InfoCons Consumer Protection informs you – JEVTANA – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains impo rtant information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor , pharmacist or nur se.
• If you get any side effects talk to your doctor , pharmacist or nurse . This includes any possible side eff ects not listed in this leaflet. See section 4.

What is i n this leaflet 1. What JEVTANA is and what it is used for 2. What you need to know b efore you are given JEVTANA 3. How to use JEVTANA 4. Possible side effects 5. How to store JEVTANA 6. Contents of t he pack and other information

ℹ️ 1. What JEVTANA is and what it is used for

The name of your medicine is JEVTANA. Its common name is cabazi taxel. It belongs to a group of medicines called “taxanes” used to treat cancers.

JEVTANA is used to treat prostate c ancer that has progressed after having had other chemotherapy . It works by stopping cells from growing and multiplying.

As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day . Ask your docto r to give you information about this other medicine .

⚠️ 2. What you need to know before you are given JEVTANA

Do not use JEVTANA if

• you are allerg ic (hypersensiti ve) to cabazitaxel , to other taxanes, or polysorbate 80 or any of the other excipients of this m edicine (listed in section 6),
• the number of your white blood cells is too low (neutrophil counts less than or equal to 1,500 /mm 3),
• you have severe abnormal liver function,
• you have recently received or are about to receive a vaccine against yellow fever .

You should not be given JEVTANA if any of the above apply to you. If you are not sure, talk to your doctor before having JEVTANA.

Warnings and precautions

Before each treatment with JEVTANA, you will have blood tests to check that you have enough blo od cells and sufficient liver and kidney functions to receive JEVTANA.

Tell your doctor immediately if :

• you have fever. During treatment with JEV TANA, it is more likely that your white blood cell count may be reduced. Your doctor will monitor your blood and general condition for signs of 36 infections. He /she may give you other medicines to maintain the number of your blood cells.

People with low blood counts can develop life -threatening infections. The earliest sign of infection may be fever, so if you expe rience fever, tell your doctor right away.

• you have ever had any allergies . Serious allergic reactions can occur during treatment with JEVTANA.
• you have severe or long- lasting diarrhoea, you feel sick (nausea ) or you are being sick (vomiting ). Any of t hese events could cause severe dehydration. Your doctor may need to treat you.
• you have feeling of numbness , tingling, burning or decreased sensati on in your hands or feet .
• you have any bleeding problems from the gut or have changes in the colour of your sto ol or stomach pain . If the bleeding or pain is severe, your doctor will stop your treatment with JEVTANA. This is because JEVTANA may increase t he risk of bleeding or developing holes in the gut wall.
• you have kidney problems .
• you have yellowing of t he skin and eyes , darkening of the urine, severe nausea (feeling sick) or vomiting, as they could be signs or symptoms of liver problems.
• you expe rience any significant increase or decrease in daily urinary volume.
• you have blood in your urine.

If any of the above applies to you, tell your doctor immediately. Your doctor may reduce the dose of JEVTANA or stop the treatment.

Other medicines and J EVTANA

Please tell your doctor , pharmacist or nurse if you are taking or have recently taken any other medi cines. This includ es medicines obtained without a prescription. This is because some medicines can affect the way JEVTANA works or JEVTANA can affe ct how other medicines work. These medicines include the following:

• ketoconazole, rifampicin (for infection s);
• carbamazepine, phenobarbital or phenytoin ( for seizures) ;
• St John’s Wort (Hypericum perforatum ) (herbal remedy for depression and other conditions );
• statins (such as simvastatin, lovastatin, a torvastatin, rosuvastatin, or pravastatin ) (for redu cing the cholesterol in your blood) ;
• valsartan (for hypertension );
• repaglinide ( for diabetes ).

Talk to your doctor before getting vaccinations while you are receiving JEVTANA.

Pregnancy, breast -feeding and fertility JEVTANA is not indicated for u se in women .

Use a condom during sex if your partner is or could become pregnant. JEVTANA could be present in your semen an d may affect the foetus. You are advised not to father a child during and up to 4 months after treatment and to seek advice on conservation of spe rm prior to treatment because JEVTANA may alter male fertility.

