Leaflet: information for the user

Docetaxel Aurovit 20 mg/ml concentrate for infusion EFG

Read this 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, consult your doctor, pharmacist or nurse.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to use Docetaxel Aurovit

3.How to use Docetaxel Aurovit

4.Possible side effects

5.Storage of Docetaxel Aurovit

6.Contents of the pack and additional information

The name of this medication is Docetaxel Aurovit. Its common name is docetaxel. Docetaxel is a substance derived from the needles (leaves) of the yew tree.

Docetaxel belongs to the group of cancer-fighting medications 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, stomach cancer, or head and neck cancer:

•For the treatment of advanced breast cancer, docetaxel may be administered either alone or in combination with doxorubicina, trastuzumab, or capecitabina.

•For the treatment of early breast cancer with or without lymph node involvement, docetaxel may be administered in combination with doxorubicina and ciclofosfamida.

•For the treatment of lung cancer, docetaxel may be administered either alone or in combination with cisplatino.

•For the treatment of prostate cancer, docetaxel is administered in combination with prednisona or prednisolona.

•For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatino and 5‑fluorouracilo.

•For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatino and 5‑fluorouracilo.

You should not be given Docetaxel Aurovit

•if you are allergic (hypersensitive) to docetaxel or to any of the other components of this medication (listed in section6).

•if your white blood cell count is too low.

•if you have severe liver disease.

Warnings and precautions

Before each treatment with docetaxel, a blood test will be performed to check that you have a sufficient number of blood cells and sufficient liver function to receive docetaxel. If there are abnormalities in your white blood cells, you may experience fever or associated infections.

Inform your doctor, pharmacist, or nurse immediately if you experience abdominal pain or tenderness, diarrhea, rectal bleeding, bloody stools, or fever. These symptoms may 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 experience vision problems. In the case of vision problems, particularly blurred vision, an immediate eye and vision examination must be performed.

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 or worsening lung problems (fever, difficulty breathing, cough), inform your doctor, pharmacist, or nurse immediately. Your doctor may interrupt your treatment immediately.

Your doctor will recommend taking premedication, consisting of an oral corticosteroid such as dexamethasone, one day before docetaxel administration and continuing for 1 or 2 days afterwards to minimize some 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 count.

Severe skin problems such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized pustular psoriasis (AGPP) 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 experience symptoms similar to the flu at the same time, such as fever, chills, or muscle pain.

•AGPP symptoms may include a red, scaly, and generalized rash with inflamed skin bumps (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 Aurovit contains alcohol. Consult your doctor if you are dependent on alcohol, have epilepsy, or liver disorders. See also the section “Docetaxel Aurovit contains ethanol (alcohol)” below.

Other medications and Docetaxel Aurovit

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. The reason is that docetaxel or the other medication may not work as expected and you may be more likely to experience an adverse effect.

The alcohol content of this medication may alter the effects of other medications.

Pregnancy, breastfeeding, and fertility

Consult your doctor before any medication is administered.

DocetaxelSHOULD NOTbe administered if you are pregnant, unless clearly indicated by your doctor.

You should not become pregnant while receiving this medication and should 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 should not be used during breastfeeding.

If you are a man receiving docetaxel, it is recommended that you do not father a child during treatment and for 6 months after treatment, and that you inform your doctor about sperm conservation before treatment, as docetaxel may affect male fertility.

Driving and operating machinery

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

You may experience adverse effects from this medication that may alter your ability to drive, use tools, or operate machinery (see section 4 Possible adverse 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)

1 ml vial:

This medication contains 50% by volume of 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 medication contains 50% by volume of 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 medication contains 50% by volume of 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 medication is harmful to people with alcoholism.

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

The alcohol content of this medication may have effects on the central nervous system (part of the nervous system that includes the brain and spinal cord).

Docetaxel will be administered by a healthcare professional.

Usual Dose

The dose will depend on your weight and overall 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 through a vein (intravenous route) via infusion. The infusion will last approximately 1 hour during which time you will be in the hospital.

Administration Frequency

You will receive the treatment, via intravenous infusion, once every 3 weeks.

Your doctor may change the dose and frequency of administration based on your blood test results, overall condition, and response to docetaxel. In particular, inform your doctor if you experience diarrhea, mouth sores, numbness or tingling, fever, and provide your blood test results. This information will allow your doctor to decide if a dose reduction is necessary.

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

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

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

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

The severity of docetaxel side effects may increase when given in combination with other chemotherapy agents.

During hospital infusion, 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 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 side effects, report them immediately.

Between docetaxel infusions, the following may occur and their frequency may vary depending on the combination of medications you receive:

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

•infections, a decrease in red or white blood cells (important for fighting infections) 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.

•alteration of taste.

•inflammation of the eye or excessive tearing.

•swelling caused by defective lymphatic drainage.

•shortness of breath.

•excessive nasal secretion; inflammation of the throat and nose; cough.

•nasal bleeding.

•mouth sores.

•stomach discomfort including nausea, vomiting, and diarrhea, constipation.

•abdominal pain.

•indigestion.

•hair loss: in most cases, your hair will grow back normally.In some cases (unknown frequency), 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 in arms, face, or body).

