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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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The content of this website has been produced in line with the BESPONSA®▼ (inotuzumab ozogamicin) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. BESPONSA▼ Prescribing Information for Great Britain click here. BESPONSA▼ Prescribing Information for Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.

Adverse Event Management: VOD/SOS

Evaluate VOD Risk

Proactively manage VOD

Evaluate VOD risk with focused monitoring, particularly for patients proceeding to HSCT1,2

Incidence of VOD in the INO-VATE ALL study1,2

†May include cases which occurred in follow-up with subsequent anticancer therapy (e.g. maintenance therapy), but without or before intervening HSCT (VOD/SOS onset was before post-study therapy HSCT or there was no post-study therapy HSCT)3.
*5 cases were fatal.
‡Up to 56 days after final dose or during follow-up without an intervening HSCT.

When using BESPONSA2:

Monitor closely for signs and symptoms of VOD/SOS, especially after allogeneic HSCT

  • Elevated bilirubin
  • Hepatomegaly, which may be painful
  • Rapid weight gain
  • Ascites

Be aware:

Monitor ALT, AST, total bilirubin and ALP before and after each dose

Reduce risk:

Avoid HSCT conditioning regimens containing two alkylating agents

Be cautious:

For patients >65 years and those at greater risk of VOD, carefully consider the benefit/risk of BESPONSA before administration

ALL, acute lymphoblastic leukaemia; ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; HSCT, haematopoietic stem cell transplantation; SoC, standard chemotherapy; SOS, sinusoidal obstruction syndrome; VOD, veno-occlusive disease

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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

 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.
  1. Kantarjian HM, et al. Cancer 2019;125:2474–2487.
  2. BESPONSA Summary of Product Characteristics for Great Britain click here. BESPONSA Summary of Product Characteristics for Northern Ireland click here.​​​​​​​
  3. Pfizer, Data on file.
PP-INO-GBR-0509. August 2021

Support and resources

Access Support and Resources to read the guidelines or watch videos from leading specialists.

Access here

For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

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If you select 'No', you will be redirected to where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021



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