Italian Medicines Agency Agenzia Italiana del Farmaco

Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion - Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion

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Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion

Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion:
risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion.

Summary

  • There is a risk of medication errors due to the presence on the market of different cabazitaxel presentations:
    • Cabazitaxel Accord (20 mg/mL) concentrate for solution for infusion requires a single-step dilution process; 
    • Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion requires a two-step dilution process.
  • Before the final dilution step either in glucose solution or sodium chloride solution for infusion, the concentration of cabazitaxel is:
    • 20 mg/ml for Cabazitaxel Accord 
    • 10 mg/ml for Jevtana 
  • A mix-up between the products may lead to medication errors resulting in either overdosing with potentially fatal outcome, or underdosing with reduction of therapeutic effect (see background section below).
  • Always check carefully which product is being used and the dilution instructions to ensure that the patient receives the correct dose of cabazitaxel.


Published on: 16 June 2021

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