Prospecto: Information for the User

Docetaxel Aurovitas 20 mg/ml Concentrate for Solution for Infusion

Read this prospectus carefully before starting to use this medicine, as it contains important information for you.

-Keep this prospectus, 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 effects, consult your doctor, hospital pharmacist or nurse, even if they are not listed in this prospectus. See section 4.

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

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

3.How to use Docetaxel Aurovitas

4.Possible adverse effects

5.Storage of Docetaxel Aurovitas

6.Contents of the package and additional information

The name of this medication is Docetaxel Aurovitas. Its common name is docetaxel. Docetaxel is a substance derived from the needles of the yew tree.

Docetaxel belongs to the group of cancer 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 alone or in combination with doxorubicin, or trastuzumab, or capecitabina.

-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 stomach 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.

You should not be administered Docetaxel Aurovitas

-if you are allergic (hypersensitive) to docetaxel or to any of the other components of this medication (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 should be performed to ensure that you have sufficient blood cells and that your liver functions sufficiently to be treated with docetaxel. If there is an alteration in your 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 your 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, hospital pharmacist or nurse if you have vision problems. In case of vision problems, 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 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 continue for one or two days afterwards, in order to reduce certain adverse 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 medications to maintain your blood cell count.

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

-The symptoms of SSJ/TEN 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 symptoms similar to the flu at the same time, such as fever, chills or muscle pain.

-The symptoms of AGPP may include a red, scaly and widespread rash with inflamed skin lumps (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.

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

Other medications and Docetaxel Aurovitas

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

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

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

Pregnancy, breastfeeding and fertility

Consult with your doctor before any medication is administered.

Pregnancy

DocetaxelSHOULD NOTbe administered during pregnancy unless specifically indicated by your doctor.

You should not become pregnant while being treated and for 2 months after completing treatment with this medication. You should use an effective contraceptive method during treatment and for 2 months after completing treatment due to the fact that docetaxel may be harmful to the fetus. If you become pregnant during treatment, inform your doctor immediately.

Breastfeeding

DO NOTbreastfeed during treatment with docetaxel.

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

Fertility

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 completing treatment with this medication. It is recommended that you inform about sperm conservation before starting your treatment, as docetaxel may alter male fertility.

Driving and operating machinery

The alcohol content of this medication may alter your ability to drive and use machines. You may experience adverse effects of 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 with your doctor, nurse or hospital pharmacist.

Docetaxel Aurovitas contains ethanol (alcohol)

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

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

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

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

This medication is harmful to people with alcoholism.

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

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

Docetaxel must be administered by a healthcare professional.

Normal 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 through a vein (intravenous route) by infusion. The infusion will last approximately one hour, during which time you should remain in the hospital.

Administration Frequency

It is normally administered every 3 weeks.

Your doctor may change the dose and administration frequency based on the results of your blood tests, your overall condition, and your response to docetaxel. Inform your doctor especially in the case of diarrhea, mouth sores, numbness or tingling, fever, and blood test results. This information will allow your doctor to decide when a dose reduction is necessary. If you have any other questions about the use of this medication, ask your doctor or the hospital 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 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 docetaxel side effects may be increased when docetaxel is administered 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 severe 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 side effects may occur, varying in frequency depending on the combinations of medications you have received:

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

•infections, decrease in red or white blood cells (anemia) or platelets.

•fever: if it occurs, 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 lymphatic drainage deficiency.

•shortness of breath.

•runny nose, inflammation of the nose and throat, cough.

•nasal bleeding.

•mouth sores.

•uncomfort in the stomach, including nausea, vomiting, and diarrhea, constipation.

•abdominal pain.

•indigestion.

•hair loss (in most cases, normal hair growth returns). 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 may cause skin peeling (this can also occur on the arms, face, or body).

•change in nail color, which may 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 symptoms of a cold.

•weight gain or loss.

•upper respiratory tract infection.

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

•oral candidiasis.

•dehydration.

•dizziness.

•hearing loss.

•decrease in blood pressure; rapid or irregular heartbeat.

•heart failure.

•esophagitis.

•dry mouth.

•difficulty or pain swallowing.

•bleeding.

•increase in liver enzymes (so 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):

•syncope.

•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 in combination with other anticancer treatments.

