PATIENT INFORMATION LEAFLET

Patient Information Leaflet:Information for the Patient

Docetaxel Glenmark 20 mg/1 ml Concentrate for Solution for Infusion EFG

Read 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, consult your doctor, pharmacist or nurse.
• If you experience any side effects,consult your doctor, pharmacist or nurse,eveniftheydo not appear in this leaflet. See section 4.

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

Docetaxel belongs to the group of anticancer drugs 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, stomach cancer, or head and neck cancer:

• For the treatment of advanced breast cancer, docetaxel may be administered either alone or in combination with doxorubicin, trastuzumab, or capecitabina.
• 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 either 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.

No use Docetaxel Glenmark

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

Advertencias y precauciones

Consult your doctor, pharmacist or nurse before starting to use docetaxel.

Before each treatment with docetaxel, a blood test will be performed to check that you have a sufficient number of blood cells and adequate liver function to receive this medication. If you have alterations in white blood cells, you may experience fever or associated infections.

Inform your doctor, hospital pharmacist or nurse immediately if you have abdominal pain or tenderness, diarrhea, rectal bleeding, bloody stools or fever. These symptoms may 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. If you have vision problems, particularly blurred vision, an immediate eye and vision examination must be performed.

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

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

During treatment, you may receive other medications to maintain your blood cell count.

Severe skin problems have been reported with docetaxel, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized pustular psoriasis (AGPP):

• The 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 symptoms similar to the flu at the same time, such as fever, chills or muscle pain.
• The AGPP symptoms may include a red, scaly and generalized rash with inflamed skin lumps (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 treatment with docetaxel if you have kidney problems or high blood levels of uric acid.

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

Otros medicamentos y Docetaxel Glenmark

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medicationincluding those acquired without a prescription.

The reason is that docetaxel or the other medication may not work as expected and you may have a higher risk of experiencing an adverse effect. The alcohol content of this medication may alter the effects of other medications.

Embarazo,lactanciay fertilidad

If you are pregnant or breastfeeding, consultyour doctor or pharmacist before using this medication.

Consult with your doctor before using any medication.

Docetaxel should not be administered if you are pregnant, unless clearly indicated by your doctor.

You should not become pregnant while receiving this medication and should use an effective contraceptive method during therapy, as docetaxel may be harmful to the fetus. If you become pregnant during your treatment, you must inform your doctor immediately.

Docetaxel should not be used during breastfeeding.

If you are a man receiving docetaxel, it is recommended that you do not father a child during treatment and for 6 months after, and that you inform about sperm conservation before treatment, as docetaxel may affect male fertility.

Conducción y uso de máquinas

The alcohol content of this medication may affect your ability to drive and use machines. You may experience adverse effects with this medication that may impair your ability to drive, use tools or operate machinery (see section 4 Possible adverse effects). If this happens, do not drive or use any tools or machinery before consulting with your doctor, nurse or hospital pharmacist.

Docetaxel Glenmark contains etanol (alcohol)

20 mg/1 ml

This medication 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 medication is equivalent to less than 10 ml of beer or 4 ml of wine.

80 mg/4 ml

This medication 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 medication is equivalent to less than 40 ml of beer or 17 ml of wine.

160 mg/8 ml

This medication 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 medication is equivalent to less than 80 ml of beer or 33 ml of wine.

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

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

Consult your doctor or pharmacist before taking this medication if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before taking this medication if you have a history of alcohol dependence.

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

Docetaxel will be administered by a healthcare professional.

Usual Dose

The dose will depend on your weight and overall condition. 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 through intravenous infusion in one of your veins. The infusion will last approximately one hour during which time you will be in the hospital.

Administration Frequency

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

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

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

The most common side effects of docetaxel when administered alone are: a 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 administered in combination with other chemotherapy agents.

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

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

Other more severe reactions may occur.

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

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

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

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

• infections, a decrease in the number of red blood cells (anemia) or white blood cells (which are important for fighting infections) 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
• alteration of taste
• inflammation of the eye or excessive tearing
• swelling caused by defective lymphatic drainage
• shortness of breath
• nasal secretion; inflammation of the throat and nose; cough
• nasal bleeding
• mouth sores
• stomach discomfort including nausea, vomiting, and diarrhea, constipation
• abdominal pain
• indigestion
• hair loss (in most cases, your hair will regrow normally). In some cases (unknown frequency), 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 can also occur on arms, face, or body)
• change in nail color, which may fall off
• muscle pain; back or bone pain
• changes or absence of menstrual period
• swelling of hands, feet, legs
• fatigue; or catarrah symptoms
• weight gain or loss
• upper respiratory tract infection.

