Diroximel fumarate
VUMERITY
Pronunciation: dye-rox-i-mel-FYOO-ma-rayt (vyoo-MER-i-tee)
What it isNRF2-activating prodrug of monomethyl fumarate; relapsing multiple sclerosis.
Why this oneEquivalent active-metabolite exposure causes less GI intolerance than dimethyl fumarate.
What limits itLymphopenia raises PML risk; monitor counts, and expect flushing despite the improved GI tolerability.
FDA-approved for
- relapsing multiple sclerosis (2019)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Relapsing forms of multiple sclerosis | Adult | 231 mg BID x7d | 462 mg BID | 462 mg BID |
Titration After 7 days at starting dose, increase to maintenance.
Renal No adjustment for mild impairment; not recommended in moderate or severe impairment.
Hepatic Undefined
Instructions
- Swallow capsules whole; do not crush, chew, or sprinkle on food
- If taken with food, avoid a high-fat/high-calorie meal (≤700 cal, ≤30 g fat); non-enteric aspirin 325 mg 30 min prior may reduce flushing
- Avoid co-administration with alcohol
- Temporary reduction to 231 mg BID if maintenance not tolerated; resume 462 mg BID within 4 weeks
- Obtain CBC with lymphocyte count and LFTs before initiation
Available strengths
- DR cap 231 mg
- cap 231 mg
Contraindications
- Co-administration with dimethyl fumarate
Cautions
- Anaphylaxis and angioedema — discontinue and do not restart
- Progressive multifocal leukoencephalopathy (PML)
- Herpes zoster and other serious opportunistic infections
- Lymphopenia — monitor CBC/lymphocytes
- Liver injury — monitor LFTs
- Flushing
- Serious GI reactions
Adverse reactions
- Flushing
- Abdominal pain
- Diarrhea
- Nausea
Pregnancy No adequate data; animal studies show embryofetal harm (skeletal abnormalities, mortality, reduced weight, neurobehavioral impairment).
Lactation No data on presence in human milk; effects on infant/milk unknown.
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 231 mg | DR cap | 60 BID | not offered |
Generic entry2025
NO BOXED WARNINGS
Principal riskLymphopenia raising PML risk
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilitySerious infection, cytopenias, hepatic injury and malignancy risk require laboratory and clinical monitoring.