DOCETAXEL GLENMARK 20 mg/1 ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

PACKAGE LEAFLET

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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is not listed in this leaflet. See section 4.

Contents of the pack

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

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

The name of this medicine is Docetaxel Glenmark. Its common 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 administered alone or in combination with doxorubicin, or trastuzumab or capecitabine.
• For the treatment of early breast cancer with or without lymph node involvement, docetaxel may be administered in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, docetaxel may be administered alone or in combination with cisplatin.
• For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.

2. What you need to know before you use Docetaxel Glenmark

Do not use Docetaxel Glenmark

• if you are allergic (hypersensitive) to docetaxel or 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 treatment with docetaxel, you will have a blood test to check that you have a sufficient number of blood cells and adequate liver function to receive this medicine. If you have altered white blood cell counts, you may suffer from fever or associated infections.

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

Inform your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision problems, particularly blurred vision, an eye examination and vision test must be performed immediately.

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 or worsening lung problems (fever, difficulty breathing, cough), immediately inform your doctor, hospital pharmacist or nurse. Your doctor may immediately interrupt your treatment.

Your doctor will recommend that you take premedication, consisting of an oral corticosteroid such as dexamethasone, one day before administration of docetaxel and continue for one or two days after to minimize some side 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 count.

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

• SJS/TEN symptoms may include blisters, peeling or bleeding on 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.
• AGEP symptoms may include a red, scaly and widespread rash with bumps under the inflamed skin (including skin folds, trunk and upper limbs) and blisters accompanied by fever.

If you develop severe skin reactions or any of the above reactions, contact your doctor or healthcare professional immediately.

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

Docetaxel Glenmark contains alcohol. Consult your doctor if you have a history of alcohol dependence, epilepsy or liver disorders. See also the 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 take any other medicines, including those obtained without a prescription.

The reason is that it is possible that docetaxel or the other medicine may not work as well as expected and that you may have more chance of getting a side effect. The alcohol content of this medicine may alter the effects of other medicines.

Pregnancy, breast-feedingand fertility

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

Consult with your doctor before using any medicine.

Docetaxel MUST NOT be administered if you are pregnant, unless clearly indicated by your doctor.

You must not become pregnant while being treated with this medicine and must use an effective method of contraception during therapy, as docetaxel may be harmful to the fetus. If you become pregnant during treatment, you must immediately inform your doctor.

Docetaxel must not be used during breast-feeding.

If you are a man being treated with docetaxel, you are advised not to father a child during and up to 6 months after treatment, and to seek advice on conservation of sperm before treatment, as docetaxel may alter male fertility.

Driving and using machines

The alcohol content of this medicine may affect your ability to drive and use machines. You may experience side effects with this medicine that could affect your ability to drive, use tools or operate machinery (see section 4 Possible side effects). If this happens, do not drive or use any tools or machines before discussing it with 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 1 vial of 1 ml 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 1 vial of 4 ml 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 1 vial of 8 ml 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 a noticeable effect on adults or adolescents. It may 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 breast-feeding, consult your doctor or pharmacist before taking this medicine.

If you have a history of alcohol dependence, 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.

Usual dose

The dose will depend on your weight and overall health. Your doctor will calculate your body surface area in square meters (m2) and determine the dose you should receive.

Form and route of administration

Docetaxel will be administered by infusion into one of your veins (intravenously). The infusion will last approximately one hour during which you will be in the hospital.

Frequency of administration

You will receive the treatment, by infusion, once every 3 weeks.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effects of docetaxel, when used alone, are: decrease in the number of red or white blood cells, hair loss, nausea, vomiting, mouth sores, diarrhea and fatigue.

The severity of the side effects of this medicine may increase when used in combination with other chemotherapy agents.

During the infusion in the 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,
• low blood pressure.

More serious reactions may occur.

