其 他 安 全 警 示
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| Singapore: Mavenclad® (cladribine) – risk of serious liver injury and recommendations for liver function monitoring (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Merck Pte Ltd to inform healthcare professionals of adverse events of liver injury following treatment with Mavenclad® (cladribine) and recommendations for liver function monitoring of patients on Mavenclad®. Liver injury, including serious cases and cases leading to discontinuation of treatment, has been reported in patients treated with Mavenclad®. A recent review of available safety data has concluded an increased risk for liver injury following treatment with Mavenclad®. Healthcare professionals are advised to take a detailed patient history of the underlying liver disorders or episodes of liver injury with other medicines before treatment initiation and to assess the patient’s liver function tests prior to initiation of therapy in year 1 and year 2. If a patient develops clinical signs, including unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction, healthcare professionals are advised to promptly measure serum transaminases and total bilirubin and interrupt or discontinue treatment with Mavenclad® as appropriate.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/mavenclad-(cladribine)-risk-of-serious-liver-injury-and-recommendations-for-liver-function-monitoring
In Hong Kong, there is 1 registered pharmaceutical product containing cladribine. The product is a prescription-only medicine. So far, the Department of Health (DH) has not received cases of adverse drug reaction related to cladribine.
Related news was previously issued by the European Medicine Agency and was posted on the Drug Office website on 15 Jan 2022. Letters to inform local healthcare professionals were issued by the DH on the same day. As previously reported, DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities and consider if any further action deemed necessary.
Ends/ Saturday, Feb 19, 2022
Issued at HKT 12:00
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