VUMERITY Offers the Well-Understood Safety of dimethyl fumarate1

The data described in the following sections were obtained using dimethyl fumarate delayed-release capsules, which has the same active metabolite as VUMERITY

  • The adverse reactions presented in the table below are based on safety information from 769 patients treated with dimethyl fumarate 240 mg twice a day and 771 placebo-treated patients
  • The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea

Adverse reactions in Study 1 and Study 2 reported for dimethyl fumarate 240 mg BID
at ≥2% higher incidence than placebo

     
  DMFn=769 Placebon=771
Flushing 40% 6%
Abdominal pain 18% 10%
Diarrhea 14% 11%
Nausea 12% 9%
Vomiting 9% 5%
Pruritus 8% 4%
Rash 8% 3%
Albumin urine present 6% 4%
Erythema 5% 1%
Dyspepsia 5% 3%
Aspartate aminotransferase increased 4% 2%
Lymphopenia 2% <1%

Gastrointestinal (GI) Events

  • Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia)
  • 4% of patients treated with dimethyl fumarate and less than 1% of placebo patients discontinued due to GI events
  • The incidence of serious GI events was 1% in patients treated with dimethyl fumarate
  • The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo

Hepatic Transaminases

  • An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate was seen primarily during the first 6 months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials
  • Elevations of alanine aminotransferase and aspartate aminotransferase to ≥3 times the ULN occurred in a small number of patients treated with both dimethyl fumarate and placebo and were balanced between groups
  • No elevations in transaminases ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN
  • Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with dimethyl fumarate or placebo

Eosinophilia

  • A transient increase in mean eosinophil counts was seen during the first 2 months of therapy