JEVTANA 60 mg Концентрат Для Приготовления Раствора Для Инфузий

Содержание инструкции

1. JEVTANA 60 mg concentrate and solvent for infusion solution
   1. What is JEVTANA and what is it used for
   2. What you need to know before you use JEVTANA
   3. How to use JEVTANA
   4. Possible side effects
   5. How to store JEVTANA
   6. Content of the pack and other information

JEVTANA 60 mg concentrate and solvent for infusion solution

cabazitaxel

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
• 1. What JEVTANA is and what it is used for
• 2. What you need to know before you use JEVTANA
• 3. How to use JEVTANA
• 4. Possible side effects
• 5. How to store JEVTANA
• 6. Contents of the pack and other information

1. What is JEVTANA and what is it used for

The name of the medicine is JEVTANA. The common name is cabazitaxel. It belongs to a group of
medicines called “taxanes” used to treat cancer.
JEVTANA is used for the treatment of prostate cancer that has progressed after receiving other
chemotherapeutic treatments. It works by blocking the growth and proliferation of cells.
As part of the treatment, you will also take a corticosteroid (prednisone or
prednisolone) orally every day. Consult your doctor for information about this second medicine.

2. What you need to know before you use JEVTANA

Do not use JEVTANA if:

• you are allergic to cabazitaxel, to other taxanes or to polysorbate 80 or to any of the other ingredients of this medicine (listed in section 6),
• your white blood cell count is too low (neutrophil count of 1 500/mm³ or less),
• you have severe impaired liver function,
• you have recently received or are about to receive the yellow fever vaccination. If any of these apply to you, do not receive JEVTANA. If you are unsure, consult your doctor before using JEVTANA. Warnings and precautionsBefore each treatment with JEVTANA, you will need to have blood tests to check that your blood cells are sufficient and that your liver and kidney function are such as to allow the administration of JEVTANA. Tell your doctor immediately:
• if you have a fever. During treatment with JEVTANA, your white blood cell count is more likely to decrease. Your doctor will monitor your blood and your overall condition to identify any signs of infection. They may give you other medicines to keep your

blood cell count stable. People with a low number of blood cells
may develop potentially life-threatening infections. The first sign of an infection may
be a fever, so tell your doctor immediately if you have a fever;

• if you have ever had any allergies. Serious allergic reactions may occur during treatment with JEVTANA;
• if you suffer from severe or prolonged diarrhoea, if you have nausea or vomiting. Each of these events can cause severe dehydration. Your doctor may consider it necessary to subject you to treatment;
• if you have a sensation of numbness, tingling, burning or reduced sensitivity in your hands or feet;
• if you have intestinal bleeding or have noticed changes in the colour of your stools or stomach pain. If the bleeding or pain is severe, your doctor will stop treatment with JEVTANA. This is because JEVTANA may increase the risk of bleeding or the development of perforations in the wall of the intestine;
• if you suffer from kidney problems;
• if you develop liver problems during treatment;
• if you notice yellowing of the skin and eyes, darkening of the 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 daily urine output;
• if 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 treatment. Other medicines and JEVTANATell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including those available without a prescription. This is because some medicines may affect how JEVTANA works or JEVTANA may affect the effect of other medicines. These medicines include the following:
• ketoconazole, rifampicin (for infections);
• carbamazepine, phenobarbital or phenytoin (for epileptic seizures);
• St John's wort (Hypericum perforatum) (herbal product for depression and other conditions);
• statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (for reducing blood cholesterol);
• valsartan (for high blood pressure);
• repaglinide (for diabetes). Consult your doctor before receiving any vaccination during treatment with JEVTANA. Pregnancy, breastfeeding and fertilityJEVTANA is not indicated for use in women. Use a condom during sexual intercourse if your partner is pregnant or may become pregnant. JEVTANA may be present in semen and have adverse effects on the foetus. It is recommended not to conceive a child during treatment and for 4 months afterwards and to seek advice on sperm preservation before treatment, as JEVTANA may alter male fertility. Driving and operating machineryDuring taking this medicine you may feel tired or dizzy. If this happens, do not drive vehicles or use machinery until you feel better.

