEL KABI
Possible side effects
How to store DOCETAXEL KABI
Contents of the pack and other information

1. What DOCETAXEL KABI is and what it is used for
The name of this medicine is DOCETAXEL KABI. The active substance is docetaxel.
Docetaxel is a substance derived from the needle-like leaves of the yew tree and belongs to a group of anticancer agents called taxoids.
DOCETAXEL KABI has been prescribed by your doctor for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, stomach adenocarcinoma, or head and neck cancer:

For the treatment of advanced breast cancer, DOCETAXEL KABI may be given alone or in combination with doxorubicin, trastuzumab, or capecitabine.
For the treatment of early-stage breast cancer, with or without lymph node involvement, DOCETAXEL KABI may be given in combination with doxorubicin and cyclophosphamide.
For the treatment of lung cancer, DOCETAXEL KABI may be given alone or in combination with cisplatin.
For the treatment of prostate cancer, DOCETAXEL KABI is given in combination with prednisone or prednisolone.
For the treatment of metastatic stomach adenocarcinoma, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.
For the treatment of head and neck cancer, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.

2. What you need to know before using DOCETAXEL KABI

Do not take DOCETAXEL KABI:

if you are allergic (hypersensitive) to docetaxel or to any of the excipients of DOCETAXEL KABI (listed in section 6);
if your white blood cell count is too low;
if you have severe liver problems.

Warnings and precautions
Before each treatment with DOCETAXEL KABI, you will undergo blood tests to determine whether your blood cells are sufficiently numerous and whether your liver function is adequate for receiving DOCETAXEL KABI.
If abnormalities in white blood cells occur, you may also experience fever or infections.
Immediately inform your doctor, hospital pharmacist, or nurse if you have abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stools, or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor will take immediate action.
Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience vision problems, particularly blurred vision, you must immediately have your eyes and vision checked.
Inform your doctor, hospital pharmacist, or nurse if you have had an allergic reaction to previous treatment with paclitaxel.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If you develop acute lung problems or if pre-existing symptoms worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue treatment.
You will be asked to take preventive treatment with oral corticosteroids, such as dexamethasone, one day before administration of DOCETAXEL KABI and to continue for one or two days afterwards, in order to reduce certain adverse effects that may occur following infusion of DOCETAXEL KABI, particularly allergic reactions and fluid retention (swelling of the hands, feet, legs, or weight gain).
During treatment, you may need medications to maintain your blood cell counts.
Severe skin reactions have been reported with DOCETAXEL KABI, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP).

Symptoms of SJS/TEN may include blisters, peeling or bleeding of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also simultaneously experience flu-like symptoms such as fever, chills, or muscle pain.
Symptoms of AGEP may include a widespread scaly and red rash with swollen skin bumps (including skin folds, trunk, and upper extremities) and blisters accompanied by fever. If you develop severe skin reactions or any of the reactions listed above, contact your doctor or healthcare professional immediately.

Other medicines and DOCETAXEL KABI:
The amount of alcohol in this medicine may alter the effects of other medicines. Inform your doctor or pharmacist if you are taking other medicines.
Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. This is because DOCETAXEL KABI or the other medicines may not work as expected, and you may be more susceptible to adverse effects.

Pregnancy, breastfeeding, and fertility
Ask your doctor for advice before taking any medicine.
DOCETAXEL KABI must not be administered during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment and for 2 months after the end of treatment with this medicine. You must use adequate contraceptive measures during treatment and for 2 months after the end of treatment, as DOCETAXEL KABI may be harmful to the unborn child. If you become pregnant during treatment, inform your doctor immediately.
You must not breastfeed during treatment with DOCETAXEL KABI.
If you are a man receiving treatment with DOCETAXEL KABI, you must not father a child and must use adequate contraceptive measures during treatment and for 4 months after the end of treatment with this medicine. It is recommended that you seek advice on sperm preservation before starting treatment, as docetaxel may impair male fertility.

Driving and using machines:
The amount of alcohol in this medicine may impair your ability to drive or operate machinery.
You may experience adverse effects from this medicine that could impair your ability to drive, use equipment, or operate machinery (see section 4 Possible side effects).
If this occurs, do not drive and do not use any equipment or machinery until you have discussed it with your doctor, nurse, or hospital pharmacist.

DOCETAXEL KABI contains ethanol (alcohol).
This medicine contains 2.37 g of alcohol (ethanol) in each 6 ml, equivalent to 39.5% p/v.
The amount in a 9 ml dose is equivalent to 88.9 ml of beer or 35.6 ml of wine.
The alcohol contained in this preparation may affect children. These effects may include drowsiness and mood swings. It may also impair concentration and physical performance.
If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, talk to your doctor or pharmacist before taking this medicine.

