Cabazitaxel Aurovit 20 mg/ml concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cabazitaxel Aurovit 20 mg/ml concentrate for solution for infusion

Read all of this leaflet very 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 adverse reactions, talk to your doctor, pharmacist or nurse, even if it is an adverse reaction not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The name of your medicine is Cabazitaxel Aurovit. Its common name is cabazitaxel. It belongs to a group of medicines called "taxanes," which are used to treat cancers.

Cabazitaxel is used to treat prostate cancer that has progressed after treatment with another chemotherapy. It works by stopping the growth and multiplication of cancer cells.

As part of your treatment, you will also take a corticosteroid (prednisone or prednisolone) orally every day. Please ask your doctor for information about this additional medicine.

2. What you need to know before Cabazitaxel Aurovit is administered to you

Do not use Cabazitaxel Aurovit

• if you are allergic to cabazitaxel, to other taxanes, to polysorbate 80, or to any of the other components of this medicine (listed in section 6).
• if your white blood cell count is very low (neutrophil count less than or equal to 1,500/mm³).
• if you have severe liver problems.
• if you have recently received or are scheduled to receive the yellow fever vaccine.

You must not receive cabazitaxel if any of the above apply to you. If you are unsure, consult your doctor before receiving this medicine.

Warnings and precautions

Before starting treatment with this medicine, you will have blood tests to ensure you have enough blood cells and that your kidneys and liver are functioning adequately for cabazitaxel treatment.

Inform your doctor immediately if:

• you have a fever. During treatment with cabazitaxel, your white blood cell count is more likely to decrease. Your doctor will monitor your blood and general condition for signs of infection. You may be given other medicines to maintain your blood cell counts. People with low blood cell counts may develop infections that could be life-threatening. Fever may be the first sign of infection, so inform your doctor immediately if you develop a fever.
• you have ever had any allergies. Severe allergic reactions may occur during treatment with this medicine.
• you have severe or persistent diarrhea, feel unwell (nausea), or are vomiting. Any of these conditions may lead to severe dehydration. Your doctor will need to provide treatment.
• you experience numbness, tingling, burning, or reduced sensation in your hands or feet.
• you have intestinal bleeding or notice changes in the color of your stools or stomach pain. If bleeding or pain is severe, your doctor may interrupt your treatment with cabazitaxel. This is because this medicine may increase the risk of bleeding or the development of perforations in the intestinal wall.
• you have kidney problems.
• you develop yellowing of the skin or eyes, dark urine, severe nausea (feeling unwell), or vomiting, as these may be signs or symptoms of liver problems.
• you notice a significant increase or decrease in your urine volume.
• you have blood in your urine.

If any of the above occur, inform your doctor immediately. Your doctor may reduce the dose of this medicine or interrupt treatment.

Other medicines and Cabazitaxel Aurovit

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is because some medicines may affect the effectiveness of cabazitaxel, or cabazitaxel may affect the effectiveness of other medicines. These medicines include:

• ketoconazole, rifampicin (for infections).
• carbamazepine, phenobarbital, or phenytoin (for seizures).
• St. John’s wort (Hypericum perforatum) (a herbal remedy used to treat depression and other conditions).
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (to reduce cholesterol in your blood).
• valsartan (for hypertension).
• repaglinide (for diabetes).

While being treated with cabazitaxel, consult your doctor before getting vaccinated.

Pregnancy, breastfeeding, and fertility

This medicine is not indicated for use in women.

Use condoms during sexual intercourse if your partner is or could be pregnant. Cabazitaxel may be present in your semen and could affect the fetus. It is recommended that you avoid fathering a child during treatment and for 4 months after treatment ends. You should seek advice about sperm preservation before starting treatment, as this medicine may impair male fertility.

Driving and using machines

During treatment with this medicine, you may feel tired or dizzy. If this happens, do not drive or operate tools or machinery until you feel better.

Cabazitaxel Aurovit contains ethanol (alcohol)

This medicine contains 1,185 mg of alcohol (ethanol) per vial, equivalent to 395 mg/ml. The amount of alcohol in each vial is equivalent to 30 ml of beer or 12 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect in adults or adolescents. However, it may have some effects in young children, such as drowsiness.

