Mavenclad® (Cladribine): Risk of Serious Liver Injury and New Recommendations About Liver Function Monitoring

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Description

Cladribine is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease in adults. Due to its safety profile, cladribine is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternative drug indicated for the treatment of MS.

The National Pharmaceutical Regulatory Agency (NPRA) had received information from the European Medicines Agency (EMA), on the risk of liver injury, including serious cases and cases leading to discontinuation of treatment with Mavenclad® (cladribine).

Most cases of liver injury were presented with mild clinical symptoms. However, in rare cases, a transient transaminase elevation exceeding 1,000 units per litre and jaundice was described. Time to onset varied, with most cases occurring within eight (8) weeks after the first treatment course.

Healthcare professionals are advised to take a detailed patient history of underlying liver disorders or episodes of liver injury with other medicines. Liver function tests should be assessed prior to initiation of therapy and during treatment. In case a patient develops signs or symptoms suggestive of liver injury, treatment with Mavenclad® should be interrupted or discontinued, as appropriate.

The prescribing information of Mavenclad® will be updated to reflect the risk of liver injury. On 9th May 2022, the NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Merck Sdn. Bhd. to highlight this safety issue. For further information, please contact your local salesperson 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 (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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