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Besponsa ▼ (inotuzumab ozogamicin)

What is BESPONSA and what is it used for?1

BESPONSA belongs to a group of medicines that target cancer cells. These medicines are called antineoplastic agents.

BESPONSA is used to treat adults with acute lymphoblastic leukaemia. Acute lymphoblastic leukaemia is a cancer of blood where you have too many white blood cells. BESPONSA is intended for the treatment of acute lymphoblastic leukaemia for adult patients who have previously tried other treatments and for whom those treatments have failed.

BESPONSA acts by attaching to cells with a protein called CD22. Acute lymphoblastic leukaemia cells have this protein. Once attached to the acute lymphoblastic leukaemia cells, the medicine delivers a substance into the cells that interferes with the cells’ DNA and eventually kills them.

The active ingredient is called inotuzumab ozogamicin and a doctor or nurse will give you BESPONSA through a drip in your vein (intravenous infusion) which will run for 1 hour.

The medicine can only be obtained with a prescription.

 

REFERENCE INFORMATION

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. One of the ways they do this is by producing evidence-based guidance. See NICE guidance on BESPONSA

The Scottish Medicines Consortium is the national source of advice on the clinical and cost-effectiveness of all new medicines for NHS Scotland. Their aim is to ensure that people in Scotland have timely access to medicines that provide most benefit based on best available evidence. See SMC guidance on BESPONSA

The European Medicines Agency (EMA) is an agency of the European Union (EU). The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. See EMA guidance on BESPONSA

Medicines in Northern Ireland fall under the remit of the European Medicines Agency (EMA) whilst medicines in Great Britain (England, Scotland and Wales) fall under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA) since Brexit. These agencies are responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies.

If you would like to see the Summary of Product Characteristics (SPC) or Patient Information Leaflet (PIL) for BESPONSA please follow these links:

 

Great Britain

BESPONSA (inotuzumab ozogamicin)

Northern Ireland

BESPONSA (inotuzumab ozogamicin)

 

This medicine is subject to additional monitoring.

If you get any side effects when taking this or any other medicine, talk to your doctor or other relevant health professional e.g. pharmacist, nurse. This includes any possible side effects not listed in the packaging leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search the Google Play or Apple App Store for MHRA Yellow Card. By reporting side effects, you can help provide more information on the safety of this medicine.

Pfizer is unable to provide advice on personal medical matters. Please consult your doctor or other relevant health professional for specific, health-related advice and support.

 

References

  1. BESPONSA® Patient Information Leaflet. September 2021
PP-INO-GBR-0558 / Sept 2021