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
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
Tetanus toxoid-containing vaccine
Pneumococcal polysaccharide vaccine
Meningococcal vaccine
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
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
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
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
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
Safety and effectiveness in pediatric patients have not been established
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
No dosage adjustment is necessary in patients with mild renal impairment
VUMERITY is not recommended in patients with moderate or severe renal impairment