BIVALIRUDIN FOR INJECTION 250 MG
BIVALIRUDIN : 250 MG · DIN 02435268 · FRESENIUS KABI CANADA LTD
Health Canada status: MARKETED
What is BIVALIRUDIN FOR INJECTION?
BIVALIRUDIN FOR INJECTION 250 MG contains BIVALIRUDIN : 250 MG. It is listed in the Health Canada Drug Product Database under DIN 02435268, held by FRESENIUS KABI CANADA LTD, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 23-Apr-2019. 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 BIVALIRUDIN FOR INJECTION used for?
Anticoagulant for patients undergoing PCI, including those with ACS (UA/NSTEMI/STEMI) or at risk of HIT/TS. Also for patients with HIT/TS undergoing cardiac surgery.
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 | 02435268 |
|---|---|
| Brand name | BIVALIRUDIN FOR INJECTION |
| Generic / active ingredient | BIVALIRUDIN : 250 MG |
| Manufacturer | FRESENIUS KABI CANADA LTD |
| Strength | 250 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | B01AE06 BIVALIRUDIN |
| AHFS class | 20:12.04.12 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 23-Apr-2019 |
| Original market date | 2019-04-23 00:00:00 |
How is it administered?
Administered as an intravenous bolus followed by an infusion. In PCI: 0.75 mg/kg bolus then 1.75 mg/kg/h infusion. Dose adjustments required for renal impairment.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15-30°C. Reconstituted solution is stable for 24 hours at 2-8°C. Do not freeze.
How is it supplied?
250 mg / vial (Single-use vial)
Contraindications
Hypersensitivity, uncontrollable active bleeding, major blood clotting disorders, acute gastric/duodenal ulcer, cerebral hemorrhage, severe cerebro-spinal trauma, bacterial endocarditis.
Warnings and precautions
Do not administer IM. No known antidote. Risk of acute stent thrombosis in STEMI patients. Use with extreme caution in patients at increased risk of hemorrhage. Not for brachytherapy.
Is BIVALIRUDIN in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Active — reported by AVIR PHARMA INC., last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code B01AE06 BIVALIRUDIN. 5 of 7 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 |
|---|---|---|---|---|---|
| ANGIOMAX | 250 MG | POWDER FOR SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02246533 |
| BIVALIRUDIN FOR INJECTION | 250 MG | POWDER FOR SOLUTION | JUNO PHARMACEUTICALS CORP. | MARKETED | DIN 02511452 |
| BIVALIRUDIN FOR INJECTION | 250 MG | POWDER FOR SOLUTION | FORMATIVE PHARMA INC. | MARKETED | DIN 02539586 |
| BIVALIRUDIN INJECTION | 5 MG | SOLUTION | AVIR PHARMA INC. | MARKETED | DIN 02505517 |
| BIVALIRUDIN | 250 MG | POWDER FOR SOLUTION | SANDOZ CANADA INCORPORATED | CANCELLED PRE MARKET | DIN 02450402 |
| BIVALIRUDIN FOR INJECTION | 250 MG | POWDER FOR SOLUTION | DR REDDY'S LABORATORIES LTD | CANCELLED PRE MARKET | DIN 02518643 |
Who else supplies BIVALIRUDIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. BIVALIRUDIN appears in 8 registered pack listings across 3 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.