Docetaxel-ebeve

Package Leaflet: Information for the User

Docetaxel-Ebewe, 10 mg/ml, Concentrate for Solution for Infusion

Docetaxel

Read All of This Leaflet Carefully Before You Start Using This Medicine.

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

Contents of the Pack

• 1. What Docetaxel-Ebewe is and What it is Used For
• 2. Before You Use Docetaxel-Ebewe
• 3. How to Use Docetaxel-Ebewe
• 4. Possible Side Effects
• 5. How to Store Docetaxel-Ebewe
• 6. Contents of the Pack and Other Information

1. What Docetaxel-Ebewe is and What it is Used For

Docetaxel-Ebewe contains the active substance docetaxel. Docetaxel is a substance obtained from the needles of yew trees. Docetaxel-Ebewe belongs to a group of anticancer medicines called taxoids. Docetaxel-Ebewe is prescribed by doctors for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, stomach cancer, or head and neck cancer:

• in the treatment of advanced breast cancer, Docetaxel-Ebewe may be given alone (as monotherapy) or in combination with doxorubicin or trastuzumab, or capecitabine;
• in the treatment of early-stage breast cancer with or without lymph node involvement, Docetaxel-Ebewe may be given in combination with doxorubicin and cyclophosphamide;
• in the treatment of lung cancer, Docetaxel-Ebewe may be given alone (as monotherapy) or in combination with cisplatin;
• in the treatment of prostate cancer, Docetaxel-Ebewe is given in combination with prednisone or prednisolone;
• in the treatment of stomach cancer with metastases, Docetaxel-Ebewe is given with cisplatin and 5-fluorouracil;
• in the treatment of head and neck cancer, Docetaxel-Ebewe is given in combination with cisplatin and 5-fluorouracil.

2. Before You Use Docetaxel-Ebewe

When You Should Not Use Docetaxel-Ebewe

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

if you have a low white blood cell count;

if you have severe liver disease.

Warnings and Precautions

Before each administration of Docetaxel-Ebewe, blood tests will be performed to check if your blood cell count is normal and if your liver function allows the administration of the medicine. If you have a low white blood cell count, you may be at risk of developing fever or infections.

If you experience abdominal pain or tenderness, diarrhea, bleeding from the rectum, blood in your stools, or fever, you should immediately inform your doctor, hospital pharmacist, or nurse. These may be the first signs of a serious gastrointestinal toxicity that can lead to death. Your doctor should immediately initiate appropriate treatment.

If you experience vision disturbances, you should inform your doctor, hospital pharmacist, or nurse. Vision disturbances, particularly blurred vision, require urgent ophthalmological examination.

If you have previously experienced an allergic reaction during treatment with paclitaxel, you should inform your doctor, hospital pharmacist, or nurse.

If you have heart problems, you should inform your doctor, hospital pharmacist, or nurse.

If you experience acute symptoms or worsening of existing symptoms from the lungs (fever, shortness of breath, or cough), you should immediately inform your doctor, hospital pharmacist, or nurse. Your doctor may decide to stop the treatment immediately.

Your doctor will advise you to take preventive oral corticosteroids, such as dexamethasone, one day before and one to two days after the administration of Docetaxel-Ebewe, to reduce the severity of side effects that may occur after the administration of Docetaxel-Ebewe, particularly allergic reactions and fluid retention symptoms (swelling of hands, feet, legs, or weight gain).

During treatment, your doctor may give you medications to maintain a normal blood cell count.

During treatment with docetaxel, serious skin reactions have been reported, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP):

• SJS/TEN symptoms may include blistering, peeling, or bleeding from any part of the body (including the mouth, eyes, genitalia, hands, or feet) with or without a rash. Flu-like symptoms, such as fever, chills, or muscle aches, may also occur.
• AGEP symptoms may include a red, widespread, peeling rash with bumps under the swollen skin (including skin folds, torso, and upper limbs) and blisters, accompanied by fever. If you experience serious skin reactions or any of the reactions mentioned above, you should immediately contact your doctor or healthcare professional.

If you have kidney problems or high levels of uric acid in your blood, you should inform your doctor, hospital pharmacist, or nurse before starting treatment with Docetaxel-Ebewe.

Docetaxel-Ebewe contains alcohol. Patients with alcohol dependence, epilepsy, or liver dysfunction should discuss this with their doctor. See also the section "Docetaxel-Ebewe contains ethanol (alcohol)".

Docetaxel-Ebewe and Other Medicines

You should inform your doctor or hospital pharmacist about all the medicines you are taking or have recently taken, including those obtained without a prescription.

Docetaxel-Ebewe or other medicines may not work as expected or may increase the risk of side effects.

The amount of alcohol present in the medicine may affect the action of other medicines.

