European CHMP to review direct healthcare professional communication (DHPC) informing of the risk of serious liver injury with cladribine (Mavenclad)

Liver injury, including serious cases and cases leading to discontinuation of treatment, has been reported in patients treated with Mavenclad. The draft DHPC aims to inform healthcare professionals about this risk and contains new recommendations on liver function monitoring.

SPS commentary:

The DHPC for Mavenclad will be forwarded to the European CHMP. Following approval, it will be disseminated to healthcare professionals and published on the Direct healthcare professional communications page and in national registers in EU Member States.

Liver injury is not included as an adverse effect in the current UK SPC for Mavenclad.

European Medicines Agency