Additional Considerations When Treating With VUMERITY1

Half-life

  • The terminal half-life of monomethyl fumarate (MMF) is approximately 1 hour
  • The accumulation of MMF does not occur with multiple doses of VUMERITY
  • MMF is mainly eliminated as carbon dioxide in the expired air
  • 2-hydroxyethyl succinimide (HES) is mainly eliminated in urine

Drug interaction studies

  • VUMERITY metabolism does not involve CYP enzymes, therefore no clinically meaningful interactions are expected when administered with CYP inhibitors or inducers
  • Aspirin, when administered approximately 30 minutes before TECFIDERA, did not alter the pharmacokinetics of MMF
  • In a study conducted with dimethyl fumarate, no relevant effects of MMF on oral contraceptive exposure were observed when administered with a combined oral contraceptive (norelgestromin and ethinyl estradiol). No interaction studies have been performed with oral contraceptives containing other progestogens
  • Administration of VUMERITY at the same time with 5% v/v and 40% v/v ethanol did not alter total MMF exposure relative to administration with water, demonstrating that the coingestion of ethanol does not induce dose dumping. The mean peak plasma MMF concentration for VUMERITY was decreased by 9% and 21%, when co-administered with 240 mL of 5% v/v and 40% v/v of ethanol, respectively 

Use in Specific Populations

Pregnancy

  • There are no adequate data on the developmental risk associated with the use of VUMERITY in pregnant women
  • Instruct patients that if they are pregnant or plan to become pregnant while taking VUMERITY, they should inform their physician

Lactation

  • There are no data on the presence of VUMERITY or metabolites (MMF, HES) in human milk. The effects on the breastfed infant and on milk production are unknown

Pediatric use

  • Safety and effectiveness in pediatric patients have not been established

Geriatric use

  • Clinical studies of dimethyl fumarate and VUMERITY did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients

Renal impairment

  • No dosage adjustment is necessary in patients with mild renal impairment
  • VUMERITY is not recommended in patients with moderate or severe renal impairment