NIASTASE 2.4 MG
EPTACOG ALFA (ACTIVATED) : 2.4 MG · DIN 02239660 · NOVO NORDISK CANADA INC
Health Canada status: CANCELLED POST MARKET
What is NIASTASE?
NIASTASE 2.4 MG contains EPTACOG ALFA (ACTIVATED) : 2.4 MG. It is listed in the Health Canada Drug Product Database under DIN 02239660, held by NOVO NORDISK CANADA INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled post market, status dated 22-Jul-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 NIASTASE used for?
Hemophilia A/B patients with inhibitors to FVIII or FIX for treatment of bleeding episodes (including surgery). Suitable for all inhibitor patients due to lack of anamnestic response.
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 | 02239660 |
|---|---|
| Brand name | NIASTASE |
| Generic / active ingredient | EPTACOG ALFA (ACTIVATED) : 2.4 MG |
| Manufacturer | NOVO NORDISK CANADA INC |
| Strength | 2.4 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | B02BD08 COAGULATION FACTOR VIIa |
| AHFS class | 20:28.16 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 22-Jul-2013 |
| Original market date | 1999-08-05 00:00:00 |
How is it administered?
Intravenous bolus only. Bleeding episodes/Surgery: 90 μg/kg initially, then every 2 hours until improvement; interval may increase to 2-6 hours if continued therapy is required.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at room temperature (not specified in summary, but reconstitution instructions mention bringing to room temperature not above 37°C). Reconstituted solution stable for 3 hours.
How is it supplied?
Vials of 1.2 mg (60 KIU), 2.4 mg (120 KIU), and 4.8 mg (240 KIU). Reconstitution requires Sterile Water for Injection.
Contraindications
Known hypersensitivity to the active substance, excipients, or to mouse, hamster or bovine protein.
Warnings and precautions
Serious arterial and venous thromboembolic events reported. Risk of anti-Factor VII antibodies in FVII deficient patients. Monitor for signs of thrombosis or hypersensitivity/anaphylaxis.
What can be used instead?
Other Canadian products sharing ATC code B02BD08 COAGULATION FACTOR VIIa. 3 of 11 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 |
|---|---|---|---|---|---|
| NIASTASE RT | 1 MG | POWDER FOR SOLUTION ; KIT | NOVO NORDISK CANADA INC | MARKETED | DIN 02417103 |
| NIASTASE RT | 2 MG | POWDER FOR SOLUTION ; KIT | NOVO NORDISK CANADA INC | MARKETED | DIN 02417111 |
| NIASTASE RT | 5 MG | POWDER FOR SOLUTION ; KIT | NOVO NORDISK CANADA INC | MARKETED | DIN 02417138 |
| NIASTASE | 1.2 MG | POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | CANCELLED POST MARKET | DIN 02239659 |
| NIASTASE | 4.8 MG | POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | CANCELLED POST MARKET | DIN 02239661 |
| NIASTASE RT | 1 MG | KIT ; POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | APPROVED | DIN 02347113 |
| NIASTASE RT | 2 MG | KIT ; POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | APPROVED | DIN 02347121 |
| NIASTASE RT | 5 MG | KIT ; POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | APPROVED | DIN 02347148 |
| NIASTASE RT | 8 MG | POWDER FOR SOLUTION ; KIT | NOVO NORDISK CANADA INC | APPROVED | DIN 02417146 |
| NIASTASE RT | 8 MG | KIT ; POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | APPROVED | DIN 02365669 |
Who else supplies COAGULATION FACTOR VIIa worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. COAGULATION FACTOR VIIa appears in 109 registered pack listings across 5 markets, published on 3 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.