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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

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.
References
  1. Kantarjian HM, et al. Cancer 2019;125:2474–2487.
  2. Pfizer Limited. BESPONSA® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/650/smpc [accessed March 2021].
  3. Pfizer, Data on file.
PP-INO-GBR-0390. March 2021

Support and resources

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

Access here

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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PP-PFE-GBR-2688. December 2020

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