Label: BAFIERTAM- monomethyl fumarate capsule

  • NDC Code(s): 69387-001-01
  • Packager: Banner Life Sciences LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 31, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use BAFIERTAM safely and effectively. See full prescribing information for BAFIERTAM. BAFIERTAM® (monomethyl fumarate) delayed-release ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    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 ...
  • 2 DOSAGE AND ADMINISTRATION
    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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    BAFIERTAM is available as soft gelatin delayed-release capsules containing 95 mg of monomethyl fumarate. The 95 mg capsule is white, opaque, oval, coated, and printed with “95” in black ink on the ...
  • 4 CONTRAINDICATIONS
    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 ...
  • 5 WARNINGS AND PRECAUTIONS
    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 ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and Angioedema [see Warnings and Precautions (5.1)] Progressive Multifocal ...
  • 7 DRUG INTERACTIONS
    7.1 Concomitant Dimethyl Fumarate or Diroximel Fumarate - Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate. Therefore, BAFIERTAM is contraindicated in ...
  • 8 USE IN SPECIFIC POPULATIONS
    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 ...
  • 11 DESCRIPTION
    BAFIERTAM contains the active ingredient monomethyl fumarate, which is an unsaturated monomethyl ester. It is also known by its chemical name, fumaric acid monomethyl ester, (C5H6O4). It has the ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Carcinogenicity studies of dimethyl fumarate (DMF) were conducted in mice and rats. In mice, oral administration ...
  • 14 CLINICAL STUDIES
    The efficacy of BAFIERTAM is based upon bioavailability studies in healthy subjects comparing oral dimethyl fumarate delayed-release capsules to BAFIERTAM delayed-release capsules [see Clinical ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - BAFIERTAM is available as soft gelatin delayed-release capsules containing 95 mg of monomethyl fumarate. The 95 mg capsules are white, opaque, oval, and coated with “95 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosage - Inform patients that they will be provided one strength of BAFIERTAM when starting treatment: take ...
  • PATIENT PACKAGE INSERT
    This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2023 - Patient Information - BAFIERTAM® (bah”feer'tam) (monomethyl ...
  • PRINCIPAL DISPLAY PANEL
    Principal Display Panel – Bottle Label - 69387-001-01 - 120 capsules - Rx only - Bafiertam® (monomethyl fumarate) Delayed-release capsules - 95 mg - Dispense in Original Package. Swallow capsules ...
  • INGREDIENTS AND APPEARANCE
    Product Information