3. How to use DOCETAXEL KABI

DOCETAXEL KABI will be administered to you by a healthcare professional.
Recommended dose:
The dose will depend on your body weight and general health condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
Method and route of administration:
DOCETAXEL KABI will be administered by intravenous infusion (for intravenous use).
The infusion will last approximately 1 hour and will be given in a hospital setting.
Frequency of administration:
The infusion is normally administered once every 3 weeks.
Your doctor may adjust the dose and frequency based on blood test results, your general condition, and your response to DOCETAXEL KABI. In particular, inform your doctor if you experience diarrhoea, mouth inflammation, numbness, tingling, or fever, and show your blood test results. Such information will help the doctor decide whether a dose reduction is necessary. If you have any doubts about the use of this medicine, consult your doctor or hospital pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Your doctor will discuss this with you and explain the potential risks and benefits of your treatment.
The most commonly reported adverse reactions with DOCETAXEL KABI alone are: reduction in red or white blood cells, hair loss, nausea, vomiting, mouth inflammation, diarrhoea, and fatigue.
If you are given this medicine in combination with other chemotherapeutic agents, the severity of the side effects of DOCETAXEL KABI may increase.

During the hospital infusion, the following allergic reactions may occur (may affect more than 1 in 10 people):

hot flushes, skin reactions, itching
tightness in the chest, difficulty breathing
fever or chills
back pain
low blood pressure

More severe reactions may occur. If you have previously had a hypersensitivity reaction to paclitaxel, you may also develop a hypersensitivity reaction to docetaxel, which could be more severe.

Your condition will be closely monitored by hospital staff during treatment.
Inform hospital staff immediately if you notice any of these effects.

Between DOCETAXEL KABI infusions, the following side effects may occur, and their frequency may vary depending on the concomitant medications you are taking:

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

infections, decreased number of red blood cells (anaemia) or white blood cells (the latter are important in fighting infections) and platelets
fever: in this case, you must inform your doctor immediately
allergic reactions as described above
loss of appetite (anorexia)
insomnia
sensation of numbness, tingling, or pain in joints or muscles
headache
altered sense of taste
eye inflammation or increased eye tearing
swelling due to insufficient lymphatic drainage
difficulty breathing
nasal mucus discharge; throat and nose inflammation; cough
nosebleeds
mouth inflammation
stomach disorders including nausea, vomiting, diarrhoea, constipation
abdominal pain
indigestion
hair loss: in most cases, hair regrowth returns to normal. In some cases (frequency not known), permanent hair loss has been observed
redness and swelling of the palms of the hands or soles of the feet, which may cause skin peeling
(this may also occur on arms, face or body)
changes in nail colour, which may lead to nail loss
muscle pain; back pain or bone pain
changes or absence of menstrual period
swelling of hands, feet, legs
fatigue or flu-like symptoms
weight gain or weight loss
upper respiratory tract infection

Common (may affect up to 1 in 10 people):

oral candidiasis
dehydration
dizziness
hearing disturbance
low blood pressure; irregular or rapid heartbeat
heart failure
oesophagitis
dry mouth
difficulty or pain when swallowing
bleeding
increased liver enzymes (requiring regular blood tests)
increased blood sugar levels (diabetes)
decreased levels of potassium, calcium, and/or phosphate in the blood

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

fainting
injection site reactions, phlebitis (vein inflammation), or swelling
blood clot formation
acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel in combination with certain other anticancer treatments.

Rare (may affect up to 1 in 1,000 people):

inflammation of the colon or small intestine, which may be fatal (frequency not known); intestinal perforation.

Frequency not known (cannot be estimated from available data):

interstitial lung disease (lung inflammation that may cause cough and breathing difficulties. Lung inflammation may also develop when docetaxel treatment is administered concurrently with radiotherapy)
pneumonia (lung infections)
pulmonary fibrosis (scarring and thickening in the lungs causing shortness of breath)
blurred vision due to swelling of the retina inside the eye (cystoid macular oedema)
reduced levels of sodium and/or magnesium in the blood (electrolyte imbalance)
ventricular arrhythmia or ventricular tachycardia (manifesting as rapid or irregular heartbeats, severe shortness of breath, dizziness and/or fainting). Some of these symptoms may be serious. If this occurs, you must inform a doctor immediately
injection site reactions at the site of a previous reaction
non-Hodgkin’s lymphoma (a tumour affecting the immune system) and other tumours may occur in patients treated with docetaxel in combination with certain other anticancer treatments
Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blisters, peeling or bleeding of the skin anywhere on the body (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms such as fever, chills or muscle pain at the same time)
Acute Generalized Exanthematous Pustulosis (AGEP) (widespread scaly, red rash with swollen skin bumps (including skin folds, trunk, and upper limbs) and blisters accompanied by fever)
Tumour lysis syndrome is a serious condition revealed by changes in blood tests such as increased levels of uric acid, potassium, and phosphate, and decreased calcium levels; it causes symptoms such as seizures, kidney failure (reduced urine output or dark urine), and heart rhythm disturbances. In such cases, you must inform your doctor immediately
Myositis (muscle inflammation – warmth, redness and swelling – causing muscle pain and weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOCETAXEL KABI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the label of the
vial after Exp. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the medicine in the original packaging to protect it from direct light.
Use the vial immediately after opening. If not used immediately, the storage times during use and conditions are the responsibility of the user.
From a microbiological standpoint, reconstitution/dilution must be carried out under controlled and aseptic conditions.
Use the medicine immediately after it has been added to the infusion bag. If not used immediately, the storage times during use and conditions are the responsibility of the user and it should generally not be kept for longer than 6 hours at a temperature not exceeding 25°C, including a one-hour infusion.
Docetaxel solution for infusion is supersaturated and may therefore crystallize over time. If crystals form, the solution must no longer be used and must be discarded.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Package contents and other information

