Tecfidera Generic Name & Formulations
Legal Class
General Description
How Supplied
Manufacturer
Generic Availability
Tecfidera Indications
Indications
Tecfidera Dosage and Administration
Adult
Children
Tecfidera Contraindications
Not Applicable
Tecfidera Boxed Warnings
Not Applicable
Tecfidera Warnings/Precautions
Warnings/Precautions
Tecfidera Pharmacokinetics
Absorption
The median Tmax of MMF is 2-2.5 hours. The peak plasma concentration (Cmax) and overall exposure (AUC) increased approximately dose proportionally in the dose range studied (120 mg to 360 mg). Following administration of Tecfidera 240 mg twice a day with food, the mean Cmax of MMF was 1.87 mg/L and AUC was 8.21 mg.hr/L in MS patients.
A high-fat, high-calorie meal did not affect the AUC of MMF but decreased its Cmax by 40%. The Tmax was delayed from 2.0 hours to 5.5 hours. In this study, the incidence of flushing was reduced by approximately 25% in the fed state.
Distribution
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
Exhalation of CO2 is the primary route of elimination, accounting for approximately 60% of the Tecfidera dose. Renal and fecal elimination are minor routes of elimination, accounting for 16% and 1% of the dose respectively. Terminal half-life: ~1 hour.
Tecfidera Interactions
Tecfidera Adverse Reactions
Adverse Reactions
Tecfidera Clinical Trials
Tecfidera Note
Notes
Tecfidera Patient Counseling
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