OTULFI I.V. 5 MG
USTEKINUMAB : 5 MG · DIN 02554305 · FRESENIUS KABI CANADA LTD
Health Canada status: MARKETED
What is OTULFI I.V.?
OTULFI I.V. 5 MG contains USTEKINUMAB : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02554305, held by FRESENIUS KABI CANADA LTD, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 16-Apr-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 OTULFI I.V. used for?
Plaque psoriasis (adults/pediatrics 6-17), active psoriatic arthritis (adults), moderately to severely active Crohn’s disease (adults), and ulcerative colitis (adults).
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 | 02554305 |
|---|---|
| Brand name | OTULFI I.V. |
| Generic / active ingredient | USTEKINUMAB : 5 MG |
| Manufacturer | FRESENIUS KABI CANADA LTD |
| Strength | 5 MG |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | L04AC05 USTEKINUMAB |
| Biosimilar | Yes |
| Health Canada status | MARKETED |
| Status date | 16-Apr-2025 |
How is it administered?
Psoriasis/PsA: 45mg (90mg if >100kg) SC at weeks 0, 4, then every 12 weeks. CD/UC: Weight-based IV induction (approx. 6mg/kg), then 90mg SC at week 8 and every 8 weeks thereafter.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 2-8°C. Do not freeze. Keep in original carton to protect from light. (Note: Diluted IV solution stable for 8 hours).
How is it supplied?
SC: 45mg/0.5mL and 90mg/mL pre-filled syringes; 45mg/0.5mL single-use vial. IV: 130mg/26mL (5mg/mL) single-use vial.
Contraindications
Hypersensitivity to ustekinumab or any ingredient in the formulation. Severe infections such as sepsis, tuberculosis, and opportunistic infections.
Warnings and precautions
May increase risk of infections and reactivate latent TB. Potential for increased risk of malignancy. Monitor for skin cancer. Avoid live vaccines. Risk of hypersensitivity reactions.
What can be used instead?
Other Canadian products sharing ATC code L04AC05 USTEKINUMAB. 24 of 25 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 |
|---|---|---|---|---|---|
| FINLIUS | 45 MG / 0.5 ML | SOLUTION | JANSSEN INC | MARKETED | DIN 02537303 |
| FINLIUS | 90 MG / 1 ML | SOLUTION | JANSSEN INC | MARKETED | DIN 02537257 |
| FINLIUS I.V. | 5 MG | SOLUTION | JANSSEN INC | MARKETED | DIN 02537311 |
| JAMTEKI | 45 MG / 0.5 ML | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02543036 |
| JAMTEKI | 90 MG / 1 ML | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02543044 |
| JAMTEKI I.V. | 5 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02553120 |
| OTULFI | 45 MG / 0.5 ML | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | DIN 02554283 |
| OTULFI | 90 MG | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | DIN 02554291 |
| PYZCHIVA | 45 MG / 0.5 ML | SOLUTION | SAMSUNG BIOEPIS CO., LTD | MARKETED | DIN 02550539 |
| PYZCHIVA | 90 MG / 1 ML | SOLUTION | SAMSUNG BIOEPIS CO., LTD | MARKETED | DIN 02550547 |
Who else supplies USTEKINUMAB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. USTEKINUMAB appears in 425 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.