What DOCETAXEL KABI contains

The active substance is anhydrous docetaxel. Each ml of concentrate for infusion solution contains 20 mg of docetaxel.
The excipients are polysorbate 80, anhydrous ethanol (see section 2), and citric acid (to adjust pH).

Marketing Authorisation Holder:
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany

Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last updated on: (MM/YYYY)

The following information is intended exclusively for healthcare professionals.

GUIDE FOR THE PREPARATION OF DOCETAXEL 120 mg/6 ml CONCENTRATE FOR
INFUSION SOLUTION

It is important to read the entire content of this guide before preparing the infusion solution of DOCETAXEL KABI.

Recommendations for safe handling
Docetaxel is an antineoplastic agent and, as with other potentially toxic products, care must be taken when handling and preparing its solutions. The use of gloves is recommended.
If concentrated DOCETAXEL KABI or the infusion solution comes into contact with the skin, wash immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.

Preparation for intravenous administration
Preparation of the infusion solution

Do not use other docetaxel-containing medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Kabi 120 mg/6 ml concentrate for infusion solution containing only 1 vial).

DOCETAXEL KABI 120 mg/6 ml concentrate for infusion solution does NOT require dilution with a solvent prior to use and is ready to be added directly to the infusion solution.

Each vial is for single use only and must be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for infusion solution may be required to achieve the patient's required dose. For example, a 140 mg docetaxel dose requires 7 ml of docetaxel concentrate for infusion solution.
Aseptically withdraw the required amount of concentrate for infusion solution using a graduated syringe.

In each vial of DOCETAXEL KABI 120 mg/6 ml, the concentration of docetaxel is 20 mg/ml.

Inject in a single injection into an infusion bag or vial of 250 ml containing either 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. If a docetaxel dose exceeding 190 mg is required, use a larger volume of diluent to ensure that the final docetaxel concentration does not exceed 0.74 mg/ml.
Mix the bag or vial manually using a rotational motion.
From a microbiological standpoint, reconstitution/dilution must be performed under controlled, aseptic conditions, and the infusion solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Once added as recommended to the infusion bag, the docetaxel infusion solution is stable for 6 hours when stored below 25°C. It must be used within 6 hours (including the approximately 1 hour required for intravenous infusion).

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

As with all parenteral products, the infusion solution must be visually inspected before use; solutions containing precipitates must be discarded.

Package leaflet: Information for the user

DOCETAXEL KABI 160mg/8 ml concentrate for solution for infusion

docetaxel
Please read this leaflet carefully before using this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, hospital pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, hospital pharmacist, or nurse. See section 4.

Contents of this leaflet:

What DOCETAXEL KABI is and what it is used for
What you need to know before using DOCETAXEL KABI
How to use DOCETAXEL KABI
Possible side effects
How to store DOCETAXEL KABI
Contents of the pack and other information

1. What DOCETAXEL KABI is and what it is used for
The name of this medicine is DOCETAXEL KABI. The active substance is docetaxel.
Docetaxel is a substance derived from the needle-like leaves of the yew tree and belongs to a group of anticancer agents called taxoids.
DOCETAXEL KABI has been prescribed by your doctor for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, stomach adenocarcinoma, and head and neck cancer:

For the treatment of advanced breast cancer, DOCETAXEL KABI may be given alone or in combination with doxorubicin, trastuzumab, or capecitabine.
For the treatment of early-stage breast cancer, with or without lymph node involvement, DOCETAXEL KABI may be given in combination with doxorubicin and cyclophosphamide.
For the treatment of lung cancer, DOCETAXEL KABI may be given alone or in combination with cisplatin.
For the treatment of prostate cancer, DOCETAXEL KABI is given in combination with prednisone or prednisolone.
For the treatment of metastatic stomach adenocarcinoma, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.
For the treatment of head and neck cancer, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.

2. What you need to know before using DOCETAXEL KABI

Do not use DOCETAXEL KABI:

if you are allergic (hypersensitive) to docetaxel or to any of the excipients of DOCETAXEL KABI (listed in section 6);
if your white blood cell count is too low;
if you have severe liver problems.