•change in nail color, which may fall off.

•muscle pain, back pain, or bone pain.

•changes or absence of menstrual period.

•swelling of hands, feet, legs.

•fatigue; or catarrah symptoms.

•weight gain or loss.

•upper respiratory tract infection.

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

•oral candidiasis.

•dehydration.

•dizziness.

•hearing loss.

•decreased blood pressure, irregular or rapid heartbeats.

•heart failure.

•esophagitis.

•dry mouth.

•difficulty or pain swallowing.

•bleeding.

•elevation of liver enzymes (hence the need for regular blood tests).

•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):

•syncope.

•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 (unknown frequency); intestinal perforation.

Unknown frequency(cannot be estimated from available data):

•pulmonary interstitial disease (inflammation of the lungs that produces cough and difficulty breathing. Lung inflammation may also occur when docetaxel treatment is used with radiation therapy).

•pneumonia (lung infection).

•fibrosis of the lungs (scarring and thickening of the lungs with difficulty breathing).

•blurred vision due to inflammation of the retina inside the eye (cystoid macular edema).

•decrease in sodium and/or magnesium in the blood (electrolyte imbalance).

•ventricular arrhythmia or ventricular tachycardia (manifesting as irregular or rapid heartbeats, severe shortness of breath, dizziness, 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 lymphoma (a cancer that affects the immune system) and other types of cancer may occur in patients receiving docetaxel treatment in combination with other anticancer treatments.

•Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET) (blisters, peeling, or bleeding in 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.

•generalized acute pustular psoriasis (PEGA) (red, scaly, and widespread rash with inflamed skin bumps (including skin folds, trunk, and upper limbs) and blisters accompanied by fever).

•tumor lysis syndrome, a serious condition that manifests by changes in blood tests, such as increased levels of uric acid, potassium, phosphate, and decreased levels of calcium; and results in symptoms such as seizures, kidney failure (reduced or dark urine), and heart rhythm disturbances. If this happens, inform your doctor immediately.

•myositis (inflammation of the muscles -heat, redness, and swelling- that produces muscle pain and weakness).

Reporting side effects

If you experience any type of side effect, consult your doctor or hospital pharmacistor nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly towww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton and on the vial label after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect it from light.

Do not freeze.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Docetaxel Aurovit

-The active ingredient is docetaxel. Each milliliter of concentrate for infusion solution contains 20 mg of docetaxel.

-The other components are: polisorbate 80, anhydrous ethanol (see section 2) and citric acid.

Aspect of the product and contents of the package

Docetaxel Aurovit concentrate for infusion solution is a transparent yellow to yellow-brown oily solution.

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

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

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

Only some package 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 Member States of the European Economic Area with the following names:

Germany:Docetaxel AqVida 20 mg/ml Concentrate for the Preparation of an Infusion Solution

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

Greece:Taxovina 20 mg/mlΠυκν?δι?λυμαγια?γχυση

Last review date of this leaflet: July 2021

This information is intended solely for healthcare professionals:

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

It is essential to read 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. Gloves should be used.

If contact with the skin of the docetaxel concentrate or infusion solution occurs, wash immediately and thoroughly with water and soap. If the docetaxel concentrate or infusion solution enters contact with mucous membranes, wash immediately and thoroughly with plenty of water.

Preparation for intravenous administration

Preparation of the infusion solution

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

•Docetaxel Aurovit20 mg/ml concentrate for infusion solution EFG, which contains a single vial of 1 ml (20 mg/1 ml).

•Docetaxel Aurovit20 mg/ml concentrate for infusion solution EFG, which contains a single vial of 4 ml (80 mg/4 ml).

•Docetaxel Aurovit20 mg/ml concentrate for infusion solution EFG, which contains a single vial of 8 ml (160 mg/8 ml).

Docetaxel Aurovit 20 mg/ml concentrate for infusion solution 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 times and conditions of storage before use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C.

It has been demonstrated that the chemical and physical stability in use of the opened vial is for 4 weeks at 2-8°C.

•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 ofdocetaxel concentrate for infusion solution.

•Extract the required amount of concentrate for infusion solution in an aseptic manner 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 once (with a single injection) into a 250 ml infusion bag or bottle, which contains either a 5% glucose solution or a 0.9% sodium chloride solution. If a dose greater than 190 mg of docetaxel is required, use a larger volume of infusion solution to avoid exceeding the concentration of 0.74 mg/ml of docetaxel.

•Mix the infusion bag or bottle manually by rotating it.

•From a microbiological point of view, the reconstitution/dilution should be performed in controlled aseptic conditions, and the medication should be used immediately. If not used immediately, the times and conditions of storage are the responsibility of the userand should not normally exceed 24 hours at 2º-8°C, unless the dilution has been performed in controlled aseptic conditions and validated. It has been demonstrated that the chemical and physical stability in use in polyolefin bags is for 72 hours at 2º-8ºC and for 8 hours at 25°C. Although the contact time is very short, as a precaution, it is recommended to use only sets of tubes and administration that are not PVC.

•The docetaxel infusion solution is supersaturated, and it 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,discardingthe solutionsthat present aprecipitate.

Elimination

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations. Medications should not be disposed of through the drains. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.