(gemtuzumab ozogamicin)

What is MYLOTARG and what is it used for?1

MYLOTARG contains the active substance gemtuzumab ozogamicin, an anticancer medicine, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. This substance is delivered to cancer cells by the monoclonal antibody. A monoclonal antibody is a protein which recognises certain cancer cells. MYLOTARG is used to treat a certain type of cancer called acute myeloid leukaemia (AML) in which the bone marrow makes abnormal white blood cells. MYLOTARG is intended for the treatment of AML for patients age 15 years and above who have not tried other treatments. MYLOTARG is not for use in patients with a type of cancer called acute promyelocytic leukaemia (APL). A doctor or nurse will give you MYLOTARG through a drip in your vein (intravenous infusion [IV]) gradually over 2 hours. The medicine can only be obtained with a prescription.


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 MYLOTARG

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 MYLOTARG

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 MYLOTARG

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) following the UK leaving the European Union. 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 MYLOTARG please follow these links:

Great Britain
MYLOTARG (gemtuzumab ozogamicin)

Northern Ireland
MYLOTARG (gemtuzumab 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 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.


  1. MYLOTARG® Patient Information Leaflet. Accessed Dec 2021.


PP-MYL-GBR-0536 / December 2021