DOCETAXEL TILLOMED 20 mg/mL concentrate for infusion solution

Introduction

Package Leaflet: Information for the User

Docetaxel Tillomed 20 mg/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, hospital pharmacist or nurse.
• If you get any side effects, talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The name of this medicine is Docetaxel Tillomed. Its common name is docetaxel. Docetaxel is a substance derived from the needles 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, special forms 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 can 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 can be administered in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, docetaxel can 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 Tillomed

Docetaxel Tillomed should not be administered to you

• if you are allergic 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, blood tests will be carried out to check that you have enough blood cells and that your liver is working sufficiently to be treated with docetaxel. In case of alteration 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, blood in stools or fever. These symptoms could be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor should 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 and vision examination should be carried out immediately.

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

Inform your doctor, hospital 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.

You will be asked to take an oral corticosteroid such as dexamethasone, one day before the administration of docetaxel and will continue for one or two days after, in order to reduce certain side effects that may occur after the infusion of docetaxel, especially allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).

During treatment, you may need to take other medicines to maintain your blood cell count.

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

• SSJ/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 reactions mentioned above, contact your doctor or healthcare professional immediately.

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

Docetaxel Tillomed contains alcohol. Talk to your doctor if you suffer from alcohol dependence, epilepsy or liver failure. See also the section "Docetaxel Tillomed contains ethanol (alcohol)" below.

Other medicines and docetaxel tillomed

Inform your doctor or hospital 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 have the expected effect and that you may have more chances of suffering a side effect.

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

This medicine contains alcohol (50.00% v/v ethanol); each milliliter of Docetaxel 20 mg/ml includes 0.395 g of alcohol.

Docetaxel 20 mg/mL fill volume (1 mL, 4 mL and 8 mL) contains:

• Vial of 1 ml contains 0.395 g of alcohol, equivalent to 10 ml of beer or 4 ml of wine.
• Vial of 4 ml contains 1.58 g of alcohol, equivalent to 40 ml of beer or 16 ml of wine.
• Vial of 8 ml contains 3.16 g of alcohol, equivalent to 80 ml of beer or 32 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have an effect on adults and adolescents, and it is likely that its effects in children will not be noticeable. It may have some effects in smaller children, for example, drowsiness.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

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

Pregnancy, breastfeeding and fertility

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

Consult your doctor before you are given any medicine.

Docetaxel SHOULD NOT be administered during pregnancy unless it is specifically indicated by your doctor.

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

You should not breastfeed while being treated with docetaxel.

If you are a man being treated with docetaxel, you should not father a child and should use an effective contraceptive method during treatment and for 4 months after the end of treatment with this medicine. It is recommended to consult about sperm preservation before treatment because 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 side effects of this medicine that may affect your ability to drive, use tools or operate machinery (see section 4). If this happens, do not drive or use any tools or machinery before consulting your doctor, nurse or hospital pharmacist.

Docetaxel tillomed contains ethanol (anhydrous alcohol)

This medicine contains approximately 50% by volume of anhydrous ethanol (alcohol), i.e.,

• up to 395 mg of anhydrous ethanol per 1 ml vial, equivalent to 10 ml of beer or 4 ml of wine.
• up to 1.58 g of anhydrous ethanol per 5 ml vial, equivalent to 40 ml of beer or 17 ml of wine.
• up to 3.16 g of anhydrous ethanol per 10 ml vial, equivalent to 80 ml of beer or 33 ml of wine.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.

The alcohol content in 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 Tillomed

Docetaxel should be administered by a healthcare professional.

Usual dose

The dose depends 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 a vein (intravenously). The infusion will last approximately one hour, during which you will need to stay in the hospital.

Frequency of administration

Normally, an infusion is administered every 3 weeks.

Your doctor may change the dose and frequency of dosing based on the results of your blood tests, your overall health and your response to docetaxel.

Inform your doctor especially in case of diarrhea, mouth sores, numbness or tingling, fever and the results of your blood tests. This information will allow your doctor to decide when 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.

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

The most frequently reported side effects of docetaxel 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 be increased when docetaxel is 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 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 status during treatment. If you notice any of these effects, inform them immediately.

Between infusions of docetaxel, the following effects may occur, and the frequency may vary depending on the combinations of medicines you have received:

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

• infections, decrease in the number of red or white blood cells and platelets.
• fever: in case it appears, you should 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 eyes or increased tearing of the eyes.
• swelling due to lack of lymphatic drainage.
• shortness of breath.
• runny nose, inflammation of the nose and throat, cough.
• nosebleeds.
• mouth sores.
• discomfort in the stomach, including nausea, vomiting and diarrhea, constipation.
• abdominal pain.
• indigestion.
• hair loss: in most cases, normal hair growth returns. 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 can cause skin peeling (this can also occur on the arms, face or body).
• change in nail color, which can lead to nail detachment.
• muscle pain, back pain or bone pain.
• change or absence of menstrual period.
• swelling of the hands, feet, legs.
• fatigue, or flu-like symptoms.
• weight gain or loss.
• upper respiratory tract infection.

