Adverse Reactions in 2 Clinical Trials1

The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea

Adverse Reactions Reported for TECFIDERA 240 mg BID
at ≥2% Higher Incidence Than Placebo

  TECFIDERAn=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%

Overall discontinuation: discontinuation rates due to an adverse reaction with TECFIDERA were 14% vs 11% with placebo in 2 pivotal trials2

There are strategies to help guide patients' treatment experiences

Gastrointestinal1,2

  • TECFIDERA caused gastrointestinal (GI) events (eg, nausea, vomiting, diarrhea, abdominal pain, and dyspepsia)
  • 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 TECFIDERA compared with placebo
  • Four percent (4%) of patients treated with TECFIDERA and less than 1% of placebo patients discontinued due to gastrointestinal events
  • The incidence of serious GI events was 1% in patients treated with TECFIDERA
TECFIDERA Incidence of GI Events chart
TECFIDERA Incidence of GI Events chart

Hepatic transaminases1

  • An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the first six 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 TECFIDERA and placebo and were balanced between groups
  • There were 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 TECFIDERA or placebo

Eosinophilia1

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