• Multiple sclerosis

Bafiertam Generic Name & Formulations

General Description

Monomethyl fumarate 95mg; delayed-release caps (soft gelatin).

Pharmacological Class

Nrf2 pathway activator.

How Supplied



Generic Availability


Bafiertam Indications


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

Bafiertam Dosage and Administration


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.


Not established.

Bafiertam Contraindications


Concomitant dimethyl fumarate or diroximel fumarate.

Bafiertam Boxed Warnings

Not Applicable

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 Pharmacokinetics


Following oral administration of Bafiertam 190 mg (two 95 mg monomethyl fumarate delayed-release capsules) under fasting conditions, the median Tmax of MMF is 4.03 hours; and the peak plasma concentration (Cmax) and overall exposure (AUC) of monomethyl fumarate are bioequivalent to those after oral administration of 240 mg dimethyl fumarate delayed-release capsule.


From studies with dimethyl fumarate (the prodrug of Bafiertam), it is shown that the apparent volume of distribution of MMF varies between 53 and 73 L in healthy subjects. Human plasma protein binding of MMF is 27–45% and independent of concentration.


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.


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.

Bafiertam Interactions

Not Applicable

Bafiertam Adverse Reactions

Adverse Reactions

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

Bafiertam Clinical Trials

See Literature

Bafiertam Note

Not Applicable

Bafiertam Patient Counseling

See Literature