CABAZITAXEL FRESENIUS KABI 20 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

A.

Package Leaflet: Information for the User

Cabazitaxel Fresenius Kabi 20 mg/mL Concentrate for Solution for Infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Cabazitaxel Fresenius Kabi and what is it used for

The name of your medicine is Cabazitaxel Fresenius Kabi. 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 other chemotherapy. It works by stopping the growth of cells and their multiplication.

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

2. What you need to know before you are given Cabazitaxel Fresenius Kabi

Do not use Cabazitaxel Fresenius Kabi

• if you are allergic (hypersensitive) to cabazitaxel, other taxanes, polysorbate 80, or 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 been or are going to be vaccinated against yellow fever.

Do not receive cabazitaxel if any of the above circumstances apply to you. If you are not sure, consult your doctor before receiving cabazitaxel.

Warnings and precautions

Before starting treatment with cabazitaxel, you will have blood tests to check that you have enough blood cells and that your kidneys and liver are working properly to receive cabazitaxel.

Tell 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 general condition to detect signs of infection. You may be given other medicines to maintain your blood cell count. People with low cell counts can develop life-threatening infections. The first sign of infection may be a fever, so if you have a fever, tell your doctor immediately.

• you have ever had any allergy. During treatment with cabazitaxel, severe allergic reactions can occur.

• you have severe or persistent diarrhea, feel unwell (nausea) or are being sick (vomiting). Any of these situations can cause severe dehydration. Your doctor should provide treatment.

• you have a feeling of numbness, tingling, burning, or decreased sensitivity in your hands and feet.

• you have any bleeding problems in the intestine or have changes in the color of your stools or stomach pain. If the bleeding or pain is severe, your doctor will interrupt your treatment with cabazitaxel. This is because cabazitaxel may increase the risk of bleeding or development of perforations in the intestinal wall.

• you have kidney problems.

• you have yellowing of the skin and eyes, dark urine, severe nausea (feeling unwell) or vomiting, as these may be signs or symptoms of liver problems.

• you notice that the volume of your urine increases or decreases significantly.

• you have blood in your urine.

If any of the above circumstances apply to you, tell your doctor immediately. Your doctor may reduce the dose of cabazitaxel or interrupt treatment.

Other medicines and Cabazitaxel Fresenius Kabi

Tell your doctor, pharmacist, or nurse if you are using or have recently used other medicines, including those obtained without a prescription. This is because some medicines can 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 medicinal plant used to treat depression and other problems);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (to reduce cholesterol in your blood);
• valsartan (for high blood pressure);
• repaglinide (for diabetes).

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

Pregnancy, breastfeeding, and fertility

Cabazitaxel is not indicated for use in women.

Use condoms in your sexual relationships 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 ask for information about sperm preservation before treatment, as cabazitaxel may alter male fertility.

Driving and using machines

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

Cabazitaxel Fresenius Kabi contains ethanol (alcohol)

This medicine contains 395 mg of alcohol (ethanol) per 1 ml, equivalent to 39.5% p/v. The amount in the dose of this medicine is 2.25 ml, equivalent to 23 ml of beer or 9 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect. If you have an alcohol addiction, have liver disease, or have epilepsy, consult your doctor or pharmacist.

3. How to use Cabazitaxel Fresenius Kabi

Instructions for use

Before receiving cabazitaxel, you will be given anti-allergic medicines to reduce the risk of allergic reactions.

• Cabazitaxel will be administered by a doctor or nurse.

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

• Cabazitaxel will be administered in the hospital through a drip (infusion) into one of your veins (intravenously) for approximately 1 hour.

• As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth 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 the dose you should receive.

• Usually, you will receive an infusion every 3 weeks.

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

4. Possible side effects

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

Go to your doctor immediately if you notice any of the following side effects:

• fever (high temperature). This is common (may affect up to 1 in 10 people).

