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Adverse Events

Common/Very Common AEs
Serious Adverse Events

VERY COMMON AND COMMON ADVERSE EVENTS* THAT OCCURRED DURING TREATMENT¹

Please refer to the product SmPC for full details

Table adapted from: Mylotarg^TM Summary of Product Characteristics.
*Only selected safety data were collected in this study of newly-diagnosed AML. †Including fatal outcome.
^‡Veno-occlusive liver disease includes the following reported preferred terms: Veno-occlusive disease and veno-occlusive liver disease.
^§Frequency is based on laboratory values (Grade per NCI CTCAE v4.03).
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; SmPC, Summary of Product Characteristics.

Reference

MYLOTARG™ Summary of Marketing Product Characteristics.

PP-MYL-GBR-0089. December 2019

SERIOUS ADVERSE EVENTS AND ADVERSE EVENTS OF SPECIAL INTEREST¹

View the ALFA 0701 study

Serious adverse events that occurred during treatment

Table adapted from: Mylotarg^TM 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.

Reference

MYLOTARG™ Summary of Marketing Product Characteristics.

PP-MYL-GBR-0089. December 2019

Prescribing Information

MYLOTARG™ (gemtuzumab ozogamicin) 5 mg powder for concentrate for solution for infusion
Legal category: Prescription only medicine. Cost: £6,300 per vial.
Click here to access the MYLOTARG Summary of Product Characteristics hosted on Datapharm’s ‘electronic Medicines Compendium’.

▼ 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.

Cytarabine 20 mg/mL and 100 mg/mL solution for infusion or injection

Legal category: Prescription only medicine. Basic NHS price: Cytarabine 100 mg/mL, supplied as single vials containing 100 mg/mL cytarabine in 10 mL (1 g), £39.00 or 20 mL (2 g), £77.50. Cytarabine 20 mg/mL supplied as vials containing 20 mg/mL cytarabine in 5 mL (100 mg) in packs of 5, £20.48 or 25 mL (500 mg) as single vials, £19.50.
Click to access the cytarabine 20 mg/mL and 100 mg/mL Summary of Product Characteristics hosted on Datapharm’s ‘electronic Medicines Compendium’.