Diroximel Fumarate (2 brand names, 1 dosage form, 1 route)
Available dosage forms: CAPSULE, DELAYED RELEASE.
Routes of administration: ORAL.
Brand Names
- DIROXIMEL FUMARATE
- VUMERITY
Indications and Usage
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.
Contraindications
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)]. Taking dimethyl fumarate [see Drug Interactions (7.1)].
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 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)]
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.