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   DIR Return to: TECFIDERA (dimethyl fumarate, BG-12, Fumaderm)
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       #Post#: 748--------------------------------------------------
       Change in Tecfidera labeling
   DIR 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
       .
       --- End Quote ---
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