What JEVTANA contains
The active substance is cabazitaxel. One ml of concentrate contains 40 mg cabazitaxel. Each vial of concentrate contains 60 mg cabazitaxel.
The other ingredients are polysorbate 80 and citric acid in the concentrate, and ethanol 96% and water for injections in the solvent.
What JEVTANA looks like and contents of the pack
JEVTANA is a concentrate and solvent for solution for infusion (sterile 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 vial of 1.5 ml concentrate in a clear glass vial closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover.
- One single-use vial of 4.5 ml solvent in clear glass vial closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap with a colourless plastic flip-off cover.
Marketing Authorisation Holder
174, avenue de France
F - 75013 Paris
Aventis Pharma, Dagenham
Rainham Road South
Essex RM10 7XS
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien sanofi-aventis Belgium TélTel 32 02 710 54 00 LuxembourgLuxemburg sanofi-aventis Belgium TélTel 32 02 710 54 00 BelgiqueBelgien
sanofi-aventis Bulgaria EOOD . 359 02 970 53 00 Magyarország sanofi-aventis zrt., Magyarország Tel. 36 1 505 0050
eská republika sanofi-aventis, s.r.o. Tel 420 233 086 111 Malta sanofi-aventis Malta Ltd. Tel 356 21493022
Danmark sanofi-aventis Denmark AS Tlf 45 45 16 70 00 Nederland sanofi-aventis Netherlands B.V. Tel 31 0182 557 755
Deutschland Sanofi-Aventis Deutschland GmbH Tel 49 0180 2 222010 Norge sanofi-aventis Norge AS Tlf 47 67 10 71 00
Eesti sanofi-aventis Estonia OÜ Tel 372 627 34 88 Österreich sanofi-aventis GmbH Tel 43 1 80 185 0
sanofi-aventis AEBE 30 210 900 16 00 Polska sanofi-aventis Sp. z o.o. Tel. 48 22 280 00 00
España sanofi-aventis, S.A. Tel 34 93 485 94 00 Portugal sanofi-aventis - Produtos Farmacêuticos, Lda Tel 351 21 35 89 400
România sanofi-aventis România S.R.L. Tel 40 0 21 317 31 36 France sanofi-aventis France Tél 0 800 222 555 Appel depuis létranger 33 1 57 63 23 23 Ireland sanofi-aventis Ireland Ltd. Tel 353 0 1 403 56 00 Slovenija sanofi-aventis d.o.o. Tel 386 1 560 48 00
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. Tel 421 2 33 100 100
Italia sanofi-aventis S.p.A. Tel 39 02 393 91 SuomiFinland sanofi-aventis Oy PuhTel 358 0 201 200 300
sanofi-aventis Cyprus Ltd. 357 22 871600 Sverige sanofi-aventis AB Tel 46 08 634 50 00
Latvija sanofi-aventis Latvia SIA Tel 371 67 33 24 51 United Kingdom sanofi-aventis Tel 44 0 1483 505 515
UAB sanofi-aventis Lietuva
Tel: +370 5 2755224
This leaflet was last approved in .
The following information is intended for medical or healthcare professionals only.
PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION AND HANDLING OF JEVTANA 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
This information 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.
This medicine must not be mixed with other medicines except those used for the dilutions.
Shelf life and special precautions for storageFor the pack of JEVTANA 60 mg concentrate and solvent:
Do not refrigerate.
The concentrate 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 microbiological 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 solvent:
Chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature.
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.
From a microbiological 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 precautions
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 mucous 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 it.
Always dilute the concentrate for solution for infusion with the supplied solvent before adding to infusion solutions.
The following two-step dilution process must be carried out in an aseptic manner for preparing the solution for infusion.
Step 1: Initial dilution of the concentrate for solution for infusion with the supplied solvent.
- Set aside the JEVTANA concentrate vial and the supplied solvent. The solution in the concentrate vial should be clear.
- Withdraw the entire content of the supplied solvent using a syringe, by partially inverting the vial, and inject it into the corresponding vial of JEVTANA concentrate. To limit foaming as much as possible when injecting the solvent, direct the needle onto the inside wall of the vial of concentrate solution and inject slowly.
- Remove the syringe and needle and mix manually and gently by repeated inversions until obtaining clear and homogeneous solution. It could take approximately 45 seconds.
- Let this solution stand for approximately 5 minutes and then check that the solution is homogeneous and clear. It is normal for foam to persist after this time period.
This resulting concentrate-solvent mixture contains 10 mg/ml of cabazitaxel (at least 6 ml deliverable volume). It should be immediately diluted as detailed in step 2.
Step 2: Preparation of the infusion solution.
- Based on the required dose for the patient, withdraw the corresponding volume of the concentrate-solvent mixture containing 10 mg/ml of JEVTANA, with a graduated syringe. As an example, a dose of 45 mg JEVTANA would require 4.5 ml of the concentrate-solvent mixture prepared following step 1. More than one vial of the concentrate-solvent mixture may be necessary for preparing the appropriate dose.
- Since foam may persist on the wall of the vial 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.
- Use PVC-free infusion containers and inject the withdrawn volume into either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.
- Remove the syringe and mix the content of the infusion bag or bottle manually using a rocking motion.
The JEVTANA infusion solution should be used immediately. However, in-use storage time can be longer under specific conditions mentioned in section Shelf life and special precautions for storage above.
As with all parenteral products, the resulting infusion solution should be visually inspected prior to use. As the infusion solution is supersaturated, it may crystallize over time. In this case, the solution must not be used and should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
Method of administration
JEVTANA is administered as a 1 hour infusion.
An in-line filter of 0.22 micrometer nominal pore size is recommended during administration. PVC infusion containers and polyurethane infusion sets should not be used for the preparation and administration of the infusion solution.