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

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

Between docetaxel infusions, the following may occur and the frequency may vary depending on the combination of medicines you receive:

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

• infections, decrease in the number of red or white blood cells and platelets
• fever: if this happens, you must inform your doctor immediately
• allergic reactions as described above
• loss of appetite (anorexia)
• insomnia
• numbness or tingling or pain in the joints or muscles
• headache
• taste alteration
• eye inflammation or excessive tearing
• swelling caused by defective lymphatic drainage
• shortness of breath
• nasal discharge; throat and nose inflammation; cough
• nasal bleeding
• mouth sores
• stomach upset 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 cause skin peeling (this may also occur on arms, face or body)
• change in nail color, which may loosen
• muscle pain; back pain or bone pain
• changes or absence of menstrual period
• swelling of hands, feet, legs
• fatigue; or cold-like symptoms
• weight gain or 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 heartbeats
• heart failure
• esophagitis
• dry mouth
• difficulty or pain when swallowing
• bleeding
• elevation of liver enzymes (hence the need for regular blood tests)
• increase in blood sugar levels (diabetes)
• decrease in potassium, calcium and/or phosphate in your blood.

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

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

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

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

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

• interstitial lung disease (inflammation of the lungs causing cough and difficulty breathing. Lung inflammation may also occur when treatment with docetaxel is used with radiotherapy)
• pneumonia (lung infection)
• pulmonary fibrosis (scarring and thickening in the lungs with difficulty breathing)
• blurred vision due to inflammation of the retina within the eye (cystoid macular edema)
• decrease in sodium and/or magnesium in your blood (electrolyte imbalance disorders)
• ventricular arrhythmia or ventricular tachycardia (which may manifest as irregular and/or rapid heartbeats, severe shortness of breath, dizziness and/or fainting). Some of these symptoms may be severe. If this happens, inform your doctor immediately
• reactions at the injection site, at the site of a previous reaction
• non-Hodgkin's lymphoma (a cancer that affects the immune system) and other types of cancer may occur in patients receiving treatment with docetaxel in combination with other anticancer treatments
• Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (blisters, peeling or bleeding on 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) (red, scaly and widespread 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 that manifests as changes in blood tests, such as increased uric acid, potassium, phosphorus and decreased calcium levels; and results in symptoms such as seizures, kidney failure (reduced or darkened urine) and heart rhythm disturbances. If this happens, you must inform your doctor immediately.
• myositis (inflammation of the muscles - heat, redness and swelling - that causes muscle pain and weakness).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 which is stated on the outer packaging and on the label of the vial after CAD. The expiry date is the last day of the month stated.

From a microbiological point of view, it should be reconstituted/diluted under controlled and aseptic conditions. Use the vial immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

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

The physical and chemical stability of the prepared infusion solution as recommended is demonstrated for up to 24 hours if 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 should not be used and should be discarded.

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

6. Package Contents and Additional 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 ingredients are polysorbate 80, anhydrous ethanol (see section 2), and anhydrous citric acid.

Appearance and Package Contents of the Product

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

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

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

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

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

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

Each pack contains an 8 ml vial of concentrate (160 mg of 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

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area 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 the last revision of this leaflet:December 2022

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

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This information is intended only for healthcare professionals:

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

It is important that you read the contents of this guide carefully before preparing the docetaxel infusion solution.

Recommendations for safe handling

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

If the docetaxel concentrate or infusion solution comes into contact with the skin, the skin should be washed immediately and thoroughly with water and soap. If it comes into contact with the mucous membranes, it should be rinsed immediately and thoroughly with water.

Preparation for intravenous administration

Preparation of the infusion solution

DO NOT USE this medicine with other medicines that contain docetaxel in 2 vials (concentrate and solvent).

• Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion, in a single vial with 1 ml (20 mg/1 ml)
• Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion, in a single vial with 4 ml (80 mg/4 ml)
• Docetaxel Glenmark 20 mg/1 ml concentrate for solution for infusion, in a single vial with 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 to the infusion solution.

• Each vial is for single use and should be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user. It may be necessary to use more than 1 vial of concentrate for infusion solution to obtain the required dose for the patient. For example, for a dose of 140 mg of docetaxel, 7 ml of docetaxel concentrate for infusion would be required.
• Extract the required amount of docetaxel concentrate for infusion solution aseptically using a calibrated syringe with a 21G needle.

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

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

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

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

• Manually mix the infusion bag or bottle by rotating it.
• From a microbiological point of view, it should be reconstituted/diluted under controlled and aseptic conditions, and the medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

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

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

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

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

Disposal

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