• Relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Contraindicated in:

• Hypersensitivity to monomethyl fumarate, dimethyl fumarate, or diroximel fumarate.
• Concurrent use of dimethyl fumarate or diroximel fumarate.

Use Cautiously in:

• Serious infections (treatment may be withheld)
• Persistent lymphopenia (>6 mo) (↑ risk of PML)
• OB: Safety not established in pregnancy
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established in children.

Derm: flushing, erythema, pruritus, rash.

GI: abdominal pain, diarrhea, nausea, dyspepsia, HEPATOTOXICITY, vomiting.

GU: albuminuria.

Hemat: eosinophilia, lymphopenia.

Neuro: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML).

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFECTION (BACTERIAL, VIRAL [ESPECIALLY HERPES ZOSTER], AND FUNGAL).

Drug-Drug:

• Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate; concurrent use contraindicated.

• Delayed-release capsules: 95 mg;

• PO (Adults): 95 mg twice daily for 7 days, then ↑ to 190 mg twice daily.

Bafiertam

• Activates nuclear factor (Nrf2) pathway involved in cellular response to oxidative stress.

• Decreased incidence/severity of relapse with decreased progression of lesions and disability.

Therapeutic Classification: anti-multiple sclerosis agents

Absorption: Delayed by ingestion of high-fat meals.

Distribution: Well distributed to extravascular tissues.

Metabolism/Excretion: Metabolized by the tricarboxylic acid cycle. 60% eliminated via exhalation of CO₂. Minor amounts eliminated by renal (16%) and fecal (1%) routes.

Half-life: 30 min.

(plasma concentrations)

• Instruct patient to take medication as directed. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Inform patient that medication may cause flushing. Usually begins at start of therapy and improves or resolves over time. Administration of non-enteric coated aspirin (up to 325 mg) 30 min before therapy may reduce the incidence or severity of flushing.
• Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reactions, PML (progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision; changes in thinking, memory, and orientation leading to confusion and personality changes; may progress gradually over days to weeks), infection, or liver injury occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Encourage patient to follow up with lab tests to monitor for side effects.

MON-oh-METH-il FUE-ma-rate