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

• oral candidiasis.
• dehydration.
• dizziness.
• hearing impairment.
• decrease in blood pressure; rapid or irregular heartbeat.
• heart failure.
• esophagitis.
• dry mouth.
• difficulty or pain when swallowing.
• bleeding.
• increase in liver enzymes (for which regular blood tests are necessary).
• increase in blood sugar levels (diabetes).
• decrease in potassium, calcium and/or phosphate 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.
• blood clots.
• 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 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 produces cough and difficulty breathing. Lung inflammation can 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 retinal swelling (Cystoid Macular Edema).
• decrease in sodium and/or magnesium and/or calcium in the blood (electrolyte imbalance disorders).
• ventricular arrhythmia or ventricular tachycardia (which manifests as irregular and/or rapid heartbeats, severe shortness of breath and/or fainting). Some of these symptoms can be serious. 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 who receive treatment with docetaxel along with other anticancer treatments.
• Stevens-Johnson syndrome (SSJ) 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 should 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 side effects, talk to your doctor, hospital pharmacist or nurse, even if it is possible side effects 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 Tillomed

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

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

Do not store above 25°C.

Store in the original package 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.

Chemical and physical stability in use has been demonstrated for 6 hours below 25°C, as well as for 48 hours between 2°C and 8°C in non-PVC infusion bags and glass bottles.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2°C to 8°C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

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

Do not throw any medicine into the sewage system. Ask your pharmacist how to dispose of medicines that are no longer used. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Docetaxel Tillomed

• 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 citric acid monohydrate.

Appearance and Package Contents of the Product:

Docetaxel Tillomed concentrate for solution for infusion is a clear, colorless, or pale yellow to yellowish-brown solution.

The concentrate is supplied in

• a 2 ml transparent glass vial (type I) with a dark grey rubber stopper and an aluminium flip-off cap.
• a 5 ml transparent glass vial (type I) with a dark grey rubber stopper and an aluminium flip-off cap.
• a 10 ml transparent glass vial (type I) with a dark grey rubber stopper and an aluminium flip-off cap.

The vials may or may not be coated with a thermoretractable plastic sleeve/shrink band. This plastic sleeve is not in contact with the medicine and is there to provide additional protection during transport. This improves the safe handling of the medicine by both healthcare professionals and pharmacy staff.

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

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Tillomed Spain, S.L.U

C/ Cardenal Marcelo Spínola, 8

28016 Madrid

Spain

Manufacturer

MIAS Pharma Limited

Suite 1, Stafford House,

Strand Road Portmarnock,

Co. Dublin,

Ireland

This medicine is authorised in the Member States of the EEA and the UK with the following names:

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

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

France: Docetaxel Tillomed 20 mg/ml, solution à diluer pour perfusion

Italy: Docetaxel Tillomed

Netherlands: Docetaxel Tillomed 20 mg/ml concentraat voor oplossing voor infusie

Date of the last revision of this leaflet:

12/2024

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 USE OF DOCETAXEL TILLOMED 20 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION EFG

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

Recommendations for safe handling

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

If the docetaxel concentrate or infusion solution comes into contact with the skin, wash immediately and thoroughly with water and soap. If it comes into contact with the mucous membranes, rinse immediately and abundantly with water.

Preparation for intravenous administration

Preparation of the infusion solution

DO NOT use other docetaxel medicines that consist of 2 vials (concentrate and solvent) with this medicine (Docetaxel Tillomed 20 mg/ml concentrate for solution for infusion EFG, which contains only 1 vial).

Docetaxel Tillomed 20 mg/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 should be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for infusion solution may be necessary 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 solution.
• Asceptically extract the required amount of concentrate for infusion solution with a calibrated syringe equipped with a 21G needle.

In Docetaxel Tillomed, the concentration of docetaxel is 20 mg/ml.

• Then, inject through a single injection (one take) into a 250 ml bag or bottle of infusion containing 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 the infusion vehicle so that the concentration of 0.74 mg/ml of docetaxel is not exceeded.
• Manually mix the infusion bag or bottle with a rocking motion.
• From a microbiological point of view, the reconstitution/dilution should be carried out under controlled and aseptic conditions, and the infusion solution should be used immediately. If not used immediately, the in-use 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 6 hours. It should be used within 6 hours (including 1 hour of intravenous infusion administration).

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

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

• As with all parenteral products, the infusion solution should be inspected visually before use; solutions that contain a precipitate should be discarded.

Elimination

All materials used for dilution and administration should be discarded according to standard procedures. Do not throw any medicine into the sewage system. Ask your pharmacist how to dispose of medicines that are no longer used. These measures will help protect the environment.