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Click here for Besponsa® (inotuzumab ozogamicin) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

Safety Data

BESPONSA offers a well-characterised and manageable safety profile1​​​​​​​

Most common (≥20%) adverse reactions:

  • Thrombocytopenia (51%)
  • Neutropenia (49%)
  • Infection (48%)
  • Anaemia (36%)
  • Leukopenia (35%)
  • Fatigue (35%)
  • Haemorrhage (33%)
  • Pyrexia (32%)
  • Nausea (31%)
  • Headache (28%)
  • Febrile neutropenia (26%)
  • Increased transaminases (26%)
  • Abdominal pain (23%)
  • Increased gamma-glutamyltransferase (21%)
  • Hyperbilirubinaemia (21%)

Most common (≥2%) serious adverse reactions (Grade ≥3):

  • Infection (23%)
  • Febrile neutropenia (11%)
  • Haemorrhage (5%)
  • Abdominal pain (3%)
  • Pyrexia (3%)
  • VOD/SOS (2%)
  • Fatigue (2%)

Please click here to consult the BESPONSA summary of product characteristics which contains a full list of adverse events

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Key data from the INO-VATE study

Hear Dr. Anna Castleton discuss the key data for BESPONSA vs standard care from the INO-VATE study

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* SOS, sinusoidal obstruction syndrome; VOD, veno-occlusive disease.
 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
References
  1. Pfizer Limited. BESPONSA Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/650/smpc [accessed March 2021].
PP-INO-GBR-0389. March 2021

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