Cabazitaxel (Jevtana▼): risk of medication error resulting in overdose

It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel. It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel Pharmacies should review worksheets used in the preparation of cabazitaxel to ensure that they inform pharmacy staff to add the entire contents of the solvent vial to the concentrate vial

Article date: November 2013

Background

Cabazitaxel (Jevtana▼) in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

There have been reports of medication error that have occurred because the entire fill volume of the solvent vial was not added to the concentrate vial. This has resulted in some patients receiving a higher dose (15–20% higher) of cabazitaxel than was intended.

The solvent vial and the concentrate vial each contain an overfill to compensate for liquid lost during the initial dilution process. Therefore, the entire contents of the solvent vial must be added to the concentrate vial to ensure that the resulting concentrate-solvent mixture contains the intended concentration of 10 mg/mL cabazitaxel and has a minimal extractable volume of 6 mL.

The required volume of the concentrate-solvent mixture should be diluted immediately (within 1 hour) to prepare the solution for infusion, as described in the Summary of Product Characteristics, which should be consulted before preparing the cabazitaxel solution for infusion.

Advice for healthcare professionals:

  • All healthcare professionals involved in the preparation of cabazitaxel solution for infusion should be aware that the entire contents of the solvent vial must be added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel
  • Pharmacists should review worksheets that are used in the preparation of cabazitaxel to ensure that they correctly inform pharmacy staff to add the entire content of the solvent vial to the concentrate vial
  • Please report suspected adverse reactions, including those related to medication error, occurring with cabazitaxel on a Yellow Card (www.mhra.gov.uk/yellowcard)  

Further information

Letter sent to healthcare professionals sent Oct 23, 2013

Article citation: Drug Safety Update volume 7 issue 4, November 2013: A4.

Help us improve GOV.UK

Don’t include personal or financial information, eg your National Insurance number or credit card details.