Loading…
AURO-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: Auro-Dimethyl Fumarate (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 Delayed-Release Capsules in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules) Page 5 of 43 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. However, caution should be exercised when treating patients with these conditions (see 7 WARNINGS AND PRECAUTIONS, Special Populations; 10 CLINICAL PHARMACOLOGY, Pharmacokinetics).
• Pediatric patients: Auro-Dimethyl Fumarate 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. Physicians who choose to treat geriatric patients should consider that treatment with Auro-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 Auro-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.
Auro-Dimethyl Fumarate can be taken with or without food. For those patients who may experience gastrointestinal side effects, taking Auro-Dimethyl Fumarate with food may improve tolerability. 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.
, Clinical Trial Adverse Reactions). Administration of Auro-Dimethyl Fumarate with food or a temporary dose reduction to 240 mg/day may improve tolerability in patients who experience gastrointestinal adverse events (see 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment).
Dimethyl Fumarate Delayed-Release Capsules has not been evaluated in patients with severe active gastrointestinal disease and caution should be exercised when treating these patients. AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules) Page 8 of 43 Hematologic Dimethyl Fumarate Delayed-Release Capsules may decrease lymphocyte counts (see 8 ADVERSE REACTIONS, Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data).
In the MS placebo-controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with Dimethyl Fumarate Delayed-Release Capsules then remained stable at this reduced level for the duration of treatment.
91 x 109/L). 8 x 109/L for at least six months. 5 x 109/L with continued therapy. Four weeks after stopping Dimethyl Fumarate Delayed-Release Capsules, mean lymphocyte counts increased but did not return to baseline. 2 Pharmacodynamics.
The following precautions should be taken: • Prior to initiating treatment with Auro-Dimethyl Fumarate, obtain a complete blood count (CBC), including lymphocytes, if no recent (within 6 months) result is available. A CBC, including lymphocytes, is also recommended after 6 months of treatment, then every 6 to 12 months, and as clinically indicated.
5 x 109/L persisting for more than 6 months. • Assess the benefit-risk in patients who experience moderate lymphopenia for more than 6 months. • In patients with lymphocyte counts below lower limit of normal (LLN) as defined by local laboratory reference range, regular monitoring of absolute lymphocyte counts is recommended.
, Geriatrics). 2 CONTRAINDICATIONS • Auro-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. 1 Dosing Considerations AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules) Page 5 of 43 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. However, caution should be exercised when treating patients with these conditions (see 7 WARNINGS AND PRECAUTIONS, Special Populations; 10 CLINICAL PHARMACOLOGY, Pharmacokinetics).
• Pediatric patients: Auro-Dimethyl Fumarate 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. Physicians who choose to treat geriatric patients should consider that treatment with Auro-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).
• Auro-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.
Know a brand we are missing in Canada? Suggest a brand →
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). AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules) Page 6 of 43 Health Canada has not authorized an indication for pediatric use.
4 Administration Auro-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 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.
Additional factors that might further augment the individual PML risk should be considered (see also Progressive Multifocal Leukoencephalopathy below). • In all cases of lymphopenia, lymphocyte counts should be followed until recovery.
Where Auro-Dimethyl Fumarate treatment has been stopped, decisions about whether or not to restart Auro-Dimethyl Fumarate should be individualized based on clinical circumstances. • A CBC is also recommended prior to switching patients to other therapies that are known to reduce lymphocyte counts to avoid additive immune effects (see 8 ADVERSE REACTIONS, Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data).
• Patients with pre-existing low lymphocyte counts, and patients concomitantly taking other immunomodulating treatments, were excluded from the multiple sclerosis clinical AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules) Page 9 of 43 trials.
, immunodeficiency syndrome), due to the potential risk of additive immune system effects. Hepatic/Biliary During clinical trials in patients with multiple sclerosis, elevations in liver transaminases (ALT and AST) > 1 x the upper limit of normal (ULN) and less than 3 x ULN occurred more frequently in patients treated with Dimethyl Fumarate Delayed-Release Capsules than in patients that received placebo.
The increased incidence of elevations of hepatic transaminases in patients treated with Dimethyl Fumarate Delayed-Release Capsules relative to placebo was primarily seen during the first 6 months of treatment (see 8 ADVERSE REACTIONS, Clinical Trial Adverse Reactions, Hepatic Transaminases).
Prior to initiating treatment with Auro-Dimethyl Fumarate, serum aminotransferase, alkaline phosphatase and total bilirubin levels should be obtained (within 6 months). During treatment, evaluation of transaminases is recommended after 6 months of treatment, then every 6 to 12 months, and as clinically indicated.
Discontinue Auro-Dimethyl Fumarate if clinically significant liver injury induced by Auro-Dimethyl Fumarate is suspected. Clinically significant cases of liver injury have been reported in patients treated with Dimethyl Fumarate Delayed-Release Capsules in the postmarketing setting.
The onset has ranged from a few days to several months after initiation of treatment with Dimethyl Fumarate Delayed- Release Capsules. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed.
These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients.
Immune Infections:
Treatment with Auro-Dimethyl Fumarate should not be initiated in patients with signs and symptoms of a serious infection. Decreases in lymphocyte counts […]
2 Recommended Dose and Dosage Adjustment • Initial dose: The starting dose for Auro-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.
Auro-Dimethyl Fumarate can be taken with or without food. For those patients who may experience gastrointestinal side effects, taking Auro-Dimethyl Fumarate with food may improve tolerability. 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). AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules) Page 6 of 43 Health Canada has not authorized an indication for pediatric use.
4 Administration Auro-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 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. 5 OVERDOSAGE Cases of overdose with Dimethyl Fumarate Delayed-Release Capsules have been reported.
The symptoms described in these cases were consistent with the known adverse event profile of Dimethyl Fumarate Delayed-Release Capsules. There are no known therapeutic interventions to enhance elimination of Dimethyl Fumarate Delayed-Release Capsules nor is there a known antidote.
In the event of overdose, it is recommended that symptomatic supportive treatment be initiated as clinically indicated. Safety of cumulative doses higher than 720 mg daily has not been adequately evaluated (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics).
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Delayed-release capsules 120 mg and 240 mg Enteric-coated micro tablets: Croscarmellose sodium, FD&C Blue 2 (240 mg capsule), gelatin, iron oxide yellow (240 mg capsule), magnesium stearate, methacrylic acid - ethyl acrylate copolymer, methacrylic acid - methyl methacrylate copolymer, silica colloidal anhydrous, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate.
AURO-DIMETHYL FUMARATE (Dimethyl Fumarate Delayed-Release Capsules) Page 7 of 43 Description Auro-Dimethyl Fumarate. White to off – white, Round shape biconvex tablets, plain on both sides. 120 mg Capsules: White Cap White body Size ‘0’ hard gelatin capsules imprinted in black ink with ‘’DMT 120’’ on the body containing white to off –white, round shape biconvex tablets, plain on both Sides.
Packaging: 14’s count: white opaque PVC/PE/PVDC 90 GSM with plain AI. Lidding foil blister pack. 1x14’s and 4x14’s. 240 mg Capsules: Green Cap /green body Size ‘0’ hard gelatin capsules imprinted in black ink with ‘’DMT 240’’ on the body containing white to off –white, round shape biconvex tablets, plain on both Sides.
Packaging: 14’s count: white opaque PVC/PE/PVDC 90 GSM with plain AI. Lidding foil blister pack. 1x14’s and 4x14’s. 7 WARNINGS AND PRECAUTIONS General During treatment with Auro-Dimethyl Fumarate, simultaneous use of […]