其 他 安 全 警 示
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| European Union: Mavenclad: risk of serious liver injury (English only) |
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The European Medicines Agency (EMA) announces that the PRAC discussed a direct healthcare professional communication (DHPC) containing important safety information for Mavenclad. This DHPC aims to inform healthcare professionals about adverse events of liver injury with Mavenclad (cladribine), and gives new recommendations about liver function monitoring.
Mavenclad is a medicine used to treat adults with the relapsing forms (repeated flare-ups of the symptoms) of multiple sclerosis, a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord (demyelination). Mavenclad is used in patients whose disease is highly active.
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 on an increased risk for liver injury following treatment with Mavenclad. Most patients who experienced liver injury had mild clinical symptoms. However, in some cases, transitory high levels of enzyme transaminase exceeding 1000 units per litre and jaundice (liver affection causing, amongst others, yellowing of the skin and eyes) were described.
Liver injury will be included in the product information of Mavenclad as an adverse drug reaction of uncommon frequency.
Healthcare professionals are advised to perform a detailed review of patient history of underlying liver disorders or episodes of liver injury with other medicines before initiating patient treatment. During treatment, liver function tests should be conducted, and repeated as necessary. In case a patient develops liver injury, treatment with Mavenclad should be interrupted or discontinued, as appropriate.
Patients should be advised to report immediately to their healthcare professional any signs or symptoms of liver injury. Healthcare professionals are asked to report any suspected adverse reactions via their national reporting system. Reporting suspected adverse reactions after authorisation of the medicinal product is important to ensure patient safety.
The DHPC for Mavenclad will be forwarded to EMA’s human medicines committee, the CHMP. Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in EU Member States.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-january-2022
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. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued. The DH will remain vigilant on safety update of the drug issued by the EMA and other overseas drug regulatory authorities and consider if any further action deemed necessary.
Ends/ Saturday, January 15, 2022
Issued at HKT 12:30
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