Driving and using machines

37 You may feel tired or dizzy when having this medicine. If this ha ppens, do not drive or use any tools or machines until you feel better .

JEVTANA cont ains ethano l (alcohol) This medicine contains 573 mg of alcohol (ethanol) in each solvent vial. The amount in the dose of this medicine is equivalent to less than 1 1 ml beer or 5 ml wine. The small amount of alcohol in this medicine will not have any noti ceable effects. If you are addicted to alcohol, have liver disease or epilepsy, talk to your doctor or pharmacist befor e taking this medicine.

💊 3. How to use JEVTANA

Instructions for use Anti-allergic medicines will be given to you before you have JEVTANA to reduce t he risk of allergic reactions.

• JEVTANA will be given to you by a doctor or a nurse.
• JEVTANA must be prepare d (diluted) before it is given. Practical information for handling and administration of JEVTANA for doctors, nurses and pharmacists is provided wi th this lea flet.
• JEVTANA will be given by a drip (infusion) into one of your veins (intravenous use) in hospital for about an hour.
• As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth e very day.

How much and how often to have

• The usual dose depends on your body surface area. Your doctor will calculate your body surface area in square meters (m²) and will decide the dose you should have.
• You will usually have an infusion once every 3 weeks.

If you have any further questions on the use of this medicine , ask your doctor , pharmacist or nurse .

❗ 4. Possibl e side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss the se with you and will explain the potential risks and benefits of your treatment.

See a doctor immediately if you notice any of the following side effect s:

• fever (high temperature). This is common ( may affect up to 1 in 10 people ).
• severe loss of body fl uids (dehydration). This is common ( may affect up to 1 in 10 people ).

This can occur if you have severe or long- lasting diarrhoea, or fever, or if you are being sick (vomiting).

• severe stomach pain or stomach pain that doesn’t go away. This can occur if you have a hole in the stomach, food pipe, gut or bowel (gastrointestinal perforation) . This can lead to death .

If any of the above applies to you, tell your doctor immediately.

38 Other side effects include:

Very common ( may affect more than 1 in 10 people )

• decrease in the number of red (anaemia), or white blood cells (which are i mportant in fighting infection)
• decrease in the number of platelets (which results in increased risk of bleeding)
• loss o f appetite (anorexia)
• stomach upsets including feeling sick (nausea ), being sick ( vomiting ), diarrhoea or constipation
• back pain
• blood in the urine
• feeling tired , weak or lack of energy .

Common (may affect up to 1 in 10 people )

• alteration of taste
• shortness of breath
• cough
• abdominal pain
• short term hair loss ( in most cas es normal hair growth should return)
• joint pain
• urinary tract infection
• lack of white blood cells associated with fever and infection
• feeling of numbness , tingling, burning or decreased sensations in hands and feet
• dizziness
• headache
• decrease or increase in blood pressure
• uncomfortable feeling in the stomach, heart burn or belching
• stomach pain
• haemorrhoids
• muscle spasm
• painful or frequent urination
• urinary incontinence
• kidney disease or problems
• sore in the mouth or on lips
• infections or risk of infecti ons
• high blood sugar
• insomnia
• mental confusion
• feeling anxious
• abnormal feeling or loss of sensation or pain in hands and feet
• trouble with balance
• rapid or irregular heartbeat
• blood clot in the leg or in the lung
• skin feeling flushed
• pain in mouth or th roat
• rectal bleeding
• muscle discomfort, aches , weakness or pain
• swelling of the f eet or leg s
• chills .
• nail dis order (change in the colour of your nails ; nails may detach )

Uncommon (may affect up to 1 in 100 people)

• low blood potassium
• ringin g in the ea r 39 • skin feeling hot
• redness of the skin
• inflammation of the bladder, which can occur when your bladder has bee n previously exposed to radiation therapy (cystitis due to radiation recall phenomenon).

Frequency not known (cannot be estimated from the availab le data) :

• interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store JEVTANA

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

Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vials after EXP. The expiry date refers to the last day of that month.

