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   DIR Return to: TECFIDERA (dimethyl fumarate, BG-12, Fumaderm)
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       #Post#: 748--------------------------------------------------
       Change in Tecfidera labeling
       By: agate Date: April 28, 2015, 6:37 pm
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       The MSAA reports this change in the labeling for Tecfidera
       (April 28, 2015):
       [quote]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
  HTML http://www.tecfidera.com
  HTML http://www.tecfidera.com
       .[/quote]
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