Prospecto: information for the patient

Cabazitaxel Aurovit 20 mg/ml concentrate for solution for infusion

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

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

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

3.How to use Cabazitaxel Aurovit

4.Possible adverse effects

5.Storage of Cabazitaxel Aurovit

6.Contents of the package and additional information

The name of your medication is Cabazitaxel Aurovit. Its common name is cabazitaxel. It belongs to a group of medications called "taxanes", used to treat cancers.

Cabazitaxel is used for the treatment of prostate cancer that has progressed after receiving another chemotherapy. It acts by stopping the growth of cells and their multiplication.

As part of your treatment, you will also take a corticosteroid (prednisone or prednisolone) daily by mouth. Ask your doctor for information about this other medication.

No useCabazitaxel Aurovit

•If you are allergic to cabazitaxel, other taxanes, polisorbate 80, or any of the other components of this medication (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 been or are to be vaccinated against yellow fever.

You should not receive cabazitaxel if any of the above circumstances occur. If you are unsure, consult your doctor before receiving this medication.

Warnings and precautions

Before starting treatment with this medication, blood tests will be performed to check that you have sufficient blood cells and that your kidneys and liver are functioning properly to receive cabazitaxel.

Inform your doctor immediately if:

•You have a fever. During treatment with cabazitaxel, it is more likely that your white blood cell count will decrease. Your doctor will monitor your blood and overall condition to detect signs of infection. You may be given other medications to maintain your blood cell count. People with low cell counts may develop life-threatening infections. The first sign of infection could be fever, so if you have a fever, inform your doctor immediately.

•You have ever had any allergy. During treatment with this medication, severe allergic reactions may occur.

•You have severe diarrhea or are feeling unwell (nausea) or are vomiting. Any of these situations may cause severe dehydration. Your doctor will need to provide treatment.

•You have numbness, tingling, burning, or decreased sensation in your hands and feet.

•You have intestinal bleeding problems or changes in your stool color or stomach pain. If the bleeding or pain is severe, your doctor will stop your treatment with cabazitaxel. This is because this medication may increase the risk of bleeding or development of intestinal wall perforations.

•You have kidney problems.

•You have yellow skin and eyes, dark urine, intense nausea (feeling unwell), or vomiting, as these may be signs or symptoms of liver problems.

•You notice a significant increase or decrease in the volume of your urine.

•You have blood in your urine.

If any of the above circumstances occur, inform your doctor immediately. Your doctor may reduce the dose of this medication or stop treatment.

Other medications and Cabazitaxel Aurovit

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription. This is because some medications may affect the efficacy of cabazitaxel or this medication may affect the efficacy of other medications. These medications include:

-ketoconazole, rifampicin (for infections).

-carbamazepine, phenobarbital, or phenytoin (for seizures).

-St. John's Wort or Hypericum perforatum (a medicinal plant 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 undergoing treatment with cabazitaxel, consult your doctor before being vaccinated.

Pregnancy, breastfeeding, and fertility

This medication is not indicated for use in women.

Use condoms in your sexual relations if your partner is or may be pregnant. Cabazitaxel may be present in your semen and may affect the fetus. It is recommended not to conceive during and up to 4 months after treatment and to request information on sperm preservation before treatment, as this medication may alter male fertility.

Driving and operating machinery

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

Cabazitaxel Aurovit contains ethanol (alcohol)

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

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

The amount of alcohol contained in this medication may affect the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

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

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

Usage Instructions

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

•This medication will be administered by a doctor or a nurse.

•This medication must be prepared (diluted) before administration. This leaflet provides practical information for the manipulation and administration of this medication for doctors, nurses, and pharmacists.

•This medication will be administered in the hospital through an infusion (perfusion) into one of your veins (intravenous route) for approximately 1 hour.

•As part of your treatment, you will also take a corticosteroid medication (prednisone or prednisolone) orally every day.

How Much and How Often It Is Administered

•The usual dose depends on your body surface area. Your doctor will calculate your body surface area in square meters (m2) and decide on the dose you should receive.

•You will usually receive an infusion every 3 weeks.

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

Like all medicines, this medicine may cause side 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 side effects:

•fever (high temperature). This is very common (it may affect more than 1 in 10 people).

•severe loss of body fluids (dehydration). This is common (it may affect up to 1 in 10 people). This can occur if you have severe or prolonged diarrhea, fever, or if you have been vomiting.

•severe stomach pain or stomach pain that does not resolve. This can happen if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This can be fatal.

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

Other side 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 results in an increased risk of bleeding).

•loss of appetite (anorexia).

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

•back pain.

•blood in the urine.

•fatigue, weakness, or lack of energy.

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

•alteration of taste.

•shortness of breath.

•cough.

•abdominal pain.

•temporary hair loss (in most cases, hair will grow back normally).

•joint pain.

•urinary tract infection.

•leukopenia associated with fever and infections.

