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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire 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, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Docetaxel Aurovit is and what it is 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 given either alone or in combination with doxorubicin, trastuzumab, or capecitabine.
• For the treatment of early-stage breast cancer with or without lymph node involvement, docetaxel may be given in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, docetaxel may be given either alone or in combination with cisplatin.
• For the treatment of prostate cancer, docetaxel is given in combination with prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, docetaxel is given in combination with cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, docetaxel is given in combination with cisplatin and 5-fluorouracil.

2. What you need to know before using Docetaxel Aurovit

Do not use Docetaxel Aurovit

• 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 docetaxel treatment, you will have a blood test to ensure you have sufficient blood cells and adequate liver function to receive docetaxel. If your white blood cells are abnormal, you may experience fever or associated infections.

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

Inform your doctor, pharmacist, or nurse if you have vision problems. If you experience visual disturbances, particularly blurred vision, an immediate eye and vision examination should be performed.

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

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

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

Your doctor will recommend that you take premedication consisting of an oral corticosteroid such as dexamethasone, starting one day before docetaxel administration and continuing for 1 or 2 days afterwards, to minimize certain adverse 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 medications to maintain your blood cell counts.

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

• Symptoms of SJS/TEN may include blistering, peeling, or bleeding of the skin anywhere (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.
• Symptoms of AGEP may include a widespread red, scaly rash with inflamed bumps under the 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 docetaxel treatment if you have kidney problems or high levels of uric acid in your blood.

Docetaxel Aurovit contains alcohol. Consult your doctor if you have 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 need to take any other medicines, including those obtained without a prescription. This is because docetaxel or the other medicine may not work as expected, and you may be more likely to experience adverse effects.

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

Pregnancy, breastfeeding, and fertility

Consult your doctor before receiving 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 you should use an effective method of contraception during therapy, as docetaxel may harm the unborn baby. If you become pregnant during treatment, you must inform your doctor immediately.

Docetaxel must not be used during breastfeeding.

If you are a man receiving docetaxel treatment, you are advised not to father a child during treatment and for 6 months after treatment, and you should seek information about sperm preservation before starting treatment, as docetaxel may impair male fertility.

Driving and using machines

The alcohol content of this medicine may affect your ability to drive and use machines.

You may experience adverse effects from this medicine that could impair your ability to drive, use tools, or operate machinery (see section 4 Possible adverse effects). If this occurs, do not drive or use any tools or machinery until you have consulted your doctor, nurse, or pharmacist.

Docetaxel Aurovit contains ethanol (alcohol)

1 ml vial:

This medicine contains 50% by volume ethanol (alcohol), corresponding to 395 mg (0.5 ml) per vial, equivalent to 10 ml of beer or 4 ml of wine per vial.

4 ml vial:

This medicine contains 50% by volume ethanol (alcohol), corresponding to 1,580 mg (2 ml) per vial, equivalent to 40 ml of beer or 16 ml of wine per vial.

8 ml vial:

This medicine contains 50% by volume ethanol (alcohol), corresponding 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 for individuals suffering from alcoholism.

The alcohol content should be taken into account in 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 body weight and general condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.

Method and route of administration

Docetaxel will be given as an intravenous infusion into one of your veins. The infusion will last approximately 1 hour, during which time you will remain in the hospital.

Frequency of administration

The treatment will be administered via intravenous infusion once every 3 weeks.

Your doctor may adjust the dose and frequency of administration depending on your blood test results, your general condition, and your response to docetaxel. In particular, inform your doctor if you experience diarrhea, mouth sores, numbness or tingling sensations, fever, and provide the results of your blood tests. This information will help your doctor decide whether a dose reduction is necessary.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

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

The severity of docetaxel's adverse effects may increase when it is administered in combination with other chemotherapeutic agents.

During the infusion at 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.
• Decreased blood pressure.

Other more serious reactions may also occur.

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

Hospital staff will closely monitor your health 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, decreased number of red blood cells (anemia) or white blood cells (which are important for fighting infections), and platelets.
• Fever: if this occurs, you must inform your doctor immediately.
• Allergic reactions as described above.
• Loss of appetite (anorexia).
• Insomnia.
• Numbness, tingling, or pain in joints.
• Headache.
• Altered taste.
• Eye inflammation or excessive tearing.
• Swelling due to defective lymphatic drainage.
• Shortness of breath.
• Runny nose; throat and nasal inflammation; cough.
• Nosebleeds.
• Mouth sores.
• Stomach discomfort including nausea, vomiting, 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 lead to skin peeling (this may also occur in arms, face, or body).
• Changes in nail color, which may fall off.
• Muscle pain, back pain, or bone pain.
• Changes or absence of menstrual periods.
• Swelling of hands, feet, legs.
• Fatigue; or cold-like symptoms.
• Weight gain or weight loss.
• Upper respiratory tract infection.

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

• Oral candidiasis.
• Dehydration.
• Dizziness.
• Hearing impairment.
• Low blood pressure, irregular or rapid heartbeat.
• Heart failure.
• Esophagitis.
• Dry mouth.
• Difficulty or pain when swallowing.
• Bleeding.
• Increased liver enzymes (hence the need for regular blood tests).
• Increased blood sugar levels (diabetes).
• Decreased potassium, calcium, and/or phosphate levels in the blood.

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

• Fainting.
• Skin reactions, phlebitis (vein inflammation), or swelling at the infusion site.
• Blood clot formation.
• In patients treated with docetaxel in combination with other anticancer therapies, 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 or small intestine, which could be fatal (frequency not known); intestinal perforation.

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

• Interstitial lung disease (lung inflammation causing cough and difficulty breathing). Lung inflammation may also occur when docetaxel treatment is used with radiotherapy.
• Pneumonia (lung infection).
• Pulmonary fibrosis (scarring and thickening in the lungs causing difficulty breathing).
• Blurred vision due to retinal inflammation inside the eye (cystoid macular edema).
• Decreased sodium and/or magnesium levels in your blood (electrolyte imbalance).
• Ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting). Some of these symptoms may be serious. If this occurs, inform your doctor immediately.
• Reactions at the injection site, or at the site of a previous reaction.
• Non-Hodgkin's lymphoma (a cancer affecting the immune system) and other types of cancer may occur in patients receiving 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 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) (widespread red, scaly 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 characterized by changes in blood tests such as increased levels of uric acid, potassium, and phosphate, and decreased calcium levels; leading to symptoms such as seizures, kidney failure (reduced or darkened urine), and heart rhythm disturbances. If this occurs, you must inform your doctor immediately.
• Myositis (muscle inflammation—characterized by warmth, redness, and swelling—leading to muscle pain and weakness).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, hospital pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via www.notificaram.es. By reporting adverse 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 stated on the outer packaging and on the label of the vial after EXP. The expiry date refers to the last day of the month indicated.

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 any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Docetaxel Aurovit

• The active substance 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 contents of the container

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

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

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

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

Only certain 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

Tel.: 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 European Economic Area (EEA) member states under the following names:

Germany: Docetaxel AqVida 20 mg/ml concentrate for solution for infusion

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

Greece: Taxovina 20 mg/ml Πυκνό διάλυμα για έγχυση

Date of the most recent review of this leaflet: July 2021

This information is intended for healthcare professionals only:

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

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

Safe handling recommendations

Docetaxel is an antineoplastic agent, and as with all 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, wash immediately and thoroughly with soap and water. If the concentrate or infusion solution contacts mucous membranes, rinse immediately and thoroughly with copious amounts of water.

Preparation for intravenous administration

Preparation of the infusion solution

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

• Docetaxel Aurovit 20 mg/ml concentrate for solution for infusion EFG, containing a single 1 ml vial (20 mg/1 ml).

• Docetaxel Aurovit 20 mg/ml concentrate for solution for infusion EFG, containing a single 4 ml vial (80 mg/4 ml).

• Docetaxel Aurovit 20 mg/ml concentrate for solution for infusion EFG, containing 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 directly to the infusion solution.

• Each vial is for single use only. From a microbiological standpoint, the concentrate should be used immediately after opening. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C.

Chemical and physical in-use stability of the opened vial has been demonstrated for 4 weeks at 2–8°C.

• More than one vial of concentrate for solution for infusion may be required to achieve the patient's required dose. For example, a 140 mg dose of docetaxel would require 7 ml of docetaxel concentrate for solution for infusion.
• Aseptically withdraw the required amount of concentrate for solution for infusion using a calibrated syringe with a 21G needle.

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

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

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

• Then, inject the concentrate in a single injection into a 250 ml infusion bag or bottle containing either 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution. If a docetaxel dose exceeding 190 mg is required, use a larger volume of infusion fluid to ensure that the docetaxel concentration does not exceed 0.74 mg/ml.
• Mix the infusion bag or bottle manually by gentle rotation.
• From a microbiological perspective, reconstitution/dilution must be performed under controlled aseptic conditions, and the product should be used immediately. If not used immediately, storage times and conditions are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless dilution has been carried out under validated controlled aseptic conditions. Chemical and physical in-use stability has been demonstrated in polyolefin bags for 72 hours at 2–8°C and for 8 hours at 25°C. Although contact time is very short, as a precaution, only administration sets and tubing that are not made of PVC are recommended.
• The docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals appear, the solution must not be used and should be discarded.
• As with all parenteral products, the infusion solution should be inspected visually before use, and any solution showing precipitation should be discarded.

Disposal

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