Dimethyl Fumarate
· Kit
- Prescription only
- Active substance
- Dimethyl Fumarate
- Made by
- Ascend Laboratories, LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (DIMETHYL FUMARATE). It describes the substance, not this exact product.
The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown.
DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.
In humans, dimethyl fumarate is extensively metabolized by esterases, which are ubiquitous in the gastrointestinal tract, blood, and tissues, before it reaches the systemic circulation.
Following administration of dimethyl fumarate delayed-release capsules 240 mg twice a day with food, the mean C max of MMF was 1.87 mg/L and AUC was 8.21 mg.hr/L in MS patients.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-30
Safety of the active substance
From the US prescribing label for the same active substance (DIMETHYL FUMARATE). It describes the substance, not this exact product.
- Dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules.
- Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )].
- Known hypersensitivity to dimethyl fumarate or any of the excipients of dimethyl fumarate delayed-release capsules.
Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
BulgariaNo exact match for this strength and form
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Ascend Laboratories, LLC |
|---|---|
| Active substance | Dimethyl Fumarate |
| Form | Kit |
| Packs | 1 KIT in 1 KIT * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC |
| NDC | 67877-557 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
43 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Capsule, Delayed Release34 products
- Kit7 products
—7
— · 7 companies
- Capsule2 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.