Dimethyl Fumarate

What it is and how it works

Mechanism of Action The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown. DMF and the metabolite, monomethyl fumarate (MMF), have 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

Dimethyl fumarate delayed-release capsules are 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. Dimethyl fumarate delayed-release capsules are 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)

Starting dose: 120 mg twice a day, orally, for 7 days Maintenance dose after 7 days: 240 mg twice a day, orally Swallow dimethyl fumarate delayed-release capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food Take dimethyl fumarate delayed-release capsules with or without food Dosing Information The starting dose for dimethyl fumarate delayed-release capsules is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose.

Contraindications

Dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules. Reactions have included anaphylaxis and angioedema . Known hypersensitivity to dimethyl fumarate or any of the excipients of dimethyl fumarate delayed-release capsules.

Warnings and precautions

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

Pregnancy

Pregnancy Risk Summary Available data from the dimethyl fumarate delayed-release capsules Pregnancy Registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Storage and supply

Dimethyl fumarate is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate. Dimethyl Fumarate Delayed-Release Capsules, 120 mg are white cap/white body size ‘0’ hard gelatin capsules imprinted in black ink with “DMT 120” on the body containing white to off-white, round shaped bic…

Source: Dimethyl Fumarate (Dimethyl Fumarate) — US FDA prescribing information, 2024-04-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.