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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet 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, consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Package leaflet contents

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

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

The name of your medicine is Cabazitaxel Vivanta. 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 receiving another chemotherapy treatment. It works by stopping the growth and multiplication of cells.

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

2. What you need to know before you are given Cabazitaxel Vivanta

Do not use Cabazitaxel Vivanta

• if you are allergic (hypersensitive) 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 been vaccinated or are about to be vaccinated against yellow fever.

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

Warnings and precautions

Before starting treatment with Cabazitaxel Vivanta, you will have blood tests to check that you have enough blood cells and that your kidneys and liver are functioning adequately 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 general condition to detect signs of infection. You may be given other medications 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 if you have a fever, inform your doctor immediately.
• you have ever had any allergies. Severe allergic reactions may occur during treatment with cabazitaxel.
• 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 sensations, or reduced sensation in your hands and feet.
• you have intestinal bleeding or changes in the color of your stools or stomach pain. If bleeding or pain is severe, your doctor will interrupt your treatment with cabazitaxel. This is because cabazitaxel could 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 situations occur, inform your doctor immediately. Your doctor may reduce the dose of this medicine or interrupt the treatment.

Other medicines and Cabazitaxel Vivanta

Inform your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is because some medicines may affect the effectiveness of this medicine, or this medicine 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 this medicine, consult your doctor before receiving any vaccination.

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 harm the fetus. It is recommended that you do not father a child during treatment and for 4 months after treatment. Seek advice on sperm preservation before starting treatment, as this medicine may impair male fertility.

Driving and operating machinery

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 Vivanta contains ethanol (alcohol)

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

Cabazitaxel Vivanta contains polysorbate 80

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

3. How to use Cabazitaxel Vivanta

Before receiving cabazitaxel, you will be given anti-allergic 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 leaflet provides practical information on the handling and administration of this medicine for doctors, nurses, and pharmacists.
• This medicine will be given to you in the hospital through an intravenous infusion (a 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) every day by mouth.

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 determine the dose you should receive.
• You will usually receive an infusion every 3 weeks.

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

4. Possible adverse effects

Like all medicines, cabazitaxel may produce adverse effects, although not everyone experiences them. Your doctor will discuss this with you and explain the potential risks and benefits of your treatment.

Contact your doctor immediately if you notice any of the following adverse 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 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 cause death.

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 impairment
• mouth or lip ulcers
• infections or increased risk of infections
• high blood sugar levels
• insomnia
• mental confusion
• feeling of anxiety
• unusual sensation 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 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 potassium levels in the blood
• ringing in the ears
• sensation of warmth in the skin
• red skin
• inflammation of the bladder, which may occur when the bladder has previously been exposed to radiotherapy (radiation recall cystitis).

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

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

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through 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 Vivanta

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

Do not use this medicine after the expiry date stated on the carton and on the label of the vials 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 physicians or healthcare professionals on the preparation, administration and handling of Cabazitaxel Vivanta” includes information on the storage and duration of use of Cabazitaxel Vivanta once it has been diluted and is ready for use.

Disposal of unused medicine and of all materials that have been in 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 additional information

Composition of Cabazitaxel Vivanta

The active substance 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 injections in the solvent (see section 2 “Cabazitaxel Vivanta contains ethanol (alcohol)”).

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

Appearance of the product and contents of the pack

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

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

The solvent is a clear, colourless solution.

One pack of Cabazitaxel Vivanta contains:

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

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 26001, Cakovice

196 00 Prague 9

Czech Republic

Manufacturer Responsible

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park,

Paola, PLA3000,

Malta

You may request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Local Representative:

Vivanta Generics s.r.o. Spanish branch

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Netherlands: Cabazitaxel Vivanta 60 mg concentrate and solvent for infusion solution
Ireland: Cabazitaxel MSN
Spain: Cabazitaxel Vivanta 60 mg concentrate and solvent for infusion solution EFG
Germany: Cabazitaxel AXiromed 60 mg concentrate and solution for infusion
Poland: Cabazitaxel Medical Valley
Finland: Cabazitaxel Medical Valley 60 mg infusion concentrate and solvent for solution
Denmark: Cabazitaxel Medical Valley
Sweden: Cabazitaxel Medical Valley 60 mg concentrate and solvent for infusion solution
Norway: Cabazitaxel Medical Valley

Date of the most recent review of this leaflet: September 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/

The following information is intended for healthcare professionals only.

PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL VIVANTA 60 mg CONCENTRATE AND SOLVENT FOR INFUSION SOLUTION

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

For the pack of Cabazitaxel Vivanta 60 mg concentrate and solvent

After opening the vial

The vials of concentrate and solvent should be used immediately. If not used immediately, the storage time and conditions are the responsibility of the user. From a microbiological standpoint, the two-step dilution process must be carried out under controlled and aseptic conditions (see below “Preparation and administration precautions”).

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

After 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 under refrigeration (2°C – 8°C), including the hour of infusion time.

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

Preparation and administration precautions

As with other antineoplastic 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 at any stage of preparation Cabazitaxel Vivanta comes into contact with the skin, wash immediately and thoroughly with soap and water. If contact occurs with mucous membranes, rinse immediately and thoroughly with water.

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

The concentrate for infusion solution must always be diluted with the complete solvent provided before being added to infusion solutions.

Preparation steps

Carefully read ALL of this section before mixing and diluting. Cabazitaxel Vivanta requires TWO dilutions before administration. Follow the preparation instructions provided below.

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

To prepare the infusion solution, the following two-step dilution process must be performed aseptically.

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

Step 1.1

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

Step 1.2

Using a syringe equipped with a fixed needle, aseptically withdraw the entire content of the provided solvent by partially inverting the solvent vial.

Step 1.3

Inject the entire content into the corresponding concentrate vial.

To minimize foam formation during injection of the solvent, direct the needle against the inner wall of the concentrate vial and inject slowly.

After reconstitution, the resulting solution contains 10 mg/ml of cabazitaxel.

Step 1.4

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

Step 1.5

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

It is normal for foam to persist after this time.

This resulting concentrate-solvent mixture contains 10 mg/mL of cabazitaxel (at least 6 mL of released volume). The second dilution must be performed immediately (within 1 hour), as described in Step 2.

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

Step 2: Final dilution for infusion

Step 2.1

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

Since foam may still remain on the vial wall after the preparation described in Step 1, it is preferable to position the syringe needle in the middle of the solution during withdrawal.

Step 2.2

Inject into a sterile, non-PVC container of 5% glucose solution or sodium chloride solution mg/mL (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 manually mix the contents of the infusion bag or bottle by gentle swirling.

Step 2.4

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 such cases, the solution must not be used and should be discarded.

The infusion solution should be used immediately. However, the in-use storage duration may be longer under the specific conditions mentioned in the section Storage period and special precautions for storage.

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

Method of administration

Cabazitaxel Vivanta is administered as an intravenous infusion over 1 hour.

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

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