Health Canada: BLINCYTO (blinatumomab) and Benzyl Alcohol Toxicity for Pediatric Patients
Healthcare professionals including hematologists, oncologists, hospital and oncology pharmacists, and cancer clinic staff
- Serious and fatal adverse reactions including “gasping syndrome” can occur in pediatric patients, particularly in neonates and infants treated with BLINCYTO containing benzyl alcohol as a preservative.
- BLINCYTO has recently been authorized with an additional option of preparing a 7-day infusion bag containing benzyl alcohol for patients weighing greater than or equal to 22 kg. It is not recommended for use in patients weighing less than 22 kg.
- When preparing bags of BLINCYTO solution for infusion in neonates, infants and patients weighing less than 22 kg, healthcare professionals are advised to only utilize preservative-free saline.
- The Canadian Product Monograph has been updated to reflect this new safety information
For more information go to http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67016a-eng.php