pharmacopeia

Monomethyl Fumarate

Other immunosuppressantsUS-FDASourced from openFDA
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Mechanism of action

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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.

Indications

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  • 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. 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.ICD-10: G35

Contraindications

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  • 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 )].contraindicated

Dosage & administration

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Blood tests are required prior to initiation of BAFIERTAM. ( 2.1 ) Starting dose: 95 mg twice a day, orally, for 7 days ( 2.2 ) Maintenance dose after 7 days: 190 mg (administered as two 95 mg capsules) twice a day, orally ( 2.2 ) Swallow BAFIERTAM capsules whole and intact. Do not crush, chew, or mix contents with food. ( 2.3 ) Take BAFIERTAM with or without food. ( 2.3 ) 2.1 Blood Tests Prior to Initiation of BAFIERTAM Obtain the following prior to treatment with BAFIERTAM: A complete blood cell count (CBC), including lymphocyte count [see Warnings and Precautions ( 5.4 )] . Serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warnings and Precautions ( 5.5 )] . 2.2 Dosing Information The starting dosage for BAFIERTAM is 95 mg twice a day orally for 7 days. After 7 days, the dosage should be increased to the maintenance dosage of 190 mg (administered as two 95 mg capsules) twice a day orally. Temporary dosage reductions to 95 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage. Within 4 weeks, the recommended dosage of 190 mg twice a day should be resumed. Discontinuation of BAFIERTAM should be considered for patients unable to tolerate return to the maintenance dosage. Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to BAFIERTAM dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology ( 12.3 )] . 2.3 Administration Instructions Swallow BAFIERTAM capsules whole and intact. Do not crush, chew, or mix the contents with food.

Warnings & precautions

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Anaphylaxis and Angioedema: Discontinue and do not restart BAFIERTAM if these occur. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML): Withhold BAFIERTAM at the first sign or symptom suggestive of PML. ( 5.2 ) Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding BAFIERTAM in cases of serious infection until the infection has resolved. ( 5.3 ) 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. ( 5.4 ) 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. ( 5.5 ) 5.1 Anaphylaxis and Angioedema BAFIERTAM can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (the prodrug of BAFIERTAM) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue BAFIERTAM and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema. 5.2 Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (the prodrug of BAFIERTAM).

Adverse reactions

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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 )] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Banner Life Sciences at toll-free phone: 1-866-MMF- 95MG or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the following sections were obtained using dimethyl fumarate delayed-release capsules (the prodrug of BAFIERTAM). Adverse Reactions in Placebo-Controlled Trials with Dimethyl Fumarate In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate with an overall exposure of 2244 person-years [see Clinical Studies ( 14 )].

Use in specific populations

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Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BAFIERTAM during pregnancy. Pregnant women exposed to BAFIERTAM and healthcare providers are encouraged to contact Banner Life Sciences at 1-866-MMF-95MG (1-866-663-9564). Risk Summary There are no adequate data on the developmental risk associated with the use of BAFIERTAM in pregnant women. Available data from a pregnancy registry for dimethyl fumarate (the prodrug of BAFIERTAM), observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy ( see Data ). In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses ( see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Pharmacokinetics

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Metabolism
Pharmacokinetics of monomethyl fumarate have previously been characterized after oral administration of its prodrug, dimethyl fumarate, as delayed-release capsules, in healthy subjects and subjects with multiple sclerosis. After oral administration, dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its active metabolite, monomethyl fumarate (MMF).

Approval history

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  • Apr 28, 2020NDANDA210296Banner Life Sciences

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
904 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Flushing34638%
  2. 2Pruritus11012%
  3. 3Product Dose Omission Issue839.2%
  4. 4Nausea748.2%
  5. 5Erythema657.2%
  6. 6Abdominal Discomfort637.0%
  7. 7Abdominal Pain Upper515.6%
  8. 8Fatigue475.2%
  9. 9Diarrhoea455.0%
  10. 10Rash444.9%
  11. 11Dizziness434.8%
  12. 12Paraesthesia424.6%
  13. 13Feeling Hot414.5%
  14. 14Headache394.3%
  15. 15Burning Sensation343.8%

Literature

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Recent PubMed references pinned to Monomethyl Fumarate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Monomethyl Fumarate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Monomethyl Fumarate work?
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.
What is Monomethyl Fumarate used for?
According to FDA labeling, Monomethyl Fumarate carries indications including: 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. 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Monomethyl Fumarate?
Monomethyl Fumarate is classified as Other immunosuppressants.
What are the brand names for Monomethyl Fumarate?
Monomethyl Fumarate is marketed under brand names including Bafiertam.
What are the contraindications for Monomethyl Fumarate?
Monomethyl Fumarate labeling lists contraindications including: 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 )].. Always consult the full prescribing information and a clinician.
Note. Data for monomethyl-fumarate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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