Cabazitaxel tevagen 10 mg/ml concentrado para soluciÓn para perfusiÓn

Prospecto:Information for the patient

Cabazitaxel Tevagen 10 mg/ml concentrated solution for infusion

Read this prospectus carefully before starting to use this medicine,because 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 any adverse effects,consult your doctor, pharmacist, or nurse,eveniftheydo not appear in this prospectus. See section 4.

1.What is Cabazitaxel Tevagen and how it is used

2.What you need to knowbeforestarting touse Cabazitaxel Tevagen

3.How to use Cabazitaxel Tevagen

4.Possible adverse effects

5Storage of Cabazitaxel Tevagen

6.Contents of the package and additional information

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 another 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.

You should not use Cabazitaxel Tevagen if:

• you are allergic to cabazitaxel, other taxanes, polisorbate 80, or any of the other ingredients in 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 occur. If you are unsure, consult your doctor before receiving cabazitaxel.

Warnings and precautions

Before each treatment with cabazitaxel, blood tests will be performed to ensure 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. Your doctor may administer other medications to maintain your blood cell count. People with low blood 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 may cause severe dehydration. Your doctor should administer 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 yellowish 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 your daily urine volume.
• you have blood in your urine.

If any of the above circumstances occur, inform your doctor immediately. Your doctor may reduce the cabazitaxel dose or interrupt treatment.

Other medicines and Cabazitaxel Tevagen

Inform your doctor, pharmacist, or nurse if you are taking or have recently taken other medicines, including those purchased without a prescription. This is because some medicines may affect the efficacy of cabazitaxel or cabazitaxel may affect the efficacy of other medicines. These medicines 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 cabazitaxel, consult your doctor before being vaccinated.

Pregnancy,breastfeeding, and fertility

Cabazitaxel 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 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 cabazitaxel may alter male fertility.

Driving and operating 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 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 an alcohol addiction, liver disease, or epilepsy, consult your doctor or pharmacist before taking this medicine.

Usage Instructions

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

• Cabazitaxel will be administered by a doctor or a nurse.
• Cabazitaxel must be prepared (diluted) before administration. This prospect provides practical information for the manipulation 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 (intravenous) 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.

In case ofoverdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested

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 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 cause death.

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
• labored breathing
• cough
• abdominal pain
• temporary hair loss (in most cases, hair will grow back 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 heartbeats
• blood clots in the legs or lungs
• sensation of suffocation on the skin
• mouth or throat pain
• rectal bleeding
• muscle aches, disorders, weakness, or pains
• inflammation of feet or legs
• chills
• nail disorders (change in nail color; 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 on 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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging and on the labelafter CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

For information on the conservation and use time of CABAZITAXEL TEVAGEN, once it has been diluted and is ready to use, see the section “PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ABOUT THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL TEVAGEN”.

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 Tevagen

• The active ingredient is cabazitaxel. One milliliter of concentrate contains 2-propanol solvent equivalent to 10 mg of cabazitaxel. A vial of 6 milliliters of concentrate contains 2-propanol solvent equivalent to 60 mg of cabazitaxel.
• The other components are citric acid, anhydrous ethanol, polisorbate 80, and macrogol (see section 2 “Cabazitaxel Tevagen contains ethanol (alcohol)”).

Appearance of the product and contents of the pack

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 milliliters of concentrate. The vials may or may not be in a protective sleeve (a transparent, colorless protective sheet covering around the vial (sleeved) to provide additional safety measures).

Each pack contains 1 vial.

Marketing Authorization Holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

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

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid),

Spain

Last update of this leaflet: December 2023

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

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This information is intended solely for healthcare professionals:

INFORMATION FOR MEDICAL PRACTITIONERS OR HEALTHCARE PROFESSIONALS ABOUT 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 to read the entire content of this procedure before preparing the infusion solution.

Incompatibilities

This medicinal product should not be mixed with other medicinal products except those used for dilutions.

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Period of validity and special precautions for storage

Unopened vial

This medicinal product does not require special storage conditions.

After opening the vial

The concentrate for solution for infusion should 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 should be performed in controlled and aseptic conditions (see below “Precautions for preparation and administration”).

After dilution in the infusion bag/reservoir

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 should be used immediately. If not used immediately, the times and storage conditions are the responsibility of the user and should normally not be more than 24 hours at 2°C to 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 manipulation and preparation of Cabazitaxel Tevagen solutions, taking into account the use of safety devices, personal protective equipment (e.g., gloves), and preparation procedures.

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

Preparation stages

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

To prepare the infusion solution, the following two-stage dilution process should be performed in aseptic conditions.

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

Dilution for infusion

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

Each vial is for single use only.

The disposal of unused medicinal product and all materials that have been in contact with it will be carried out in accordance with local regulations.

Method of administration

Cabazitaxel Tevagen is administered intravenously.

Cabazitaxel Tevagen is administered in infusion over 1 hour.

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

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