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EfficacyEfficacyKey Take AwaysHospitalisation DataSafetySafetyAdverse Event Management: VOD/SOSSelected Adverse ReactionsDosingDosing and Dose ModificationsAdministrationSupport and ResourcesPublications
BESPONSA Safety Profile Compared With SCAdverse reactions with ≥ 10% incidence that occurred with BESPONSA1,*
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Adverse reaction Patients, %
Infections and infestations
Infection 48
Blood and lymphatic system disorder
Febrile neutropenia 26
Neutropenia 49
Thrombocytopenia 51
Leukopenia 35
Lymphopenia 18
Anemia  36
Metabolism and nutrition disorders
Decreased appetite 12
Nervous system disorders
Headache 28
Vascular disorders
Haemorrhage 33
Gastrointestinal disorders
Nausea 31
Abdominal pain 23
Diarrhoea 17
Constipation 17
Vomiting 15
Stomatitis 13
Hepatobiliary disorders
Hyperbilirubinemia 21
Increased transaminases 26
Increased GGT 21
General disorders and administration site conditions
Fatigue 35
Pyrexia 32
Chills 11
Investigations
ALP increased 13
Injury, poisoning and procedural complications
Infusion related reactions 10
  • In patients who received BESPONSA, the most common (≥ 2%) serious adverse reactions were infection, febrile neutropenia, haemorrhage, abdominal pain, pyrexia,  VOD/SOS, and fatigue1
  • BESPONSA increased the risk of VOD/SOS above that of SC regimens (reported in 23/164 [14%] patients versus 3/143 [2.1%] patients). This risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment (18/79 [23%] patients)1,2
  • BESPONSA has a lower incidence of VOD in first salvage: During study treatment/follow-up without HSCT (1.8% [n = 2/111] in S1 vs 5.9% [n = 3/51] in S2) or following HSCT (19.0% [n = 11/58] in S1 vs 35.0% [n = 7/20] in S2)3
  • It is recommended to monitor closely for toxicities post HSCT, including signs and symptoms of infection and VOD1
Safety was assessed in a total of 307 patients, including 164 patients receiving BESPONSA and 143 receiving SC.*Adverse reactions included treatment-emergent all-causality events that commenced on or after Cycle 1 Day 1, within 42 days after the last dose of BESPONSA, but prior to the start of a new anticancer treatment (including HSCT). ALP=alkaline phosphatase; FLAG=fludarabine + cytarabine + granulocyte colony-stimulating factor; GGT=gamma-glutamyltransferase; Gr=grade; HiDAC=high dose cytarabine; HSCT=hematopoietic stem cell transplantation; MXN/AraC =mitoxantrone + cytarabine; S1=salvage 1; S2=salvage 2; SC=standard chemotherapy; SOS=sinusoidal obstruction syndrome; VOD=veno-occlusive disease.
ALL=acute lymphoblastic leukemia; HSCT=hematopoietic stem cell transplantation; R/R=relapsed/refractory; RWE=real-world evidence; SmPC=Summary of Product Characteristics; SOS=sinusoidal obstruction syndrome; VOD=veno-occlusive disease.References:BESPONSA Summary of Product CharacteristicsKantarjian HM, et al. Cancer. 2019;125(14):2474-2487.  Jabbour E, et al. Leuk Lymphoma. 2020;61(8):2012-2015.
Safety Besponsa Prescribing Information VisitLoading Contact Us Visit Loading Post Transplant Outcomes and VOD Mitigation Strategies

Please click here to view the importance of transplant and VOD mitigation with BESPONSA in patients with R/R B-Cell ALL

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