Docetaxel Aurovitas 20 mg/ml concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Docetaxel Aurovitas 20 mg/ml concentrate for solution for infusion

Read the entire leaflet carefully before you start using this medicine, as 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, hospital pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor, hospital pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

The name of this medicine is Docetaxel Aurovitas. 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, 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 alone or in combination with doxorubicin, or 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 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 Aurovitas

Do not use Docetaxel Aurovitas

• 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, blood tests must be performed to ensure you have enough blood cells and that your liver is functioning adequately for docetaxel treatment. If your white blood cells are reduced, you may experience fever or infections.

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

Inform your doctor, hospital pharmacist, or nurse if you experience vision problems. If you have visual disturbances, particularly blurred vision, an immediate eye and vision examination should 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 lung symptoms (fever, difficulty breathing, cough), inform your doctor, pharmacist, or nurse immediately. Your doctor may discontinue your treatment immediately.

You will be required to take an oral corticosteroid such as dexamethasone one day before docetaxel administration and continue for one or two days afterwards, to reduce 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 need to take additional 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 on the body (including lips, eyes, mouth, nose, genitals, hands, or feet), with or without rash. You may also experience 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), blisters, and fever.

If you develop severe skin reactions or any of the reactions listed above, contact your doctor or healthcare professional immediately.

Docetaxel Aurovitas contains alcohol. If you have epilepsy or liver problems, consult your doctor or hospital pharmacist before using this medicine. If you are an alcoholic, consult your doctor or hospital pharmacist before using this medicine. See also the section “Docetaxel Aurovitas contains ethanol (alcohol)” below.

Other medicines and Docetaxel Aurovitas

Inform your doctor or hospital 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 have the intended effect, and you may be more likely to experience adverse effects.

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

Consult your doctor or hospital pharmacist if you are taking other medicines.

Pregnancy, breastfeeding, and fertility

Talk to your doctor before receiving any medication.

Pregnancy

Docetaxel must NOT be administered during pregnancy unless specifically indicated by your doctor.

You must not become pregnant while being treated and for 2 months after completion of treatment with this medicine. You should use an effective method of contraception during treatment and for 2 months after treatment ends, because docetaxel may harm the unborn baby. If you become pregnant during treatment, inform your doctor immediately.

Breastfeeding

You must NOT breastfeed during treatment with docetaxel.

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

Fertility

If you are a man receiving docetaxel treatment, you must not father a child and should use an effective method of contraception during treatment and for 4 months after completing treatment with this medicine. It is recommended that you discuss sperm preservation before starting treatment, as docetaxel may impair male fertility.

Driving and use of 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 side effects). If this occurs, do not drive or operate any tools or machinery before consulting your doctor, nurse, or hospital pharmacist.

Docetaxel Aurovitas contains ethanol (alcohol)

This medicine contains 51% ethanol (alcohol), corresponding to 400 mg per 1 ml vial, equivalent to 10 ml of beer or 4.16 ml of wine.

This medicine contains 51% ethanol (alcohol), corresponding to 1600 mg per 4 ml vial, equivalent to 40 ml of beer or 16.67 ml of wine.

This medicine contains 51% ethanol (alcohol), corresponding to 2800 mg per 7 ml vial, equivalent to 70 ml of beer or 29.17 ml of wine.

This medicine contains 51% ethanol (alcohol), corresponding to 3200 mg per 8 ml vial, equivalent to 80 ml of beer or 33.33 ml of wine.

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 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 Aurovitas

Docetaxel must be administered by a healthcare professional.

Normal dose

The dose depends on your body weight and general health status. 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 by intravenous infusion into a vein. The infusion will last approximately one hour, during which you must remain in the hospital.

Frequency of administration

It is usually administered once every 3 weeks.

Your doctor may adjust the dose and frequency based on the results of your blood tests, your general condition, and your response to docetaxel. Inform your doctor especially if you experience diarrhea, mouth sores, numbness or tingling sensations, fever, or if there are any changes in your blood test results. This information will help determine whether a dose reduction is necessary. If you have any further questions about the use of this medicine, ask your doctor or hospital 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 potential risks and benefits of your treatment.

The most frequently reported adverse effects of docetaxel when given alone are: decreased number of red or white blood cells, alopecia, nausea, vomiting, mouth sores, diarrhea, and fatigue.

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

During the infusion in 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.

Other more severe 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 effects may occur, with frequency varying depending on the combination of medicines you have received:

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 the joints or muscles.
• headache.
• altered taste.
• eye inflammation or increased tearing.
• swelling due to impaired lymphatic drainage.
• shortness of breath.
• runny nose, nasal and throat inflammation, cough.
• nosebleeds.
• mouth sores.
• stomach discomfort, including nausea, vomiting, diarrhea, constipation.
• abdominal pain.
• indigestion.
• hair loss (in most cases, normal hair regrowth occurs). 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 the arms, face, or body).
• changes in nail color, which may lead to nail loss.
• muscle pain, back pain, or bone pain.
• changes or absence of menstrual periods.
• swelling of the hands, feet, or legs.
• fatigue or flu-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; rapid or irregular heartbeat.
• heart failure.
• esophagitis.
• dry mouth.
• difficulty or pain when swallowing.
• bleeding.
• increased liver enzymes (therefore regular blood tests are necessary).
• increased blood sugar levels (diabetes).
• decreased potassium, calcium, and/or phosphate levels in blood.

