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

Information on how to access Mylotarg™​​​​​​​​​​​​​​ (gemtuzumab ozogamicin) and cytarabine prescribing information and adverse event reporting can be found at the bottom of the page.

Selected Adverse Events

Infection and Veno-occlusive disease (VOD)

Haemorrhage and thrombocytopenia

Selected* adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)1

The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection

The rate of infection was similar with MYLOTARG+ chemotherapy vs chemotherapy alone1

MYLOTARG + chemotherapy arm:
All-causality severe (Grade ≥ 3) infections were reported in 102 (77.9%) patient
​​​​​​​Treatment-related death due to septic shock was reported in 1 (0.8%) patient

MYLOTARG+ chemotherapy and chemotherapy alone arm:
Fatal severe infection was reported in 2 (1.5%) patients in the MYLOTARG + chemotherapy arm and 4 (2.9%) patients in the chemotherapy alone arm

*Only selected safety data were collected in this study of newly diagnosed AML
**Including fatal outcome​​​​​​​

VOD was a common (≥ 1%) adverse event with MYLOTARG + chemotherapy vs chemotherapy alone1

MYLOTARG + chemotherapy and chemotherapy alone arm:
Six (4.6%) patients in the MYLOTARG + chemotherapy arm and 2 (1.5%) patients in the chemotherapy alone arm experienced VOD
Two (1.5%) patients in the MYLOTARG + chemotherapy arm died owing to VOD
​​​​​​​The two VOD events in the chemotherapy arm occurred after MYLOTARG re-treatment for relapse

*Only selected safety data were collected in this study of newly diagnosed AML
**Including fatal outcome
VOD, veno-occlusive disease.​​​​​​​

Please refer to the MYLOTARG SmPC for full details or ask our Medical Information department​​​​​​​

Explore more

Efficacy and Safety of MYLOTARG video


Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA study

Learn more

AML Landscape: Present and Future video


Watch Dr Eleni Tholouli discuss the NICE approval for MYLOTARG and efficacy data using the ALFA schedule

Learn more


▼ 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.
Reference
  1. MYLOTARG Summary of Marketing Product Characteristics.
PP-MYL-GBR-0229. March 2021

Read the Fast Facts Guide for brand overview

Click here to download a copy

Order a hard copy

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