Rare(may affect up to 1 in 1,000 people):

•inflammation of the colon, small intestine, which could be fatal (unknown frequency); intestinal perforation.

Frequency not known(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).

•neumonia (lung infection).

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

•blurred vision due to retinal edema (Cystoid Macular Edema).

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

•ventricular arrhythmia or ventricular tachycardia (manifesting as irregular or rapid heartbeat, severe shortness of breath, dizziness, or syncope). Some of these symptoms may be severe. If this occurs, 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 treatment with docetaxel in combination with other anticancer treatments.

•Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET) (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 symptoms similar to the flu at the same time, such as fever, chills, or muscle pain.

•generalized acute pustular psoriasis (PEGA) (red, scaly, and generalized 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 cardiac arrhythmias. If this occurs, 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 type of side effect, consult your doctor, hospital pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.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 packaging and on the vial.

Store below 25°C.

Store in the original packaging to protect it from light.

Do not refrigerate or freeze.

After opening the vial:

Each vial is for single use and should be used immediately after opening. If not used immediately, storage times and conditions in 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, storage times and conditions in use are the responsibility of the user and should normally not exceed3 days if stored between 2 and 8°C protected from lightor 8 hours at room temperature (below 25°C) including the time for infusion.

The disposal 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 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 ofDocetaxel Aurovitas

-The active ingredient is docetaxel. Each milliliter of docetaxel solution contains 20 mg of anhydrous docetaxel.

-The other components are anhydrous citric acid, povidone, absolute ethanol, and polisorbate 80.

Aspect of theproductand contents of the package:

Docetaxel Aurovitas concentrated solution for infusion is a transparent, pale yellow solution.

Docetaxel Aurovitas is supplied in a transparent glass vial with a rubber stopper and an aluminum flip-off cap with a polypropylene disk. The vial may be packaged with or without a plastic protective wrapper.

Packaging 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 packaging sizes may be commercially available.

Marketing Authorization 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

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19,Venda Nova

2700-487 Amadora

Portugal

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Last review date of this leaflet: November 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for medical professionals or healthcare professionals:

Docetaxel Aurovitas 20 mg/ml concentrated solution for infusion

Instructions for use

Docetaxel is an antineoplastic agent, and, like other potentially toxic compounds, precautions should be taken during manipulation and preparation of docetaxel solutions. These types of preparations should only be prepared and manipulated by qualified personnel in the safe handling of cytotoxic agents. Female personnel who are pregnant should not handle cytotoxic agents. Before starting, local recommendations on cytotoxics should be consulted. The use of gloves is recommended. In the event of contact with the skin of the concentrate or docetaxel infusion solution, wash immediately and thoroughly with water and soap. In the event of contact with mucous membranes of the concentrate or docetaxel infusion solution, wash immediately and thoroughly with water. In the event of a spill, qualified personnel, with 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 abundant water. All contaminated cleaning materials should be disposed of in accordance with local regulations.

Preparation of the infusion solution

It may be necessary to use more than one vial ofdocetaxel20 mg/ml concentrated solution for infusion to obtain the required dose for a specific patient. Using graduated syringes with a needle, aspirate aseptically from the required vials, the volume of docetaxel 20 mg/ml corresponding to the required dose for the patient expressed in mg. For example, a dose of 140 mg of docetaxel would require 7 ml ofDocetaxel Aurovitas20 mg/ml concentrated solution for infusion.

For doses less than 192 mg of docetaxel, inject the required volume ofdocetaxel20 mg/mlconcentrated solution for infusioninto a 250 ml infusion bag or bottle containing either 250 ml of a 50 mg/ml glucose solution for infusion or a 9 mg/ml sodium chloride solution for infusion. For doses greater than 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 infusion solution.

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

Like all parenteral products, this medication should be visually inspected before use, and solutions that present a precipitate should be rejected.

The disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.

Storage after opening

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

Storage after dilution

From a microbiological point of view, reconstitution/dilution should be carried out in controlled aseptic conditions, and the medication should be used immediately. If not used immediately, the storage conditions in use are the responsibility of the user.

Once added to the infusion bag as recommended, the docetaxel infusion solution is stable for 8 hours if stored below 25°C in bags that are not PVC. It should be used within this 8-hour period (including the 1-hour infusion by intravenous infusion).

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

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.

Disposal

The disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.