Jevtana Caution For Usage

Special Precautions for Disposal and Other Handling: JEVTANA should only be prepared and administered by personnel trained in handling cytotoxic agents. Pregnant staff should not handle the product. 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.
Always dilute the concentrate for solution for infusion with the entire supplied solvent before adding to infusion solution.
Read this ENTIRE section carefully before mixing and diluting. JEVTANA requires TWO dilutions prior to administration. Follow the preparation instructions provided as follows.
Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/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 after 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: Initial dilution 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 clear.
Step 1.2: Using a syringe fitted with a needle, aseptically withdraw the entire contents of the supplied solvent by partially inverting the vial.
Step 1.3: Inject the entire contents into the corresponding concentrate vial.
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.
Once reconstituted, the resultant solution contains 10 mg/ml of cabazitaxel.
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 foam to persist 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: Second (final) dilution for infusion.
Step 2.1: Aseptically withdraw the required amount of concentrate-solvent mixture (10 mg/ml of cabazitaxel), with a graduated syringe fitted with a needle.
As an example, a dose of 45 mg.
JEVTANA would require 4.5 ml of the concentrate-solvent mixture prepared following Step 1.
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.
Step 2.2: Inject in a sterile PVC-free container of 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.
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 supersaturated, it may crystallize over time. In this case, the solution must not be used and should be discarded.
The infusion solution should be used immediately. However, in-use storage time can be longer under specific conditions mentioned in Shelf Life under Storage.
An in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) is recommended during administration.
Do not use PVC infusion containers or polyurethane infusion sets for the preparation and administration of JEVTANA.
JEVTANA must not be mixed with any other medicinal products than those mentioned.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.