Pregnancy, Breast-feeding, and Fertility

Before taking any medicine, you should consult your doctor.

Docetaxel-Ebewe should not be used in pregnant women unless your doctor considers it absolutely necessary.

During treatment and for 2 months after the end of treatment, female patients must avoid becoming pregnant.

Female patients must use effective contraception during treatment and for 2 months after the end of treatment, as docetaxel may be harmful to the unborn child. If you become pregnant during treatment, you should immediately inform your doctor.

You should not breast-feed during treatment with Docetaxel-Ebewe.

Male patients receiving Docetaxel-Ebewe must avoid fathering a child and must use effective contraception during treatment with this medicine and for 4 months after the end of treatment. Before starting treatment, you should consult your doctor about the possibility of storing sperm, as docetaxel may impair male fertility.

Driving and Using Machines

The amount of alcohol present in the medicine may impair your ability to drive or operate machinery.

Side effects of the medicine may affect your ability to drive or operate machinery (see section 4 "Possible Side Effects"). In such cases, you should not drive or operate machinery before consulting your doctor, nurse, or hospital pharmacist.

Docetaxel-Ebewe Contains Ethanol (Alcohol)

This medicine contains 265 mg of ethanol (alcohol) per ml of concentrate for solution for infusion, which corresponds to 26% w/w. The amount of alcohol in 1 ml of this medicine is equivalent to 7 ml of beer or 3 ml of wine.

Alcohol may have a harmful effect on individuals with alcohol dependence.

The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effects in children are unlikely to be noticeable. However, it may cause some effects in younger children, such as drowsiness.

Alcohol in this medicine may affect the action of other medicines. If you are taking other medicines, you should consult your doctor or pharmacist.

The alcohol content should be taken into account in pregnant or breast-feeding women, as well as in children and individuals at high risk, such as patients with liver disease and epilepsy.

If you are alcohol-dependent, you should consult your doctor or pharmacist before taking this medicine.

The amount of alcohol present in the medicine may affect the central nervous system (the part of the nervous system that includes the brain and spinal cord).

3. How to Use Docetaxel-Ebewe

Docetaxel-Ebewe is a medicine administered by medical personnel.

Recommended Dose

The dose depends on your body surface area and overall health. Your doctor will calculate your body surface area in square meters (m2) and determine the dose to be administered based on this calculation.

Method and Route of Administration

Docetaxel-Ebewe is administered as an intravenous infusion into one of your veins. The intravenous infusion, which lasts about one hour, is given in a hospital setting.

Frequency of Administration

The infusion is usually given every 3 weeks.

Your doctor may adjust the dose and frequency of administration based on the results of your blood tests, your overall health, and your response to treatment with Docetaxel-Ebewe. You should inform your doctor, in particular, about the occurrence of diarrhea, mouth sores, numbness, tingling, fever, and show them your blood test results. This information will allow your doctor to decide whether to reduce the dose.

If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Docetaxel-Ebewe can cause side effects, although not everybody gets them.

You should consult your doctor to discuss the possible risks and benefits of treatment.

The most common side effects reported after administration of Docetaxel-Ebewe alone are:

reduction in red or white blood cell count, hair loss, nausea, vomiting, mouth sores, diarrhea, and fatigue.

The severity of side effects of Docetaxel-Ebewe may be greater if it is administered in combination with other chemotherapeutic agents.

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

redness of the skin, skin reactions, itching of the skin

chest tightness, difficulty breathing

fever or chills

back pain

low blood pressure

More severe reactions may also occur.

If you have experienced allergic reactions to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe.

Medical personnel will closely monitor your condition during treatment. You should immediately inform the hospital staff if you observe any of these symptoms.

Between administrations of Docetaxel-Ebewe, the following side effects may occur, and their frequency may vary depending on the treatment regimen:

Very Common(may occur in more than 1 in 10 people)

infections, reduction in red or white blood cell count or platelet count

fever: if you experience a temperature increase, you should immediately inform your doctor

allergic reactions, as described above

loss of appetite (anorexia)

insomnia

numbness, tingling, or pain in the joints or muscles

headache

change in taste

eye inflammation or increased tearing

swelling caused by abnormal lymphatic drainage

shortness of breath

nasal congestion; pharyngitis; cough

nosebleeds

mouth sores

gastrointestinal disorders, including nausea, vomiting, and diarrhea, constipation

abdominal pain

indigestion

hair loss (in most cases, hair regrowth occurs after the end of treatment);

permanent hair loss has been observed (frequency not known)

redness and swelling of the palms of the hands and soles of the feet with possible peeling of the skin (may also affect the arms, face, or other parts of the body)

change in nail color, which may separate from the nail bed

pain (including persistent pain) in the muscles; back pain or bone pain

change in menstrual cycle or absence of menstruation

swelling of the hands, feet, legs

fatigue or flu-like symptoms

weight gain or loss

upper respiratory tract infection.