The amount of alcohol contained in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

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

If you have alcohol addiction, consult your doctor or pharmacist before taking this medicine.

Cabazitaxel Aurovit contains polysorbate 80 (E433)

This medicine contains 1,620 mg of polysorbate 80 in each 3 ml vial, equivalent to 540 mg/ml.

Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Polysorbates may have an effect on your heart and blood circulation (e.g., irregular or abnormal heartbeats, or low blood pressure).

3. How to use Cabazitaxel Aurovit

Instructions for use

Before receiving cabazitaxel, you will be given antiallergic medications to reduce the risk of allergic reactions.

• This medicine will be administered by a doctor or nurse.
• This medicine must be prepared (diluted) before administration. This package leaflet provides practical information on handling and administering the medicine for doctors, nurses, and pharmacists.
• This medicine will be administered in the hospital through an intravenous infusion (drip) into one of your veins over approximately 1 hour.
• As part of your treatment, you will also take an oral corticosteroid medicine (prednisone or prednisolone) daily by mouth.

Dosage and frequency of administration

• The usual dose depends on your body surface area. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
• You will usually receive an infusion every 3 weeks.

If you have any further questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Your doctor will discuss this with you and explain the potential risks and benefits of your treatment.

Seek immediate medical attention if you notice any of the following adverse effects:

• fever (high temperature). This is very common (may affect more than 1 in 10 people).
• severe loss of body fluids (dehydration). This is common (may affect up to 1 in 10 people). This may occur if you have severe or prolonged diarrhea, fever, or have been vomiting.
• severe stomach pain or stomach pain that does not go away. This may happen if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This may be fatal.

If any of the above occur, inform your doctor immediately.

Other adverse effects include:

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

• reduction in the number of red blood cells (anemia), or white blood cells (which are important for fighting infections).
• reduction in the number of platelets (which increases the risk of bleeding).
• loss of appetite (anorexia).
• stomach discomfort, including nausea, vomiting, diarrhea, or constipation.
• back pain.
• blood in the urine.
• tiredness, weakness, or lack of energy.

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

• altered taste.
• shortness of breath.
• cough.
• abdominal pain.
• temporary hair loss (in most cases, hair grows back normally).
• joint pain.
• urinary tract infection.
• low white blood cell count associated with fever and infections.
• sensation of numbness, tingling, burning, or reduced sensation in hands and feet.
• dizziness.
• headache.
• increased or decreased blood pressure.
• stomach discomfort, heartburn, or burping.
• stomach pain.
• hemorrhoids.
• muscle spasms.
• frequent or painful urination.
• urinary incontinence.
• kidney problems or kidney impairment.
• mouth or lip ulcers.
• infections or risk of infections.
• high blood sugar levels.
• insomnia.
• mental confusion.
• feeling of anxiety.
• unusual sensation, loss of sensation, or pain in hands and feet.
• balance problems.
• rapid or irregular heartbeat.
• blood clots in the legs or lungs.
• skin flushing.
• mouth or throat pain.
• rectal bleeding.
• discomfort, disorders, weakness, or muscle pain.
• swelling of feet or legs.
• chills.
• nail disorders (change in nail color; nails may fall off).

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

• low blood potassium levels.
• ringing in the ears.
• sensation of warmth in the skin.
• redness of the skin.
• bladder inflammation, which may occur when your bladder has previously been exposed to radiotherapy (radiation recall cystitis).

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

• interstitial lung disease (lung inflammation causing cough and difficulty breathing).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, 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 Cabazitaxel Aurovit

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

Do not use this medicine after the expiry date stated on the container and label of the vial after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

The section “Practical information for doctors or healthcare professionals on the preparation, administration and handling of Cabazitaxel Aurovit 20 mg/ml concentrate for solution for infusion” includes information on the storage and duration of use of this medicine once it has been diluted and is ready for use.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations. These measures will help protect the environment.

6. Contents of the container and other information

Composition of Cabazitaxel Aurovit

• The active substance is cabazitaxel. One ml of concentrate contains 20 mg of cabazitaxel. Each 3 ml vial of concentrate contains 60 mg of cabazitaxel.
• The other components are: polysorbate 80 (E433), citric acid, and anhydrous ethanol (see Section 2. “Cabazitaxel Aurovit contains ethanol (alcohol)” and “Cabazitaxel Aurovit contains polysorbate 80 (E433)”).

Appearance of the product and contents of the container

Cabazitaxel Aurovit is a concentrate for solution for infusion (sterile concentrate). It is a transparent oily solution, yellow to yellowish-brown in color.

Each vial contains 3 ml of sterile concentrate.

The pack size available is 1 vial.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

AqVida GmbH

Kaiser-Wilhelm-Str. 89

20355 Hamburg

Germany

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

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Date of the most recent review of this leaflet: November 2025

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:

“Practical information for physicians or healthcare professionals on the preparation, administration, and handling of Cabazitaxel Aurovit 20 mg/ml concentrate for solution for infusion”

This information complements sections 3 and 5 for the user.

It is important to read the entire content of this procedure before preparing the infusion solution.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those used for dilution.

Shelf life and special precautions for storage

Storage of the unopened vial

This medicinal product does not require special storage conditions.

Storage after opening the vial

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

From a microbiological standpoint, the vial should be used immediately after opening. If not used immediately, the storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C, unless dilution has been carried out under controlled and validated aseptic conditions.

Storage after dilution in 5% glucose solution or 0.9% sodium chloride solution

Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25°C and for 14 days at 2°C–8°C when stored in a non-PVC infusion bag/bottle.

From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C, unless dilution has been carried out under controlled and validated aseptic conditions.

Preparation and administration precautions

As with other antineoplastic agents, caution must be exercised during the preparation and administration of cabazitaxel solutions, taking into account the use of safety devices, personal protective equipment (e.g., gloves), and preparation procedures.

If at any stage of preparation cabazitaxel comes into contact with the skin, wash immediately and thoroughly with water and soap. If contact occurs with mucous membranes, wash immediately and thoroughly with water.

Cabazitaxel Aurovit must only be prepared and administered by personnel trained in the handling of cytotoxic agents. Pregnant healthcare workers must not handle this product.

Preparation steps

DO NOT USE this medicinal product, which consists of a single vial containing 3 ml of concentrate (60 mg/3 ml), with other cabazitaxel-containing medicines that use 2 vials (concentrate and solvent), nor with other cabazitaxel-containing medicines that contain a single vial (concentrate only) but with a different concentration.

Each vial is for single use only and should be used immediately. Any unused solution must be discarded.

The dilution process for preparing the infusion solution must be performed aseptically.

Preparation of the infusion solution

Step 1:

It may be necessary to use more than one vial of cabazitaxel concentrate to achieve the required patient dose.

Aseptically withdraw the required volume from the Cabazitaxel Aurovit vial (containing 20 mg/ml of cabazitaxel) using a graduated syringe equipped with a fine needle.

For example, a 45 mg dose of cabazitaxel would require 2.25 ml of Cabazitaxel Aurovit.

Step 2:

Inject into a sterile, non-PVC container of 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion. The concentration of the infusion solution must be between 0.10 mg/ml and 0.26 mg/ml.

Step 3:

Remove the syringe and mix the contents of the infusion bag or bottle manually by gentle rocking.

Step 4:

As with all parenteral products, the resulting infusion solution should be inspected visually before use. Since the infusion solution is supersaturated, crystallization may occur over time. In such cases, the solution must not be used and must be discarded.

Method of administration

The infusion solution should be used immediately. However, the in-use storage period may be longer as described in “Shelf life and special precautions for storage”.

This medicinal product is administered by 1-hour infusion.

The use of an in-line filter with a nominal pore size of 0.22 micrometers (also referred to as 0.2 micrometers) is recommended during administration.

PVC infusion containers or polyurethane infusion sets must not be used for the preparation and administration of cabazitaxel.

Cabazitaxel must not be mixed with other medicinal products except those mentioned.

Disposal

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