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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.

Very common, common and serious adverse events

Selected Adverse Reactions in patients who received MYLOTARG in combination therapy study​​​​​​​​​​​​​​

MYLOTARG™ + SC (n=131)

SC (n=137)

System organ class

Very common
 (≥ 10%)

Common
(≥ 1%)

Very common (≥ 10%)

Common
(≥ 1%)

Infections and infestations

Infection (77.9%)

Infection (77.4%)

Vascular disorders

Haemorrhage (90.1%)§

Haemorrhage (78.1%)§

Hepatobiliary disorders

Increased AST (89.2%), increased ALT (78.3%), hyperbilirubinaemia (51.6%)

Veno-occlusive liver disease (4.6%)†ǁ

Increased AST (73.9%), increased ALT (81.3%), hyperbilirubinaemia (50.8%)

Veno-occlusive liver disease (1.5%)ǁ

Blood and lymphatic disorders

Haemoglobin decreased (100%), thrombocytopenia (100%), leukopenia (100%), lymphopenia (98.5%), neutropenia (97.7%), increased PT (84.8%), prolonged aPTT (80%)

Haemoglobin decreased (100%), thrombocytopenia (100%), leukopenia (99.3%), lymphopenia (97.8%), neutropenia (98.5%), increased PT (89.1%), prolonged aPTT (57.5%)

Metabolism and nutrition disorders

Hyperglycaemia (92.0%), hyperuricaemia (32.5%)

Hyperglycaemia (91.1%), hyperuricaemia (28.5%)

Investigations

Increased ALP (79.7%)

Increased ALP (68.9%)

Table adapted from: MYLOTARG Summary of Product Characteristics

*Only selected safety data were collected in this study of newly-diagnosed AML. All-grade events.
†Including fatal outcome. Fatal outcomes associated with VOD were observed in patients in the MYLOTARG™ + SC arm, not in the SC arm.2
‡Includes sepsis and bacteraemia (53%), fungal infection (15%), lower respiratory tract infection (5%), bacterial infection (9%),
gastrointestinal infection (8%), skin infection (2%), other infections (28%).
§Includes central nervous system haemorrhage (3%), upper gastrointestinal haemorrhage (34%), lower gastrointestinal haemorrhage (18%), subcutaneous haemorrhage (60%), other haemorrhage (65%), and epistaxis (63%).
¶Frequency is based on laboratory values (Grade per NCI CTCAE v4.0.3).
IIVeno-occlusive liver disease includes the following reported preferred terms: Veno-occlusive disease and veno-occlusive liver disease.
AML, acute myeloid leukaemia; ALP, alkaline phosphatase; ALT, alanine aminotransferase; aPTT, activated partial thromboplastin time; AST, aspartate aminotransferase; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; PT, prothrombin time; SC, standard chemotherapy; SmPC, Summary of Product Characteristics; VOD, veno-occlusive disease.

Serious Adverse Events and Adverse Events of Special Interest1

Serious adverse events that occurred during treatment​​​​​​​

Adverse event

MYLOTARG™ + chemotherapy
(n=131)

Chemotherapy
(n=137)

Grade ≥ 3, %

Grade ≥ 3, %

Thrombocytopenia

100

100

Leukopenia

100

99.3

Neutropenia

96.1

97.0

Lymphopenia

90.7

89.6

Haemoglobin decreased

86.2

89.7

Infection*‡

76.3

74.4

Haemorrhage*‡

20.6

8.8

Hyperglycaemia

19.2

17.8

Increased AST

14.0

9.0

Increased ALP

13.3

5.3

Increased ALT

10.9

15.7

Table adapted from: MYLOTARG Summary of Product Characteristics.

*Including fatal outcome. †Infection includes sepsis and bacteraemia (53.4%), fungal infection (15.3%), lower respiratory tract infection (5.3%), bacterial infection (9.2%), gastrointestinal infection (8.4%), skin infection (2.3%) and other infections (28.4%). ‡Haemorrhage includes central nervous system haemorrhage (3.1%), upper gastrointestinal haemorrhage (33.6%), lower gastrointestinal haemorrhage (17.6%), subcutaneous haemorrhage (60.3%), other haemorrhage (64.9%) and epistaxis (62.6%).
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; VOD, veno-occlusive disease.

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

Table adapted from: MylotargTM Summary of Product Characteristics.

*Including fatal outcome. †Infection includes sepsis and bacteraemia (53.4%), fungal infection (15.3%), lower respiratory tract infection (5.3%), bacterial infection (9.2%), gastrointestinal infection (8.4%), skin infection (2.3%) and other infections (28.4%).
‡Haemorrhage includes central nervous system haemorrhage (3.1%), upper gastrointestinal haemorrhage (33.6%), lower gastrointestinal haemorrhage (17.6%), subcutaneous haemorrhage (60.3%), other haemorrhage (64.9%) and epistaxis (62.6%).
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; VOD, veno-occlusive disease

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.
References
  1. ​​​​​​​​​​​​MYLOTARG Summary of Marketing Product Characteristics.
  2. Lambert J, et al. Haematologica 2019;104:113–119. Supplementary appendix
PP-MYL-GBR-0228. March 2021

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