Dimethyl Fumarate Kit

1 INDICATIONS AND USAGE Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: • Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.1 )] • Progressive multifocal leukoencephalopathy [see Warnings and Precautions ( 5.2 )] • Herpes Zoster and Other Serious Opportunistic Infections [see Warnings and Precautions ( 5.3 )] • Lymphopenia [see Warnings and Precautions ( 5.4 )] • Liver Injury [see Warnings and Precautions ( 5.5 )] • Flushing [see Warnings and Precautions ( 5.6 )] • Serious Gastrointestinal Reactions [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea.

8.1 Pregnancy Risk Summary Available data from the Dimethyl Fumarate Delayed-Release Capsules Pregnancy Registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see Data) .

5 WARNINGS AND PRECAUTIONS • Anaphylaxis and Angioedema: Discontinue and do not restart dimethyl fumarate delayed-release capsules if these occur. ( 5.1 ) • Progressive Multifocal Leukoencephalopathy (PML): Withhold dimethyl fumarate delayed-release capsules at the first sign or symptom suggestive of PML. ( 5.2 ) • Herpes Zoster and Other Serious Opportunistic infections: Consider withholding dimethyl fumarate delayed-release capsules in cases of serious infection until the infection has resolved. ( 5.3 ) • Lymphopenia: Obtain a CBC including lymphocyte count before initiating dimethyl fumarate delayed-release capsules, after 6 months, and every 6 to 12 months thereafter. 4 CONTRAINDICATIONS Dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1)].