SEVERE HEPATOTOXICITY AND ACUTE PANCREATITIS ASSOCIATED WITH THE USE OF BLINATUMOMAB IN A PATIENT WITH ACUTE LYMPHOBLASTIC LEUKEMIA
- 1Hospital Universitário Professor Edgard Santos (HUPES-UFBA), Salvador, BA, Brazil
Abstract
Background: Blinatumomab is a bispecific anti-CD19/CD3 antibody used in the treatment of refractory B-cell acute lymphoblastic leukemia (ALL) with measurable residual disease. Although it has a favorable safety profile, neurotoxicity and cytokine release syndrome are the most common adverse events. Drug-induced liver injury (DILI) and acute pancreatitis are rare but potentially serious events, and their early recognition is essential for proper management and patient safety. Case report: A 31-year-old female patient with Philadelphia-negative B-cell ALL diagnosed in March 2020. She received augmented HyperCVAD chemotherapy followed by allogeneic bone marrow transplantation in December 2020. In September 2023, she presented with extramedullary relapse and underwent salvage therapy. In June 2024, she was admitted for biliary prosthesis replacement via ERCP and oncological treatment, at which time blinatumomab was initiated as a bridge therapy for a potential CAR-T therapy or a second transplant. On June 17, 2024, AST (20 U/L), ALT (51 U/L), AMI (34 U/L), and LIP (26 U/L) were within the normal range. The infusion was initiated on June 18, 2024 (9 mcg/day), and after eight hours, elevated transaminases were observed: AST (280 U/L) and ALT (341 U/L), indicating grade 3 hepatotoxicity, associated with severe headache. The medication was discontinued, resulting in clinical and laboratory improvement. After six days, it was reintroduced without recurrence of hepatotoxicity. On July 2, 2024, following an increase in the dose to 28 mcg/day, the patient developed a significant elevation in AMI (894 U/L) and LIP (3111 U/L), along with abdominal pain consistent with acute pancreatitis, leading to another suspension of blinatumomab. After pancreatic enzymes normalized within three days, treatment was started again and completed without further events. Discussion: The temporal association between blinatumomab use and the hepatic and pancreatic abnormalities, combined with the exclusion of infectious, autoimmune, metabolic, and obstructive causes, as well as any medical procedures performed, supported the diagnosis of drug-induced liver injury (DILI) and acute pancreatitis induced by the medication. Causality was confirmed through validation of the suspected Adverse Drug Reaction by a pharmacovigilance center, corroborated by the RUCAM, Naranjo, WHO, and European Union algorithms. Although the mechanisms remain uncertain, it is believed that immune activation and cytokine release play a significant role. This case highlights the importance of laboratory monitoring, early discontinuation of the drug, and careful reintroduction after resolution of the events, allowing for the continuation of onco-hematological treatment. Conclusion: DILI and acute pancreatitis associated with blinatumomab are rare but potentially serious events. Early recognition, systematic investigation, and multidisciplinary management enabled clinical and laboratory recovery, as well as the safe resumption of therapy. This report reinforces the role of active pharmacovigilance and intensive monitoring, especially at the start of infusion and after dose escalation, contributing to greater safety in the use of immunobiological agents in patients with ALL.
