Diroximel Fumarate

What it is and how it works

Mechanism of Action 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. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro .

Indications

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.

Dosage and administration (summary)

Blood tests are required prior to initiation of VUMERITY Starting dose: 231 mg twice a day, orally, for 7 days Maintenance dose after 7 days: 462 mg (administered as two 231 mg capsules) twice a day, orally Swallow VUMERITY capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food Avoid administration of VUMERITY with a high-fat, high-calorie meal/snack Avoid co-administration of VUMERITY with alcohol Blood Tests Prior to Initiation of VUMERITY Obtain the following prior to treatment with VUMERITY: A complete blood cell count (CBC), including lymphocyte count . Serum aminotransferase, alkaline phosphatase, and total bilirubin levels .

Contraindications

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 . Taking dimethyl fumarate . Known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY Co-administration with dimethyl fumarate

Warnings and precautions

Anaphylaxis and Angioedema: Discontinue and do not restart VUMERITY if these occur. Progressive Multifocal Leukoencephalopathy (PML): Withhold VUMERITY at the first sign or symptom suggestive of PML. Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding VUMERITY in cases of serious infection until the infection has resolved. 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.

Pregnancy

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.

Storage and supply

Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Source: Diroximel Fumarate (Vumerity) — US FDA prescribing information, 2025-05-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.