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GLN-DIMETHYL FUMARATE 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: GLN-DIMETHYL FUMARATE (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 GLN-DIMETHYL FUMARATE in patients with primary progressive multiple…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Dosing in special populations: • Renal or hepatic impairment: Dimethyl fumarate has not been studied in patients with renal or hepatic impairment. Based on the pharmacokinetics and metabolic fate of dimethyl fumarate in healthy adults, neither condition would be expected to affect exposure to MMF PrGLN-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed Release Capsules) Page 5 of 40 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: GLN-DIMETHYL FUMARATE is not indicated for use in pediatric patients (see 1 INDICATIONS AND 10 CLINICAL PHARMACOLOGY).
• Geriatric patients: Clinical studies of dimethyl fumarate 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 dimethyl fumarate 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 GLN-DIMETHYL FUMARATE 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 GLN-DIMETHYL FUMARATE 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.
GLN-DIMETHYL FUMARATE can be taken with or without food. For those patients who may experience gastrointestinal side effects, taking GLN-DIMETHYL FUMARATE with food may improve tolerability. Administration of 325 mg non-enteric coated acetylsalicylic acid prior to dimethyl fumarate dosing reduced the occurrence and severity of flushing in a 4-day healthy volunteer study.
2 Pharmacodynamics 11/2023 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 .........................................................................................................
6 5 OVERDOSAGE ........................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................... 6 7 WARNINGS AND PRECAUTIONS .............................................................................
• GLN-DIMETHYL FUMARATE 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 GLN-DIMETHYL FUMARATE 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 mini-tablets 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 .................................................................................................... 13 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 .........................................................................
18 9 DRUG INTERACTIONS ............................................................................................ 2 Drug Interactions Overview ................................................................................ 4 Drug-Drug Interactions .......................................................................................
5 Drug-Food Interactions ....................................................................................... 20 10 CLINICAL PHARMACOLOGY ................................................................................ 1 Mechanism of Action ........................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 22 11 STORAGE, STABILITY AND DISPOSAL ..............................................................
25 PrGLN-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed Release Capsules) Page 3 of 40 12 SPECIAL HANDLING INSTRUCTIONS ................................................................. 25 PART II: SCIENTIFIC INFORMATION ....................................................................................
26 13 PHARMACEUTICAL INFORMATION .................................................................... 26 14 CLINICAL TRIALS .................................................................................................. 1 Clinical Trials by Indication ...............................................................................
26 Relapsing remitting multiple sclerosis ...................................................................... 3 Comparative Bioavailability Studies ................................................................. 30 15 MICROBIOLOGY ....................................................................................................
31 16 NON-CLINICAL TOXICOLOGY .............................................................................. 31 17 SUPPORTING PRODUCT MONOGRAPHS ........................................................... 33 PATIENT MEDICATION INFORMATION ................................................................................
34 PrGLN-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed Release Capsules) Page 4 of 40 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS GLN-DIMETHYL FUMARATE (dimethyl fumarate) is indicated as monotherapy for: • treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical […]