Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion EFG

Package Leaflet: Information for the Patient

Introduction

Package Leaflet: Information for the Patient

Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, talk to your doctor, hospital pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Docetaxel Glenmark is and what it is used for
2. What you need to know before using Docetaxel Glenmark
3. How to use Docetaxel Glenmark
4. Possible side effects
5. How to store Docetaxel Glenmark
6. Contents of the pack and other information

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

The name of this medicine is Docetaxel Glenmark. Its generic name is docetaxel. Docetaxel is a substance derived from the needles (leaves) of the yew tree.

Docetaxel belongs to a group of anticancer medicines called taxoids.

Docetaxel Glenmark has been prescribed by your doctor for the treatment of breast cancer, certain types of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer:

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

2. What you need to know before using Docetaxel Glenmark

Do not use Docetaxel Glenmark

• if you are allergic (hypersensitive) to docetaxel or to any of the other ingredients of this medicine (listed in section 6).
• if your white blood cell count is too low.
• if you have severe liver disease.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with docetaxel.

Before each docetaxel treatment, you will have a blood test to ensure you have an adequate number of blood cells and adequate liver function to receive this medicine. If your white blood cells are low, you may develop fever or infections.

Immediately inform your doctor, hospital pharmacist, or nurse if you experience abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in stools, or fever. These symptoms could be early signs of severe gastrointestinal toxicity, which may be fatal. Your doctor must address this immediately.

Inform your doctor, hospital pharmacist, or nurse if you experience vision problems. If you have vision problems, particularly blurred vision, you should have an immediate eye and vision examination.

Inform your doctor, hospital pharmacist, or nurse if you have heart problems.

Inform your doctor, hospital pharmacist, or nurse if you have previously experienced allergic reactions to paclitaxel.

If you develop acute problems or worsening of lung conditions (fever, difficulty breathing, cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may stop your treatment immediately.

Your doctor will recommend premedication consisting of an oral corticosteroid such as dexamethasone, starting one day before docetaxel administration and continuing for one or two days afterwards, to minimize certain adverse effects that may occur after docetaxel infusion, particularly allergic reactions and fluid retention (swelling of hands, feet, legs, or weight gain).

During treatment, you may receive other medicines to maintain your blood cell counts.

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

• Symptoms of SJS/TEN may include blistering, peeling, or bleeding of the skin anywhere (including lips, eyes, mouth, nose, genitals, hands, or feet), with or without rash. 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 red, scaly rash with inflamed 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 mentioned above, contact your doctor or healthcare professional immediately.

Inform your doctor, hospital pharmacist, or nurse before starting docetaxel treatment if you have kidney problems or high levels of uric acid in your blood.

Docetaxel Glenmark contains alcohol. Consult your doctor if you have alcohol dependence, epilepsy, or liver disorders. See also section below “Docetaxel Glenmark contains ethanol (alcohol)”.

Other medicines and Docetaxel Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

This is because docetaxel or the other medicine may not work as expected, and you may be more likely to experience an adverse effect. The alcohol content of this medicine may alter the effects of other medicines.

Pregnancy, breastfeeding, and fertility

Talk to your doctor before using any medicine.

Docetaxel must NOT be given during pregnancy unless clearly indicated by your doctor.

You must not become pregnant while being treated and for 2 months after the end of treatment with this medicine. You should use an effective method of contraception during treatment and for 2 months after stopping treatment, as docetaxel may harm the unborn baby. If you become pregnant during treatment, you must inform your doctor immediately.

Docetaxel must not be used during breastfeeding.

If you are a man receiving docetaxel treatment, you must not father a child and should use an effective method of contraception during treatment and for 4 months after stopping treatment with this medicine. It is recommended that you seek advice about sperm preservation before treatment, as docetaxel may affect male fertility.

Driving and using machines

The alcohol content of this medicine may affect your ability to drive and use machines. You may experience adverse effects with this medicine that could impair your ability to drive, use tools, or operate machinery (see section 4 Possible side effects). If this occurs, do not drive or use any tools or machinery until you have consulted your doctor, nurse, or hospital pharmacist.

Docetaxel Glenmark contains ethanol (alcohol)

20 mg/1 ml

This medicine contains 395 mg (0.5 ml) of alcohol (ethanol) in each 1 ml vial, equivalent to 50 vol %. The amount in one 1 ml vial of this medicine is equivalent to less than 10 ml of beer or 4 ml of wine.

80 mg/4 ml

This medicine contains 1.58 g (2 ml) of alcohol (ethanol) in each 4 ml vial, equivalent to 50 vol %. The amount in one 4 ml vial of this medicine is equivalent to less than 40 ml of beer or 17 ml of wine.

160 mg/8 ml

This medicine contains 3.16 g (4 ml) of alcohol (ethanol) in each 8 ml vial, equivalent to 50 vol %. The amount in one 8 ml vial of this medicine is equivalent to less than 80 ml of beer or 33 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect in adults or adolescents. It could have some effects in young children, such as drowsiness.

The amount of alcohol in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

The alcohol content of this medicine may have effects on the central nervous system (part of the nervous system that includes the brain and spinal cord).

3. How to use Docetaxel Glenmark

Docetaxel will be administered to you by a healthcare professional.

Recommended dose

The dose will depend on your weight and general 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 will be given by infusion into one of your veins (intravenous route). The infusion will last approximately one hour, during which time you will remain in the hospital.

Frequency of administration

The treatment will be administered by infusion once every 3 weeks.

Your doctor may adjust the dose and frequency of administration depending on your blood test results, your general condition, and your response to docetaxel. In particular, inform your doctor if you experience diarrhea, mouth sores, numbness or tingling sensations, or fever, and provide the results of your blood tests. This information will help your doctor decide whether a dose reduction is necessary. If you have any further questions about the use of this medicine, ask your doctor or the hospital pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most common adverse effects of docetaxel when administered alone are: decrease in red or white blood cells, alopecia, nausea, vomiting, mouth sores, diarrhea, and fatigue.

The severity of the adverse effects of this medicine may increase when it is administered in combination with other chemotherapeutic agents.

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

• flushing, skin reactions, itching,
• chest tightness, difficulty breathing,
• fever or chills,
• back pain,
• decreased blood pressure.

Other more serious reactions may also occur.

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

Hospital staff will closely monitor your health status during treatment. If you notice any of these effects, inform them immediately.

Between one docetaxel infusion and another, the following may occur, and their frequency may vary depending on the combination of medicines you receive:

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

• infections, decrease in red blood cells (anemia) or white blood cells (which are important for fighting infections) and platelets,
• fever: if this occurs, you must inform your doctor immediately,
• allergic reactions as described above,
• loss of appetite (anorexia),
• insomnia,
• sensation of numbness or tingling, or pain in joints or muscles,
• headache,
• altered taste,
• eye inflammation or excessive tearing,
• swelling due to defective lymphatic drainage,
• shortness of breath,
• nasal discharge; throat and nose inflammation; cough,
• nosebleeds,
• mouth sores,
• stomach discomfort including nausea, vomiting and diarrhea, constipation,
• abdominal pain,
• indigestion,
• hair loss (in most cases, your hair will grow back normally). 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 in arms, face or body),
• change in nail color, which may lead to nail loss,
• muscle pain; back or bone pain,
• changes or absence of menstrual periods,
• swelling of hands, feet, legs,
• fatigue; or cold-like symptoms,
• weight gain or weight loss,
• upper respiratory tract infection.

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

• oral candidiasis,
• dehydration,
• dizziness,
• hearing impairment,
• low blood pressure, irregular or rapid heartbeat,
• heart failure,
• esophagitis,
• dry mouth,
• difficulty or pain when swallowing,
• bleeding,
• elevated liver enzymes (hence the need for regular blood tests),
• increased blood sugar levels (diabetes),
• decreased potassium, calcium and/or phosphate levels in your blood.

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

• fainting,
• skin reactions, phlebitis (vein inflammation), or swelling at the infusion site,
• blood clot formation,
• acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel along with other anticancer treatments.

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

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

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

• interstitial lung disease (lung inflammation causing cough and difficulty breathing. Lung inflammation may also occur when docetaxel treatment is used with radiotherapy),
• pneumonia (lung infection),
• pulmonary fibrosis (scarring and thickening in the lungs causing difficulty breathing),
• blurred vision due to retinal inflammation inside the eye (cystoid macular edema),
• decreased sodium and/or magnesium levels in your blood (electrolyte imbalance),
• ventricular arrhythmia or ventricular tachycardia (manifesting as irregular and/or rapid heartbeats, severe shortness of breath, dizziness and/or fainting). Some of these symptoms may be serious. If this occurs, inform your doctor immediately,
• reactions at the injection site, or at the site of a previous reaction,
• non-Hodgkin lymphoma (a cancer affecting the immune system) and other types of cancer may occur in patients receiving docetaxel treatment along with other anticancer treatments,
• Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blisters, peeling or bleeding in any part of your skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without rash. You may also have flu-like symptoms at the same time, such as fever, chills or muscle pain),
• Acute Generalized Exanthematous Pustulosis (AGEP) (widespread red, scaly rash with bumps under the inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever,
• tumor lysis syndrome, a serious condition characterized by changes in blood tests such as increased levels of uric acid, potassium, and phosphorus, and decreased calcium levels; resulting in symptoms such as seizures, kidney failure (reduced or dark urine) and heart rhythm disturbances. If this occurs, you must inform your doctor immediately,
• myositis (muscle inflammation—characterized by warmth, redness, and swelling—causing muscle pain and weakness).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, hospital pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Docetaxel Glenmark

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

No special storage conditions are required.

Do not freeze.

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

From a microbiological standpoint, reconstitution/dilution must be performed under controlled aseptic conditions. The vial should be used immediately after opening. If not used immediately, the user is responsible for the duration and storage conditions prior to use.

Once added to the infusion bag as recommended, the docetaxel infusion solution is stable for 6 hours when stored below 20°C to 25°C. It must be used within this 6-hour period (including the time required for intravenous infusion).

The in-use chemical and physical stability of the prepared infusion solution, as recommended, has been demonstrated for up to 24 hours when stored between 25°C and 2-8°C in non-PVC bags.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Package contents and other information

Composition of Docetaxel Glenmark

• The active substance is docetaxel (as trihydrate). Each ml of concentrate for solution for infusion contains 20 mg of docetaxel.
• The other components are polysorbate 80, anhydrous ethanol (see section 2), and anhydrous citric acid.

Appearance of the product and contents of the container

Docetaxel Glenmark concentrate for solution for infusion is a clear, pale yellow to yellow-brown solution.

The concentrate is supplied in a 5 ml Type I glass vial, with a rubber stopper and sealed with a flip-off aluminum cap.

Each pack contains one vial of 1 ml concentrate (20 mg docetaxel).

The concentrate is supplied in a 5 ml Type I glass vial, with a rubber stopper and sealed with a flip-off aluminum cap.

Each pack contains one vial of 4 ml concentrate (80 mg docetaxel).

The concentrate is supplied in a 10 ml Type I glass vial, with a rubber stopper and sealed with a flip-off aluminum cap.

Each pack contains one vial of 8 ml concentrate (160 mg docetaxel).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

APIS Labor GmbH
Resslstrasse 9
9065 Ebenthal in Kärnten
Austria

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Austria: Docetaxel Koanaa 20 mg/1 ml Konzentrat zur Herstellung einer Infusionslösung
Germany: Docetaxel Glenmark 20 mg/1 ml Konzentrat zur Herstellung einer Infusionslösung
Spain: Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion EFG

Date of latest revision of this leaflet: June 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

PREPARATION GUIDE FOR THE USE OF DOCETAXEL GLENMARK 20 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION

It is important to carefully read this guide before preparing the docetaxel infusion solution.

Recommendations for safe handling

Docetaxel is an antineoplastic agent and, as with all potentially toxic compounds, caution should be exercised when handling and preparing docetaxel solutions. The use of gloves is recommended.

If the docetaxel concentrate or infusion solution comes into contact with the skin, wash the affected area 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 this medicine with other medicines containing docetaxel in 2 vials (concentrate and solvent).

• Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion, in a single vial containing 1 ml (20 mg/1 ml)
• Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion, in a single vial containing 4 ml (80 mg/4 ml)
• Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion, in a single vial containing 8 ml (160 mg/8 ml)

Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion does not require prior dilution with a solvent 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 storage time and conditions during use are the responsibility of the user. More than one vial of concentrate for infusion solution may be needed to achieve the required patient dose. For example, a dose of 140 mg docetaxel would require 7 ml of docetaxel concentrate.
• Aseptically withdraw the required amount of docetaxel concentrate for infusion solution using a calibrated syringe with a 21G needle.

The concentration of docetaxel in the Docetaxel Glenmark 20 mg/1 ml vial is 20 mg/ml.

The concentration of docetaxel in the Docetaxel Glenmark 80 mg/4 ml vial is 20 mg/ml.

The concentration of docetaxel in the Docetaxel Glenmark 160 mg/8 ml vial is 20 mg/ml.

• Then, inject it at once (in a single injection) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose exceeding 190 mg of docetaxel is required, use a larger volume of infusion fluid to avoid exceeding a docetaxel concentration of 0.74 mg/ml.

• Mix the infusion bag or bottle manually by gentle rotation.

• From a microbiological standpoint, reconstitution/dilution should be performed under controlled aseptic conditions and the product should be used immediately. If not used immediately, the storage periods and conditions during use are the responsibility of the user.

Once added to the infusion bag as recommended, the docetaxel infusion solution is stable for 6 hours when stored below 25°C. It must be used within this 6-hour period (including the time required for intravenous infusion administration).

In addition, the in-use physical and chemical stability of the prepared infusion solution, as recommended, has been demonstrated for up to 48 hours when stored between 2°C and 8°C in non-PVC bags.

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

• As with all parenteral products, the docetaxel infusion solution should be inspected visually before use; any solutions showing precipitate formation should be discarded.

Disposal

Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations. Do not dispose of medicines via wastewater. Ask your pharmacist where to dispose of medicines no longer in use. This will help protect the environment.