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SANDOZ DIMETHYL FUMARATE DELAYED-RELEASE 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: Sandoz Dimethyl Fumarate Delayed-Release Capsules (dimethyl fumarate delayed-release capsules) 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 dimethyl fumarate…
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 delayed-release capsules has not been studied in patients with renal or hepatic impairment. Based on the pharmacokinetics and metabolic fate of dimethyl fumarate delayed-release capsules in healthy adults, neither condition would be expected to affect exposure to MMF and therefore no dosage adjustment is necessary.
3 Pharmacokinetics). Pediatric patients: Sandoz Dimethyl Fumarate Delayed-Release Capsules is not indicated for use in pediatric patients (see 1 INDICATIONS and 10 CLINICAL PHARMACOLOGY). Geriatric patients: Clinical studies of dimethyl fumarate delayed-release capsules 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 delayed-release capsules 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. 4 Geriatrics). 2 Recommended Dose and Dosage Adjustment Initial dose: The starting dose for Sandoz Dimethyl Fumarate Delayed-Release Capsules 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. Sandoz Dimethyl Fumarate Delayed-Release Capsules can be taken with or without food. For those patients who may experience gastrointestinal side effects, taking Sandoz Dimethyl Fumarate Delayed-Release Capsules with food may improve tolerability.
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Sandoz Dimethyl Fumarate Delayed-Release Capsules Page 6 of 46 Administration of 325 mg non-enteric coated acetylsalicylic acid prior to dimethyl fumarate delayed-release capsules dosing reduced the occurrence and severity of flushing in a 4-day healthy volunteer study.
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 Sandoz Dimethyl Fumarate Delayed-Release Capsules 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.
2 Pharmacodynamics 12/2023 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 ..................................... 7 7 WARNINGS AND PRECAUTIONS .....................................................................................
1 Special Populations ................................................................................................ 1 Pregnant Women ..................................................................................................
2 Breast-feeding ....................................................................................................... 3 Pediatrics ...............................................................................................................
4 Geriatrics ............................................................................................................... 14 8 ADVERSE REACTIONS ....................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions .............................................................................. 3 Less Common Clinical Trial Adverse Events............................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings .............................................................................. 5 Post Market Adverse Reactions................................................................................
21 9 DRUG INTERACTIONS .................................................................................................... 2 Drug Interactions Overview......................................................................................
4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food Interactions............................................................................................
24 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ..............................................................................................
2 Pharmacodynamics ................................................................................................. 3 Pharmacokinetics ....................................................................................................
26 11 STORAGE, STABILITY AND DISPOSAL ............................................................................ 29 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 29 PART II: SCIENTIFIC INFORMATION ......................................................................................
30 13 PHARMACEUTICAL INFORMATION ............................................................................. 30 14 CLINICAL TRIALS ..........................................................................................................
1 Trial Design and Study Demographics ..................................................................... 2 Study Results ........................................................................................................... 3 Comparative Bioavailability Studies .......................................................................
35 15 MICROBIOLOGY .......................................................................................................... 36 16 NON-CLINICAL TOXICOLOGY ........................................................................................
36 17 SUPPORTING PRODUCT MONOGRAPHS ...................................................................... 38 PATIENT MEDICATION INFORMATION ................................................................................. 39 Sandoz Dimethyl Fumarate […]
Sandoz Dimethyl Fumarate Delayed-Release Capsules 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. Sandoz Dimethyl Fumarate Delayed-Release Capsules Page 5 of 46
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.