NPLATE 625 MCG
ROMIPLOSTIM : 625 MCG · DIN 02322862 · AMGEN CANADA INC
Health Canada status: MARKETED
What is NPLATE?
NPLATE 625 MCG contains ROMIPLOSTIM : 625 MCG. It is listed in the Health Canada Drug Product Database under DIN 02322862, held by AMGEN CANADA INC, supplied as POWDER FOR SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 15-Apr-2009. 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 NPLATE used for?
To increase platelet levels in adult patients with immune thrombocytopenia (ITP) who are nonsplenectomized (inadequate response to steroids/IG) or splenectomized (inadequate response to 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 | 02322862 |
|---|---|
| Brand name | NPLATE |
| Generic / active ingredient | ROMIPLOSTIM : 625 MCG |
| Manufacturer | AMGEN CANADA INC |
| Strength | 625 MCG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | SUBCUTANEOUS |
| Schedule | Prescription |
| ATC code | B02BX04 ROMIPLOSTIM |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 15-Apr-2009 |
How is it administered?
Initial dose: 1 mcg/kg weekly SC. Adjust by 1 mcg/kg increments to maintain platelets ≥ 50 x 10^9/L. Max dose 10 mcg/kg. Monitor platelets weekly until stable, then monthly.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store lyophilized product at 2°C to 8°C. Protect from light. Reconstituted solution in vial is stable for 24 hours at 25°C or 2°C to 8°C if protected from light.
How is it supplied?
Single-use vials (375 mcg or 625 mcg) in a dispensing pack containing one vial. Deliverable amounts are 250 mcg or 500 mcg after reconstitution.
Contraindications
Hypersensitivity to romiplostim, any ingredient in the formulation, or any E. coli-derived product.
Warnings and precautions
Risk of progression of MDS to AML; bone marrow reticulin/fibrosis; thrombotic/thromboembolic complications; recurrence of thrombocytopenia/bleeding after cessation.
What can be used instead?
Other Canadian products sharing ATC code B02BX04 ROMIPLOSTIM. 2 of 2 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 |
|---|---|---|---|---|---|
| NPLATE | 250MCG | POWDER FOR SOLUTION | AMGEN CANADA INC | MARKETED | DIN 02322854 |
Who else supplies ROMIPLOSTIM worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ROMIPLOSTIM appears in 29 registered pack listings across 13 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.