Warnings and precautions
Before each treatment with DOCETAXEL KABI, you will undergo blood tests to determine whether your blood cells are sufficiently numerous and whether your liver function is adequate for receiving DOCETAXEL KABI.
If abnormalities in white blood cells occur, you may also experience fever or infections.
Immediately inform your doctor, hospital pharmacist, or nurse if you have abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in stools, or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor will address this immediately.
Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience vision problems, especially blurred vision, you must have your eyes and vision checked immediately.
Inform your doctor, hospital pharmacist, or nurse if you have had an allergic reaction to previous treatment with paclitaxel.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If you develop acute lung problems or if pre-existing symptoms worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue treatment.
You will be asked to take preventive oral corticosteroid treatment, such as dexamethasone, starting one day before administration of DOCETAXEL KABI and continuing for one or two days afterwards, to reduce certain adverse effects that may occur following infusion of DOCETAXEL KABI, particularly allergic reactions and fluid retention (swelling of hands, feet, legs, or weight gain).
During treatment, you may need medication to maintain your blood cell counts.
Serious skin reactions have been reported with DOCETAXEL KABI, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP).

Symptoms of SJS/TEN may include blisters, peeling or bleeding of any skin area (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms at the same time, such as fever, chills, or muscle pain.
Symptoms of AGEP may include a widespread scaly and red rash with swollen skin bumps (including skin folds, trunk, and upper extremities) and blisters accompanied by fever. If you develop severe skin reactions or any of the reactions listed above, contact your doctor or a healthcare professional immediately.

Before starting DOCETAXEL KABI, inform your doctor, hospital pharmacist, or nurse if you have kidney problems or elevated levels of uric acid in your blood.
DOCETAXEL KABI contains alcohol. Inform your doctor if you suffer from alcohol dependence, epilepsy, or liver impairment. See also the section “DOCETAXEL KABI contains ethanol (alcohol)” below.
Other medicines and DOCETAXEL KABI:
The amount of alcohol in this medicine may alter the effects of other medicines. Inform your doctor or pharmacist if you are taking other medicines.
Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including those without a prescription. This is because DOCETAXEL KABI or the other medicines may not work as expected, and you may be more likely to experience adverse effects.
Pregnancy, breastfeeding and fertility
Ask your doctor for advice before taking any medicine.
DOCETAXEL KABI must NOT be administered during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment and for 2 months after the end of treatment with this medicine. You must use adequate contraceptive measures during treatment and for 2 months after treatment ends, because DOCETAXEL KABI may be harmful to the unborn child.
If you become pregnant during treatment, inform your doctor immediately.
You must not breastfeed during treatment with DOCETAXEL KABI.
If you are a man receiving treatment with DOCETAXEL KABI, you must not father a child and must use adequate contraceptive measures during treatment and for 4 months after the end of treatment with this medicine. It is recommended that you seek advice about sperm preservation before treatment, as docetaxel may impair male fertility.
Driving and using machines:
The amount of alcohol in this medicine may impair your ability to drive or operate machinery. You may experience adverse effects from this medicine that could affect your ability to drive, use equipment, or operate machinery (see section 4 Possible side effects). If this occurs, do not drive and do not use any equipment or machinery until you have discussed it with your doctor, nurse, or hospital pharmacist.
DOCETAXEL KABI contains ethanol (alcohol).
This medicine contains 3.16 g of alcohol (ethanol) in each 8 ml, equivalent to 39.5% p/v.
The amount in a 9 ml dose is equivalent to 88.9 ml of beer or 35.6 ml of wine.
The alcohol contained in this preparation may affect children. These effects may include feeling drowsy and mood swings. It may also impair concentration and physical performance.
If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, talk to your doctor or pharmacist before taking this medicine.

3. How to use DOCETAXEL KABI

DOCETAXEL KABI will be administered to you by a healthcare professional.
Usual dosage:
The dosage will depend on your body weight and general health condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you will receive.
Method and route of administration:
DOCETAXEL KABI will be administered by intravenous infusion (for intravenous use only).
The infusion will last approximately 1 hour and will be given in a hospital setting.
Frequency of administration:
The infusion is normally administered once every 3 weeks.
Your doctor may adjust the dose and frequency based on blood test results, your general condition, and your response to DOCETAXEL KABI. In particular, inform your doctor if you experience diarrhoea, mouth inflammation, numbness, tingling, or fever, and show your blood test results. This information will help the doctor decide whether a dose reduction is necessary. If you have any doubts about the use of this medicine, consult your doctor or hospital pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Your doctor will discuss this with you and explain the potential risks and benefits of the treatment.
The most commonly reported adverse reactions with DOCETAXEL KABI alone are: decrease in red or white blood cells, hair loss, nausea, vomiting, mouth inflammation, diarrhoea, and fatigue.
If you are given this medicine in combination with other chemotherapeutic agents, the severity of the side effects of DOCETAXEL KABI may increase.
During the infusion in hospital, the following allergic reactions may occur (may affect more than 1 in 10 people):

flushing, skin reactions, itching
sensation of tightness in the chest, difficulty breathing
fever or chills
back pain
low blood pressure

More severe reactions may occur. If you have previously had a hypersensitivity reaction to paclitaxel, you may develop a hypersensitivity reaction to docetaxel, which could be more severe.