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

• fainting.
• at the injection site: skin reactions, phlebitis (vein inflammation), 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 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 swelling (Cystoid Macular Edema).
• decreased sodium and/or magnesium levels in 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.
• injection site reactions at the site of a previous reaction.
• non-Hodgkin lymphoma (a cancer affecting the immune system) and other types of cancer may occur in patients receiving docetaxel treatment along with other anticancer treatments.
• Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (blisters, peeling, or bleeding anywhere on the 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) (widespread red, scaly rash with bumps under 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—heat, redness, and swelling—causing muscle pain and weakness).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, hospital pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Docetaxel Aurovitas

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 vial.

Store below 25°C.

Keep in the original packaging to protect from light.

Do not refrigerate or freeze.

After opening the vial:

Each vial is for single use only and should be used immediately after opening. If not used immediately, the storage times and conditions during use are the responsibility of the user.

Once added to the infusion bag:

The diluted solution should be used immediately after preparation. If not used immediately, the storage times and conditions during use are the responsibility of the user and should normally not exceed 3 days if stored between 2 and 8°C protected from light, or 8 hours at room temperature (below 25°C), including the time required for infusion.

Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Docetaxel Aurovitas

• The active substance is docetaxel. Each millilitre of docetaxel solution contains 20 mg of anhydrous docetaxel.
• The other components are anhydrous citric acid, povidone, absolute ethanol and polysorbate 80.

Appearance of the product and contents of the container:

Docetaxel Aurovitas concentrate for solution for infusion is a clear, pale yellow solution.

Docetaxel Aurovitas is supplied in a clear glass vial with a rubber stopper and an aluminium flip-off cap with a polypropylene disc. The vial may be packaged with or without a protective plastic overwrap.

Pack sizes:

1 single-dose vial of 1 ml

1 single-dose vial of 4 ml

1 single-dose vial of 7 ml

1 single-dose vial of 8 ml

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Date of the most recent review of this leaflet: November 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

Docetaxel Aurovitas 20 mg/ml concentrate for solution for infusion

Instructions for use

Docetaxel is an antineoplastic agent, and as with other potentially toxic compounds, precautions should be taken during handling and preparation of docetaxel solutions. Such preparations should only be prepared and handled by appropriately trained personnel experienced in the safe handling of cytotoxic agents. Pregnant female personnel should not handle cytotoxic agents. Local recommendations regarding cytotoxic agents should be consulted prior to beginning work. Use of gloves is recommended. In case of contact with the skin of the concentrate or the solution for infusion of docetaxel, wash immediately and thoroughly with water and soap. In case of contact with mucous membranes of the concentrate or the solution for infusion of docetaxel, wash immediately and thoroughly with water. In case of spillage, trained personnel wearing appropriate personal protective equipment should remove as much material as possible using a cytotoxic drug spill kit or designated absorbent materials. The area should be washed with a large amount of water. All contaminated cleaning materials should be disposed of in accordance with local regulations.

Preparation of the solution for infusion

More than one vial of docetaxel 20 mg/ml concentrate for solution for infusion may be required to obtain the required dose for a given patient. Using graduated syringes with a needle, aseptically withdraw from the necessary number of vials the volume of docetaxel 20 mg/ml corresponding to the required patient dose expressed in mg. For example, a dose of 140 mg of docetaxel would require 7 ml of Docetaxel Aurovitas 20 mg/ml concentrate for solution for infusion.

For doses below 192 mg of docetaxel, inject the required volume of docetaxel 20 mg/ml concentrate for solution for infusion into an infusion bag or bottle containing either 250 ml of glucose 50 mg/ml (5%) solution for infusion or sodium chloride 9 mg/ml (0.9%) solution for infusion. For doses above 192 mg of docetaxel, more than 250 ml of infusion solution is required, as the maximum concentration of docetaxel is 0.74 mg per ml of solution for infusion.

Mix the infusion bag or bottle manually by gentle agitation. The diluted solution should be used within 8 hours and administered aseptically as a 1-hour infusion at room temperature under normal light conditions.

As with all parenteral products, this medicinal product should be inspected visually before use, and solutions showing precipitation should be discarded.

Disposal of unused medicinal product and of all materials that have been in contact with it must be carried out in accordance with local regulations.

Storage after opening

Each vial is for single use only and should be used immediately after opening. If not used immediately, the storage times and conditions during use are the responsibility of the user.

Storage after dilution

From a microbiological standpoint, reconstitution/dilution should be performed under controlled aseptic conditions and the medicinal product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user.

Once added to the infusion bag as recommended, the docetaxel solution for infusion is stable for 8 hours when stored below 25°C in non-PVC bags. It should be used within this 8-hour period (including the one hour of intravenous infusion administration).

In addition, the physical and chemical stability of the solution for infusion, prepared as recommended, has been demonstrated for 3 days when stored between 2°C and 8°C, protected from light.

The docetaxel solution for infusion is supersaturated; therefore, it may crystallize over time. If crystals appear, the solution should not be used and must be discarded.

Disposal

Disposal of unused medicinal product and of all materials that have been in contact with it must be carried out in accordance with local regulations.