Do not store above 30° C. Do not ref rigerate .

Information about storage and the time t o use JEVTANA, once it has been diluted and is ready to use , is described in the sect ion “ Practi cal information for medical or healthcare professionals on preparation, administration and handling of Jevtana“.

Any unused product or waste material should be disposed of in accordance with local requirements.

These measures will help to protect the envi ronment.

📦 6. Contents of the pack and other information

What JEVTANA contains

The active substance is cabazi taxel. One ml of concentrate contains 40 mg cabazitaxel. One vial of concentrate contains 60 mg cabazitaxel.

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

Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and t he solvent vial (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation. This overfi ll ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel.

What JEVTA NA looks like and contents of the pack

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

The concentrate is a clear yellow to brownish -yellow oily solution.

The solvent is a clear and colourless solution.

One pack of JEVTANA contains: − One single use clear glass vial , closed with a grey rubber stopper sealed by a n aluminium cap with a light green plastic flip -off cover , containing 1.5 ml (nominal volume) concentrate . − One single use clear glass vial , closed wit h a grey rubber stopper sealed by a gold colou r aluminium cap with a colourless plastic flip -off cover , containing 4.5 ml (nominal volume) solvent.

40 Marketing Authorisation Holder Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France Manufa cturer Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Germany For any information abo ut this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 ( Belgique/Belgien) Česká republika sanofi- aventis, s.r.o.

Tel: +420 233 086 111 Magyarország SANOFI -AVENTIS Z rt., Tel.: +36 1 505 0050 Danmark Sanofi A/S Tlf: +45 45 16 70 00 Malta Sanofi S. r.l Tel: +39 02 39394275 Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 996 Tel. aus dem Auslan d: +49 69 3 05 70 13 Nederland Sanofi B.V.

Tel: +31 20 245 4000 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge sanofi- aventis Norge AS Tlf: +47 67 10 71 00 Ελλάδα Sanofi- Aventis Μονοπρόσωπη AEBE Τηλ: +30 210 900 16 00 Österreich sanofi- aventis GmbH Tel: +43 1 80 185 – 0 España sanofi-aventis, S.A. Tel: +34 93 485 94 00 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00 France Sanofi Winthrop Indust rie Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23 Portugal Sanofi – Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400 41 Hrvatska Swixx Biopharma d.o.o.

Tel: +385 1 2078 500 România Sanofi Rom ania SRL Tel: +40 (0) 21 317 31 36 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00 Slovenija Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00 Ísland Vistor hf.

Sími : +354 535 7000 Slovenská republika Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600 Italia Sanofi S.r .l.

Tel: +39.800 .536389 Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 Κύπρος C.A. Papaellinas Ltd.

Τηλ: +357 22 741741 Sverige Sanofi AB Tel: +46 (0)8 634 50 00 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50 United Kingdom (Northern Ireland) sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525 This leaflet was last revised in MMM/YYYY.

Other sources of information Detailed information on this medicine is available on the Eur opean Medicines Agency web site: http://www.ema.europa.eu .

🩺 Information intended for healthcare professionals only

PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION This inf ormation supplements sections 3 and 5 for the user.

It is important that you read the entire content of this procedure prior to the preparation of the infusion solution.

Incompatibilities This medicine must not be mixed with other medicines excep t those used fo r the dilutions.

Shelf life and s pecial precautions for storage For the pack of JEVTANA 60 mg concentrate and solvent Do not store above 30° C.

Do not refrigerate.

After opening The con centrate and solvent vials must be used immediately. If not used immediately, in -use storage times and conditions are the responsibility of the user. From a micr obiological point of view, the two-step dilution process must take place in controlled and aseptic conditions (see below “Preparation and administration precautions”).

After initial dilution of JEVTANA 60 mg concentrate with the entire contents of the solvent vial chemical and physical in- use stability has been demonstrated for 1 hour at ambient t emperature.

After final dilution in the infusion bag/bottle Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (15°C – 30°C) including the 1- hour infusion time and for 48 hours at refrigerated conditions including the 1- hour infusion time .

