Prospecto: information for the user

Cabazitaxel Vivanta 60 mg concentrate and solvent for solution for infusion EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

Content of the prospect

1. What Cabazitaxel Vivanta is and for what it is used
2. What you need to know before Cabazitaxel Vivanta is administered to you
3. How to use Cabazitaxel Vivanta
4. Possible adverse effects
5. Storage of Cabazitaxel Vivanta
6. Contents of the package and additional information

The name of your medicine is Cabazitaxel Vivanta. Its common name is cabazitaxel. It belongs to a group of medicines 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 medicine.

No use Cabazitaxel Vivanta

• If you are allergic (hypersensitive) 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 Vivanta if any of the above circumstances occur. If you are unsure, consult your doctor before receiving Cabazitaxel Vivanta.

Warnings and precautions

Before starting treatment with Cabazitaxel Vivanta, 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 cabazitaxel, severe allergic reactions may occur.
• You have severe or prolonged diarrhea, feel unwell (nausea) or are vomiting. Any of these situations can cause severe dehydration. Your doctor should 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 bleeding or pain is severe, your doctor will interrupt your cabazitaxel treatment. This is because cabazitaxel 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 they 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 circumstances occur, inform your doctor immediately. Your doctor may reduce the dose of this medication or interrupt treatment.

Other medications and Cabazitaxel Vivanta

Inform your doctor, pharmacist, or nurse if you are using or have recently used other medications, including those purchased without a prescription. This is because some medications may affect the efficacy of this medication 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 (Hypericum perforatum) (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 this medication, consult your doctor before being vaccinated.

Pregnancy, breastfeeding, and fertility

This medication is not indicated for use in women.

Use condoms during sexual intercourse if your partner is or may be pregnant. Cabazitaxel may be present in your semen and can affect the fetus. It is recommended not to father a child 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 occurs, do not drive or use tools or machinery until you feel better.

Cabazitaxel Vivanta contains ethanol (alcohol)

This medication contains 573 mg of alcohol (ethanol) in each vial of solvent. The amount in the dose of this medication is equivalent to less than 11 ml of beer or 5 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect. If you have an alcohol addiction, liver disease, or epilepsy, consult your doctor or pharmacist before taking this medication.

Cabazitaxel Vivanta contains polisorbate 80

Polysorbates may affect circulation and the heart (e.g., low blood pressure, changes in heartbeats).

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

• This medication will be administered by a doctor or nurse.
• This medication must be prepared (diluted) before administration. This leaflet provides practical information for the handling 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.

• 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, cabazitaxel 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 medical attention immediately if you notice any of the following side effects:

• fever (high temperature). This is common (it may affect up to 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 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.

Inform your doctor immediately if any of the above circumstances occur.

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 regrow normally)
• joint pain
• urinary tract infection
• low white blood cell count 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
• ulcers in the mouth or lips
• infections or risk of infections
• elevated blood sugar level
• insomnia
• confusion
• sensation of anxiety
• sensation of numbness or loss of sensation or pain in hands and feet
• balance problems
• rapid or irregular heartbeat
• blood clots in the legs or lungs
• sensation of suffocation in the skin
• mouth or throat pain
• rectal bleeding
• muscle aches, disorders, weakness, or pains
• inflammation of feet or legs
• chills
• changes in nails (change in color of nails; nails may become detached).

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

• low potassium level in the blood
• ringing in the ears
• sensation of heat in the skin
• red skin
• inflammation of the bladder, which may occur when the bladder has previously been exposed to radiation therapy (radiation recall cystitis).

Unknown frequency(cannot be estimated from available data)

• interstitial lung 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, 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 the 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 label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Information on the conservation and use time of Cabazitaxel Vivanta, once it has been diluted and is ready to use, is included in the section “Practical information for healthcare professionals on the preparation, administration, and handling of Cabazitaxel Vivanta”.

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 protect the environment.

Composition of Cabazitaxel Vivanta

The active ingredient is cabazitaxel. One ml of concentrate contains 40 mg of cabazitaxel. One vial of concentrate contains 60 mg of cabazitaxel.

The other components are polysorbate 80 and citric acid in the concentrate, and 96% ethanol and water for injection in the solvent (see section 2 “Cabazitaxel Vivanta contains ethanol (alcohol)”).

Nota: both the vial of Cabazitaxel Vivanta 60 mg/1.5 ml concentrate (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the vial of solvent (fill volume: 5.67 ml) contain an overfill to compensate for the loss of liquid during preparation. This overfill ensures that after dilution with the complete content of the solvent provided, there is a solution containing 10 mg/ml of cabazitaxel.

Appearance of the product and contents of the pack

Cabazitaxel Vivanta is a concentrate and solvent for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless to pale yellow viscous solution.

The solvent is a clear, colourless solution.

A pack of Cabazitaxel Vivanta contains:

• One single-use glass vial, closed with a chlorobutyl rubber stopper, sealed with an aluminium cap, covered with a flip-off plastic stopper, containing 1.5 ml (nominal volume) of concentrate.
• One single-use glass vial, closed with a chlorobutyl rubber stopper, sealed with an aluminium cap, covered with a flip-off plastic stopper, containing 4.5 ml (nominal volume) of solvent.

Marketing authorisation holder

Vivanta Generics s.r.o.