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

• severe stomach pain or stomach pain that does not go away. This can happen if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This can be life-threatening.

If any of the above circumstances apply to you, tell 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):

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

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

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

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

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cabazitaxel Fresenius Kabi

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

Do not use this medicine after the expiry date which is stated on the carton and label of the vials after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

After opening the vial

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

After final dilution in the infusion bag/bottle

The chemical and physical stability of the infusion solution has been demonstrated for 8 hours at 15-30°C (including 1 hour infusion time) and for 48 hours under refrigeration (including 1 hour infusion time) in non-PVC infusion containers.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cabazitaxel Fresenius Kabi

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

The other components are polysorbate 80, anhydrous ethanol, and citric acid (see section 2 "Cabazitaxel Fresenius Kabi contains alcohol").

Appearance and packaging of the product

Cabazitaxel Fresenius Kabi is a concentrate for solution for infusion. The concentrate is a clear, colorless to pale yellow solution.

It is supplied as a single-use vial with an administration volume of 3 ml of concentrate in a 6 ml clear glass vial.

Package size

Each box contains a single-use vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi España, S.A.U.

Torre Mapfre – Vila Olímpica

C/ Marina 16 – 18

08005 Barcelona (Spain)

Manufacturer

Fresenius Kabi Deutschland GmbH

Pfingstweide 53

61169 Friedberg

Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:November 2024

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only.

Practical information for doctors or healthcare professionals on the preparation, administration, and handling of Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusion

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

Cabazitaxel Fresenius Kabi 20 mg/mL concentrate for solution for infusion DOES NOT require prior dilution with a solvent and is ready to be added to the infusion solution.

Shelf-life and special precautions for storage

For the packaging of Cabazitaxel Fresenius Kabi 20 mg/mL concentrate for solution for infusion: This medicinal product does not require special storage conditions.

After opening the vial

Each vial is for single use and must be used immediately after opening. If not used immediately, the in-use storage times and conditions will be the responsibility of the user.

After final dilution in the infusion bag/bottle

The chemical and physical stability of the infusion solution has been demonstrated for 8 hours at 15-30°C (including 1 hour infusion time) and for 48 hours under refrigeration conditions (including 1 hour infusion time) in non-PVC infusion containers.

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 normally should not exceed 24 hours at 2°C - 8°C, unless the dilution has been performed under 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, at any stage of preparation, 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 should only be prepared and administered by personnel trained in the handling of cytotoxic agents. Pregnant healthcare workers should not handle it.

Preparation stages

DO NOT use with other cabazitaxel medicinal products with a different concentration of cabazitaxel. Cabazitaxel contains 20 mg/ml of cabazitaxel (at least 3 ml administration volume).

Each vial is for single use and must be used immediately. Discard any unused solution.

More than one vial of cabazitaxel may be necessary to administer the prescribed dose.

To prepare the infusion solution, the dilution process must be carried out aseptically.

Preparation of the infusion solution

Step 1

Aseptically withdraw the required amount of Cabazitaxel Fresenius Kabi (containing 20 mg/ml of cabazitaxel) with a graduated syringe fitted with a needle. For example, a dose of 45 mg of cabazitaxel would require 2.25 ml of Cabazitaxel Fresenius Kabi.

Inject into a sterile non-PVC container 5% glucose solution or 9 mg/ml (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.

Required amount of concentrate

5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution for infusion

Remove the syringe and mix the contents of the infusion bag or bottle manually by rocking. The infusion solution is clear and colorless.

As with all parenteral products, the resulting infusion solution should be inspected visually 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 should be used immediately. Information on shelf-lifeand special precautions for storagecan be found above.

Any remaining medicinal product and all materials used for its reconstitution, dilution, and administration must be disposed of in accordance with hospital procedures applicable to cytotoxic agents and in accordance with current legislation on the disposal of hazardous waste materials.

Method of administration

Cabazitaxel Fresenius Kabi is administered as an infusion over 1 hour.

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

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