Monomethyl Fumarate (1 brand name, 1 dosage form, 1 route)
Available dosage forms: CAPSULE, DELAYED RELEASE.
Routes of administration: ORAL.
Brand Names
- BAFIERTAM
Indications and Usage
BAFIERTAM 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
BAFIERTAM is contraindicated in patients: with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. Reactions may include anaphylaxis or angioedema [see Warnings and Precautions (5.1)]. taking dimethyl fumarate or diroximel fumarate [see Drug Interactions (7.1)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the 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 monomethyl fumarate (MMF) exerts its therapeutic effect in multiple sclerosis is unknown. MMF 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.