TECFIDERA 120 MG
DIMETHYL FUMARATE : 120 MG · DIN 02404508 · BIOGEN CANADA INC
Health Canada status: MARKETED
What is TECFIDERA?
TECFIDERA 120 MG contains DIMETHYL FUMARATE : 120 MG. It is listed in the Health Canada Drug Product Database under DIN 02404508, held by BIOGEN CANADA INC, supplied as CAPSULE (DELAYED RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 12-Apr-2013. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is TECFIDERA used for?
TECFIDERA (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 TECFIDERA in patients with primary progressive multiple sclerosis has not been established. TECFIDERA should only be prescribed by clinicians who are experienced in the diagnosis and management of multiple sclerosis.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02404508 |
|---|---|
| Brand name | TECFIDERA |
| Generic / active ingredient | DIMETHYL FUMARATE : 120 MG |
| Manufacturer | BIOGEN CANADA INC |
| Strength | 120 MG |
| Dosage form | CAPSULE (DELAYED RELEASE) |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L04AX07 DIMETHYL FUMARATE |
| AHFS class | 04:08.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 12-Apr-2013 |
| Original market date | 2013-07-01 00:00:00 |
How is it administered?
Starting dose: 120 mg twice a day for 7 days. Maintenance dose: 240 mg twice a day. Swallow capsules whole; do not crush, divide, or dissolve. Can be taken with or without food.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
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How is it supplied?
14 Capsule Cartons: one folded wallet containing 14 capsules per blister, 56 Capsule Cartons: two folded wallets containing two blisters with 14 capsules per blister
Contraindications
Hypersensitivity to dimethyl fumarate or to any ingredient in the formulation, including any non-medicinal ingredients, or component of the container.
Warnings and precautions
Risk of Progressive Multifocal Leukoencephalopathy (PML), serious opportunistic infections, lymphopenia (monitor CBC), clinically significant liver injury, and anaphylaxis/angioedema.
What can be used instead?
Other Canadian products sharing ATC code L04AX07 DIMETHYL FUMARATE. 12 of 22 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-DIMETHYL FUMARATE | 120 MG | CAPSULE (DELAYED RELEASE) | APOTEX INC | MARKETED | DIN 02505762 |
| APO-DIMETHYL FUMARATE | 240 MG | CAPSULE (DELAYED RELEASE) | APOTEX INC | MARKETED | DIN 02505770 |
| AURO-DIMETHYL FUMARATE | 120 MG | CAPSULE (DELAYED RELEASE) | AURO PHARMA INC | MARKETED | DIN 02540746 |
| AURO-DIMETHYL FUMARATE | 240 MG | CAPSULE (DELAYED RELEASE) | AURO PHARMA INC | MARKETED | DIN 02540754 |
| JAMP DIMETHYL FUMARATE | 120 MG | CAPSULE (DELAYED RELEASE) | JAMP PHARMA CORPORATION | MARKETED | DIN 02516047 |
| JAMP DIMETHYL FUMARATE | 240 MG | CAPSULE (DELAYED RELEASE) | JAMP PHARMA CORPORATION | MARKETED | DIN 02516055 |
| MAR-DIMETHYL FUMARATE | 120 MG | CAPSULE (DELAYED RELEASE) | MARCAN PHARMACEUTICALS INC | MARKETED | DIN 02502690 |
| MAR-DIMETHYL FUMARATE | 240 MG | CAPSULE (DELAYED RELEASE) | MARCAN PHARMACEUTICALS INC | MARKETED | DIN 02502704 |
| PMS-DIMETHYL FUMARATE | 120 MG | CAPSULE (DELAYED RELEASE) | PHARMASCIENCE INC | MARKETED | DIN 02497026 |
| PMS-DIMETHYL FUMARATE | 240 MG | CAPSULE (DELAYED RELEASE) | PHARMASCIENCE INC | MARKETED | DIN 02497034 |
Who else supplies DIMETHYL FUMARATE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DIMETHYL FUMARATE appears in 166 registered pack listings across 9 markets, published on 8 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.