Cabazitaxel Ever Pharma 10 mg/ml concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cabazitaxel Ever Pharma 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, as you may need to read it again.

? If you have any questions, ask 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.

Contents of this leaflet

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

1. What Cabazitaxel Ever Pharma is and what it is used for

The name of this medicine is Cabazitaxel Ever Pharma. Its international non-proprietary name (INN) 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 cancer cells.

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

2. What you need to know before you are given Cabazitaxel Ever Pharma

Do not use Cabazitaxel Ever Pharma:

• if you are allergic (hypersensitive) to cabazitaxel, to other taxanes, to polysorbate 80, or to any of the other ingredients 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 received or are due to receive the yellow fever vaccine.

You must not be given this medicine if any of the above apply to you. If you are unsure, consult your doctor before being treated with Cabazitaxel Ever Pharma.

Warnings and precautions

Before starting treatment with Cabazitaxel Ever Pharma, 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 this medicine.

Inform your doctor immediately:

• if you have a fever. During treatment with Cabazitaxel Ever Pharma, your white blood cell count is more likely to 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 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.
• if you have ever had any allergies. Severe allergic reactions may occur during treatment with Cabazitaxel Ever Pharma.
• if you have severe or persistent diarrhea, feel unwell (nausea), or are vomiting. Any of these conditions may lead to severe dehydration. Your doctor may need to provide treatment.
• if you experience numbness, tingling, burning, or reduced sensation in your hands and feet.
• if you have intestinal bleeding or changes in the color of your stools or stomach pain. If bleeding or pain is severe, your doctor will stop your treatment with Cabazitaxel Ever Pharma. This is because Cabazitaxel Ever Pharma may increase the risk of bleeding or the development of perforations in the intestinal wall.
• if you have kidney problems.
• if you have yellowing of the skin or eyes, dark urine, severe nausea (feeling unwell), or vomiting, as these may be signs or symptoms of liver problems.
• if you notice a significant increase or decrease in your urine volume.
• if you have blood in your urine.

If any of the above occur, inform your doctor immediately. Your doctor may reduce the dose of Cabazitaxel Ever Pharma or stop treatment.

Using Cabazitaxel Ever Pharma with other medicines

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 Ever Pharma, or Cabazitaxel Ever Pharma 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 high blood pressure);
• repaglinide (for diabetes).

While being treated with Cabazitaxel Ever Pharma, consult your doctor before receiving any vaccination.

Pregnancy, breastfeeding, and fertility

Cabazitaxel Ever Pharma must not be used in pregnant women or women of childbearing age who are not using contraception.

Cabazitaxel Ever Pharma must not be used during breastfeeding.

Use condoms during sexual intercourse if your partner is or could be pregnant. Cabazitaxel Ever Pharma may be present in semen and could affect the fetus. It is recommended not to father a child during and for at least 6 months after treatment, and to seek advice about sperm preservation before treatment, as Cabazitaxel Ever Pharma 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 Ever Pharma contains ethanol (alcohol)

4.5 ml vial

This medicine contains 19.75% p/v ethanol (alcohol), corresponding to 888.8 mg per vial, equivalent to 22.5 ml of beer or 9.4 ml of wine.

5 ml vial

This medicine contains 19.75% p/v ethanol (alcohol), corresponding to 987.5 mg per vial, equivalent to 25 ml of beer or 10.4 ml of wine.

6 ml vial

This medicine contains 19.75% p/v ethanol (alcohol), corresponding to 1,185 mg per vial, equivalent to 30 ml of beer or 12.5 ml of wine.

The amount of alcohol in this medicine is unlikely to have effects in adults and adolescents.

The alcohol content in this medicine may alter the effects of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

This medicine is harmful for people with alcoholism.

The alcohol content should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

3. How to use Cabazitaxel Ever Pharma

Instructions for use

Before receiving cabazitaxel 10 mg/ml concentrate for solution for infusion, you will be given antiallergic medications to reduce the risk of allergic reactions.

? Cabazitaxel will be administered by a doctor or nurse.

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

? Cabazitaxel will be given in the hospital through an intravenous infusion (drip) into one of your veins over approximately 1 hour.

? As part of your treatment, you will also take an oral corticosteroid medication (prednisone or prednisolone) daily by mouth.

Dosage and frequency of administration

? 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, this medicine can 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 occur if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This may cause death.

If any of the above situations 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

? 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 reduced sensation in hands and feet

? dizziness

? headache

? increase or decrease in 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

? confusion

? feeling of anxiety

? unusual sensation, 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

? muscle discomfort, disorders, weakness, or pain

? swelling of feet or legs

? chills

? nail disorders (change in nail color; nails may become detached).

