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

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive
 

 

Description:

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.

  • Healthcare providers are advised to monitor patients for any new or worsening neurologic, cognitive or behavioural signs and symptoms that may be suggestive of PML as part of the differential diagnosis of CNS disorders.
  • If PML is suspected, patients should be referred to a specialist and appropriate diagnostic testing should be performed. Discontinue Kyprolis® if PML diagnosis is confirmed.

 

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

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

  • Healthcare providers are advised to test patients for HBV infection before initiating treatment with Kyprolis®.
  • For patients who are HBV carriers, prophylaxis with antivirals should be considered. HBV carriers who require treatment with Kyprolis® should be closely monitored for signs and symptoms of active HBV infection throughout and following the end of treatment.
  • Consider consulting a specialist for patients who test positive for HBV prior to or during treatment with Kyprolis®. The safety of resuming Kyprolis® after HBV reactivation is adequately controlled is not known. Prescribers should weigh the risks and benefits when considering resumption of therapy in this situation.

 

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.

 

DISCLAIMER

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.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Monday 21 September 2020, 10:03:22.
© Copyright 2019 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Main Menu English

Choose Your Language