Regulatory
Published · Updated · 2 min read
PRAC recommends lenalidomide label updates: an HLH warning and PML as a rare adverse reaction
What it means for practice
Consider the new warning on haemophagocytic lymphohistiocytosis and the inclusion of PML as a rare adverse reaction to lenalidomide. The benefit–risk balance for approved indications remains unchanged.
Summary
The State Expert Centre of the Ministry of Health of Ukraine reported recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) to update safety information for lenalidomide. The European Medicines Agency (EMA) published the minutes of the PRAC meeting held on 31 August – 03 September 2026. The review was based on an assessment of periodic safety update reports.
What changes
The product information should include a warning about the risk of haemophagocytic lymphohistiocytosis (HLH). Progressive multifocal leukoencephalopathy (PML) should be included as an adverse reaction with a frequency of “rare”. The communication does not provide this frequency category for HLH.
Lenalidomide is indicated for multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma. Based on the analysis of safety and efficacy data, the benefit–risk balance for approved indications remains unchanged.
Further monitoring
Marketing authorisation holders must closely monitor and fully document fatal cases, particularly those with an unknown cause of death, as well as cases of HLH, non-infectious myocarditis, stress cardiomyopathy and PML.
Important identified risks for the next report include teratogenicity, serious infections, thromboembolic events, second primary malignancies, heart failure, cardiac arrhythmias, ischaemic heart disease, including myocardial infarction, and tumour flare reaction. Off-label use remains an important potential risk.
Source
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Зміни інформації з безпеки лікарських засобів, що містять леналідомід (lenalidomide) за результатами засідання Комітету з оцінки ризиків у фармаконагляді (PRAC) від 31 серпня – 03 вересня 2026 року. Державний експертний центр МОЗ України.
Reviewed by: DrugCard editorial team ·
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