CABAZITAXEL TEVAGEN 10 mg/mL concentrate for solution for infusion

Introduction

Package Leaflet:Information for the patient

Cabazitaxel Tevagen 10 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 pack

1. What Cabazitaxel Tevagen is and what it is used for
2. What you need to know before you use Cabazitaxel Tevagen
3. How to use Cabazitaxel Tevagen
4. Possible side effects

5 Storage of Cabazitaxel Tevagen

1. Contents of the pack and other information

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

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

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

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 use Cabazitaxel Tevagen

Do not use Cabazitaxel Tevagen if:

• you are allergic to cabazitaxel, other taxanes, polysorbate 80, or any of the other ingredients of this medicine (listed in section 6),
• your white blood cell count is very low (neutrophil count less than or equal to 1,500/mm3),
• you have severe liver problems,
• 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 each 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 keep your blood cell count up. People with low cell counts may 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 give you treatment.
• you have a feeling of numbness, tingling, burning, or decreased sensation in your hands and feet.
• you have any bleeding problems in your intestine or have changes in the color of your stools or stomach pain. If the bleeding or pain is severe, your doctor will stop 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 your daily urine output 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 stop treatment.

Other medicines and Cabazitaxel Tevagen

Tell 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 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 or hypericum (Hypericum perforatum) (herbal medicine used to treat depression and other problems);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (to lower 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, breast-feeding, and fertility

Cabazitaxel 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 may affect the fetus. It is recommended not to father a child during and up to 4 months after treatment and to seek 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 Tevagen contains ethanol (alcohol)

This medicine contains 1.092 mg of alcohol (ethanol) in each vial containing 6 ml of concentrate, which is equivalent to 23% vol. The amount in 6 ml of this medicine is equivalent to 27.6 ml of beer or 11.04 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

If you have alcohol dependence, liver disease, or epilepsy, consult your doctor or pharmacist before taking this medicine.

3. How to use Cabazitaxel Tevagen

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 handling and administration of cabazitaxel for doctors, nurses, and pharmacists.
• Cabazitaxel will be administered in the hospital through a drip (infusion) in 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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 fever, 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 your stomach, esophagus, or intestine (gastrointestinal perforation). This can be life-threatening.

If you experience any of the above circumstances, 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 upset, 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
• 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
• numbness, tingling, burning, or decreased sensation in hands and feet
• dizziness
• headache
• increased or decreased blood pressure
• stomach upset, heartburn, or belching
• stomach pain
• hemorrhoids
• muscle spasms
• urinating frequently or with pain
• urinary incontinence
• kidney problems
• mouth or lip ulcers
• infections or risk of infections
• high blood sugar levels
• insomnia
• confusion
• feeling anxious
• 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
• flushing of the skin
• mouth or throat pain
• rectal bleeding
• muscle 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
• bladder inflammation, which can occur when your bladder has previously been 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 Information System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cabazitaxel Tevagen

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 after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

In the section "PRACTICAL INFORMATION FOR DOCTORS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL TEVAGEN" information is included on the storage and use time of CABAZITAXEL TEVAGEN, once it has been diluted and is ready to use.

Disposal of unused medicine 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.

6. Container Contents and Additional Information

Composition of Cabazitaxel Tevagen

• The active substance is cabazitaxel. One ml of concentrate contains 2-propanol solvate of cabazitaxel equivalent to 10 mg of cabazitaxel. A 6 ml vial of concentrate contains 2-propanol solvate of cabazitaxel equivalent to 60 mg of cabazitaxel.
• The other components are citric acid, anhydrous ethanol, polysorbate 80, and macrogol (see section 2 "Cabazitaxel Tevagen contains ethanol (alcohol)").

Appearance of the Product and Container Contents

Cabazitaxel Tevagen concentrate for solution for infusion (sterile concentrate) is a clear, oily, and light yellow solution.

Cabazitaxel Tevagen is provided in a closed glass vial with a bromobutyl rubber stopper sealed with an aluminum cap with a polypropylene disc, containing 6 ml of concentrate. The vials may or may not be in a protective sleeve (a transparent, colorless, protective sheet covering the vial (sleeved) to provide additional safety measures).

Each container contains 1 vial.

Marketing Authorization Holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

Netherlands

Manufacturer

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25.

Zagreb, 10000

Croatia

or

S.C. SINDAN-PHARMA S.R.L.

11, Ion Mihalache Blvd., Sector 1,

011171, Bucharest,

Romania

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

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid),

Spain

Date of the last revision of thisleaflet: December 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

PRACTICAL INFORMATION FOR DOCTORS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL TEVAGEN 10 MG/ML CONCENTRATE 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 must not be mixed with other medicines except those used for dilutions.

.

Shelf Life and Special Precautions for Storage

Unopened vial

This medicine does not require special storage conditions.

After opening the vial

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

After dilution in the infusion bag/bottle

The chemical and physical stability of the infusion solution has been demonstrated for 48 hours at 25°C (including 1 hour of infusion time) and for 72 hours at a temperature of 2°C to 8°C (including 1 hour of 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 not normally exceed 24 hours at 2°C - 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.

Precautions for Preparation and Administration

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

If at any stage of handling, Cabazitaxel Tevagen comes into contact with the skin, wash immediately and thoroughly with water and soap. If it comes into contact with mucous membranes, rinse immediately and thoroughly with water.

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

Preparation Stages

Read this entire section carefully before diluting. Cabazitaxel Tevagen requires ONEdilution before administration. Follow the preparation instructions provided below.

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

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

Infusion Dilution

The infusion solution must be used immediately. However, the storage time in use may be longer under the specific conditions mentioned in the section Shelf Life and Special Precautions for Storage.

Each vial is for single use.

The disposal 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 Tevagen is used intravenously.

Cabazitaxel Tevagen is administered by infusion over 1 hour.

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

Do not use PVC infusion containers or polyurethane infusion sets for the preparation and administration.