Cabazitaxel Tevagen 10 mg/ml concentrate for infusion solution

Package Leaflet: Information for the user

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 questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Cabazitaxel Tevagen is and what it is used for
2. What you need to know before using Cabazitaxel Tevagen
3. How to use Cabazitaxel Tevagen
4. Possible side effects
5. How to store Cabazitaxel Tevagen
6. 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," which are 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) orally every day. Ask your doctor for information about this other medicine.

2. What you need to know before using Cabazitaxel Tevagen

Do not use Cabazitaxel Tevagen if:

• you are allergic to cabazitaxel, to other taxanes, to polysorbate 80, or to 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 received or are scheduled to receive the yellow fever vaccine.

You must not receive cabazitaxel if any of the above apply to you. If you are unsure, 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 functioning properly enough 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 for signs of infection. You may be given other medicines 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 inform your doctor immediately if you develop a fever.
• 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 treat you accordingly.
• 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 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 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 daily urine output.
• you have blood in your urine.

If any of the above occur, inform 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, have recently taken, or might take 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 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 cabazitaxel, consult your doctor before receiving any vaccination.

Pregnancy, breastfeeding, and fertility

Cabazitaxel 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 affect the fetus. It is recommended that you avoid fathering a child during treatment and for up to 4 months after treatment ends. You should also seek advice about sperm preservation before starting treatment, as cabazitaxel may impair male fertility.

Driving and using machines

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 Tevagen contains ethanol (alcohol)

This medicine contains 1,092 mg of alcohol (ethanol) per 6 ml concentrate vial, 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 contained in this medicine does not produce any noticeable effect.

If you are alcohol-dependent, or have 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 antiallergic 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 patient information leaflet provides practical guidance on the handling and administration of cabazitaxel for doctors, nurses, and pharmacists.
• Cabazitaxel will be given to you in the hospital by intravenous infusion (through 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.

Dosage and frequency

• 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.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 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 can be fatal.

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 kidney 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
• 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 blood potassium levels
• ringing in the ears
• sensation of warmth in the skin
• redness of the skin
• bladder inflammation, which may occur when your bladder has previously been exposed to radiotherapy (radiation recall cystitis)

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

• interstitial lung disease (lung inflammation causing cough and difficulty breathing)

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the container and label, following CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

The section titled “PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL TEVAGEN” includes information regarding the storage and duration of use of CABAZITAXEL TEVAGEN once it has been diluted and is ready for use.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Cabazitaxel Tevagen

• The active substance is cabazitaxel. One ml of concentrate contains cabazitaxel 2-propanol solvate equivalent to 10 mg of cabazitaxel. A 6 ml vial of concentrate contains cabazitaxel 2-propanol solvate 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 contents of the pack

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

Cabazitaxel Tevagen is supplied in a glass vial closed with a bromobutyl rubber stopper sealed with an aluminium cap with a polypropylene disc, containing 6 ml of concentrate. Vials may or may not be in a protective overwrap (a transparent, colourless protective sleeve covering the vial (overwrapped) to provide additional safety measures).

Each pack contains 1 vial.

Marketing Authorisation Holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

The 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas (Madrid),

Spain

Date of the most recent revision of this leaflet: December 2023

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

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This information is intended for healthcare professionals only:

PRACTICAL INFORMATION FOR PHYSICIANS 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 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

Unopened vial

This medicinal product 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-step dilution process must be carried out under controlled and aseptic conditions (see below “Preparation and administration precautions”).

After dilution in the infusion bag/bottle

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 standpoint, the infusion solution should be used immediately. If not used immediately, 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 has been carried out under controlled, validated aseptic conditions.

Precautions for preparation and administration

As with other antineoplastic agents, caution must be exercised during 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 contact occurs with mucous membranes, rinse immediately and thoroughly with water.

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

Preparation steps

Read carefully ALL of this section before diluting. Cabazitaxel Tevagen requires ONE dilution step before administration. Follow the preparation instructions provided below.

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

More than one vial of concentrate may be needed 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 section Shelf life and special precautions for storage.

Each vial is for single use only.

Any unused medicinal product and waste materials that have come into contact with it should be disposed of in accordance with local regulations.

Method of administration

Cabazitaxel Tevagen is administered by intravenous route.

Cabazitaxel Tevagen is administered as a 1-hour infusion.

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

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