Additional Considerations When Treating With TECFIDERA1

Half-life

  • The terminal half-life of the active metabolite of TECFIDERA (monomethyl fumarate [MMF]) is ~1 hour, and there are no circulating metabolites at 24 hours in the majority of individuals
  • The accumulation of MMF does not occur with multiple doses of TECFIDERA
  • TECFIDERA can be discontinued if necessary, without the need for accelerated elimination or additional agents

Drug interaction studies

  • TECFIDERA has no known drug interactions identified from in vitro CYP inhibition and induction studies, or from P-glycoprotein studies
  • Aspirin, when administered approximately 30 minutes before TECFIDERA, did not alter the pharmacokinetics of MMF

Oral contraceptives

  • Coadministration of TECFIDERA with a combined oral contraceptive (norelgestromin and ethinyl estradiol) did not elicit any relevant effects in oral contraceptives exposure
  • No interaction studies have been performed with oral contraceptives containing other progestogens

Vaccines

  • A randomized, open-label study examined the concomitant use of TECFIDERA and several nonlive vaccines in adults 27—55 years of age with relapsing forms of MS (38 subjects undergoing treatment with TECFIDERA at the time of vaccination and 33 subjects undergoing treatment with nonpegylated interferon at the time of vaccination)
  • Relative to antibody exposure in patients treated with interferons, simultaneous exposure to TECFIDERA did not weaken antibody responses to the following nonlive vaccines:
    • Tetanus toxoid-containing vaccine
    • Pneumococcal polysaccharide vaccine
    • Meningococcal vaccine
  • The impact of these findings on vaccine effectiveness in this patient population is unknown. The safety and effectiveness of live or live-attenuated vaccines administered simultaneously with TECFIDERA have not been assessed

Specific populations

Pregnancy

  • There are no adequate data on the developmental risk associated with the use of TECFIDERA in pregnant women
  • Instruct patients who are pregnant or plan to become pregnant while taking TECFIDERA that they should inform their healthcare professional
    • Encourage patients to enroll in the TECFIDERA Pregnancy Registry if they become pregnant while taking TECFIDERA

Lactation

  • There are no data on the presence of TECFIDERA or MMF in human milk. The effects on the breastfed infant and on milk production are unknown