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

infections, decreased number of red blood cells (anaemia) or white blood cells (the latter being important in fighting infections), and platelets
fever: in this case, you must inform your doctor immediately
allergic reactions as described above
loss of appetite (anorexia)
insomnia
sensation of numbness, tingling, or pain in joints or muscles
headache
altered sense of taste
eye inflammation or increased eye tearing
swelling due to insufficient lymphatic drainage
difficulty breathing
nasal mucus discharge; throat and nose inflammation; cough
nosebleeds
mouth inflammation
stomach disorders including nausea, vomiting, diarrhoea, constipation
abdominal pain
indigestion
hair loss: in most cases, hair regrowth returns to normal. In some cases (frequency not known), permanent hair loss has been observed.
redness and swelling of the palms of the hands or soles of the feet, which may lead to skin peeling
(this may also occur on arms, face or body)
changes in nail colour, which may lead to nail loss
muscle pain; back pain or bone pain
changes or absence of menstrual period
swelling of hands, feet, legs
tiredness or flu-like symptoms
weight gain or weight loss
upper respiratory tract infection

Common (may affect up to 1 in 10 people):

oral candidiasis
dehydration
dizziness
hearing disturbances
low blood pressure; irregular or rapid heartbeat
heart failure
oesophagitis
dry mouth
difficulty or pain when swallowing
haemorrhage
increased liver enzymes (requiring regular blood tests)
increased blood sugar levels (diabetes)
reduced levels of potassium, calcium and/or phosphate in the blood

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

fainting
skin reactions at injection site, phlebitis (vein inflammation) or swelling
blood clot formation
acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel in combination with certain other anticancer treatments

Rare (may affect up to 1 in 1,000 people):

inflammation of the colon or small intestine, which may be fatal (frequency not known); intestinal perforation

Frequency not known (cannot be estimated from available data):

interstitial lung disease (lung inflammation that may cause cough and difficulty breathing. Lung inflammation may also develop when docetaxel treatment is administered concurrently with radiotherapy)
pneumonia (lung infections)
pulmonary fibrosis (scarring and thickening in the lungs causing shortness of breath)
blurred vision due to swelling of the retina inside the eye (cystoid macular oedema)
reduced levels of sodium and/or magnesium in the blood (electrolyte imbalance)
ventricular arrhythmia or ventricular tachycardia (manifested as rapid or irregular heartbeats, severe shortness of breath, dizziness and/or fainting). Some of these symptoms may be serious. If this occurs, you must inform a doctor immediately
injection site reactions at the site of a previous reaction
non-Hodgkin’s lymphoma (a cancer affecting the immune system) and other tumours may occur in patients treated with docetaxel in combination with certain other anticancer treatments
Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blisters, peeling or bleeding of the skin in any area (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms such as fever, chills or muscle pain)
Acute Generalized Exanthematous Pustulosis (AGEP) (widespread scaly and red rash with swollen skin bumps (including skin folds, trunk and upper limbs) and blisters accompanied by fever)
Tumour lysis syndrome is a serious condition indicated by changes in blood tests such as increased levels of uric acid, potassium, and phosphate, and decreased calcium levels; it causes symptoms such as seizures, kidney failure (reduced urine output or dark urine), and heart rhythm disturbances. In such cases, it is necessary to inform the doctor immediately
Myositis (muscle inflammation – warmth, redness and swelling – causing muscle pain and weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOCETAXEL KABI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the label of the
vial after Exp. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store the medicine in the original packaging to protect it from direct light.
Use the vial immediately after opening. If not used immediately, the storage times and conditions during use are the responsibility of the user.
From a microbiological standpoint, reconstitution/dilution must be carried out under controlled and aseptic conditions.
Use the medicine immediately after it has been added to the infusion bag. If not used immediately, the storage times and conditions during use are the responsibility of the user and it should normally not be kept for more than 6 hours at temperatures below 25°C, including a one-hour infusion.
Docetaxel solution for infusion is supersaturated and may therefore crystallize over time. If crystals form, the solution must no longer be used and must be discarded.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Package contents and other information

What DOCETAXEL KABI contains

The active substance is anhydrous docetaxel. Each ml of concentrate for infusion solution contains 20 mg of docetaxel.
The excipients are polysorbate 80, anhydrous ethanol (see section 2), and citric acid (to adjust pH).

Marketing Authorization Holder:
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany

Manufacturer:
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

This leaflet was last updated on: (MM/YYYY)

The following information is intended for healthcare professionals only.

GUIDE FOR THE PREPARATION OF DOCETAXEL 160mg/8ml CONCENTRATE FOR INFUSION SOLUTION

It is important that you read the entire content of this guide before preparing the DOCETAXEL KABI infusion solution.

Recommendations for safe handling
Docetaxel is an antineoplastic agent and, as with other potentially toxic products, caution should be exercised when handling and preparing its solutions. The use of gloves is recommended.
If concentrated DOCETAXEL KABI or infusion solution comes into contact with the skin, wash immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.

Preparation for intravenous administration
Preparation of the infusion solution

Do not use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Kabi 160mg/8ml concentrate for infusion solution containing only 1 vial).

