Dimethyl fumarate information updated to include ways to minimise PML
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Dimethyl fumarate information updated to include ways to minimise PML Product information for dimethyl fumarate (Tecfidera) is being updated to include data to minimise the risk of PML* in the setting of mild lymphoma, says Dr Mihaela Vlaicu from Biogen Idec (Ireland). As Biogen Idec’s Senior Director of Medical Affairs (UK and Ireland), Dr Vlaicu released a Direct Healthcare Professional Communication in agreement with the EMA and Biogen Netherlands B.V. advising of the updated recommendations for Tecfidera, which is approved in the EU for the treatment of adults with relapsing-remitting multiple sclerosis (MS). Dr Vlaicu explained that "among over 475,000 patients exposed to Tecfidera, 11 cases of PML have been confirmed. The single commonality in all 11 confirmed cases is a decreased absolute lymphocyte count (ALC), which is a biologically plausible risk factor for PML". In addition, three of the above-mentioned cases developed within a setting of mild lymphopenia (i.e. lymphocyte count of ≥ 0.8 x 109/L), while the remaining eight cases occurred in a setting of moderate to severe lymphopenia (i.e. PML had been confirmed only within this setting). The Tecfidera Product Information is being revised to include the following key information: • Cases of PML have been reported in Tecfidera-treated patients in the setting of mild lymphopenia. • Tecfidera is contraindicated in patients with suspected or confirmed PML. • Treatment 9with Tecfidera should not be initiated in patients with severe lymphopenia (lymphocyte counts of < 0.5 x 10 /L). • A thorough assessment of possible causes of a lymphocyte count below the normal range should be completed before initiating treatment with Tecfidera. • Tecfidera should be discontinued in patients with severe lymphopenia that persists for >6 months. • At the first sign or symptom suggestive of PML, Tecfidera should be withheld and appropriate diagnostic evaluations carried out (including determination of JCV DNA in cerebrospinal fluid by quantitative polymerase chain reaction methodology). • Tecfidera must be permanently discontinued if a patient develops PML. • Healthcare professionals should advise their patients to inform partners/caregivers about their treatment and symptoms suggestive of PML, since they may notice symptoms of which the patient is not aware of. • Patients developing PML after recent discontinuation of natalizumab (Tysabri; a monoclonal antibody used in the treatment of relapsing-remitting MS) may not necessarily present with lymphopenia. * PML = progressive multifocal leukoencephalopathy; a serious opportunistic infection caused by the John-Cunningham virus that may be fatal or result in severe disability. Vlaicu M. Tecfidera (dimethyl fumarate): Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia. Internet Document : [3 pages], 12 Nov 2020. Available from: URL: https://www.hpra.ie/docs/default-source/default-document-library/important-safetyinformation---tecfidera-(dimethyl-fu
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