Dimethyl fumarate

Red

Brand Name(s):Tecfidera

Indication:MS – relapsing & remitting

Rationale:1,2

Considered:May-13

Review Date:May-26

Comments:
Safety update MHRA -The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild lymphopenia. Continue to monitor lymphocyte counts and advise patients to seek urgent medical attention if they experience any symptoms or signs suggestive of PML.

Drug Safety Update
Risk of progressive multifocal leukoencephalopathy
April 2016
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Drug Safety update
Fatal PML in an MS patient with severe, prolonged lymphopenia. Full details at:https://www.gov.uk/drug-safety-update/dimethyl-fumarate-tecfidera-fatal-pml-in-a-ms-patient-with-severe-prolonged-lymphopenia
March 2015
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NICE CG186 Management of MS in Primary & Secondary Care:
http://www.nice.org.uk/guidance/cg186/resources/guidance-multiple-sclerosis-pdf
Oct 2014
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