JEVTANA contains ethanol (alcohol)
This medicine contains 573 mg of alcohol (ethanol) in each vial of solvent. The amount in
a dose of this medicine is equivalent to less than 11 mL of beer or 5 mL of wine. The small amount
of alcohol in this medicine will have no noticeable effect. If you are alcohol dependent, if you suffer from
liver disease or epilepsy, ask your doctor or pharmacist before taking this medicine.

3. How to use JEVTANA

Instructions for use
Before starting treatment with JEVTANA, you will need to take anti-allergic medications to reduce the
risk of allergic reactions:

• JEVTANA will be administered to you by a doctor or nurse.
• JEVTANA must be prepared (diluted) before being administered. This leaflet contains practical information on the handling and administration of JEVTANA for doctors, nurses and pharmacists.
• JEVTANA will be administered to you in hospital via intravenous infusion (intravenous infusion) lasting approximately 1 hour.
• As part of the treatment, you will also take a corticosteroid (prednisone or prednisolone) orally daily. What doses and how often is the administration
• The usual dose depends on the body surface area. The doctor will calculate the body surface area in square meters (m²) and decide what dose you should be given.
• Normally you will be given an infusion every 3 weeks.

If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You will discuss these with your doctor, who will also explain the potential risks and
benefits of treatment.

Seek medical attention immediately if you notice any of the following side effects:

• fever (high body temperature). This is a common effect (may affect up to 1 in 10 people);
• severe loss of body fluids (dehydration). This is a common effect (may affect up to 1 in 10 people). This can occur if you have severe or prolonged diarrhea, fever or vomiting;
• severe stomach pain or upset stomach that does not go away. This can happen if you have a perforation in the stomach, esophagus or intestine (gastrointestinal perforation). This can lead to death. If any of these applies to you, inform your doctor immediately. Other side effects:Very common(may affect more than 1 in 10 people):
• low number of red blood cells (anemia) or white blood cells (which are important in fighting infections)
• low number of platelets (which causes an increased risk of bleeding)
• loss of appetite (anorexia)
• stomach disorders including nausea, vomiting, diarrhea or constipation
• back pain
• blood in the urine
• feeling tired, weak or lacking energy. Common(may affect up to 1 in 10 people):
• altered taste
• shortness of breath
• cough
• abdominal pain
• temporary hair loss (in most cases the hair will grow back)
• joint pain
• urinary tract infection
• low white blood cell count associated with fever and infection
• feeling of numbness, tingling, burning or decreased sensitivity in hands and feet
• dizziness
• headache
• low or high blood pressure
• feeling of discomfort in the stomach, burning or belching
• stomach ache
• hemorrhoids
• muscle spasm
• pain or increased frequency in urination
• urinary incontinence
• kidney diseases or disorders
• ulcers in the mouth or on the lips
• infections or risk of infections
• high blood sugar
• insomnia
• mental confusion
• feeling of anxiety
• abnormal sensation or loss of sensitivity or pain in hands and feet
• problems with balance
• fast or irregular heartbeat
• blood clots in the legs or lungs
• skin redness
• pain in the mouth or throat
• rectal bleeding
• discomfort, weakness or muscle pain
• swelling of feet or legs
• chills
• nail disorders (change in nail color; nails may detach). Uncommon(may affect up to 1 in 100 people):
• low levels of potassium in the blood
• ringing in the ears
• skin burning
• skin redness
• bladder inflammation, which can occur when the bladder has been previously exposed to radiation therapy (cystitis due to radiation recall phenomenon).

