Molecule
Monomethyl is a prescription medicine 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. MedsAcross supplies Monomethyl for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Blood tests are required prior to initiation of BAFIERTAM. Starting dose: 95 mg twice a day, orally, for 7 days. Maintenance dose after 7 days: 190 mg (administered as two 95 mg capsules) twice a day, orally. Swallow BAFIERTAM capsules whole and intact. Do not crush, chew, or mix contents with food. Take BAFIERTAM with or without food.
Source: US FDA prescribing information
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. taking dimethyl fumarate or diroximel fumarate. Known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or any of the excipients of BAFIERTAM. Co-administration with dimethyl fumarate or diroximel fumarate.
Source: US FDA prescribing information
Anaphylaxis and Angioedema: Discontinue and do not restart BAFIERTAM if these occur. Progressive Multifocal Leukoencephalopathy (PML): Withhold BAFIERTAM at the first sign or symptom suggestive of PML. Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding BAFIERTAM in cases of serious infection until the infection has resolved. Lymphopenia: Obtain a CBC including lymphocyte count before initiating BAFIERTAM, after 6 months, and every 6 to 12 months thereafter. Consider interruption of BAFIERTAM if lymphocyte counts <0.5 x 10 9 /L persist for more than six months. Liver Injury: Obtain serum aminotransferase, alkaline phosphatase and total bilirubin levels before initiating BAFIERTAM and during treatment, as clinically indicated. Discontinue BAFIERTAM if clinically significant liver injury induced by BAFIERTAM is suspected.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and Angioedema Progressive Multifocal Leukoencephalopathy Herpes Zoster and Other Serious Opportunistic Infections Lymphopenia Liver Injury Flushing Serious Gastrointestinal Reactions Most common adverse reactions (incidence for dimethyl fumarate [the prodrug of BAFIERTAM] ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea.
Source: US FDA prescribing information
Concomitant Dimethyl Fumarate or Diroximel Fumarate Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate. Therefore, BAFIERTAM is contraindicated in patients currently taking dimethyl fumarate or diroximel fumarate. BAFIERTAM may be initiated the day following discontinuation of either of these drugs.
Source: US FDA prescribing information
Store unopened bottles in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Opened Bottle Opened bottles may be stored at 20°C to 25°C (68°F to 77°F), excursions between 15°C and 30°C (59°F and 86°F) permitted. Store in original container.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Monomethyl, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Bafiertam 95 mg capsuleOral Cold chain | Banner Life Sciences | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 28 April 2020 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Monomethyl in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Monomethyl and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Monomethyl, including Bafiertam.
Yes. The US FDA first approved Monomethyl on 28 April 2020, according to Drugs@FDA.
At least one listed presentation of Monomethyl must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.