Multiple sclerosis:

Indications for: BAFIERTAM

Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Adult Dosage:

Swallow whole. Initially 95mg twice daily for 7 days, then increase to maintenance dose of 190mg twice daily. If maintenance dose not tolerated, temporarily reduce back to initial dose. Within 4 weeks, resume maintenance dose; if not tolerated, consider discontinuing.

Children Dosage:

Not established.

BAFIERTAM Contraindications:

Concomitant dimethyl fumarate or diroximel fumarate.

BAFIERTAM Warnings/Precautions:

Obtain a CBC including lymphocyte count prior to initiation, after 6 months, and then every 6 to 12 months thereafter; consider interruption if lymphocyte counts <0.5×109/L persist for >6 months. Pre-existing low lymphocyte counts: not studied. Serious infections; consider withholding until resolved. Monitor for herpes zoster and other opportunistic infections; evaluate and treat if develop. Monitor serum aminotransferase, alkaline phosphatase, and total bilirubin prior to initiation and during treatment; discontinue if significant liver injury is suspected. Discontinue if anaphylaxis or angioedema occurs. Withhold and evaluate at first sign/symptom suggestive of PML. Administration with non-enteric coated aspirin (up to 325mg) may reduce incidence/severity of flushing. Pregnancy. Nursing mothers.

BAFIERTAM Classification:

Nrf2 pathway activator.

Adverse Reactions:

Flushing, abdominal pain, diarrhea, nausea, vomiting, pruritus, rash, albumin urine present, erythema, dyspepsia; lymphopenia, liver injury.


In humans, metabolism of MMF occurs through the tricarboxylic acid (TCA) cycle, with no involvement of the cytochrome P450 (CYP450) system. MMF, fumaric and citric acid, and glucose are the major metabolites of MMF in plasma.

Drug Elimination:

The plasma half-life of MMF is ~0.5 hour and no circulating MMF is present at 24 hours in the majority of individual following oral administration of Bafiertam 190 mg (two 95 mg monomethyl fumarate delayed-release capsules) under fasting conditions.

Generic Drug Availability:


How Supplied: