Diroximel Fumarate

The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.

• VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.ICD-10: G35

• VUMERITY is contraindicated in patients With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Reactions may include anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )].contraindicated

Blood tests are required prior to initiation of VUMERITY ( 2.1 ) Starting dose: 231 mg twice a day, orally, for 7 days ( 2.2 ) Maintenance dose after 7 days: 462 mg (administered as two 231 mg capsules) twice a day, orally ( 2.2 ) Swallow VUMERITY capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food ( 2.3 ) Avoid administration of VUMERITY with a high-fat, high-calorie meal/snack ( 2.3 ) Avoid co-administration of VUMERITY with alcohol ( 2.3 ) 2.1 Blood Tests Prior to Initiation of VUMERITY Obtain the following prior to treatment with VUMERITY: A complete blood cell count (CBC), including lymphocyte count [see Warnings and Precautions ( 5.4 )] . Serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warnings and Precautions ( 5.5 )] . 2.2 Dosing Information The starting dosage for VUMERITY is 231 mg twice a day orally. After 7 days, the dosage should be increased to the maintenance dosage of 462 mg (administered as two 231 mg capsules) twice a day orally. Temporary dosage reductions to 231 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage. Within 4 weeks, the recommended dosage of 462 mg twice a day should be resumed. Discontinuation of VUMERITY should be considered for patients unable to tolerate return to the maintenance dosage. Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to VUMERITY dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology ( 12.3 )].

Anaphylaxis and Angioedema: Discontinue and do not restart VUMERITY if these occur. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML): Withhold VUMERITY at the first sign or symptom suggestive of PML. ( 5.2 ) Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding VUMERITY in cases of serious infection until the infection has resolved. ( 5.3 ) Lymphopenia: Obtain a CBC including lymphocyte count before initiating VUMERITY, after 6 months, and every 6 to 12 months thereafter. Consider interruption of VUMERITY if lymphocyte counts <0.5 × 10 9 /L persist for more than six months. ( 5.4 ) Liver Injury: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating VUMERITY and during treatment, as clinically indicated. Discontinue VUMERITY if clinically significant liver injury induced by VUMERITY is suspected. ( 5.6 ) 5.1 Anaphylaxis and Angioedema VUMERITY can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (which has the same active metabolite as VUMERITY) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue VUMERITY and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema. 5.2 Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (which has the same active metabolite as VUMERITY).

The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.1 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions Section ( 5.2 )] Herpes Zoster and Other Serious Opportunistic Infections [see Warnings and Precautions ( 5.3 )] Lymphopenia [see Warnings and Precautions ( 5.4 )] Liver Injury [see Warnings and Precautions ( 5.6 )] Flushing [see Warnings and Precautions ( 5.6 )] Serious Gastrointestinal Reactions [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence for dimethyl fumarate [which has the same active metabolite as VUMERITY] ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-800-456-2255 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described in the following sections were obtained using dimethyl fumarate delayed-release capsules, which has the same active metabolite as VUMERITY.

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) VUMERITY is not recommended in patients with moderate or severe renal impairment. ( 8.6 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VUMERITY during pregnancy. Encourage patients to enroll by calling 1-833-569-2635 or visiting www.vumeritypregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of VUMERITY in pregnant women. Available data from a pregnancy registry for dimethyl fumarate (which has the same active metabolite as VUMERITY), observational studies, and pharmacovigilance pertaining to dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see Data ). In animal studies, administration of diroximel fumarate during pregnancy or throughout pregnancy and lactation resulted in adverse effects on embryofetal and offspring development (increased incidences of skeletal abnormalities, increased mortality, decreased body weights, neurobehavioral impairment) at clinically relevant drug exposures [ see Data ].

Metabolism

After oral administration of VUMERITY, diroximel fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its active metabolite, monomethyl fumarate (MMF). Diroximel fumarate is not quantifiable in plasma following oral administration of VUMERITY.

• Oct 29, 2019NDANDA211855Biogen

1. 1Flushing1,58214%
2. 2Multiple Sclerosis1,0639.2%
3. 3Multiple Sclerosis Relapse9538.3%
4. 4Diarrhoea8597.5%
5. 5Product Dose Omission Issue8057.0%
6. 6Fatigue7656.6%
7. 7Nausea7386.4%
8. 8Headache6025.2%
9. 9Pruritus5805.0%
10. 10Memory Impairment5534.8%
11. 11Fall5404.7%
12. 12Abdominal Discomfort5124.4%
13. 13Product Dose Omission In Error5004.3%
14. 14Drug Ineffective4934.3%
15. 15Abdominal Pain Upper4624.0%