•sensation of numbness, tingling, burning, or decreased sensation in hands and feet.

•dizziness.

•headache.

•increase or decrease in blood pressure.

•stomach discomfort, heartburn, or belching.

•stomach pain.

•hemorrhoids.

•muscle spasms.

•urinating frequently or with pain.

•urinary incontinence.

•kidney problems or alteration.

•mouth or lip ulcers.

•infections or risk of infections.

•elevated blood sugar level.

•insomnia.

•confusion.

•sensation of anxiety.

•sensation of numbness, tingling, or pain in hands and feet.

•balance problems.

•irregular or rapid heartbeats.

•blood clots in the legs or lungs.

•sensation of suffocation on the skin.

•mouth or throat pain.

•rectal bleeding.

•muscle discomfort, weakness, or pain.

•inflammation of the feet or legs.

•chills.

•changes in nails (change in color of nails; nails may fall off)

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

•low potassium level in the blood.

•tinnitus in the ears.

•sensation of heat on the skin

•red skin.

•inflammation of the bladder, which can occur when the bladder has previously been exposed to radiation (radiation recall cystitis).

Unknown frequency(cannot be estimated from available data):

•pulmonary interstitial disease (inflammation of the lungs causing cough and difficulty breathing).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 the Vigilance of Medicinal Products 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 label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

In the section“Practical information for doctors or healthcare professionals on the preparation, administration, and handling of Cabazitaxel Aurovit 20 mg/ml concentrate for infusion solution”,information on the conservation and use time of this medication is included, once it has been diluted and is ready to use.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations. These measures will help to protect the environment.

Composition ofCabazitaxel Aurovit

-The active ingredient is cabazitaxel. One ml of concentrate contains 20 mg of cabazitaxel. Each vial of 3 ml of concentrate contains 60 mg of cabazitaxel.

-The other components are: polisorbate 80, citric acid and anhydrous ethanol (see Section 2. “Cabazitaxel Aurovit contains ethanol (alcohol)”.

Aspect of the product and contents of the package

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

Each vial contains 3 ml of sterile concentrate.

The available package size is 1 vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

AqVida GmbH

Kaiser-Wilhelm-Str. 89

20355 Hamburg

Germany

You can request more information about this medication by contacting 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 solely for healthcare professionals:

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

This information complements sections 3 and 5 for the user.

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

Incompatibilities

This medication should not be mixed with other medications except those used for dilutions.

Period of validity and special precautions for storage

Storage of the vial without opening

This medication does not require special storage conditions.

Storage after opening the vial

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

From a microbiological point of view, the vial should be used immediately after opening. If not used immediately, the storage times and conditions are the responsibility of the user and should not be more than 24 hours at 2°C-8°C, unless the dilution has been performed in controlled and validated aseptic conditions.

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

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

From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user and should not be more than 24 hours at 2°C-8°C, unless the dilution has been performed in controlled and validated aseptic conditions.

Precautions for preparation and administration

As with other antineoplastic agents, caution should 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 cabazitaxel comes into contact with the skin, wash immediately and thoroughly with water and soap. If it comes into contact with mucous membranes, wash immediately and thoroughly with water.

Cabazitaxel Aurovit should only be prepared and administered by trained personnel in the handling of cytotoxic agents. Pregnant women should not handle it.

Preparation steps

DO NOT USE this medication, which consists of a single vial with 3 ml of concentrate (60 mg/3 ml), with other medications containing cabazitaxel in 2 vials (concentrate and solvent)or with other medications containing cabazitaxel in a vial (sólo concentrate) but with a different concentration.

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

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

Preparation of the infusion solution

Step 1:

It may be necessary to use more than 1 vial of cabazitaxel concentrate to obtain the required dose for the patient.

Extract the required volume from the cabazitaxel Aurovit vial (which contains 20 mg/ml of cabazitaxel) using a graduated syringe with a fine needle in an aseptic manner.

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

Step 2:

Inject into a sterile non-PVC infusion bag or bottle containing 5% glucose solution or 0.9% sodium chloride solution for infusion. The concentration of the infusion solution should 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 gently rocking the bag or bottle.

Step 4:

As with all parenteral products, the resulting infusion solution should be visually inspected before use. Since the infusion solution is supersaturated, it may crystallize over time. In this case, it should not be used and should be discarded.

Administration form

The infusion solution should be used immediately. However, the storage time in use may be longer as explained in “Period of validity and special precautions for storage”.

This medication is administered by infusion over 1 hour.

It is recommended to use a 0.22 micrometer pore nominal filter (also known as 0.2 micrometer) during administration.

Infusion bags or sets made of PVC or polyurethane should not be used for the preparation and administration of cabazitaxel.

Cabazitaxel should not be mixed with other medications except those mentioned.

Elimination

The unused medication and all materials that have come into contact with it will be disposed of in accordance with local regulations.