Trtinová 26001, Cakovice

196 00 Prague 9

Czech Republic

Responsible for manufacturing

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Local Representative:

Vivanta Generics s.r.o. subsidiary in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

This medicine is authorised in the Member States of the European Economic Area with the following names:

NetherlandsCabazitaxel Vivanta 60 mg concentrate in solvent for solution for infusion

IrelandCabazitaxel MSN

SpainCabazitaxel Vivanta 60 mg concentrate and solvent for solution for perfusion EFG

GermanyCabazitaxel AXiromed 60 mg Concentrate and Solution for the Preparation of an Infusion Solution

PolandCabazitaxel Medical Valley

FinlandCabazitaxel Medical Valley 60 mg infusion concentrate and solvent, for solution for infusion

DenmarkCabazitaxel Medical Valley

SwedenCabazitaxel Medical Valley 60 mg concentrate and liquid for infusion solution, solution

NorwayCabazitaxel Medical Valley

Date of the last review of this leaflet: September 2023

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

The following information is intended only for healthcare professionals.

INFORMATION FOR MEDICAL PRACTITIONERS OR HEALTHCARE PROFESSIONALS ABOUT THE PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL VIVANTA 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

This information complements sections 3 and 5 for the user.

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

Incompatibilities

This medicine should not be mixed with other medicines except those used for dilutions.

Period of validity and special precautions for storage

For the pack of Cabazitaxel Vivanta 60 mg concentrate and solvent

After opening the vial

The concentrate and solvent vials must be used immediately. If not used immediately, the time and storage conditions are the responsibility of the user. From a microbiological point of view, the two-stage dilution process must be carried out in controlled and aseptic conditions (see below “Precautions for preparation and administration”).

After the initial dilutionof Cabazitaxel Vivanta 60 mg concentrate with the complete contentof the solvent vial: chemical and physical stability has been demonstrated in use for 1 hour at room temperature.

After the final dilution in the infusion bag/bottle

Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room temperature (15°C - 30°C) including 1 hour of infusion time and for 48 hours in the refrigerator including the infusion time.

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

Precautions for preparation and administration

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

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

Dilute the concentrate for infusion solution with the complete content of the solvent vial provided before adding it to the infusion solutions.

Steps for preparation

Read this section carefully before mixing and diluting. Cabazitaxel Vivanta requirestwodilutions before administration. Follow the preparation instructions provided below.

Nota: both the vial of Cabazitaxel Vivanta 60 mg/1.5 ml concentrate (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the vial of solvent (fill volume: 5.67 ml) contain an overfill to compensate for the loss of liquid during preparation. This overfill ensures that after dilution with the complete content of the solvent provided, there is a solution containing 10 mg/ml of cabazitaxel.

To prepare the infusion solution, the following two-stage dilution process must be carried out aseptically.

Step 1: initial dilution of the concentrate for infusion solution with the solvent provided.

Step 1.1

Inspect the concentrate vial and the solvent provided. The concentrate and solvent solutions must be clear and practically free of particles.

Step 1.2

Using a syringe provided with a fixed needle, extract the complete content of the solvent provided in an aseptic manner by inverting the vial partially.

Step 1.3

Inject the complete content into the corresponding concentrate vial.

To limit the formation of foam as much as possible when injecting the solvent, direct the needle towards the inner wall of the concentrate vial and inject slowly.

Once reconstituted, the resulting solution contains 10 mg/ml of cabazitaxel.

Step 1.4

Remove the syringe and needle and mix the solution manually and gently, by repeated inversion, until a clear and homogeneous solution is obtained. This may take about 45 seconds.

Step 1.5

Leave the solution to stand for approximately 5 minutes and then check that the solution is homogeneous and clear.

It is normal for foam to persist after this time.

This concentrate-solvent mixture resulting from the first dilution contains 10 mg/ml of cabazitaxel (at least 6 ml of released volume). The second dilution must be carried out immediately (within 1 hour) as detailed in Step 2.

It may be necessary to use more than one vial of the concentrate-solvent mixture to administer the prescribed dose.

Step 2: final dilution (second) for infusion

Step 2.1

Extract the required amount of the concentrate-solvent mixture (10 mg/ml of cabazitaxel) aseptically using a graduated syringe provided with a fixed needle. For example, a dose of 45 mg of Cabazitaxel Vivanta would require 4.5 ml of the concentrate-solvent mixture prepared in Step 1.

As there may still be foam in the wall of the vial of this solution after the preparation described in Step 1, it is preferable to place the needle of the syringe in the middle of the content during extraction.

Step 2.2

Inject into a sterile PVC-free infusion bag or bottle containing glucose solution 5% or sodium chloride solution 0.9% for infusion. The concentration of the infusion solution must be between 0.10 mg/ml and 0.26 mg/ml.

Step 2.3

Remove the syringe and mix the contents of the infusion bag or bottle manually, by shaking.

Step 2.4

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

The infusion solution must be used immediately. However, the storage time in use may be longer under the specific conditions mentioned in the sectionPeriod of validityand special precautions for storage.

The elimination of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

Method of administration

Cabazitaxel Vivanta is administered by infusion over 1 hour.

It is recommended to use a filter in line with a 0.22micrometre pore nominal size (also known as 0.2 micrometres) during administration.

Do not use PVC infusion bags or polyurethane infusion sets for the preparation and administration of the infusion solution.