From a microb iological point of view, the infusion solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hour at 2°C – 8°C, unless dilution has taken place in controlled and validated aseptic conditons.

Preparation and administration precau tions As for any other antineoplastic agent, caution should be exercised when handling and preparing JEVTANA solutions, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.

If JEVTANA, at any step of its handling, should come into contact with the skin, wash immediately and thoroughly with soap and water. If it should come into contact with mu cous membranes, wash immediately and thoroughly with water.

JEVTANA should only be prepared and administered by personnel trained in handling cytotoxic agents. Pregnant staff should not handle i t.

Always dilute the concentrate for solution for infusion w ith the entire supplied solvent before adding to infusion solutions.

Preparation steps Read this ENTIRE section carefully before mixing and diluting. JEVTANA requires TWO dilutions prior to adm inistration. Follow the preparation instructions provided below.

Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitax el/1.83 ml) and the solvent vial (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation. This overfill ensures that af ter dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel .

The following two-step dilution process must be carried out in an aseptic manner for preparing the solution for infusion.

Step 1: Initia l diluti on of the concentrate for solution for infusion with the supplied solvent.

Step 1.1 Inspect the concentrate vial and the supplied solvent. The concentrate solution and the solvent should be clea r.

Step 1.2 Using a syringe fitted wit h a need le, aseptically withdraw the entire contents of the supplied solvent by partially inverting t he vial.

Step 1.3 Inject the entire contents into the corresponding concentrate vial.

To limi t foaming as much as possible when injecting the solv ent, dir ect the needle onto the inside wall of the vial of concentrate solution and inject slowly.

Once reconstituted, the resultant solution contains 10 mg/ml of cabazitaxel.

Solvent vial Concentrate vial (60 mg – 1.5 ml) Solvent vial Solvent vial Concentrate – solvent mixture 10 mg/ml 44 Step 1.4 Remove the syringe and needle and mix manually and gently by repeated inversions until obtaining a clear and homogeneous solution. It could take approximately 45 seconds.

Step 1.5 Let this solution stand for approximately 5 minutes and check then that the solution is homogeneous and clear.

It is normal for fo am to pe rsist after this time period.

This resulting concentrate -solvent mixture contains 10 mg/ml of cabazitaxel (at least 6 ml deliverable volume). The second dilution should be done immediately ( within 1 hour) as detailed in Step 2.

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

Step 2: S econd (final) d ilution for infusion Step 2.1 Aseptically withdraw the required amount of concentrate- solvent mixture (10 mg/ml of cabazitaxel), with a graduated s yringe fitted with a needle. As an example, a dose of 45 mg JEVTANA would require 4.5 ml of t he concentrate solvent mixture prepared following Step 1.

Since foam may persist on the wall of the vi al of this solution, following its preparation described in Step 1, it is preferable to place the needle of the syringe in the middle when extracting.

Concentrate -solvent mixture 10 mg/ml Concentrate -solvent mixture 10 mg/ml Concentrate -solvent mixture 10 mg/ml 45 Step 2.2 Inject in a sterile PVC -free container of ei ther 5% glucose solution or sodium chlori de 9 mg/ml (0.9%) solution for infusion. The concentr ation of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.

Step 2.3 Remove the syringe and mix the content of the infusion bag or bottle manually using a rocking motion.

Step 2.4 As with all parenteral products, the resulting infusion solution should be visually inspected prior to use. As the infusion solution is supersaturat ed, it may crystallize over time. In this case, the solution must not be used and should be discarded.

The infusion solution should be used immediate ly. Howe ver, in- use storage time can be longer under specific conditions mentioned in section Shelf l ife and special precautions for storage above .

Any unused medicinal product or waste material should be disposed of in accordance with local requirements .

Metho d of administration JEVTANA is administered as a 1 hour infusion.

An in -line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) is recommended during administration.

PVC infusion containers or polyurethane infusion se ts shoul d not be used for the preparation and administration of the infusion solution.

Required amount of concentrate- solvent mixture 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information JEVTANA (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/11/676).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.