CABAZITAXEL EVER PHARMA 10 mg/mL concentrate for infusion solution

Introduction

Prospect: Information for the User

Cabazitaxel Ever Pharma 10 mg/ml Concentrate for Solution for Infusion

Read the entire prospectus carefully before starting to use this medication, as 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects that do not appear in this prospectus. See section 4.

Contents of the Prospectus

1. What is Cabazitaxel Ever Pharma and what is it 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. Storage of Cabazitaxel Ever Pharma
6. Contents of the package and additional information

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

The name of this medication is Cabazitaxel Ever Pharma. Its common name is "cabazitaxel". It belongs to a group of medications called "taxanes", used to treat cancers.

Cabazitaxel is used for the treatment of 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 medication (prednisone or prednisolone) orally every day. Ask your doctor for information about this other medication.

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

Do not useCabazitaxel Ever Pharmaif:

? you are allergic (hypersensitive) to cabazitaxel, other taxanes, polysorbate 80, or any of the other components of this medication (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 will be vaccinated against yellow fever.

This medication should not be administered to you if any of the above circumstances apply. 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 to receive this medication.

Inform your doctor immediately:

? if you have a fever. During treatment with Cabazitaxel Ever Pharma, 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. You may be given other medications to maintain your blood cell count. People with low cell counts can develop life-threatening infections. The first sign of infection may be a fever, so if you have a fever, inform your doctor immediately.

? if you have ever had any allergy. During treatment with Cabazitaxel Ever Pharma, severe allergic reactions can occur.

? if 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 provide treatment.

? if you have a sensation of numbness, tingling, burning, or decreased sensation in your hands and feet.

? if you have any bleeding problems in the intestine or have 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 Ever Pharma. This is because Cabazitaxel Ever Pharma may increase the risk of bleeding or development of perforations in the intestinal wall.

? if you have kidney problems.

? if 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.

? if you notice that the volume of your urine increases or decreases significantly.

? if you have blood in your urine.

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

Use of Cabazitaxel Ever Pharma with other medications

Inform your doctor, pharmacist, or nurse if you are using or have recently used other medications, including those purchased without a prescription. This is because some medications can affect the efficacy of Cabazitaxel Ever Pharma or Cabazitaxel Ever Pharma may affect the efficacy of other medications. These medications include:

• ketoconazole, rifampicin (for infections);
• carbamazepine, phenobarbital, or phenytoin (for seizures);
• St. John's Wort or hypericum (Hypericum perforatum) (a herbal remedy used to treat depression and other problems);
• 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 getting vaccinated.

Pregnancy, Breastfeeding, and Fertility

Cabazitaxel Ever Pharma should not be used in pregnant women or women of childbearing age who do not use contraceptives.

Cabazitaxel Ever Pharma should not be used during breastfeeding.

Use condoms during sexual intercourse if your partner is or may be pregnant. Cabazitaxel Ever Pharma may be present in your semen and can affect the fetus. It is recommended not to father a child during and up to 6 months after treatment and to seek information about sperm preservation before treatment, as Cabazitaxel Ever Pharma may alter male fertility.

Driving and Using Machines

During treatment with this medication, you may feel tired or dizzy. If this happens, do not drive or use tools or machines until you feel better.

Cabazitaxel EverPharma contains ethanol (alcohol)

Vial 4.5 ml

This medication contains 19.75% w/v ethanol (alcohol), which corresponds to an amount of 888.8 mg in each vial, equivalent to 22.5 ml of beer or 9.4 ml of wine.

Vial 5 ml

This medication contains 19.75% w/v ethanol (alcohol), which corresponds to an amount of 987.5 mg in each vial, equivalent to 25 ml of beer or 10.4 ml of wine.

Vial 6 ml

This medication contains 19.75% w/v ethanol (alcohol), which corresponds to an amount of 1185 mg in each vial, equivalent to 30 ml of beer or 12.5 ml of wine.

It is unlikely that the amount of alcohol present in this medication will have effects in adults and adolescents.

The amount of alcohol in this medication may alter the effects of other medications. Consult your doctor or pharmacist if you are taking other medications.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of 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 anti-allergic 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 prospectus provides practical information for the handling and administration of this medication 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 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 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.

4. Possible side effects

Like all medications, this medication can 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 medical attention 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 occur if you have severe or persistent diarrhea, or if you have been vomiting.

? severe stomach pain or stomach pain that does not resolve. This can occur if you have a perforation in the stomach, esophagus, or intestine (gastrointestinal perforation). This can be life-threatening.

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 (resulting 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):

? 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 infection

? sensation of 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

? frequent or painful urination

? urinary incontinence

? kidney problems or changes

? mouth or lip ulcers

? infections or risk of infections

? elevated blood sugar levels

? insomnia

? mental confusion

? feeling of anxiety

? strange sensation 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 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

? sensation of heat on the skin

? red skin

? inflammation of the bladder, which can occur when the bladder has been previously exposed to radiation (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 side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects that do not appear in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cabazitaxel Ever Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and on the label of the vials after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not freeze.

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

In the section "PRACTICAL INFORMATION FOR DOCTORS OR HEALTHCARE PROFESSIONALS ON THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL EVER PHARMA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION" is included information on the storage and use time of Cabazitaxel EVER Pharma, once it has been diluted and is ready to use.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition ofCabazitaxelEvere 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").

Appearance ofthe productandcontainer contents

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

The concentrate is a clear, yellowish oily solution.

A pack of Cabazitaxel Ever Pharma contains:

• A transparent 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.

The vials may or may not be included in protective sleeves.

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 last revision of this leaflet:

February 2022

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

The following information is intended for healthcare professionals only.

PRACTICAL INFORMATION FOR DOCTORS 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 essential that you 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 dilutions.

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 1 hour infusion time, and for 14 days in the refrigerator, including infusion time.

From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user and normally should not exceed 24 hours below 25°C, unless the dilution has been performed under controlled and validated aseptic conditions.

Precautions for preparation and administration

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

As with other antineoplastic agents, caution should 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 of preparation, Cabazitaxel Ever Pharma 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.

Preparation stages

Read this entire section carefully. Cabazitaxel requires ONEdilution 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 necessary to administer the prescribed dose.

Dilution for infusion

Stage 1:

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

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

Stage 2:

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

Stage 3:

Remove the syringe and mix the contents of the infusion bag or bottle manually by rocking motion.

Stage 4:

As with all parenteral products, the resulting infusion solution should be visually inspected before use. Since the infusion solution is supersaturated, it may crystallize over time. In this case, the solution should not be used and should 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 Shelf life and special precautions for storagesection mentioned above.

Cabazitaxel should not be mixed with other medicinal products except those mentioned.

Disposal of unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.

Method of administration

Cabazitaxel is administered by infusion over 1 hour.

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