There are two brands of G-CSF approved in Singapore, namely lenograstim (Granocyte®, Aventis) and filgrastim (Neupogen®, Amgen). These 2 products were licensed in August 2002 and October 2003 for the mobilisation of peripheral blood progenitor cells in healthy donors.
Recently, the Health Sciences Authority was notified of 2 cases of healthy donors in Japan who developed haematological disorders at the 1-year follow up after receiving of G-CSF for peripheral blood stem cells transplantation (PBSCT). A Dear Healthcare Professional Letter was issued to medical oncologists and haematologists.
Risk assessment
To-date, there are no literature reports of leukaemic change in healthy donors receiving G-CSF. The US package insert of Neupogen® states that Neupogen® is a growth factor that primarily stimulates neutrophils. However, the possibility that Neupogen® can act as a growth factor for any tumour type cannot be excluded”.
Whilst the causality for the development of the abnormal haematological events in the above 2 patients cannot be determined, the risk-benefit assessment of G-CSF in healthy donors is difficult to assess as the benefits of treatment accrue mainly to the recipient.
HSA's recommendation
Healthcare professionals are encouraged to report all cases of suspected serious ADRs on the use of G-CSF, particularly in healthy donors.