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BibTeX
@article{damasceno2026severe,
title = {{SEVERE HEPATOTOXICITY AND ACUTE PANCREATITIS ASSOCIATED WITH THE USE OF BLINATUMOMAB IN A PATIENT WITH ACUTE LYMPHOBLASTIC LEUKEMIA}},
author = {Elder Trindade DAMASCENO and Geisa Queiroz ALMEIDA and Gláucia Noblat SANTOS and Leonardo Augusto Toledo KISTER and Luana Sávia Santos SILVA and Paloma Peixoto Santos FIÚZA and Ivana Moura Leal COELHO and Maisa Rafaele Silva SILVA and Mônica Lopes Sampaio SILVA and Rafaela Leal Machado BORGES and Alessandro Moura ALMEIDA and Marianna Batista Vieira LIMA and Cristiane Almeida Requião PINNA and Daniela Dourado DUTRA and Edvan Queiroz CRUSOE},
journal = {Hematology, Transfusion and Cell Therapy},
year = {2026},
month = oct,
doi = {10.1016/j.htct.2026.107691},
url = {https://doi.org/10.1016/j.htct.2026.107691},
note = {CC BY},
}
RIS
TY - JOUR
TI - SEVERE HEPATOTOXICITY AND ACUTE PANCREATITIS ASSOCIATED WITH THE USE OF BLINATUMOMAB IN A PATIENT WITH ACUTE LYMPHOBLASTIC LEUKEMIA
AU - Elder Trindade DAMASCENO
AU - Geisa Queiroz ALMEIDA
AU - Gláucia Noblat SANTOS
AU - Leonardo Augusto Toledo KISTER
AU - Luana Sávia Santos SILVA
AU - Paloma Peixoto Santos FIÚZA
AU - Ivana Moura Leal COELHO
AU - Maisa Rafaele Silva SILVA
AU - Mônica Lopes Sampaio SILVA
AU - Rafaela Leal Machado BORGES
AU - Alessandro Moura ALMEIDA
AU - Marianna Batista Vieira LIMA
AU - Cristiane Almeida Requião PINNA
AU - Daniela Dourado DUTRA
AU - Edvan Queiroz CRUSOE
PY - 2026
DA - 2026/10/23
JO - Hematology, Transfusion and Cell Therapy
DO - 10.1016/j.htct.2026.107691
UR - https://doi.org/10.1016/j.htct.2026.107691
AB - Background: Blinatumomab is a bispecific anti-CD19/CD3 antibody used in the treatment of refractory B-cell acute lymphoblastic leukemia (ALL) with measurable residual disease. Although it has a favorable safety profile, neurotoxicity and cytokine release syndrome are the most common adverse events. Drug-induced liver injury (DILI) and acute pancreatitis are rare but potentially serious events, and their early recognition is essential for proper management and patient safety. Case report: A 31-year-old female patient with Philadelphia-negative B-cell ALL diagnosed in March 2020. She received augmented HyperCVAD chemotherapy followed by allogeneic bone marrow transplantation in December 2020. In September 2023, she presented with extramedullary relapse and underwent salvage therapy. In June 2024, she was admitted for biliary prosthesis replacement via ERCP and oncological treatment, at which time blinatumomab was initiated as a bridge therapy for a potential CAR-T therapy or a second transplant. On June 17, 2024, AST (20 U/L), ALT (51 U/L), AMI (34 U/L), and LIP (26 U/L) were within the normal range. The infusion was initiated on June 18, 2024 (9 mcg/day), and after eight hours, elevated transaminases were observed: AST (280 U/L) and ALT (341 U/L), indicating grade 3 hepatotoxicity, associated with severe headache. The medication was discontinued, resulting in clinical and laboratory improvement. After six days, it was reintroduced without recurrence of hepatotoxicity. On July 2, 2024, following an increase in the dose to 28 mcg/day, the patient developed a significant elevation in AMI (894 U/L) and LIP (3111 U/L), along with abdominal pain consistent with acute pancreatitis, leading to another suspension of blinatumomab. After pancreatic enzymes normalized within three days, treatment was started again and completed without further events. Discussion: The temporal association between blinatumomab use and the hepatic and pancreatic abnormalities, combined with the exclusion of infectious, autoimmune, metabolic, and obstructive causes, as well as any medical procedures performed, supported the diagnosis of drug-induced liver injury (DILI) and acute pancreatitis induced by the medication. Causality was confirmed through validation of the suspected Adverse Drug Reaction by a pharmacovigilance center, corroborated by the RUCAM, Naranjo, WHO, and European Union algorithms. Although the mechanisms remain uncertain, it is believed that immune activation and cytokine release play a significant role. This case highlights the importance of laboratory monitoring, early discontinuation of the drug, and careful reintroduction after resolution of the events, allowing for the continuation of onco-hematological treatment. Conclusion: DILI and acute pancreatitis associated with blinatumomab are rare but potentially serious events. Early recognition, systematic investigation, and multidisciplinary management enabled clinical and laboratory recovery, as well as the safe resumption of therapy. This report reinforces the role of active pharmacovigilance and intensive monitoring, especially at the start of infusion and after dose escalation, contributing to greater safety in the use of immunobiological agents in patients with ALL.
SN - 2531-1379
SN - 2531-1387
ER -