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Health Canada Health products

BLINCYTO (blinatumomab) and Benzyl Alcohol Toxicity for Pediatric Patients

Issued June 12, 2018
Issue
BLINCYTO has recently been authorized with an additional option of preparing a 7-day infusion bag, using bacteriostatic 0.9% sodium chloride containing 0.9% benzyl alcohol as a preservative. Benzyl alcohol has the potential to cause serious and fatal adverse reactions when administered intravenously to neonates and infants. Therefore, 0.9% sodium chloride containing 0.9% benzyl alcohol is not recommended for use in the preparation of BLINCYTO intended to be administered to neonates, infants, or patients weighing less than 22 kg.
Hazard description
Product safety