NIVESTYM 300 MCG / 0.5 ML
FILGRASTIM : 300 MCG / 0.5 ML · DIN 02485575 · PFIZER CANADA ULC
Health Canada status: MARKETED
What is NIVESTYM?
NIVESTYM 300 MCG / 0.5 ML contains FILGRASTIM : 300 MCG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02485575, held by PFIZER CANADA ULC, supplied as SOLUTION for SUBCUTANEOUS ; INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 11-May-2020. 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 NIVESTYM used for?
Decrease infection incidence in cancer patients receiving myelosuppressive chemotherapy; reduce neutropenia duration in AML; reduce neutropenia in bone marrow transplant; PBPC mobilization; SCN; HIV.
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 | 02485575 |
|---|---|
| Brand name | NIVESTYM |
| Generic / active ingredient | FILGRASTIM : 300 MCG / 0.5 ML |
| Manufacturer | PFIZER CANADA ULC |
| Strength | 300 MCG / 0.5 ML |
| Dosage form | SOLUTION |
| Route of administration | SUBCUTANEOUS ; INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L03AA02 FILGRASTIM |
| AHFS class | 20:16.00 |
| Biosimilar | Yes |
| Health Canada status | MARKETED |
| Status date | 11-May-2020 |
| Original market date | 2020-05-11 00:00:00 |
How is it administered?
Adults: 5 mcg/kg/day SC or IV. SCN: 5-12 mcg/kg/day SC. Administer no earlier than 24 hours after cytotoxic chemotherapy. Titrate based on ANC response.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not specified in provided text (refer to section 11).
How is it supplied?
Single-use prefilled syringes (300 mcg/0.5 mL, 480 mcg/0.8 mL) with needle guard; Single-use vials (300 mcg/1 mL, 480 mcg/1.6 mL). Packs of 1 or 10.
Contraindications
Known hypersensitivity to E. coli derived products, filgrastim, pegfilgrastim, or any ingredient in the formulation.
Warnings and precautions
Splenic rupture (some fatal); severe sickle cell crises; Capillary Leak Syndrome; Aortitis; potential for MDS/AML in breast/lung cancer; do not use 24h before/after chemotherapy.
What can be used instead?
Other Canadian products sharing ATC code L03AA02 FILGRASTIM. 13 of 13 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 |
|---|---|---|---|---|---|
| FILRA | 300 MCG / 0.5 ML | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02556537 |
| FILRA | 480 MCG / 0.8 ML | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02556545 |
| GRASTOFIL | 300 MCG / 0.5 ML | SOLUTION | APOTEX INC | MARKETED | DIN 02441489 |
| GRASTOFIL | 480 MCG / 0.8 ML | SOLUTION | APOTEX INC | MARKETED | DIN 02454548 |
| NEUPOGEN | 300 MCG | SOLUTION | AMGEN CANADA INC | MARKETED | DIN 01968017 |
| NEUPOGEN | 600 MCG | SOLUTION | AMGEN CANADA INC | MARKETED | DIN 02420112 |
| NEUPOGEN | 600 MCG | SOLUTION | AMGEN CANADA INC | MARKETED | DIN 02420104 |
| NIVESTYM | 300 MCG | SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02485591 |
| NIVESTYM | 480 MCG / 0.8 ML | SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02485583 |
| NIVESTYM | 480 MCG / 1.6 ML | SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02485656 |
Who else supplies FILGRASTIM worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. FILGRASTIM appears in 138 registered pack listings across 13 markets, published on 11 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.