HERZUMA 440 MG
TRASTUZUMAB : 440 MG · DIN 02480794 · CELLTRION INC.
Health Canada status: MARKETED
What is HERZUMA?
HERZUMA 440 MG contains TRASTUZUMAB : 440 MG. It is listed in the Health Canada Drug Product Database under DIN 02480794, held by CELLTRION INC., supplied as POWDER FOR SOLUTION ; KIT for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 28-Nov-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 HERZUMA used for?
Treatment of HER2-overexpressing early breast cancer (EBC), metastatic breast cancer (MBC), and metastatic gastric cancer (MGC).
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 | 02480794 |
|---|---|
| Brand name | HERZUMA |
| Generic / active ingredient | TRASTUZUMAB : 440 MG |
| Manufacturer | CELLTRION INC. |
| Strength | 440 MG |
| Dosage form | POWDER FOR SOLUTION ; KIT |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L01FD01 TRASTUZUMAB |
| AHFS class | 10:00.00 |
| Biosimilar | Yes |
| Health Canada status | MARKETED |
| Status date | 28-Nov-2025 |
| Original market date | 2019-12-11 00:00:00 |
How is it administered?
Administered via IV infusion. EBC/MGC: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks. MBC: 4 mg/kg loading dose, then 2 mg/kg weekly. Do not administer as IV push or bolus.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store vials refrigerated at 2-8°C. Reconstituted 440 mg vial (with BWFI) is stable for 28 days at 2-8°C. Reconstituted 150 mg vial (with SWFI) must be used immediately.
How is it supplied?
440 mg/vial supplied with 20 mL Bacteriostatic Water for Injection; 150 mg/vial single-dose vial.
Contraindications
Known hypersensitivity to trastuzumab, Chinese Hamster Ovary (CHO) cell proteins, or any ingredient in the formulation, including benzyl alcohol (if using BWFI).
Warnings and precautions
Cardiotoxicity (ventricular dysfunction, CHF), serious infusion reactions, pulmonary toxicity, and embryo-fetal toxicity. Monitor LVEF prior to and during treatment.
What can be used instead?
Other Canadian products sharing ATC code L01FD01 TRASTUZUMAB. 12 of 14 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 |
|---|---|---|---|---|---|
| HERCEPTIN | 440 MG | POWDER FOR SOLUTION | HOFFMANN-LA ROCHE LIMITED | MARKETED | DIN 02240692 |
| HERCEPTIN SC | 600 MG / 5 ML | SOLUTION | HOFFMANN-LA ROCHE LIMITED | MARKETED | DIN 02480697 |
| HERZUMA | 150 MG | POWDER FOR SOLUTION | CELLTRION INC. | MARKETED | DIN 02506211 |
| KANJINTI | 150 MG | POWDER FOR SOLUTION | AMGEN CANADA INC | MARKETED | DIN 02518244 |
| KANJINTI | 420 MG | KIT ; POWDER FOR SOLUTION | AMGEN CANADA INC | MARKETED | DIN 02496690 |
| OGIVRI | 150 MG | POWDER FOR SOLUTION | BIOSIMILAR COLLABORATIONS IRELAND LIMITED | MARKETED | DIN 02474425 |
| OGIVRI | 20 ML | POWDER FOR SOLUTION | BIOSIMILAR COLLABORATIONS IRELAND LIMITED | MARKETED | DIN 02474433 |
| ONTRUZANT | 150 MG | POWDER FOR SOLUTION | SAMSUNG BIOEPIS CO., LTD | MARKETED | DIN 02524317 |
| ONTRUZANT | 440 MG | POWDER FOR SOLUTION | SAMSUNG BIOEPIS CO., LTD | MARKETED | DIN 02524325 |
| TRAZIMERA | 150 MG | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02483475 |
Who else supplies TRASTUZUMAB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TRASTUZUMAB appears in 397 registered pack listings across 11 markets, published on 8 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.