This site is intended only for healthcare professionals resident in the United Kingdom

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

See all Therapy areas

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.

Key Precautions and other safety information​​​​​​​​​​​​​​

Myelosuppression/cytopenias

  • Life-threatening cases have been reported
  • Before each dose, monitor FBC
  • During treatment, monitor for infection, haemorrhage and the effects of myelosuppression
  • Following HSCT, monitor for infection
  • Severe cases might require dose interruption, reduction, or discontinuation

Infusion-related reactions

  • Before each dose, pre-medication is recommended with a corticosteroid, antipyretic, and antihistamine
  • During treatment and for at least 1 hour, closely monitor for infusion-related reactions including hypotension, hot flush or breathing problems

Tumour lysis syndrome

  • Life-threatening or fatal cases have been reported
  • For patients with a high tumour burden:
    • Before each dose, pre-medicate and hydrate to reduce uric acid levels
    • During treatment, monitor for signs of tumour lysis syndrome

QT interval prolongation

  • Be cautious when giving BESPONSA to patients:
    • With a history of 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

Interaction with other medicinal products

  • Co-administration with cytochrome P450 inhibitors or inducers or UGT metabolisers are unlikely to affect exposure to the active ingredient

Increased amylase and lipase

  • Monitor patients for increases in amylase and lipase and potential hepatobiliary disease, and treat according to standard medical practice

Pregnancy, breastfeeding and contraception

  • During treatment, it is recommended that women of childbearing potential avoid becoming pregnant
  • After the final dose, women should remain on contraception for ≥ 8 months and men with partners of childbearing potential for ≥ 5 months
  • Do not use BESPONSA during pregnancy unless potential benefit to the mother outweighs the possible risk to the foetus
  • BESPONSA can cause embryo-foetal harm when administered to pregnant women
  • There are no data measuring BESPONSA in human milk, but due to potential risk to the child, women must not breastfeed during treatment or for ≥ 2 months after the final dose
Please refer to the Besponsa Summary of Product Characterstics for full details

ECG, electrocardiogram; FBC, Full Blood Count; HSCT, Haematopoietic Stem Cell Transplantation; SmPC, Summary of Product Characteristics; UGT, uridine diphosphate-glucuronosyltransferase.

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

 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. BESPONSA Summary of Product Characteristics for Great Britain click here. BESPONSA Summary of Product Characteristics for Northern Ireland click here
PP-INO-GBR-0510. 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.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk 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-2688. December 2020

Yes

No