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EfficacyEfficacyKey Take AwaysHospitalisation DataSafetySafetyAdverse Event Management: VOD/SOSSelected Adverse ReactionsDosingDosing and Dose ModificationsAdministrationSupport and ResourcesPublications
Selected Adverse Reactions and Other Safety Information Myelosuppression/cytopenias1
  • Life-threatening cases have been reported
  • Before each dose, monitor FBC
  • During treatment, monitor for infection, haemorrhage and other effects of myelosuppression
  • Following HSCT, monitor for infection
  • Severe cases might require dose interruption, reduction, or discontinuation
Infusion-related reactions1
  • Premedication : Corticosteroid, antipyretic, and antihistamines are recommended before each dose
  • Recommended observation period: During and for at least 1 hour after the end of infusion, closely monitor for infusion-related reactions including hypotension, hot flush or breathing problems

  • Complete blood counts should be monitored prior to each dose of BESPONSA and signs and symptoms of infection should be monitored during treatment and after HSCT
  • As appropriate, prophylactic anti-infectives should be administered and surveillance testing should be employed during and after treatment
  • Management of severe infection may require a dosing interruption, dose reduction or discontinuation of treatment
  • Complete blood counts should be monitored prior to each dose of BESPONSA and signs and symptoms of bleeding/haemorrhage should be monitored during treatment
  • Management of bleeding/haemorrhage may require a dosing interruption, dose reduction or discontinuation of BESPONSA
Tumour lysis syndrome1
  • Life-threatening or fatal cases have been reported
  • For patients with a high tumour burden:
    • Before each dose, pre-medicate to reduce uric acid levels and hydrate
    • During treatment, monitor for signs and symptoms of tumour lysis syndrome
QT interval prolongation1
  • Be cautious when giving BESPONSA to patients:
    • With a history or predisposition to QT interval prolongation
    • Receiving treatments that are known to prolong the QT interval
    • With electrolyte disturbances
  • Before starting treatment, measure ECG and electrolytes and monitor periodically during treatment
Increased amylase and lipase1
  • Monitor patients for increases in amylase and lipase. Potential hepatobiliary disease should be evaluated and treated according to standard medical practice
  • The safety of immunisation with live viral vaccines during or following BESPONSA therapy has not been studied.
  • Vaccination with live viral vaccines is not recommended for at least 2 weeks prior to the start of BESPONSA treatment, during treatment, and until recovery of B lymphocytes following the last treatment cycle.
Explore More Post HSCT Survival

Short overview showing post HSCT survival outcomes with BESPONSA from INO-VATE long term follow-up and pooled analysis

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Key Data From BESPONSA Outcomes by Salvage Lines

Click here to view the key data from publication entitled, “Impact of salvage treatment phase on inotuzumab ozogamicin treatment for relapsed/refractory acute lymphoblastic leukemia: an update from the INO-VATE final study database”

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Explore BESPONSA outcomes and safety in RWE

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ALL=acute lymphoblastic leukemia; ECG=electrocardiogram; FBC=full blood count; HSCT=hematopoietic stem cell transplantation; R/R=relapsed/refractory; RWE=real-world evidence; SOS=sinusoidal obstruction syndrome; SmPC=Summary of Product Characteristics; VOD=veno-occlusive disease.References:BESPONSA Summary of Product Characteristics
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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PP-INO-IRL-0112 January 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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