Kyprolis® (carfilzomib): (i) Risk of progressive multifocal leukoencephalopathy (PML); (ii) Risk of hepatitis B virus (HBV) reactivation 

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Kyprolis® (carfilzomib) is indicated in combination with dexamethasone or lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. 


(i) Risk of progressive multifocal leukoencephalopathy (PML)

Kyprolis® may increase the risk of progressive multifocal leukoencephalopathy (PML). PML is a rare, often rapidly progressive demyelinating disease of the central nervous system (CNS) that is caused by the reactivation of John Cunningham virus (JC virus), a human polyoma virus.


(ii) Risk of hepatitis B virus (HBV) reactivation

Kyprolis® may increase the risk of hepatitis B virus (HBV) reactivation. 


NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Amgen Biopharmaceuticals Malaysia Sdn. Bhd. to highlight this safety issue. The product package insert will be updated to reflect this new information. For further information, please contact your local sales person for a copy of the DHPC.



This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.