DOCETAXEL KABI 160mg/8ml concentrate for infusion solution does NOT require dilution with a solvent prior to use and is ready to be added directly to the infusion solution.

Each vial is for single use only and should be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for intravenous infusion solution may be required to achieve the patient's required dose. For example, a 140 mg dose of docetaxel requires 7 ml of docetaxel concentrate.
Aseptically withdraw the required amount of concentrate for infusion solution using a graduated syringe.

In each vial of DOCETAXEL KABI 160mg/8ml, the concentration of docetaxel is 20 mg/ml.

Inject in a single injection into an infusion bag or vial containing 250 ml of 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. If a docetaxel dose exceeding 190 mg is required, use a larger volume of diluent to ensure that the final concentration of docetaxel does not exceed 0.74 mg/ml.
Mix the bag or vial manually using a rotational motion.
From a microbiological standpoint, reconstitution/dilution must be performed under controlled, aseptic conditions, and the infusion solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Once added as recommended to the infusion bag, the docetaxel infusion solution is stable for 6 hours when stored below 25°C. It must be used within 6 hours (including the approximately 1 hour required for intravenous infusion).

The docetaxel infusion solution is supersaturated and may crystallize over time. If crystals appear, the solution must not be used and must be discarded.

As with all parenteral products, the infusion solution should be inspected visually before use. Solutions containing precipitates must be discarded.

Disposal
All materials used for dilution and administration must be disposed of in accordance with standard procedures. Do not dispose of any medicinal product via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

Package leaflet: Information for the user

DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion

docetaxel
Please read this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, hospital pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, hospital pharmacist, or nurse. See section 4.

Contents of this leaflet:

What DOCETAXEL KABI is and what it is used for
What you need to know before using DOCETAXEL KABI
How to use DOCETAXEL KABI
Possible side effects
How to store DOCETAXEL KABI
Contents of the pack and other information

For the treatment of advanced breast cancer, DOCETAXEL KABI may be given alone or in combination with doxorubicin, trastuzumab, or capecitabine.
For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL KABI may be given in combination with doxorubicin and cyclophosphamide.
For the treatment of lung cancer, DOCETAXEL KABI may be given alone or in combination with cisplatin.
For the treatment of prostate cancer, DOCETAXEL KABI is given in combination with prednisone or prednisolone.
For the treatment of metastatic stomach adenocarcinoma, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.
For the treatment of head and neck cancer, DOCETAXEL KABI is given in combination with cisplatin and 5-fluorouracil.

2. What you should know before using DOCETAXEL KABI

Do not use DOCETAXEL KABI:

if you are allergic (hypersensitive) to docetaxel or to any of the excipients of DOCETAXEL KABI (listed in section 6);
if your white blood cell count is too low;
if you have severe liver problems.

Warnings and precautions
Before each treatment with DOCETAXEL KABI, you will have blood tests to determine whether your blood cells are sufficiently numerous and whether your liver function is adequate for receiving DOCETAXEL KABI.
If abnormalities in white blood cells occur, you may also experience fever or infections.
Immediately inform your doctor, hospital pharmacist, or nurse if you have abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stools, or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor will address this immediately.
Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience visual disturbances, particularly blurred vision, you must have your eyes and vision checked immediately.
Inform your doctor, hospital pharmacist, or nurse if you have had an allergic reaction to previous treatment with paclitaxel.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If you develop acute lung problems or if pre-existing symptoms worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue treatment.
You will be asked to take preventive oral corticosteroid treatment, such as dexamethasone, one day before administration of DOCETAXEL KABI and to continue for one or two days afterwards, in order to reduce certain adverse effects that may occur following infusion of DOCETAXEL KABI, particularly allergic reactions and fluid retention (swelling of the hands, feet, legs, or weight gain).
During treatment, you may need medication to maintain your blood cell counts.
Severe skin reactions have been reported with DOCETAXEL KABI, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP).

Symptoms of SJS/TEN may include blisters, peeling or bleeding of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms at the same time, such as fever, chills, or muscle pain.
Symptoms of AGEP may include a widespread scaly and red rash with swollen skin bumps (including skin folds, trunk, and upper extremities) and blisters accompanied by fever. If you develop severe skin reactions or any of the reactions listed above, contact your doctor or healthcare professional immediately.

