Label: information for the user

JEVTANA 60 mg concentrate and solvent for solution for infusion

cabazitaxel

Read this label carefully before starting to use this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult 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 label. See section4.

The name of your medication is JEVTANA. Its common name is cabazitaxel. It belongs to a group of medications called "taxanes," used to treat cancers.

JEVTANA 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) daily by mouth. Please ask your doctor for information about this other medication.

No use JEVTANA

• 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 going to be vaccinated against yellow fever.

You should not receive JEVTANA if any of the above circumstances occur. If you are unsure, consult your doctor before receiving JEVTANA.

Warnings and precautions

Before starting treatment with JEVTANA, blood tests will be performed to check that you have enough blood cells and that your kidneys and liver are functioning properly to receive JEVTANA.

Inform your doctor immediately if:

• You have a fever. During treatment with JEVTANA, 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 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 JEVTANA, severe allergic reactions may occur.

• You have severe or prolonged diarrhea, feel unwell (nausea) or are vomiting. Any of these situations can cause severe dehydration. Your doctor should provide treatment.

• You have a sensation of numbness, tingling, burning, or decreased sensation in your hands and feet.

• You have intestinal bleeding problems or changes in the color of your stool or stomach pain. If bleeding or pain is severe, your doctor will interrupt your treatment with JEVTANA. This is because JEVTANA 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 of discomfort) or vomiting, as they may be signs or symptoms of liver problems.
• You notice a significant increase or decrease in the volume of your urine.

• You have blood in your urine.

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

Use of JEVTANA with other medications

Inform your doctor, pharmacist, or nurse if you are using or have recently used other medications, even those purchased without a prescription. This is because some medications may affect the efficacy of JEVTANA or JEVTANA 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 receiving JEVTANA treatment, consult your doctor before being vaccinated.

Pregnancy, breastfeeding, and fertility

JEVTANA is not indicated for use in women.

Use condoms in your sexual relations if your partner is or may be pregnant. JEVTANA 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 conservation before treatment, as JEVTANA may alter male fertility.

Driving and operating 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.

JEVTANA contains ethanol (alcohol)

This medication contains 573 mg of alcohol (ethanol) in each vial of solvent. The amount in the dose of this medication is equivalent to less than 11 ml of beer or 5 ml of wine. The small amount of alcohol contained in this medication does not produce any noticeable effect. If you have an alcohol addiction, liver disease, or epilepsy, consult your doctor or pharmacist before taking this medication.

Usage Instructions

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

• JEVTANA will be administered by a doctor or nurse.

• JEVTANA must be prepared (diluted) before administration. This leaflet provides practical information for the handling and administration of JEVTANA for doctors, nurses, and pharmacists.

• JEVTANA will be administered in the hospital through an infusion (infusion) into one of your 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 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.

Like all medicines, JEVTANA 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 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 increases the 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
• shortness of breath
• cough
• abdominal pain
• temporary hair loss (in most cases, hair will regrow normally)
• joint pain
• urinary tract infection
• leukopenia 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 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 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 in the skin
• red skin
• inflammation of the bladder, which may occur if your bladder has previously been exposed to radiation (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 experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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.

Do not store at a temperature above 30°C. Do not refrigerate.

In the section “INFORMATION FOR HEALTHCARE PROFESSIONALS ABOUT THE PREPARATION, ADMINISTRATION, AND HANDLING OF JEVTANA” information is included on the conservation and use time of JEVTANA, once it has been diluted and is ready for use.

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 to protect the environment.

Composition of JEVTANA

The active ingredient is cabazitaxel. One milliliter of concentrate contains 40 mg of cabazitaxel. A vial of concentrate contains 60 mg of cabazitaxel.

The other components are polysorbate 80 and citric acid in the concentrate, and ethanol 96% and water for injectable preparations in the solvent (see section 2 “JEVTANA contains ethanol (alcohol)).

