Anaphylaxis and Angioedema: Discontinue and do not restart TECFIDERA if these occur. Progressive Multifocal Leukoencephalopathy (PML): Withhold TECFIDERA at the first sign or symptom suggestive of PML. Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding TECFIDERA in cases of serious infection until the infection has resolved. Lymphopenia: Obtain a CBC including lymphocyte count before initiating TECFIDERA, after 6 months, and every 6 to 12 months thereafter. Consider interruption of TECFIDERA if lymphocyte counts <0.5 x 10 9 /L persist for more than six months. Liver Injury: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.