Before starting DOCETAXEL KABI, inform your doctor, hospital pharmacist, or nurse if you have kidney problems or elevated levels of uric acid in your blood.
DOCETAXEL KABI contains alcohol. Inform your doctor if you have alcohol dependence, epilepsy, or liver impairment. See also the section "DOCETAXEL KABI contains ethanol (alcohol)" below.
Other medicines and DOCETAXEL KABI:
The amount of alcohol in this medicine may alter the effects of other medicines. Inform your doctor or pharmacist if you are taking other medicines.
Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. This is because DOCETAXEL KABI or the other medicines might not work as expected, and you may be more likely to experience adverse effects.
Pregnancy, breastfeeding and fertility
Ask your doctor for advice before taking any medicine.
DOCETAXEL KABI must NOT be administered during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment and for 2 months after the end of treatment with this medicine. You must use adequate contraceptive measures during treatment and for 2 months after the end of treatment, because DOCETAXEL KABI may be harmful to the unborn child.
If you become pregnant during treatment, inform your doctor immediately.
You must not breastfeed during treatment with DOCETAXEL KABI.
If you are a man undergoing treatment with DOCETAXEL KABI, you must not father a child and must use adequate contraceptive measures during treatment and for 4 months after the end of treatment with this medicine. It is recommended that you seek information about sperm preservation before treatment, as docetaxel may impair male fertility.
Driving and using machines:
The amount of alcohol in this medicine may impair your ability to drive or operate machinery. You may experience adverse effects from this medicine that could impair your ability to drive, use equipment, or operate machinery (see section 4 Possible side effects). If this occurs, do not drive or use any equipment or machinery until you have discussed it with your doctor, nurse, or hospital pharmacist.
DOCETAXEL KABI contains ethanol (alcohol).
This medicine contains 3.55 g of alcohol (ethanol) in each 9 ml, equivalent to 39.5% p/v.
The amount in a 9 ml dose is equivalent to 88.9 ml of beer or 35.6 ml of wine.
The alcohol contained in this preparation may affect children. These effects may include drowsiness and mood swings. It may also impair concentration and physical performance.
If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, talk to your doctor or pharmacist before taking this medicine.

3. How to use DOCETAXEL KABI

DOCETAXEL KABI will be administered to you by a healthcare professional.
Recommended dose:
The dose will depend on your body weight and general health condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
Method and route of administration:
DOCETAXEL KABI will be administered by intravenous infusion (for intravenous use only).
The infusion will last approximately 1 hour and will be given in a hospital setting.
Frequency of administration:
The infusion is normally administered once every 3 weeks.
Your doctor may adjust the dose and frequency of administration based on blood test results, your general condition, and your response to DOCETAXEL KABI. In particular, inform your doctor if you experience diarrhea, mouth inflammation, numbness, tingling, fever, and show the results of your blood tests. This information will help the doctor decide whether a dose reduction is necessary. If you have any doubts about how to use this medicine, consult your doctor or hospital pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Your doctor will discuss this with you and explain the potential risks and benefits of treatment.
The most commonly reported adverse reactions with DOCETAXEL KABI alone are: decrease in red or white blood cells, hair loss, nausea, vomiting, mouth inflammation, diarrhoea, and fatigue.
If this medicine is administered to you in combination with other chemotherapeutic agents, the severity of the adverse effects of DOCETAXEL KABI may increase.
During the infusion in hospital, the following allergic reactions may occur (may affect more than 1 in 10 people):

hot flushes, skin reactions, itching
feeling of tightness in the chest, difficulty breathing
fever or chills
back pain
low blood pressure. More severe reactions may also occur.

If you have previously had a hypersensitivity reaction to paclitaxel, you may also develop a hypersensitivity reaction to docetaxel, which could be more severe.
During treatment, your condition will be closely monitored by hospital staff.
Inform hospital staff immediately if you notice any of these effects.
Between two infusions of DOCETAXEL KABI, the following side effects may occur, and their frequency may vary depending on the concomitant medications you are taking:

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

infections, decreased number of red blood cells (anaemia) or white blood cells (the latter being important in fighting infections), and platelets
fever: in this case, you must inform your doctor immediately
allergic reactions as described above
loss of appetite (anorexia)
insomnia
sensation of numbness, tingling, or pain in joints or muscles
headache
altered sense of taste
eye inflammation or increased eye tearing
swelling due to insufficient lymphatic drainage
difficulty breathing
nasal mucus discharge; throat and nasal inflammation; cough
nosebleeds
mouth inflammation
stomach disorders including nausea, vomiting, diarrhoea, constipation
abdominal pain
indigestion
hair loss: in most cases, hair regrowth returns to normal. In some cases (frequency not known), permanent hair loss has been observed
redness and swelling of the palms of the hands or soles of the feet, which may lead to skin peeling
(this may also occur on arms, face, or body)
changes in nail colour, which may lead to nail loss
muscle pain; back pain or bone pain
changes or absence of menstrual periods
swelling of hands, feet, legs
tiredness or flu-like symptoms
weight gain or weight loss
upper respiratory tract infection

Common (may affect up to 1 in 10 people):

oral candidiasis
dehydration
dizziness
hearing disturbances
decreased blood pressure; irregular or rapid heartbeat
heart failure
oesophagitis
dry mouth
difficulty or pain when swallowing
bleeding
increased liver enzymes (requiring regular blood tests)
increased blood sugar levels (diabetes)
reduced potassium, calcium, and/or phosphate levels in the blood

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

fainting
injection site skin reactions, phlebitis (vein inflammation), or swelling
blood clot formation
acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel in combination with certain other anticancer treatments

Rare (may affect up to 1 in 1,000 people):

inflammation of the colon or small intestine, which may be fatal (frequency not known); intestinal perforation

