Dimethyl Fumarate (2 brand names, 1 dosage form, 1 route)
Available dosage forms: CAPSULE, DELAYED RELEASE.
Routes of administration: ORAL.
Brand Names
- DIMETHYL FUMARATE
- TECFIDERA
Indications and Usage
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.
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 [see Warnings and Precautions (5.1)].
Adverse Reactions
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 (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 (5.5)] Flushing [see Warnings and Precautions (5.6)] Serious Gastrointestinal Reactions [see Warnings and Precautions (5.7)]
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 vitroand in vivoin 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.
Overdosage
Cases of overdose with dimethyl fumarate delayed-release capsules have been reported. The symptoms described in these cases were consistent with the known adverse event profile of dimethyl fumarate delayed-release capsules. There are no known therapeutic interventions to enhance elimination of dimethyl fumarate delayed-release capsules nor is there a known antidote. In the event of overdose, initiate symptomatic supportive treatment as clinically indicated.