Patient Information

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

Read this entire 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The name of this medicine isCabazitaxel Ever Pharma. Its common name is “cabazitaxel”. It belongs to a group of medicines called “taxanes”, used to treat cancers.

Cabazitaxelis used for the treatment of prostate cancer that has progressed after receiving another chemotherapy. It acts 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.

No useCabazitaxel Ever Pharma:

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

This medication should not be administered if any of the above circumstances occur. If you are unsure, consult your doctor before being treated with Cabazitaxel Ever Pharma.

Warnings and precautions

Before starting treatment with Cabazitaxel Ever Pharma, blood tests will be performed to check that you have sufficient 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 infections. You may be given 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.

If you have ever had any allergy. During treatment with Cabazitaxel Ever Pharma, severe allergic reactions may occur.

If you have severe diarrhea or are feeling unwell (nausea) or are vomiting. Any of these situations may cause severe dehydration. Your doctor should provide treatment.

If you have numbness, tingling, burning, or decreased sensation in your hands and feet.

If you have intestinal bleeding problems or changes in your stool color 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 intestinal wall perforations.

If you have kidney problems.

If you have yellowish skin and eyes, dark urine, intense 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 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 may 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) (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 being treated with Cabazitaxel Ever Pharma, consult your doctor before being vaccinated.

Pregnancy, breastfeeding, and fertility

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

Cabazitaxel Ever Pharma should not be used during breastfeeding.

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

Driving and operating machinery

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

Cabazitaxel Ever Pharma contains ethanol (alcohol)

Vial 4.5 ml

This medication contains 19.75% w/v of ethanol (alcohol), corresponding to 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 of ethanol (alcohol), corresponding to 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 of ethanol (alcohol), corresponding to 1,185 mg in each vial, equivalent to 30 ml of beer or 12.5 ml of wine.

The amount of alcohol present in this medication is unlikely to 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 women or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

Usage Instructions

Before receiving cabazitaxel 10 mg/ml concentrate for infusion solution, they will administer 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 prospectus provides practical information for the handling and administration of this medication for doctors, nurses, and pharmacists.

?Cabazitaxel will be administered in thehospital via an infusion set (infusion) in one of its veins (intravenous route) for approximately 1 hour.

?As part of your treatment, you will also take a corticosteroid medication (prednisone or prednisolone) orally every day.

How much andhow 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.

Like all medicines, this medicine 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 (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 be fatal.

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):

. altered taste

.shortness of breath

.cough

.abdominal pain

.hair loss (in most cases, the hair will regrow 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

?abdominal 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 levels

.insomnia

?confusion

?sensation of anxiety

?sensation of numbness, tingling, burning, or decreased sensation or pain in hands and feet

?balance problems

?rapid or irregular heartbeat

?blood clots in the legs or lungs

?sensation of suffocation in the skin

?mouth or throat pain

?rectal bleeding

?muscle aches, disorders, weakness, or muscle pain

?inflammation of the feet or legs

?chills.

. nail disorders (change in color of your nails; your nails may fall off).

Uncommon(may affect up to 1 in 100 people):

.low potassium levels in the blood

.tinnitus in the ears

.sensation of heat in the skin

.red skin

?inflammation of the bladder, which may occur when your bladder has been previously exposed to radiation therapy (radiation-induced 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 the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require special storage conditions.

Do not freeze.

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

Information on the conservation and use time of CabazitaxelEVER Pharma, once it has been diluted and is ready to use, can be found in the section “PRACTICAL INFORMATION FOR MEDICAL PROFESSIONALS ABOUT THE PREPARATION, ADMINISTRATION, AND HANDLING OF CABAZITAXEL EVER PHARMA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION”.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. These measures will help protect the environment.

Composition ofCabazitaxelEvere Pharma

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

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

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

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

CabazitaxelEver Pharma 10 mg/ml concentrate for infusion solutioncontains an excess of 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 “CabazitaxelEver Pharmacontains alcohol”).

Appearance of the productandcontents of the package

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

The concentrate is a transparent, yellowish oily solution.

A package of CabazitaxelEver Pharmacontains:

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

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

Not all package sizes may be marketed.

Marketing authorization 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

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

EVER Pharma Therapeutics Spain, S.L.

C/Toledo 170

28005 Madrid

Spain

Date of the last review of this leaflet:

February 2022

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

The following information is intended only for healthcare professionals.

INFORMATION FOR DOCTORS OR HEALTHCARE PROFESSIONALS ABOUT THE PREPARATION, ADMINISTRATION AND HANDLING OF CABAZITAXEL EVER PHARMA 10 MG/ML CONCENTRATE FOR INFUSION SOLUTION

This information complements sections 3 and 5 for the user.

Please 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.

Period of validity and special precautions for storage

This medicinal product does not require special storage conditions.

Do not freeze.

After the first opening

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

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 in the refrigerator, including the 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 below 25°C, unless the dilution has been performed in 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 women should not handle it.

Like 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 cabazitaxelEver Pharmacomes 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

Please readALLthis section.CabazitaxelrequiresONEdilution before administration. Follow the preparation instructions provided below.

To prepare the infusion solution, the following dilution process must 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

Stage 1:

Aspirate aseptically the required amount of concentrate (10 mg/ml of cabazitaxel), with a graduated syringe, provided with a needle. For example, a dose of 45 mg ofcabazitaxelwould require 4.5 ml of concentrate.

Cabazitaxel contains an excess of 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 PVC-free sterile container a solution of 5% glucose or a 0.9% sodium chloride infusion solution. The concentration of the infusion solution must be between0.10 mg/ml and 0.26 mg/ml.

Stage 3:

Remove the syringe and mix the contents of the infusion bag or bottle manually, by shaking.

Stage 4:

Like all parenteral products, the resulting infusion solution should be visually inspected before use. As 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 storage time in use may be longer under the specific conditions mentioned in the section ofPeriod of validity and special precautions for storagementioned above

Cabazitaxelshould not be mixed with other medicinal products other than those mentioned.

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

Method of administration

Cabazitaxelis administered by infusion over 1 hour.

Infusion bags or bottles made of PVC or polyurethane infusion sets should not be used for the preparation and administration of theinfusion solution.