Common(may occur in less than 1 in 10 people)

oral thrush

dehydration

dizziness

hearing disorders

reduction in blood pressure, irregular or rapid heartbeat

heart failure

esophagitis

dry mouth

difficulty or pain when swallowing

bleeding

increase in liver enzyme activity (blood tests are necessary)

increase in blood glucose levels (diabetes)

reduction in potassium, calcium, and (or) phosphate levels in the blood.

Uncommon(may occur in less than 1 in 100 people)

fainting

skin reactions, vein inflammation, or swelling at the injection site

blood clots

acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel in combination with certain other anticancer therapies

Rare(may occur in less than 1 in 1000 people)

colitis, intestinal perforation, with possible fatal outcome (frequency not known)

Frequency Not Known(frequency cannot be estimated from the available data)

interstitial lung disease (inflammation of the lungs causing cough and difficulty breathing. Lung inflammation may also develop during concurrent use of docetaxel and radiotherapy)

lung inflammation

pulmonary fibrosis (scarring and thickening of lung tissue with shortness of breath)

blurred vision due to swelling of the macula (macular edema)

reduction in sodium, potassium, magnesium, and (or) calcium levels in the blood (electrolyte imbalance)

ventricular arrhythmias or ventricular tachycardia (characterized by irregular and (or) rapid heartbeat, significant shortness of breath, dizziness, and (or) fainting). Some of these symptoms may be severe. In such cases, you should immediately consult your doctor.

reactions at the injection site in the case of previous reactions

non-Hodgkin's lymphoma (a cancer affecting the immune system) and other cancers may occur in patients treated with docetaxel in combination with certain other anticancer therapies

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (blistering, peeling, or bleeding from any part of the body (including the mouth, eyes, genitalia, hands, or feet) with or without a rash. Flu-like symptoms, such as fever, chills, or muscle aches, may also occur)

acute generalized exanthematous pustulosis (AGEP) (red, widespread, peeling rash with bumps under the swollen skin (including skin folds, torso, and upper limbs) and blisters, accompanied by fever)

tumor lysis syndrome is a serious condition characterized by changes in blood test results, including elevated levels of uric acid, potassium, phosphorus, and reduced calcium levels; leading to symptoms such as seizures, kidney failure (reduced or dark urine), and arrhythmias. In such cases, you should immediately inform your doctor.

muscle inflammation (inflammation of the muscles - hot, red, swollen, and painful - causing muscle pain and weakness).

Reporting of Side Effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, hospital pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Docetaxel-Ebewe

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

Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Do not freeze.

Store the vial in the outer carton in order to protect from light.

Shelf-life after first opening

The medicine should be used within 28 days. Do not store above 25°C.

Shelf-life after dilution

The infusion solution should be used within 4 hours, including the 1-hour infusion. The chemical and physical stability of the solution has been demonstrated when stored at room temperature (below 25°C) or in a refrigerator (between 2°C and 8°C).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Docetaxel-Ebewe Contains

The active substance is docetaxel. One ml of concentrate for solution for infusion contains 10 mg of docetaxel.

The other ingredients are anhydrous citric acid, macrogol 300, polysorbate 80, ethanol 96%.

What Docetaxel-Ebewe Looks Like and Contents of the Pack

Docetaxel-Ebewe is a clear, colorless to pale yellow solution, pH 3.0-4.5, without visible particles.

Docetaxel-Ebewe is available in single packs containing 1 vial (20 mg/2 ml, 80 mg/8 ml, 160 mg/16 ml).

The vials may be placed in transparent protective covers made of plastic (Onko-Safe or "Sleeving"). The Onko-Safe and Sleeving covers do not come into contact with the medicine and provide additional protection during transport, thus increasing the safety of medical and pharmaceutical personnel.

Marketing Authorization Holder and Manufacturer

EBEWE Pharma Ges.m.b.H. Nfg. KG

Mondseestrasse 11

4866 Unterach, Austria

Manufacturer

Fareva Unterach GmbH

Mondseestraße 11

4866 Unterach, Austria

For Further Information on This Medicine, Please Contact

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warszawa

tel. 22 209 70 00

Date of Last Revision of the Leaflet:11/2023

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Information Intended for Healthcare Professionals Only Instructions for Preparation and Disposal of the Medicine

Visual Inspection Before Use

Docetaxel-Ebewe concentrate for solution for infusion should be inspected visually for particulate matter or discoloration before administration. If the solution contains particulate matter or is discolored, it should be discarded.

Preparation of the Infusion Solution

The concentrate must be diluted before use.

