travenous infusion should come into contact with the skin, immediately and thoroughly wash with soap and water. If JEVTANA Injection, first diluted solution, or second (final) dilution for intravenous infusion should come into contact with mucosa, immediately and thoroughly wash with water.
2.5 Instructions for Preparation
Do not use PVC infusion containers or polyurethane infusions sets for preparation and administration of JEVTANA infusion solution.
Read this entire section carefully before mixing and diluting. JEVTANA requires two dilutions prior to administration. Please follow the preparation instructions provided below. Note: Both the JEVTANA Injection and the diluent vials contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the entire contents of the accompanying diluent, there is an initial diluted solution containing 10 mg/mL JEVTANA.
The following two-step dilution process must be carried out under aseptic conditions to prepare the second (final) infusion solution.
Set aside the JEVTANA Injection and supplied diluent vials. The JEVTANA Injection is a clear yellow to brownish-yellow viscous solution, if appropriately stored.
Step 1 – First Dilution
Each vial of JEVTANA (cabazitaxel) 60 mg/1.5 mL must first be mixed with the entire contents of supplied diluent. Once reconstituted, the resultant solution contains 10 mg/mL of JEVTANA.
When transferring the diluent, direct the needle onto the inside wall of JEVTANA vial and inject slowly to limit foaming. Remove the syringe and needle and gently mix the initial diluted solution by repeated inversions for at least 45 seconds to assure full mixing of the drug and diluent. Do not shake.
Let the solution stand for a few minutes to allow any foam to dissipate, and check that the solution is homogeneous and contains no visible particulate matter. It is not required that all foam dissipate prior to continuing the preparation process.
The resulting initial diluted JEVTANA solution (cabazitaxel 10 mg/mL) requires further dilution before administration. The second dilution should be done immediately (within 30 minutes) to obtain the final infusion as detailed in Step 2.
Step 2 – Second (Final) Dilution
Withdraw the recommended dose from the JEVTANA solution containing 10 mg/mL as prepared in Step 1 using a calibrated syringe and further dilute into a sterile 250 mL PVC-free container of either 0.9% sodium chloride solution or 5% dextrose solution for infusion. If a dose greater than 65 mg of JEVTANA is required, use a larger volume of the infusion vehicle so that a concentration of 0.26 mg/mL JEVTANA is not exceeded. The concentration of the JEVTANA final infusion solution should be between 0.10 mg/mL and 0.26 mg/mL.
JEVTANA should not be mixed with any other drugs.
Remove the syringe and thoroughly mix the final infusion solution by gently inverting the bag or bottle.
JEVTANA final infusion solution (in either 0.9% sodium chloride solution or 5% dextrose solution) should be used within 8 hours at ambient temperature (including the one-hour infusion) or within a total of 24 hours if refrigerated (including the one-hour infusion).
As the final infusion solution is supersaturated, it may crystallize over time. Do not use if this occurs and discard.
Inspect visually for particulate matter, any crystals and discoloration prior to administration. If the JEVTANA first diluted solution or second (final) |