Recent PubMed references pinned to Diroximel Fumarate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Retrospective review of lymphocyte changes when switching between fumarates in patients with multiple sclerosis.
  Multiple sclerosis and related disorders · 2026 · Schneider M, Banks A, Zuckerman A, et al.
  PMID 41512726DOI 10.1016/j.msard.2026.106968
• Diroximel Fumarate-Loaded Solid Lipid Nanoparticles (DRF-SLNs) as Potential Carriers for the Treatment of Multiple Sclerosis: Preformulation Study.
  International journal of molecular sciences · 2025 · Santonocito D, Greco G, Sarpietro MG, et al.
  PMID 41465257DOI 10.3390/ijms262411827
• Effect of diroximel fumarate on gut dysbiosis and autoimmunity in the central nervous system.
  International immunopharmacology · 2026 · Yadav SK, Ito N, Suresh S, et al.
  PMID 41411731DOI 10.1016/j.intimp.2025.116054
• Fumarate-based drugs protect against neuroinflammation via upregulation of anti-ferroptotic pathways.
  Journal of neuroinflammation · 2025 · Fischer K, Thewes L, Prozorovski T, et al.
  PMID 41146249DOI 10.1186/s12974-025-03592-3
• Patient and healthcare provider experience of diroximel fumarate: considerations for selecting disease-modifying therapy.
  Neurodegenerative disease management · 2025 · Roman C, Garabedian M, Schobel VR, et al.
  PMID 41054231DOI 10.1080/17582024.2025.2564589
• Diroximel Fumarate Acts Through Nrf2 to Attenuate Methylglyoxal-Induced Nociception in Mice and Decrease ISR Activation in DRG Neurons.
  Diabetes · 2025 · Yousuf MS, Mancilla Moreno M, Woodall BJ, et al.
  PMID 39976640DOI 10.2337/db23-1025
• Severe gastrointestinal adverse reactions including perforation, ulceration, hemorrhage, and obstruction: A fumaric acid ester class new safety risk.
  Multiple sclerosis (Houndmills, Basingstoke, England) · 2025 · Kim T, Brinker A, Croteau D, et al.
  PMID 39931911DOI 10.1177/13524585251316518
• Comparative activity of dimethyl fumarate derivative IDMF in three models relevant to multiple sclerosis and psoriasis.
  FEBS open bio · 2025 · He Y, Gong G, Quijas G, et al.
  PMID 39825608DOI 10.1002/2211-5463.13969

The 10 most recently updated of 23 ClinicalTrials.gov registrations naming Diroximel Fumarate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
  Active not recruiting · Observational · 1,178 enrolled · Biogen
  NCT05688436updated 2026-06-04
• A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
  Recruiting · Observational · 800 enrolled · Novartis Pharmaceuticals
  NCT05344469updated 2026-06-01
• DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: DOUBLE BLIND RANDOMIZED CLINICAL TRIAL
  Recruiting · Phase 2 · Interventional · 192 enrolled · University Hospital, Lille
  NCT07275515updated 2026-05-28
• A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
  Not yet recruiting · Phase 3 · Interventional · 185 enrolled · Biogen
  NCT07483632updated 2026-03-19
• Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS
  Completed · Phase 3 · Interventional · 185 enrolled · Novartis Pharmaceuticals
  NCT04788615updated 2026-03-03
• A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)
  Completed · Phase 2 · Interventional · 127 enrolled · Biogen
  NCT05798520updated 2026-02-20
• Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia
  Recruiting · Interventional · 30 enrolled · King's College London
  NCT06957808updated 2026-02-13
• A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)
  Completed · Phase 3 · Interventional · 136 enrolled · Biogen
  NCT05083923updated 2025-10-24
• A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
  Active not recruiting · Observational · 10,500 enrolled · Biogen
  NCT05767736updated 2025-10-16
• Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
  Active not recruiting · Interventional · 900 enrolled · Johns Hopkins University
  NCT03500328updated 2025-10-14

Frequently asked questions

How does Diroximel Fumarate work?

The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.

What is Diroximel Fumarate used for?

According to FDA labeling, Diroximel Fumarate carries indications including: VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Diroximel Fumarate?

Diroximel Fumarate is classified as Other immunosuppressants, Unknown Cellular or Molecular Interaction.

What are the brand names for Diroximel Fumarate?

Diroximel Fumarate is marketed under brand names including Vumerity.

What are the contraindications for Diroximel Fumarate?

Diroximel Fumarate labeling lists contraindications including: VUMERITY is contraindicated in patients With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Reactions may include anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )].. Always consult the full prescribing information and a clinician.