Frequency not known(the frequency cannot be estimated from the available data)

• interstitial lung diseases (inflammation of the lungs causing cough and difficulty breathing) Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex 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 carton and on the label of the
vials after Exp. The expiry date refers to the last day of the month.
Do not store at a temperature above 30 °C. Do not store in a refrigerator.
For information on the storage and usage times of JEVTANA after dilution and
preparation, consult the paragraph regarding “Practical information for doctors or healthcare
professionals or physicians on the preparation, administration and handling of Jevtana”.
Unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations. This will help protect the environment.

6. Content of the pack and other information

What JEVTANA contains
The active ingredient is cabazitaxel. 1 mL of concentrate contains 40 mg of cabazitaxel. A vial
of concentrate contains 60 mg of cabazitaxel.
The other components in the concentrate are polysorbate 80 and citric acid and in the solvent are ethanol at
96% and water for injections (see section 2 “JEVTANA contains alcohol”).
Note: both the vial containing the JEVTANA 60 mg/15 mL concentrate (filling volume
73.2 mg of cabazitaxel/1.83 mL) and the vial containing the solvent (filling volume
5.67 mL) include an overfill to compensate for liquid loss during preparation. The overfill ensures that after dilution of the concentrate with the ENTIRE
contents of the supplied solvent vial, a solution containing 10 mg/mL of
cabazitaxel is obtained.

Description of JEVTANA and contents of the pack
JEVTANA is composed of a concentrate and a solvent for solution for infusion (sterile
concentrate).
The concentrate is an oily, transparent solution from yellow to yellowish-brown.
The solvent is a transparent and colorless solution.
A pack of JEVTANA contains:

• one single-use clear glass vial with a grey rubber stopper sealed with an aluminum crimp covered by a light green plastic flip-off cap, containing 1.5 mL (nominal volume) of concentrate.
• single-use clear glass vial with a grey rubber stopper sealed with a gold-colored aluminum crimp with a transparent plastic flip-off cap, containing 4.5 mL (nominal volume) of solvent.

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
65926 Frankfurt am Main
Germany
For further information on this medicinal product, 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 Zrt.,
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 Ausland: +49 69 305 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 Industrie
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

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
Sanofi Romania 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals.
PRACTICAL INFORMATION FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS ON THE
PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA 60 mg
CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
This information supplements sections 3 and 5 for the user.
Before preparing the infusion solution it is important to read the entire content of this
procedure.

Incompatibilities
This medicinal product must not be mixed with other medicinal products other than those used for
dilutions.

Shelf life and special 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 vials of concentrate and solvent must be used immediately. If not used
immediately, the storage times and conditions in use are the responsibility of the user.
From a microbiological point of view, the two-step dilution process must take place
under controlled and aseptic conditions (see section “Precautions for preparation and
administration” below).

After initial dilutionof JEVTANA 60 mg concentrate with the entirecontents of the solvent vial, chemical and physical stability in use has been demonstrated for 1 hour at room temperature.

After final dilution in the bag/infusion bottle
The chemical and physical stability of the infusion solution has been demonstrated for 8 hours at room
temperature (15 °C - 30 °C) including the 1-hour infusion time and for 48 hours in the refrigerator including
the 1-hour infusion time.
From a microbiological point of view, the infusion solution must be used immediately. If
it is not used immediately, the storage times and conditions in use are
the responsibility of the user and should not normally exceed 24 hours at 2 °C – 8 °C, unless the
dilution has been carried out under validated and controlled aseptic conditions.

Precautions for preparation and administration
As with any other antineoplastic agent, caution is recommended when
handling and preparing solutions containing JEVTANA and consideration should be given to
the use of containment devices, personal protective equipment (e.g. gloves) and
preparation procedures.
If JEVTANA, at any stage of handling, comes into contact with the skin, wash
immediately and thoroughly with soap and water. If it comes into
contact with mucous membranes, wash immediately and thoroughly with water.
JEVTANA must only be prepared and administered by qualified personnel trained in the handling of
cytotoxic agents. The medicinal product must not be handled by pregnant personnel.
Always dilute the concentrate for solution for infusion with allof the supplied solvent before
adding it to the infusion solution.

Preparation steps
Read ENTIREparagraph carefully before mixing and diluting. JEVTANA requires TWO
dilutions before administration. Follow the instructions below for preparation.
Note: both the vial containing the JEVTANA 60 mg/1.5 mL concentrate (filling volume
73.2 mg of cabazitaxel/1.83 mL) and the vial containing the solvent (filling volume
5.67 mL) include an overfill to compensate for liquid loss during the
preparation. The overfill ensures that after dilution of the concentrate with the ENTIRE
contents of the supplied solvent vial, a solution containing 10 mg/mL of
cabazitaxel is obtained.
To prepare the infusion solution, the two-step dilution process described below must be carried out aseptically.

Step 1: Initial dilution of the concentrate for solution for infusion
Step 1.1
Check the vial containing the concentrate
and the supplied solvent. The concentrate solution and the solvent
must be clear.

Step 1.2
Using a syringe with a needle, aseptically draw up the entire
contents of the supplied solvent by partially inverting the vial.

Step 1.3
Inject the entirecontents into the corresponding vial containing
the concentrate.
To minimize foam formation while injecting
the solvent, direct the needle towards the inner wall of the vial containing the
concentrate and inject slowly.
Once the solution is reconstituted

Concentrate vial Solvent
60 mg-1.5 mL

Solvent vial

Solvent vial

Concentrate vial
10 mg/mL
contains 10 mg/mL of cabazitaxel.

Step 1.4
Remove the syringe and needle and manually mix by gently inverting
repeatedly, until a clear and homogeneous solution is obtained. Approximately 45 seconds may be required.

Step 1.5
Allow the solution to stand for about 5 minutes and then check that it is
homogeneous and clear.
Foam may persist even after the indicated time.
The resulting concentrate-solvent mixture contains 10 mg/mL of cabazitaxel
(at least 6 mL of administrable volume). The second dilution must
be carried out immediately (within 1 hour) as specified in Step 2.
More than one vial of the concentrate-solvent mixture may be
required to administer the prescribed dose.

Step 2: second (final) dilution for infusion
Step 2.1
Aseptically draw up with a graduated syringe with a needle the
required amount of the concentrate-solvent mixture
(10 mg/mL of cabazitaxel). For example, a dose of 45 mg of JEVTANA
requires 4.5 mL of the concentrate solvent mixture prepared
following Step 1.
As foam may persist on the walls of the vial
of this solution, prepared following the procedure in Step 1,
it is preferable to insert the syringe needle into the center of the vial during
withdrawal.

Step 2.2
Inject the solution into a sterile, PVC-free container containing
a 5% glucose or 9 mg/mL (0.9%) sodium chloride solution for infusion. The concentration of the infusion solution
must be between 0.10 mg/mL and 0.26 mg/mL.

Concentrate-solvent
mixture 10 mg/mL

Concentrate-solvent
mixture 10 mg/mL

Concentrate-solvent mixture 10 mg/mL

5% glucose or sodium chloride
9 mg/mL (0.9%) for
infusion

Concentrate-solvent
mixture required

Step 2.3
Remove the syringe and mix the contents of the infusion bag manually
with a rocking motion.

Phase 2.4
As with all parenteral products, the resulting infusion solution must be visually inspected. Since the
infusion solution is supersaturated, it may crystallize over time.
In this case, the solution should not be used and must be discarded.
The infusion solution must be used immediately. However, the storage time in
use may be longer if the specific conditions mentioned in the paragraph are respected

Shelf life and special precautions for storagereported previously.
Unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations.

Route of administration
JEVTANA is administered as an infusion lasting 1 hour.
During administration, the use of an inline filter with a nominal pore size of
0.22 micrometers (also indicated as 0.2 micrometers) is recommended.
Do not use PVC infusion containers or polyurethane infusion sets for the preparation and
administration of the infusion solution.