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JAMP 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: JAMP 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 dimethyl fumarate in patients with primary progressive multiple sclerosis…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Dosing in special populations: Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 5 of 43 • 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 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: JAMP 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 JAMP 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 JAMP 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.
JAMP Dimethyl Fumarate can be taken with or without food. For those patients who may experience gastrointestinal side effects, taking JAMP 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.
, Clinical Trial Adverse Reactions). Administration of JAMP 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 has not been evaluated in patients with severe active gastrointestinal disease and caution should be exercised when treating these patients. Hematologic JAMP Dimethyl Fumarate (dimethyl fumarate) 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 Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 8 of 43 approximately 30% during the first year of treatment with dimethyl fumarate 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, mean lymphocyte counts increased but did not return to baseline. 2 Pharmacodynamics. The following precautions should be taken: • Prior to initiating treatment with JAMP 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. Additional factors that might further augment the individual PML risk should be considered (see also Progressive Multifocal Leukoencephalopathy below).
01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics..............................................................................................................
2 Geriatrics .............................................................................................................. 1 Dosing Considerations ..........................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................... 4 Administration ..................................................................................................... 5 Missed Dose .........................................................................................................
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 ...............................................................................................
• JAMP 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.
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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 Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 6 of 43 JAMP 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 minitablets 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.
• In all cases of lymphopenia, lymphocyte counts should be followed until recovery. Where JAMP Dimethyl Fumaratetreatment has been stopped, decisions about whether or not to restart JAMP 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 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 Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 9 of 43 in patients treated with dimethyl fumarate than in patients that received placebo.
The increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate 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 JAMP 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 JAMP Dimethyl Fumarate if clinically significant liver injury induced by JAMP Dimethyl Fumarate is suspected. Clinically significant cases of liver injury have been reported in patients treated with dimethyl fumarate in the postmarketing setting.
The onset has ranged from a few days to several months after initiation of treatment with dimethyl fumarate. 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 JAMP Dimethyl Fumarate should not be initiated in patients with signs and symptoms of a serious infection. Decreases in lymphocyte counts observed in patients treated with dimethyl fumarate in clinical trials were not associated with increased frequencies of infections.
However, due to the potential risk of infections in patients who develop sustained […]
5 Post-Market Adverse Reactions ......................................................................... 19 9 DRUG INTERACTIONS ............................................................................................... 2 Drug Interactions Overview................................................................................
4 Drug-Drug Interactions....................................................................................... 5 Drug-Food Interactions ...................................................................................... 22 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action.......................................................................................... 2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ...............................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 27 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 27 PART II: SCIENTIFIC INFORMATION ......................................................................................
28 13 PHARMACEUTICAL INFORMATION ........................................................................... 28 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ................................................................................. 2 Comparative Bioavailability Studies.................................................................... 33 15 MICROBIOLOGY .......................................................................................................
34 16 NON-CLINICAL TOXICOLOGY .................................................................................... 34 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 36 PATIENT MEDICATION INFORMATION.................................................................................
37 Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 4 of 43 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS JAMP 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 dimethyl fumarate in patients with primary progressive multiple […]