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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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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.

Adverse Event Management: VOD/SOS

Evaluate VOD Risk

Proactively manage VOD

Proactively manage VOD1-3

EBMT diagnostic, prevention and treatment recommendations, please also view the BESPONSA SmPC here

EBMT diagnostic criteria for VOD/SOS1:

Classical VOD/SOS (≤ 21 days after HSCT)

  • Bilirubin ≥ 34 μmol/L (2 mg/dL) and two of:
    • Painful hepatomegaly;
    • Weight gain > 5%;
    • Ascites

Late onset VOD/SOS (> 21 days after HSCT)

  • Classical VOD/SOS beyond Day 21

OR

Histologically proven VOD/SOS

OR

  • Two or more of:
    • Bilirubin ≥ 34 μmol/L (2 mg/dL)
    • Painful hepatomegaly
    • Weight gain > 5%
    • Ascites

AND

  • Haemodynamical and/or ultrasound evidence of VOD/SOS

EBMT recommendations for the prevention and therapeutic management of VOD/SOS2:

Prevention includes reversing risk factors, where possible, and prophylaxis:

View revised EBMT diagnosis and severity criteria

Click here

View the EBMT VOD position statement

Click here

Click here for access to the Besponsa summary of product characteristics which has a full list of adverse events

Explore more

Pharmacy Guide

Download the guide for Pharmacists for information on dosing, drug interactions, reconstitution, administration, shelf life etc. SmPC should be consulted for full guidance.

Download here

Fast Facts

Download the Fast Facts PDF document to aid your understanding of BESPONSA. SmPC should be consulted for full guidance.

Download here

EBMT, European Society for Blood and Marrow Transplantation; HSCT, haematopoietic stem cell transplantation; 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. Mohty M, et al. Bone Marrow Transplant 2016;51:906–912.
  2. Mohty M, et al. Bone Marrow Transplant 2015;50:781–789.
  3. Gentium SPA. DEFITELIO® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/4999/smpc [accessed March 2021].
PP-INO-GBR-0390. March 2021

Support and resources

Access Support and Resources to download clinical papers or watch videos from leading specialists.

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PP-PFE-GBR-2688. December 2020

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