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

• oral candidiasis
• dehydration
• dizziness
• hearing loss
• decreased blood pressure, irregular or rapid heartbeats
• heart failure
• esophagitis
• dry mouth
• difficulty or pain 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):

• syncope
• 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 could be fatal (unknown frequency); intestinal perforation.

Unknown frequency (cannot be estimated from available data):

• pulmonary interstitial disease (inflammation of the lungs that produces cough and difficulty breathing. Lung inflammation may also occur when docetaxel treatment is used with radiation therapy)
• pneumonia (lung infection)
• pulmonary fibrosis (scarring and thickening of the lungs with difficulty breathing)
• blurred vision due to inflammation of the retina inside the eye (cystoid macular edema)
• decrease in sodium and/or magnesium in your blood (electrolyte imbalance)
• ventricular arrhythmia or ventricular tachycardia (which manifests 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 lymphoma (a cancer that affects the immune system) and other types of cancer may occur in patients receiving docetaxel treatment in combination with other anticancer treatments
• Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET) (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 symptoms similar to the flu at the same time, such as fever, chills, or muscle pain
• Generalized Acute Exanthematous Pustulosis (PEGA) (red, scaly, and generalized rash with inflamed bumps under the skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever)
• tumor lysis syndrome, a severe condition that manifests by changes in blood tests, such as increased levels of uric acid, potassium, phosphate, and decreased levels of calcium; and results in symptoms such as seizures, kidney failure (reduced or dark urine) and heart rhythm alterations. If this happens, you must inform your doctor immediately.
• myositis (inflammation of the muscles -heat, redness, and swelling- that produces muscle pain and weakness).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

Do not freeze.

Do not usethis medicationafter the expiration date that appears on the outer packaging and on the vial label after CAD. The expiration date is the last day of the month indicated.

From a microbiological point of view, it must be reconstituted/diluted in controlled, aseptic conditions. Use the vial immediately after opening. If not used immediately, the periods of time and storage conditions in use 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 must be used within this 6-hour period (including the hour of intravenous infusion administration).

The physical and chemical stability in use 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, so it may crystallize over time. If crystals appear, the solution should not be used and should be discarded.

Medications should not be thrown away through the drains or in the trash. Ask your pharmacisthow to disposeofthepackaging and of themedications that you no longerneed.This will help protect the environment.

Composition of Docetaxel Glenmark

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

Appearance of the product and contents of the pack

Docetaxel Glenmark concentrate for infusion solution is a transparent pale yellow to yellowish solution.

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

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

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

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

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

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

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible person for manufacturing

APIS Labor GmbH

Resslstrasse 9

9065 Ebenthal in Kärnten

Austria

Glenmark Pharmaceuticals s.r.o,

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica S.L.U.

c/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

AustriaDocetaxel Koanaa 20 mg/1 ml Konzentrat zur Herstellung einer Infusionslösung

GermanyDocetaxel Glenmark 20 mg/1 ml Konzentrat zur Herstellung einer Infusionslösung

SpainDocetaxel Glenmark 20 mg/1 ml concentrado para solución para perfusión EFG

Last review date of this leaflet:December 2022

The detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

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

Please read this guide carefully before preparing the docetaxel infusion solution.

Recommendations for safe handling

Docetaxel is an antineoplastic agent and, like other potentially toxic compounds, it should be handled with caution when manipulating and preparing docetaxel solutions. It is recommended to use gloves.

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

Preparation for intravenous administration

Preparation of the infusion solution

DO NOT USE this medicinal product with other medicinal products containing docetaxel in 2 vials (concentrate and solvent).

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

Docetaxel Glenmark 20 mg/1 ml concentrate for infusion solution 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 must be used immediately after opening. If not used immediately, the periods of time and conditions of use 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, to administer a dose of 140 mg of docetaxel, 7 ml of docetaxel concentrate for infusion solution would be required.
• Extract the required amount of docetaxel concentrate for infusion solution in an aseptic manner 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 all at once (with a single injection) into a 250 ml infusion bag or bottle, which contains either a 5% glucose solution or a 0.9% sodium chloride solution for infusion. If a dose greater than 190 mg of docetaxel is required, use a larger volume of infusion solution to avoid exceeding the concentration of 0.74 mg/ml of docetaxel.

• Mix the infusion bag or bottle manually by rotating it.
• From a microbiological point of view, it should be reconstituted/diluted in controlled aseptic conditions and the medicinal product should be used immediately. If not used immediately, the periods and conditions of use 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 time of intravenous administration).

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

The infusion solution of docetaxel is supersaturated and may 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 with precipitate should be discarded.

Elimination

The unused medicinal product and all materials that have come into contact with it should be disposed of in accordance with local regulations. Do not dispose of the medicinal product through the sewage system. Ask your pharmacist where to dispose of the medicinal product that is no longer needed. This will help protect the environment.