Frequency not known (cannot be estimated from available data):

interstitial lung disease (lung inflammation that may cause cough and difficulty breathing. Lung inflammation may also develop when docetaxel treatment is administered concurrently with radiotherapy)
pneumonia (lung infections)
pulmonary fibrosis (scarring and thickening in the lungs causing shortness of breath)
blurred vision due to swelling of the retina inside the eye (cystoid macular oedema)
reduced sodium and/or magnesium levels in the blood (electrolyte imbalance)
ventricular arrhythmia or ventricular tachycardia (manifesting as rapid or irregular heartbeats, severe shortness of breath, dizziness and/or fainting). Some of these symptoms may be serious. If this occurs, you must inform a doctor immediately
injection site reactions at the site of a previous reaction
non-Hodgkin’s lymphoma (a tumour affecting the immune system) and other tumours may occur in patients treated with docetaxel in combination with certain other anticancer treatments
Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blisters, peeling or bleeding of the skin anywhere (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms such as fever, chills or muscle pain)
Acute Generalized Exanthematous Pustulosis (AGEP) (widespread scaly and red rash with swollen bumps under the skin (including skin folds, trunk, and upper limbs), accompanied by fever)
Tumour lysis syndrome is a serious condition indicated by changes in blood tests such as increased levels of uric acid, potassium, and phosphorus, and decreased calcium levels; it causes symptoms such as seizures, kidney failure (reduced urine output or dark urine), and heart rhythm disturbances. In such cases, you must inform your doctor immediately
Myositis (muscle inflammation – warmth, redness, and swelling – causing muscle pain and weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist, or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOCETAXEL KABI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the label of the
vial after Exp. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store the medicine in the original packaging to protect it from direct light.
Use the vial immediately after opening. If not used immediately, the storage times and conditions during use are the responsibility of the user.
From a microbiological point of view, reconstitution/dilution must be carried out under controlled and aseptic conditions.
Use the medicine immediately after it has been added to the infusion bag. If not used immediately, the storage times and conditions during use are the responsibility of the user and normally it should not be kept for longer than 6 hours at a temperature not exceeding 25°C, including a one-hour infusion.
Docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals form, the solution must no longer be used and must be discarded.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Package contents and other information

What DOCETAXEL KABI contains

The active substance is anhydrous docetaxel. Each ml of concentrate for solution for infusion contains 20 mg of docetaxel.
The excipients are polysorbate 80, anhydrous ethanol (see section 2), and citric acid (to adjust pH).

Description of the appearance of DOCETAXEL KABI and contents of the pack:
DOCETAXEL KABI concentrate for solution for infusion is a clear, colourless to pale yellow solution.
Clear, colourless glass vial (type I) of 10 ml with a Flurotec rubber stopper and an orange aluminium seal, containing 9 ml of concentrate.
Each pack contains one vial with 9 ml of concentrate (180 mg of docetaxel).

Marketing Authorization Holder:
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe
Germany

Manufacturer:
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

This leaflet was last updated on: (MM/YYYY)

The following information is intended for healthcare professionals only.

GUIDE FOR THE PREPARATION OF DOCETAXEL 180 mg/9 ml CONCENTRATE FOR
INFUSION SOLUTION

It is important that you read the entire content of this guide before preparing the infusion solution of DOCETAXEL KABI.

Recommendations for safe handling
Docetaxel is an antineoplastic agent and, as with other potentially toxic products, caution should be exercised when handling and preparing its solutions. The use of gloves is recommended.
If concentrated DOCETAXEL KABI or infusion solution comes into contact with the skin, wash immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.

Preparation for intravenous administration

Preparation of the infusion solution

Do not use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Kabi 180 mg/9 ml concentrate for infusion solution containing only one vial).

DOCETAXEL KABI 180 mg/9 ml concentrate for infusion solution does NOT require dilution with a solvent prior to use and is ready to be added directly to the infusion solution.

Each vial is for single use only and must be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for intravenous infusion solution may be required to achieve the required patient dose. For example, a 140 mg dose of docetaxel requires 7 ml of docetaxel concentrate for solution.
Aseptically withdraw the required amount of concentrate for infusion solution using a graduated syringe.

In each vial of DOCETAXEL KABI 180 mg/9 ml, the concentration of docetaxel is 20 mg/ml.

Inject in a single injection into an infusion bag or a 250 ml vial containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 190 mg of docetaxel is required, use a larger volume of diluent to ensure that the final concentration of docetaxel does not exceed 0.74 mg/ml.
Mix the bag or vial manually using a rotational motion.
From a microbiological standpoint, reconstitution/dilution must be performed under controlled, aseptic conditions, and the infusion solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Once added as recommended to the infusion bag, the docetaxel infusion solution is stable for 6 hours when stored at temperatures below 25°C. It must be used within 6 hours (including the approximately 1 hour required for intravenous infusion).

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

As with all parenteral products, the infusion solution should be inspected visually before use; solutions containing precipitates must be discarded.

Disposal
All materials used for dilution and administration must be disposed of in accordance with standard procedures. Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.