DOCETAXEL HIKMA 160 mg/8 mL Concentrate for Infusion Solution

Introduction

Package Leaflet: Information for the Patient

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

Docetaxel Hikma 80 mg/4 ml Concentrate for Solution for Infusion EFG

Docetaxel Hikma 160 mg/8 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 they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

The name of this medicine is Docetaxel Hikma. 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 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 either 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 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.

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

Docetaxel Hikma should not be administered to you

• 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

.

Before each treatment with docetaxel, you will have a blood test to check that you have a sufficient number of blood cells and sufficient liver function to receive docetaxel. In case of alterations in white blood cells, you may suffer from fever or infections.

Inform your doctor, pharmacist, or nurse immediately if you have 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, 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, pharmacist, or nurse if you have previously experienced allergic reactions to previous treatments with paclitaxel.

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

If you develop acute problems or worsening in the lungs (fever, difficulty breathing, cough), inform your doctor, pharmacist, or nurse immediately. Your doctor may interrupt your treatment immediately.

Your doctor will recommend that you take premedication, consisting of an oral corticosteroid such as dexamethasone, one day before the administration of docetaxel and that you continue for 1 or 2 days after to minimize some side effects that may occur after the infusion of docetaxel, in particular allergic reactions and fluid retention (swelling of the hands, feet, legs, or weight gain).

During treatment, you may receive other medicines to maintain the number of your blood cells.

Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and 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-mentioned reactions, contact your doctor or healthcare professional immediately.

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

Docetaxel Hikma contains alcohol. Consult your doctor if you suffer from alcohol dependence, epilepsy, or liver disorders. See also the section below "Docetaxel Hikma contains ethanol (alcohol)".

Other medicines and Docetaxel Hikma

Inform your doctor or pharmacist if you are using, have recently used, or might use 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 you may have more chances of suffering a side effect.

The alcohol content of this medicine may alter the effects of other medicines.

Pregnancy, breastfeeding, and fertility

Consult your doctor before you are given any medicine.

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

You must not become pregnant during treatment with this medicine and for 2 months after the end of treatment. You must use an effective contraceptive method during therapy and for 2 months after the end of treatment, as docetaxel may be harmful to the fetus. If you become pregnant during treatment, you must inform your doctor immediately.

Docetaxel must not be used during breastfeeding.

If you are a man being treated with docetaxel, you must not father a child and must use an effective contraceptive method during treatment and for at least 4 months after treatment with this medicine. It is recommended that you seek advice on sperm preservation 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 of this medicine that could alter 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 machinery before consulting your doctor, nurse, or pharmacist.

Docetaxel Hikma contains ethanol (alcohol)

This medicine contains 50% v/v ethanol (alcohol), i.e.:

20 mg/1 ml: 395 mg (0.5 ml) per vial, which is equivalent to 10 ml of beer or 4 ml of wine.

80 mg/4 ml: 1,580 mg (2 ml) per vial, which is equivalent to 40 ml of beer or 17 ml of wine.

160 mg/8 ml: 3,160 mg (4 ml) per vial, which is equivalent to 80 ml of beer or 33 ml of wine.

This medicine is harmful to individuals with alcohol dependence.

The alcohol content must be taken into account in the case of pregnant or breastfeeding women, children, and high-risk populations, such as patients with liver disease or epilepsy.

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 Hikma

Docetaxel will be administered to you by a healthcare professional.

Usual 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.

Form and route of administration

Docetaxel will be administered by infusion into one of your veins (intravenous route). The infusion will last approximately 1 hour, during which you will be in the hospital.

Frequency of administration

You will be given the treatment by infusion once every 3 weeks.

Your doctor may change the dose and frequency of administration depending on your blood tests, your general condition, and your response to docetaxel. In particular, inform your doctor in case of diarrhea, mouth sores, numbness or tingling, fever, and provide your blood test results. 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 pharmacist.

4. Possible side effects

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

Your doctor will discuss these with you and explain the possible risks and benefits of your treatment.

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

The severity of the side effects of docetaxel may increase when administered in combination with other chemotherapeutic agents.

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

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

More severe 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 condition 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 people):

• 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.
• headache.
• altered taste.
• eye inflammation or excessive tearing.
• swelling caused by defective lymphatic drainage.
• shortness of breath.
• nasal discharge; inflammation of the throat and nose; 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 the arms, face, or body).
• change in nail color, which may detach.
• 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 people):

• oral candidiasis.
• dehydration.
• dizziness.
• impaired hearing.
• decreased 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).
• increased blood sugar levels (diabetes).
• decrease in potassium, calcium, and/or phosphate levels in the blood.

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

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

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

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

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

• interstitial lung disease (inflammation of the lungs that causes 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 levels 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 disorders. 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 they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Docetaxel Hikma

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

Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after "EXP". The expiry date is the last day of the month stated.

Do not store above 25°C.

Store in the original packaging to protect from 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 point of view, it must be reconstituted/diluted under controlled aseptic conditions.

The medicine must be used 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 should not exceed 8 hours at a temperature below 25°C, including the infusion time.