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

? redness of the skin

? inflammation of the bladder, 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 (inflammation of the lungs causing cough and difficulty breathing).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Ever Pharma

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

Do not use this medicine after the expiry date stated on the packaging 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.

Do not freeze.

Multidose vials: Chemical, physical and microbiological stability of the solution has been demonstrated for 28 days after first opening of the vial, when stored below 25°C. Cabazitaxel Ever Pharma is suitable for multidose use.

Information on storage and duration of use of Cabazitaxel Ever Pharma after dilution and ready for administration is provided in the section “PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL EVER PHARMA 10 MG/ML CONCENTRATE FOR PERFUSION SOLUTION”.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Cabazitaxel Ever Pharma

The active substance is cabazitaxel. One ml of concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous equivalent to 10 mg of cabazitaxel.

Each 4.5 ml vial of concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous, equivalent to 45 mg of cabazitaxel.

Each 5 ml vial of concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous, equivalent to 50 mg of cabazitaxel.

Each 6 ml vial of concentrate for solution for infusion contains cabazitaxel monohydrate or anhydrous, equivalent to 60 mg of cabazitaxel.

Cabazitaxel Ever Pharma 10 mg/ml concentrate for solution for infusion contains an excess volume. This excess ensures that the extractable volume of 4.5 ml, 5 ml or 6 ml contains 10 mg/ml of cabazitaxel.

The other components are polysorbate 80; macrogol, citric acid; ethanol, anhydrous (see Section 2 “Cabazitaxel Ever Pharma contains alcohol”).

Nature of the product and contents of the pack

Cabazitaxel Ever Pharma 10 mg/ml is a concentrate for solution for infusion (sterile concentrate).

The concentrate is a yellowish, transparent oily solution.

A pack of Cabazitaxel Ever Pharma contains:

• A clear glass vial, closed with a grey bromobutyl rubber stopper, sealed with an aluminium cap covered with a plastic flip-off cap, containing 4.5 ml (5 ml or 6 ml) of concentrate.

Vials may or may not be included in protective overwraps.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer

EVER Pharma Jena GmbH
Otto-Schott-Straße 15
07745 Jena
Germany

EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany

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

EVER Pharma Therapeutics Spain, S.L.
C/Toledo 170
28005 Madrid
Spain

Date of the most recent revision of this leaflet:
February 2022

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/.

The following information is intended for healthcare professionals only.

PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL EVER PHARMA 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

This medicinal product does not require special storage conditions.

Do not freeze.

After first opening

Multi-dose vials: Chemical, physical and microbiological stability of the solution after first opening has been demonstrated for 28 days below 25°C. Cabazitaxel Ever Pharma is suitable for multi-dose use.

After dilution in the infusion bag/bottle

Chemical and physical stability of the infusion solution has been demonstrated for 48 hours below 25°C, including the 1-hour infusion time, and for 14 days under refrigeration (2°C–8°C), including the 1-hour 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 normally should not exceed 24 hours below 25°C, unless dilution has been carried out under controlled and validated aseptic conditions.

Preparation and administration precautions

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

As with other antineoplastic agents, caution must 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 during preparation, Cabazitaxel Ever Pharma 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.

Preparation steps

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

The following dilution process must be performed aseptically.

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

Dilution for infusion

Step 1:

Aseptically withdraw the required amount of concentrate (10 mg/ml of cabazitaxel) using a graduated syringe equipped with a needle. For example, a 45 mg dose of cabazitaxel would require 4.5 ml of concentrate.

Cabazitaxel contains an excess volume. This excess ensures that an extractable volume of 4.5 ml, 5 ml or 6 ml contains 10 mg/ml of cabazitaxel.

Step 2:

Inject the concentrate into a sterile, non-PVC container containing 5% glucose solution or 9 mg/ml (0.9%) sodium chloride infusion solution. The final concentration of the infusion solution must be between 0.10 mg/ml and 0.26 mg/ml.

Step 3:

Remove the syringe and mix the contents of the infusion bag or bottle manually by gentle swirling.

Step 4:

As with all parenteral products, the resulting infusion solution should be inspected visually before use. Since the infusion solution is supersaturated, crystallization may occur over time. In such cases, the solution must not be used and must be discarded.

The infusion solution should be used immediately. However, the in-use storage time may be longer under the specific conditions mentioned in the section Shelf life and special precautions for storage above.

Cabazitaxel must not be mixed with any medicinal products other than those specified.

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

Method of administration

Cabazitaxel is administered by 1-hour intravenous infusion.

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