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Bafiertam Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Bafiertam Indications
Indications
Bafiertam Dosage and Administration
Adult
Children
Bafiertam Contraindications
Contraindications
Bafiertam Boxed Warnings
Not Applicable
Bafiertam Warnings/Precautions
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. Monitor, evaluate, and discontinue if new or worsening severe GI signs/symptoms occur. Administration with non-enteric coated aspirin (up to 325mg) may reduce incidence/severity of flushing. Pregnancy. Nursing mothers.
Bafiertam Pharmacokinetics
Absorption
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.
Distribution
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.
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.
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, serious GI reactions (eg, perforation, ulceration, hemorrhage, obstruction).
Bafiertam Clinical Trials
See Literature
Bafiertam Note
Not Applicable
Bafiertam Patient Counseling
See Literature
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