TREMFYA 200 MG / 2 ML
GUSELKUMAB : 200 MG / 2 ML · DIN 02559145 · JANSSEN INC
Health Canada status: MARKETED
What is TREMFYA?
TREMFYA 200 MG / 2 ML contains GUSELKUMAB : 200 MG / 2 ML. It is listed in the Health Canada Drug Product Database under DIN 02559145, held by JANSSEN INC, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 15-Aug-2025. 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 TREMFYA used for?
Adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, or moderately to severely active ulcerative colitis.
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 | 02559145 |
|---|---|
| Brand name | TREMFYA |
| Generic / active ingredient | GUSELKUMAB : 200 MG / 2 ML |
| Manufacturer | JANSSEN INC |
| Strength | 200 MG / 2 ML |
| Dosage form | SOLUTION |
| Route of administration | SUBCUTANEOUS |
| Schedule | Prescription |
| ATC code | L04AC16 GUSELKUMAB |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 15-Aug-2025 |
How is it administered?
Psoriasis/PsA: 100mg SC at weeks 0, 4, then every 8 weeks. CD/UC Induction: 200mg IV or 400mg SC at weeks 0, 4, 8. Maintenance: 100mg SC at week 16 then every 8 weeks (or 200mg every 4 weeks).
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store in refrigerator at 2°C to 8°C. Protect from light. Do not freeze. Do not shake.
How is it supplied?
100mg/1mL or 200mg/2mL pre-filled syringes/pens/injectors; 200mg/20mL single-use vials.
Contraindications
Known serious hypersensitivity to guselkumab or any of the components.
Warnings and precautions
Potential to increase risk of infection; evaluate for TB prior to initiation. Serious hypersensitivity reactions including anaphylaxis have occurred. Avoid live vaccines.
What can be used instead?
Other Canadian products sharing ATC code L04AC16 GUSELKUMAB. 4 of 5 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 |
|---|---|---|---|---|---|
| TREMFYA | 100 MG / 1 ML | SOLUTION | JANSSEN INC | MARKETED | DIN 02469758 |
| TREMFYA I.V. | 200 MG / 20 ML | SOLUTION | JANSSEN INC | MARKETED | DIN 02559153 |
| TREMFYA ONE-PRESS | 100 MG / 1 ML | SOLUTION | JANSSEN INC | MARKETED | DIN 02487314 |
| TREMFYA | 200 MG / 2 ML | SOLUTION | JANSSEN INC | APPROVED | DIN 02559137 |
Who else supplies GUSELKUMAB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. GUSELKUMAB appears in 43 registered pack listings across 12 markets, published on 10 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.