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

The docetaxel infusion solution is supersaturated, and therefore may crystallize over time. If crystals appear, the solution must 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. Container Contents and Additional Information

Composition of Docetaxel Hikma

• The active ingredient is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg of docetaxel.
• The other components (excipients) are: polysorbate 80, anhydrous ethanol, and citric acid.

Appearance of the Product and Container Contents

Docetaxel Hikma concentrate for solution for infusion is a pale yellow to yellow-brown solution.

The concentrate is presented in a 6 ml transparent glass vial (type I) closed with a 20 mm teflon-coated chlorobutyl stopper with a 20 mm aluminum flip-off cap.

The concentrate is presented in a 10 ml transparent glass vial (type I) closed with a 20 mm teflon-coated chlorobutyl stopper with a 20 mm aluminum flip-off cap.

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

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

Each box contains an 8 ml vial of concentrate (160 mg of docetaxel).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó nº 8, 8A e 8B – Fervença

2705-906 Terrugem SNT,

Portugal

Tel.: +351 21 960 84 10

e-mail: portugalgeral@hikma.com

Manufacturer

Thymoorgan Pharmazie GmbH

Schiffgraben 23

38690 Goslar

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:Docetaxel Hikma 20 mg/ 1 ml Konzentrat zur Herstellung einer Infusionslösung

Docetaxel Hikma 80 mg/ 4 ml Konzentrat zur Herstellung einer Infusionslösung

Docetaxel Hikma 160 mg/ 8 ml Konzentrat zur Herstellung einer Infusionslösung

Austria:Docetaxel Hikma 20 mg/ ml (20 mg/ 1 ml; 80 mg/4 ml and 160 mg/8 ml) konzentrat zur Herstellung einer Infusionslösung

Belgium:Docetaxel 20mg/ml Konzentrat zur Herstellung einer Infusionslösung /concentraat voor oplossing voor infusie/ solution à diluer pour perfusion

Spain:Docetaxel Hikma 20 mg/1 ml concentrado para solución para perfusión EFG

Docetaxel Hikma 80 mg/4 ml concentrado para solución para perfusión EFG

Docetaxel Hikma 160 mg/8 ml concentrado para solución para perfusión EFG

France:Docetaxel Hikma 20 mg/ ml (20 mg/ 1 ml; 80 mg/4 ml and 160 mg/8 ml) Solution à diluer pour perfusion

Italy:Docetaxel Hikma

Portugal: Docetaxel Hikma

Date of the last revision of this leaflet: March 2025

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/)

This information is intended only for healthcare professionals:

PREPARATION GUIDE FOR THE USE OF DOCETAXEL HIKMA 20 MG/1ML, DOCETAXEL HIKMA 80 MG/4 ML AND DOCETAXEL HIKMA 160 MG/ 8ML CONCENTRATE FOR SOLUTION FOR INFUSION

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

Recommendations for safe handling

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

If there is contact with the skin of the docetaxel concentrate or infusion solution, it should be washed immediately and thoroughly with water and soap. If this medicine comes into contact with the mucous membranes, wash immediately and thoroughly with plenty of water.

Preparation for intravenous administration

Preparation of the infusion solution

DO NOT USE other medicines containing docetaxel in 2 vials (concentrate and solvent) with this medicine (Docetaxel Hikma 20 mg/1 ml concentrate for solution for infusion EFG, Docetaxel Hikma 80 mg/ 4 ml concentrate for solution for infusion EFG, Docetaxel Hikma 160 mg/ 8 ml concentrate for solution for infusion EFG; contains a single 1 ml vial.

Docetaxel Hikma 20 mg/1 ml concentrate for solution for infusion EFG, Docetaxel Hikma 80 mg/ 4 ml concentrate for solution for infusion EFG, Docetaxel Hikma 160 mg/ 8 ml concentrate for solution for infusion EFG, 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 storage times and conditions before 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, a dose of 140 mg of docetaxel would require 7 ml of docetaxel concentrate for infusion solution.

• Extract aseptically the necessary amount of concentrate for infusion solution using a calibrated syringe with a 21G needle.

The concentration of docetaxel in the vial of Docetaxel Hikma 20 mg/1 ml, 80 mg/4 ml, 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 infusion solution or a 9 mg/ml (0.9%) sodium chloride solution. If a dose greater than 190 mg of docetaxel is required, use a larger volume of infusion liquid to avoid exceeding the concentration of 0.74 mg/ml of docetaxel.

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

Once added as recommended to the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 8 hours. It should be used within 8 hours (including a 1-hour infusion administration).

In addition, the physical and chemical stability of the prepared infusion solution 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, so it may crystallize over time. If crystals appear, the solution should not be used and should be discarded.

• Like all parenteral products, the infusion solution should be visually inspected before use, discarding solutions that present a precipitate.

Disposal

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations. Medicines should not be disposed of via wastewater.

Waste material must be destroyed according to standard hospital procedures applicable to cytotoxic agents, taking into account the laws in force related to the disposal of hazardous waste.

Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.