Nota: both the vial of JEVTANA 60 mg/1.5 ml concentrate (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the vial of solvent (fill volume: 5.67 ml) contain an overfill to compensate for the loss of liquid during preparation. This overfill ensures that after dilution with the complete content of the provided solvent, there is a solution containing 10 mg/ml of cabazitaxel.

Appearance of the product and contents of the pack

JEVTANA is a concentrate and solvent for solution for infusion (sterile concentrate).

The concentrate is a transparent, yellow to yellow-brown oily solution.

The solvent is a transparent and colorless solution.

A pack of JEVTANA contains:

• A single-use glass vial, closed with a grey rubber stopper, sealed with an aluminum cap, covered with a greenish-clear plastic flip-off stopper, containing 1.5 ml (nominal volume) of concentrate.
• A single-use glass vial, closed with a grey rubber stopper, sealed with a golden aluminum cap, covered with an incolor plastic flip-off stopper, containing 4.5 ml (nominal volume) of solvent.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible person for manufacturing

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

65926 Frankfurt am Main

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals.

INFORMATION FOR MEDICAL PRACTITIONERS OR HEALTHCARE PROFESSIONALS ABOUT THE PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

This information complements sections 3 and 5 for the user.

Please read the entire procedure before preparing the infusion solution.

Incompatibilities

This medicine should not be mixed with other medicines except those used for dilutions.

Period of validity and special storage precautions

For the pack of JEVTANA 60 mg concentrate and solvent

Do not store above 30°C.

Do not refrigerate.

After opening the vial

The concentrate and solvent vials must 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 must be carried out in controlled and aseptic conditions (see below “Precautions for preparation and administration”).

After the initial dilutionof JEVTANA 60 mg concentrate with the complete contentof the vial of solvent:

chemical and physical stability has been demonstrated for 1 hour at room temperature.

After the final dilution in the infusion bag/bottle

chemical and physical stability of the infusion solution has been demonstrated for 8hours at room temperature (15°C - 30°C) including 1 hour of infusion time and for 48hours in the refrigerator including the infusion time.

From a microbiological point of view, the infusion solution must be used immediately. If not used immediately, the times and storage conditions are the responsibility of the user and are normally not more than 24hours at 2°C - 8°C, unless the dilution was carried out in controlled and validated aseptic conditions.

Precautions for preparation and administration

As with other anticancer agents, caution should be exercised during the preparation and administration of JEVTANA infusion solutions, taking into account the use of safety devices, personal protective equipment (e.g. gloves) and preparation procedures.

If JEVTANA 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.

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

Dilute the concentrate for infusion solution with the complete contentof the vial of solvent provided before adding it to the infusion solutions.

Preparation stages

Please read this section carefully before mixing and diluting. JEVTANA requires2dilutions before administration. Follow the preparation instructions provided below.

Nota: both the vial of JEVTANA 60 mg/1.5 ml concentrate (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the vial of solvent (fill volume: 5.67 ml) contain an overfill to compensate for the loss of liquid during preparation. This overfill ensures that after dilution with the complete content of the provided solvent, there is a solution containing 10 mg/ml of cabazitaxel.

To prepare the infusion solution, the following two-stage dilution process must be carried out aseptically.

Stage1: initial dilution of the concentrate for infusion solution with the solvent provided.

This concentrate-solvent mixture resulting from the first stage contains 10mg/ml of cabazitaxel (at least 6ml of released volume). The second dilution must be carried out immediately (within 1hour) as detailed in Stage2.

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

Stage2: final dilution (for infusion)

The infusion solution must be used immediately. However, the infusion time may be longer under the specific conditions mentioned in the sectionPeriod of validityand special storage precautions.

The unused medicine and all materials that have come into contact with it will be disposed of in accordance with local regulations.

Method of administration

JEVTANA is administered by infusion over 1hour.

The use of a 0.22micrometer pore nominal filter (also known as 0.2 micrometers) during administration is recommended.

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