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TECFIDERA is a brand name for Dimethyl Fumarate, supplied as a capsule (delayed release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TECFIDERA (dimethyl fumarate) is indicated as monotherapy for: • treatment of relapsing remitting multiple sclerosis (MS), to reduce the frequency of clinical exacerbations and to delay the progression of disability. The efficacy of TECFIDERA in patients with primary progressive multiple sclerosis has not been…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Dosing in special populations: • Renal or hepatic impairment: TECFIDERA (dimethyl fumarate) has not been studied in patients with renal or hepatic impairment. Based on the pharmacokinetics and metabolic fate of TECFIDERA in healthy adults, neither condition would be expected to affect exposure to MMF and therefore no dosage adjustment is necessary.
However, caution should be exercised when treating patients with these conditions (see 7 WARNINGS AND PRECAUTIONS, Special Populations; 10 CLINICAL PHARMACOLOGY, Pharmacokinetics). • Pediatric patients: TECFIDERA is not indicated for use in pediatric patients (see 1 INDICATIONS and 10 CLINICAL PHARMACOLOGY).
Pr TECFIDERA TM (dimethyl fumarate delayed-release capsules) Page 5 of 36 • Geriatric patients: Clinical studies of TECFIDERA had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether the safety and efficacy of TECFIDERA differs in elderly patients compared to younger patients.
Based on the mechanism of action there are no theoretical reasons for any requirement for dose adjustments in the elderly. Physicians who choose to treat geriatric patients should consider that treatment with TECFIDERA in the context of a greater frequency of other concomitant diseases and concomitant drug therapy warrants caution and may necessitate additional or more frequent monitoring (see 7 WARNINGS AND PRECAUTIONS, Geriatrics).
2 Recommended Dose and Dosage Adjustment • Initial dose: The starting dose for TECFIDERA is 120 mg twice a day orally, for a total of 240 mg per day. • Usual dose: After 7 days, increase to the recommended dose of 240 mg twice a day orally, for a total of 480 mg per day.
Temporary dose reduction to 120 mg twice a day (total of 240 mg per day) may reduce the occurrence of flushing and gastrointestinal (GI) side effects. Within one month, the recommended dose of 240 mg twice a day orally should be resumed.
TECFIDERA can be taken with or without food. For those patients who may experience gastrointestinal side effects, taking TECFIDERA with food may improve tolerability. Administration of 325 mg non-enteric coated acetylsalicylic acid prior to TECFIDERA dosing reduced the occurrence and severity of flushing in a 4-day healthy volunteer study.
2 Pharmacodynamics 05/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................
4 Administration ......................................................................................................... 5 Missed Dose ............................................................................................................
5 5 OVERDOSAGE............................................................................................................... 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 6 7 WARNINGS AND PRECAUTIONS ...................................................................................
• TECFIDERA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredients, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dimethyl Fumarate in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Longer term use of acetylsalicylic acid to manage flushing has not been studied and is not recommended (see 10 CLINICAL PHARMACOLOGY). Health Canada has not authorized an indication for pediatric use. 4 Administration TECFIDERA is taken orally, with or without food.
Capsules should be taken by swallowing whole. The capsule and its contents should not be crushed, divided, or dissolved, as the enteric-coating of the microtablets in the capsule helps to prevent irritant effects on the stomach. 5 Missed Dose If a dose is missed, the missed dose can be taken if there is at least 4 hours between the morning and evening doses.
Otherwise, treatment should be continued with the next dose as planned.
1 Special Populations................................................................................................ 1 Pregnant Women ............................................................................................ 2 Breast-feeding .................................................................................................
3 Pediatrics ......................................................................................................... 4 Geriatrics .........................................................................................................
11 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview ...................................................................................
2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ...................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions ............................................................................ 16 9 DRUG INTERACTIONS ................................................................................................. 2 Drug Interactions Overview ...................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions.......................................................................................... 19 10 CLINICAL PHARMACOLOGY ........................................................................................
1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ......................................................................................... 3 Pharmacokinetics ............................................................................................
21 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 24 PART II: SCIENTIFIC INFORMATION ........................................................................................
25 13 PHARMACEUTICAL INFORMATION ............................................................................. 25 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication .............................................................................. 25 15 MICROBIOLOGY .........................................................................................................
29 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 29 PATIENT MEDICATION INFORMATION ...................................................................................
31 Pr TECFIDERA TM (dimethyl fumarate delayed-release capsules) Page 4 of 36 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TECFIDERA (dimethyl fumarate) is indicated as monotherapy for: • treatment of relapsing remitting multiple sclerosis (MS), to reduce the frequency of clinical exacerbations and to delay the progression of disability.
The efficacy of TECFIDERA in patients with primary progressive multiple sclerosis has not been […]