Dosage Forms and Strengths
|JEVTANA 60 mg/1.5 mL is supplied as a kit consisting of the following:|
|JEVTANA (cabazitaxel) injection 60 mg/1.5 mL
Contains 60 mg cabazitaxel in 1.5 mL polysorbate 80
|Diluent for JEVTANA
Contains approximately 5.7 mL of 13% (w/w) ethanol in water for injection
Preparation: 2-Step Dilution Process
- Each vial of JEVTANA (cabazitaxel) injection 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 ensure 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 homogenous 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.
- 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 >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.
- Remove the syringe and thoroughly mix the final infusion solution by gently inverting the bag or bottle.
- As the final infusion solution is supersaturated, it may crystalize over time. Do not use if this occurs and discard.
- Fully prepared JEVTANA 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 for a total of 24 hours (including the one-hour infusion) under the refrigerated conditions.
- Discard any unused portion.
- Inspect visually for particulate matter, any crystals, and discoloration prior to administration. If the JEVTANA first diluted solution or second (final) infusion solution is not clear or appears to have precipitation, it should be discarded
- Use an in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) during administration
- The final JEVTANA infusion solution should be administered intravenously as a one-hour infusion at room temperature