Infusion solutions should be prepared with 0.9% sodium chloride solution or 5% glucose solution and administered as an intravenous infusion.

If the vials of Docetaxel-Ebewe concentrate for solution for infusion are stored in a refrigerator, the required number of vials should be removed and left at a temperature below 25°C until the solution reaches room temperature.

The required volume can be directly drawn from the vial.

Depending on the required dose for the individual patient, it may be necessary to use more than one vial.

Based on the required dose for the individual patient (expressed in mg), the corresponding volume of the solution containing 10 mg of docetaxel per 1 ml should be drawn from the appropriate number of vials using syringes with Luer-lock tips. For example, a dose of 140 mg of docetaxel requires the withdrawal of 14 ml of the concentrate for solution for infusion.

The required volume of Docetaxel-Ebewe concentrate for solution for infusion should be added to a 250 ml infusion bag or bottle containing 5% glucose solution or 0.9% sodium chloride solution for infusion.

If the required dose of docetaxel is greater than 200 mg, a larger volume of diluent should be used so that the concentration of docetaxel does not exceed 0.74 mg/ml.

The contents of the infusion bag or bottle should be mixed manually by gently rotating and inverting, avoiding foaming of the solution. During preparation and transportation of the solution for administration to the patient, shaking or vigorous mixing should be avoided.

The prepared docetaxel infusion solution is stable for 4 hours and should be used within this time (including the 1-hour intravenous infusion). The infusion should be administered under aseptic conditions, at room temperature (below 25°C), and under normal lighting conditions.

The infusion solution prepared from Docetaxel-Ebewe concentrate for solution for infusion should be inspected visually for particulate matter before administration. If the solution is not clear or contains particulate matter, it should be discarded.

From a microbiological point of view, the product should be used immediately.

It is not recommended to come into contact with Docetaxel-Ebewe concentrate with equipment or devices made of polyvinyl chloride (PVC) with plasticizers used for the preparation of the solution. To minimize the exposure of patients to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be released from PVC infusion bags or sets, the final diluted infusion solution of Docetaxel-Ebewe should be stored in bottles or bags made of plastic materials (such as polypropylene or polyolefin) and administered through infusion sets coated with polyethylene.

To minimize the potential for precipitation of a sediment in the infusion solution, the use of infusion bags is recommended. Glass bottles should not be used.

pH and Osmolality of the Solution After Dilution

0.3 mg/ml in 5% glucose solution: pH ≈ 3.6; 517 mOsm/kg

0.74 mg/ml in 0.9% sodium chloride solution: pH ≈ 3.3 – 3.6; 849 mOsm/kg

Guidelines for the Safe Handling of Cytotoxic Agents

Pregnant women should not handle cytotoxic agents. Injection solutions should be prepared by trained personnel in a designated area. The surface designated for the preparation of solutions should be covered with single-use absorbent paper mats with a plastic layer on the outside.

Personnel must be equipped with protective gloves, masks, and protective clothing. Appropriate measures should be taken to avoid accidental contact of the medicine with the skin or mucous membranes.

If such contact occurs, the skin or mucous membranes should be washed immediately with soap and water. If the eyes are accidentally exposed, they should be rinsed immediately with water.

Luer-lock syringes and systems should be used. The use of needles with a large diameter is recommended to minimize pressure and potential splashing. The formation of aerosols can also be reduced by using needles that allow pressure equalization. All unused product residues should be disposed of. Appropriate precautions should be taken when disposing of materials used for the preparation of the Docetaxel-Ebewe product.

All unused product residues or contaminated materials should be placed in special bags for hazardous waste. Sharp objects (needles, syringes, vials, etc.) should be placed in appropriate rigid containers. Personnel responsible for collecting and disposing of waste should be informed of the associated risks. All unused product residues or waste should be disposed of in accordance with standard procedures for cytotoxic agents. Excess solution should be poured directly into the drain with a large amount of water.

This medicine may be used multiple times, see "Shelf-life and Storage".

Incompatibilities

This medicine must not be mixed with other medicinal products.

Method of Administration

Docetaxel-Ebewe is intended for intravenous use only.

Shelf-life and Storage

Shelf-life of the Unopened Product

2 years

Shelf-life After Dilution

Chemical and physical stability has been demonstrated for 4 hours for the diluted solution in 5% glucose solution or 0.9% sodium chloride solution, stored at a temperature between 2°C and 8°C or below 25°C.

From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the responsibility for the storage conditions and shelf-life before use lies with the user.

Special Precautions for Storage

Unopened Product

Do not store above 25°C.

Do not freeze.

Store the vial in the outer carton in order to protect from light. For storage conditions after dilution, see section "Shelf-life after dilution".