DOCETAXEL AUROVIT 20 mg/ml CONCENTRATE FOR SOLUTION AND INFUSION

Introduction

Package Leaflet: Information for the User

Docetaxel Aurovit 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, 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 pack

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

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

The name of this medicine is Docetaxel Aurovit. 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 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 Aurovit

Docetaxel Aurovit 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 associated infections.

Inform your doctor, pharmacist, or nurse immediately if you have abdominal pain or sensitivity, diarrhea, rectal bleeding, blood in your 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, particularly allergic reactions and fluid retention (swelling of the 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), 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 your lips, eyes, mouth, nose, genitals, hands, or feet) with or without a 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, pharmacist, or nurse before starting treatment with docetaxel if you have kidney problems or high levels of uric acid in your blood.

Docetaxel Aurovit contains alcohol. Consult your doctor if you have a history of alcohol dependence, epilepsy, or liver disorders. See also the section below "Docetaxel Aurovit contains ethanol (alcohol)".

Other medicines and Docetaxel Aurovit

Inform 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 you may have a greater chance of experiencing 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 administered 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 contraceptive method during therapy, as docetaxel may harm 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 are advised not to father a child during treatment and for up to 6 months after, as well as to seek advice on sperm conservation 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 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 machinery before consulting your doctor, nurse, or pharmacist.

Docetaxel Aurovit contains ethanol (alcohol)

Vial of 1 ml:

This medicine contains 50% v/v ethanol (alcohol), which corresponds to 395 mg (0.5 ml) per vial, equivalent to 10 ml of beer or 4 ml of wine per vial.

Vial of 4 ml:

This medicine contains 50% v/v ethanol (alcohol), which corresponds to 1,580 mg (2 ml) per vial, equivalent to 40 ml of beer or 16 ml of wine per vial.

Vial of 8 ml:

This medicine contains 50% v/v ethanol (alcohol), which corresponds to 3,160 mg (4 ml) per vial, equivalent to 80 ml of beer or 33 ml of wine per vial.

This medicine is harmful to individuals with alcohol dependence.

The alcohol content should 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 Aurovit

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 (intravenously). The infusion will last approximately 1 hour, during which you will be in the hospital.

Frequency of administration

You will be administered the treatment, by intravenous infusion, once every 3 weeks.

Your doctor may change the dose and frequency of administration depending on your blood tests, general condition, and response to docetaxel. In particular, inform your doctor in case of 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 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 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 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 secretion; 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 in the blood.

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

• fainting.
• skin reactions, phlebitis (inflammation of the vein), or swelling at the infusion site.
• blood clot formation.
• 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 in your blood (electrolyte imbalance disorders).
• 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's lymphoma (a cancer that affects the immune system) and other types of cancer may occur in patients who receive 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 your lips, eyes, mouth, nose, genitals, hands, or feet) with or without a 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 a decrease in calcium levels; and results in symptoms such as seizures, kidney failure (reduced or darkened urine), and cardiac arrhythmias. 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 www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Docetaxel Aurovit

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 shown.

Do not store above 25°C.

Store in the original packaging to protect from light.

Do not freeze.

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 Content and Additional Information

Composition of Docetaxel Aurovit

• The active ingredient is docetaxel. 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 citric acid.

Appearance of the Product and Container Content

Docetaxel Aurovit concentrate for solution for infusion is a clear, oily solution ranging from yellow to yellow-brown.

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

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

AQVIDA GmbH

Kaiser-Wilhelm-Straße 89

20355 Hamburg

Germany

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

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

Spain: Docetaxel Aurovit 20 mg/ml concentrate for solution for infusion EFG

Greece: Taxovina 20 mg/ml Πυκν? δι?λυμα για ?γχυση

Date of the last revision of this leaflet: July 2021

This information is intended only for healthcare professionals:

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

It is essential to read the content 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, 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, it should be washed immediately and thoroughly with water and soap. If the docetaxel concentrate or infusion solution comes into contact with the mucous membranes, it should be rinsed immediately and thoroughly with plenty of water.

Preparation for intravenous administration

Preparation of the infusion solution

DO NOT USE other docetaxel-containing medications in 2 vials (concentrate and solvent) with this medication:

• Docetaxel Aurovit 20 mg/ml concentrate for solution for infusion EFG, which contains a single 1 ml vial (20 mg/1 ml).
• Docetaxel Aurovit 20 mg/ml concentrate for solution for infusion EFG, which contains a single 4 ml vial (80 mg/4 ml).
• Docetaxel Aurovit 20 mg/ml concentrate for solution for infusion EFG, which contains a single 8 ml vial (160 mg/8 ml).

Docetaxel Aurovit 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. From a microbiological point of view, the concentrate should be used immediately after opening. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C.

The chemical and physical stability of the opened vial has been demonstrated for 4 weeks at 2-8°C.

• It may be necessary to use more than 1 vial of concentrate for solution for infusion 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 for infusion.
• Asceptically withdraw the necessary amount of concentrate for solution for infusion using a calibrated syringe with a 21G needle.

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

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

The concentration of docetaxel in the vial of Docetaxel Aurovit 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 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, the reconstitution/dilution should be carried out under aseptic conditions and the medicinal product should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless the dilution has been carried out under controlled and validated aseptic conditions. The chemical and physical stability has been demonstrated in polyolefin bags for 72 hours at 2-8°C and for 8 hours at 25°C. Although the contact time is very short, as a precaution, it is recommended to use only non-PVC tubing and administration sets.
• The docetaxel infusion solution 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 infusion solution should be visually inspected before use and solutions with precipitates should be discarded.

Disposal

The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations. Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.