Blincyto Overdosage

Overdoses have been observed, including one adult patient who received 133-fold the recommended therapeutic dose of BLINCYTO delivered over a short duration.
In the dose evaluation phase of a study in pediatric and adolescent patients with relapsed or refractory B-cell precursor ALL, one patient experienced a fatal cardiac failure event in the setting of life-threatening cytokine release syndrome (CRS) at a 30 mcg/m²/day (higher than the maximum tolerated/recommended) dose [see Cytokine Release Syndrome under Precautions and Adverse Reactions].
Overdoses resulted in adverse reactions, which were consistent with the reactions observed at the recommended dosage and included fever, tremors, and headache. In the event of overdose, interrupt the infusion, monitor the patient for signs of adverse reactions, and provide supportive care [see Preparation and Administration Errors under Precautions]. Consider re-initiation of BLINCYTO at the recommended dosage when all adverse reactions have resolved and no earlier than 12 hours after interruption of the infusion [see Treatment of MRD-positive B-cell Precursor ALL, Treatment of Relapsed or Refractory B-cell Precursor ALL and Treatment of B-cell Precursor ALL in the Consolidation Phase under Dosage & Administration].