I am treating a young patient, who has relapsed B-ALL, with Blinatumomab. The patient has developed cholestatic jaundice. Bilirubin has raised to more than 6.0 and alkaline phosphatase to more than 1200. Blinatumomab has been on hold since 4 days ago when the patient's bilirubin went above 3.0.
Dear Mojtaba Akhtari.
The authors to this paper are here on RG. Their paper comprises also these email addresses. They could answer your question.
Article Blinatumomab and Pembrolizumab
According to the EPAR of Blincyto:
"Other effects [observed after each infusion] included transient increase in body temperature, CRP, liver enzymes, and bilirubin. This is consistent with the potential effects of cytokine released, notably IL-6".
Moreover, a treatment-emergent adverse events of "Blood bilirubin increased" was observed in 7.9% of patients (4.2% grade 3 or higher).
All these data were from adults, however the assessors concluded that "treatment with blinatumomab is also associated with transient elevations in liver enzymes. The majority of the events were observed within the first week of blinatumomab initiation and did not require interruption or discontinuation of blinatumomab (see SmPC sections 4.4 and 4.8). A review of 27 subjects who met the criteria of AST/ALT ≥ 3 x ULN and total blood bilirubin ≥ 2 x ULN revealed that the rapid onset of elevations in liver enzymes coincided with the onset of clinical signs and symptoms of CRS with or without infection and concomitant hepatotoxic medications (data not shown). This finding suggested that these plausible alternative aetiologies were also present. [...] Management of these events may require either temporary interruption or discontinuation of blinatumomab (see SmPC sections 4.2 and 4.4).
Hope this could be useful!
Odoardo
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