MS Speaks

Changes Made to Tecfidera's Label

In December 2014, the United States Food and Drug Administration (FDA) made some changes to the product labeling for Tecfidera® (dimethyl fumarate). These changes instruct physicians on how to best prescribe the drug for their patients to minimize the potential for certain side effects and adverse events.

To follow is a general overview of the changes to Tecfidera's labeling:

Temporary dose reductions (to half the dose) may be used for individuals unable to tolerate the drug, for up to four weeks before returning to the full dose

Discontinuation should be considered for patients unable to return to the maintenance dose after four weeks of a reduced dose

Non-enteric, coated aspirin (up to a dose of 325 mg), 30 minutes prior to Tecfidera dosing, may be given to help reduce the potential side effect of flushing

This medication is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of Tecfidera's ingredients

New warning that anaphylaxis and angioedema (allergic reactions) may occur after the first dose or at any time during treatment; symptoms have included difficulty breathing, urticaria [hives], and swelling of the throat and tongue; Tecfidera should be discontinued and immediate medical care sought if experiencing these symptoms

A fatal case of Progressive Multifocal Leukoencephalopathy (PML) occurred in one patient with MS who received Tecfidera for four years while enrolled in a clinical trial; the patient experienced prolonged lymphopenia (reduction in circulating lymphocytes) while taking Tecfidera

New warning that Tecfidera may decrease lymphocyte counts; a CBC (complete blood count), including lymphocyte count, should be obtained before initiating treatment, after six months of treatment, every six to 12 months thereafter, and as clinically indicated
Please note that these are only highlights of the labeling changes for Tecfidera. For full drug and prescribing information, please visit Tecfidera's website at http://www.tecfidera.com.