Treatment Considerations for Your VUMERITY Patients

Treatment considerations based on your patients' individual needs1-3

Half-life1
  • With a terminal half-life of ~1 hour for monomethyl fumarate (MMF), VUMERITY is eliminated from the body without the need for accelerated elimination

  • Accumulation of MMF does not occur with multiple doses of VUMERITY

  • MMF is mainly eliminated as carbon dioxide in the expired air with only trace amounts (less than 0.3% of the total dose) recovered in urine

  • 2-hydroxyethyl succinimide (HES), the major circulating inactive drug-related compound in humans, is mainly eliminated in urine

Drug-to-drug interactions1
  • 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

  • Diroximel fumarate (DRF) metabolism does not involve cytochrome P450 (CYP) enzymes; therefore, no clinically meaningful interactions are expected when administered with CYP inhibitors or inducers

  • Aspirin, when administered approximately 30 minutes before dimethyl fumarate (DMF), did not alter the pharmacokinetics of MMF

  • 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 DRF was decreased by 9% and 21% when co-administered with 240 mL of 5% v/v and 40% v/v of ethanol, respectively

  • VUMERITY is contraindicated in patients currently taking DMF, which is also metabolized to MMF. VUMERITY may be initiated the day following discontinuation of DMF

Treatment considerations for your patients planning vaccinations1

Dimethyl fumarate did NOT attenuate antibody responses to the non-live vaccines in this study

Icon of a germ
Non-live vaccines included in the study:

Tetanus toxoid-containing vaccine

Pneumococcal polysaccharide vaccine

Meningococcal vaccine

Study description:

  • A randomized, open-label study examined the use of dimethyl fumarate (which has the same active metabolite as VUMERITY) and tetanus toxoid, pneumococcal polysaccharide, and meningococcal vaccines in patients between the ages 27 and 55 years with relapsing forms of MS

  • At the time of vaccination, 38 patients underwent treatment with dimethyl fumarate and 33 patients underwent treatment with nonpegylated interferon

Limitations:

  • A small patient population was included in this study

  • 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 VUMERITY or dimethyl fumarate have not been assessed

Treatment considerations for your patients of childbearing age1

Pregnancy1
  • There are no adequate data on the developmental risk associated with the use of VUMERITY or DMF (which has the same active metabolite as VUMERITY) in pregnant women

  • Instruct patients who are pregnant or plan to become pregnant while taking VUMERITY that they should inform their healthcare professional

Lactation1
  • There are no data on the presence of diroximel fumarate or metabolites (MMF, HES) in human milk. The effects on the breastfed infant and on milk production are unknown

Contraception1
  • 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

Treatment considerations in other populations1

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

Taking all these considerations into account may help inform your treatment decisions