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

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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 haemorrhage was higher with MYLOTARG+ chemotherapy vs chemotherapy alone1

MYLOTARG + chemotherapy arm:
​​​​​​​The most frequent Grade 3 bleeding/haemorrhagic reactions were haematemesis (3.1%), haemoptysis (3.1%) and haematuria (2.3%)
Grade 4 bleeding/haemorrhagic reactions were reported in 4 (3.1%) patients (gastrointestinal haemorrhage, haemorrhage and pulmonary alveolar haemorrhage [2 patients])
Fatal bleeding/haemorrhagic reactions were reported in 3 (2.3%) patients (cerebral haematoma, intracranial haematoma and subdural haematoma)

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

Severe persistent thrombocytopenia was observed in 22 (20.4%) patients in the MYLOTARG + chemotherapy arm1

MYLOTARG + chemotherapy arm:
The median time to recovery of platelets following induction was 34 days 

CR, complete remission; CRp, complete remission with incomplete platelet recovery.​​​​​​​

*Only selected safety data were collected in this study of newly diagnosed AML
†Thrombocytopenia with platelet counts < 50,000/mm3 persisting 45 days after the start of therapy for responding patients (CR and CRp). 

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

AML; Acute Myeloid Leukaemia;  NICE, National Institute for Health and Care Excellence

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

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PP-PFE-GBR-2688. December 2020