KADCYLA 100 MG — DIN 02412365
TRASTUZUMAB EMTANSINE : 100 MG · HOFFMANN-LA ROCHE LIMITED · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is KADCYLA?
KADCYLA 100 MG contains TRASTUZUMAB EMTANSINE : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02412365, held by HOFFMANN-LA ROCHE LIMITED, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 09-Oct-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 KADCYLA used for?
Monotherapy for HER2-positive metastatic breast cancer (prior trastuzumab/taxane) and adjuvant treatment of HER2-positive early breast cancer with residual invasive disease post-neoadjuvant therapy.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Trastuzumab Emtansine cost around the world?
Trastuzumab Emtansine is listed on 14 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Bahrain publishes a retail (max); Czechia publishes a max producer price (ex-factory). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Australia | ex-manufacturer | 5 | 70 | AUD███.██ |
| Saudi Arabia | public | 12 | 16 | SAR███.██ |
| Greece | producer price (ex-factory) | 15 | 15 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 7 | 15 | NOK███.██ |
| Romania | max producer price | 11 | 13 | RON███.██ |
| Italy | ex-factory (classe H) | 12 | 12 | EUR███.██ |
| Hungary | producer price (ex-factory) | 11 | 11 | HUF███.██ |
| United Arab Emirates | public | 9 | 9 | AED███.██ |
| Bahrain | retail (max) | 4 | 8 | BHD███.██ |
| Czechia | max producer price (ex-factory) | 6 | 7 | CZK███.██ |
| Slovakia | categorised final price | 7 | 7 | EUR███.██ |
| Iceland | max wholesale | 4 | 6 | ISK███.██ |
| South Africa | single exit price | 6 | 6 | ZAR███.██ |
| Morocco | PPV (public price) | 1 | 1 | MAD███.██ |
196 pack listings across 110 brand entries and 12 price bases, refreshed 08 Sep 2026. Ranges span every Trastuzumab Emtansine pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Trastuzumab Emtansine in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
Only one market authorization holder has a Canadian DIN containing Trastuzumab Emtansine — 2 DINs, of which 2 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| HOFFMANN-LA ROCHE LIMITED | 2 | 2 | KADCYLA | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 100 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | 100 mg and 160 mg single-use vials. |
| Storage | Store reconstituted vials at 2-8ºC; discard after 24 hours. Diluted infusion solution can be stored up to 24 hours at 2-8°C. Do not freeze or shake. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Trastuzumab Emtansine |
|---|---|
| ATC code | L01FD03 |
| AHFS class | 10:00.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02412365 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2412365 |
| Brand name | KADCYLA |
| Generic / active ingredient | TRASTUZUMAB EMTANSINE : 100 MG |
| Market authorization holder | HOFFMANN-LA ROCHE LIMITED |
| Health Canada schedule | Prescription |
| ATC code | L01FD03 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01FD |
| Current status | MARKETED |
| Status date | 09-Oct-2013 |
| Original market date | 2013-10-09 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Recommended starting dose is 3.6 mg/kg IV every 3 weeks. Initial infusion over 90 mins; subsequent doses over 30 mins if tolerated. Do not administer as IV push or bolus.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Serious warnings: Medication errors with trastuzumab, Liver Toxicity (hepatotoxicity/failure), Cardiotoxicity (LVEF reduction), Hemorrhage, Interstitial Lung Disease, and Embryo-fetal Toxicity.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
2 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| KADCYLA | 160 MG | POWDER FOR SOLUTION | HOFFMANN-LA ROCHE LIMITED | MARKETED | 02473224 |
2 · Same class — other molecules in ATC L01FD
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Trastuzumab | ADHEROZA · HERCEPTIN · HERCEPTIN SC · HERZUMA · KANJINTI · OGIVRI · ONTRUZANT · TRAZIMERA | 14 | 12 | Yes |
| Trastuzumab Emtansine | KADCYLA | 2 | 2 | Yes |
| Pertuzumab | PERJETA | 1 | 1 | Yes |
| Trastuzumab Deruxtecan | ENHERTU | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC L01F
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01FX | Amivantamab · Belantamab Mafodotin · Blinatumomab · Brentuximab Vedotin · Catumaxomab · Dinutuximab Beta · Elotuzumab · Elranatamab · Enfortumab Vedotin · Epcoritamab · Gemtuzumab Ozogamicin · Glofitamab · Ipilimumab · Loncastuximab Tesirine · Mogamulizumab · Olaratumab · Polatuzumab Vedotin · Sacituzumab Govitecan · Tafasitamab · Talquetamab · Tarlatamab · Teclistamab · Tremelimumab · Zolbetuximab | 36 | 29 |
| L01FG | Bevacizumab · Ramucirumab | 14 | 14 |
| L01FF | Atezolizumab · Avelumab · Cemiplimab · Dostarlimab · Durvalumab · Nivolumab · Pembrolizumab · Retifanlimab | 14 | 12 |
| L01FA | Obinutuzumab · Ofatumumab · Rituximab | 11 | 8 |
| L01FC | Daratumumab · Isatuximab | 5 | 5 |
| L01FY | Nivolumab And Relatlimab · Pertuzumab And Trastuzumab | 4 | 4 |
| L01FE | Cetuximab · Necitumumab · Panitumumab | 5 | 3 |
| L01FB | Inotuzumab Ozogamicin | 1 | 1 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is KADCYLA called?
The same molecule, Trastuzumab Emtansine, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Trazimera | Latin | Australia, Bahrain, Czechia, Iceland, Norway, Saudi Arabia |
| Herzuma | Latin | Australia, Bahrain, Czechia, Norway, Saudi Arabia |
| Kanjinti | Latin | Australia, Iceland, Norway, Saudi Arabia |
| Ogivri | Latin | Australia, Czechia, Norway, Saudi Arabia |
| Herceptin | Latin | Bahrain, Czechia, Iceland, Morocco, Norway |
| Zercepac | Latin | Czechia, Iceland, Norway, Saudi Arabia |
| Herceptin SC | Latin | Australia |
| Ontruzant | Latin | Czechia, Norway, Saudi Arabia |
| CANHERA | Latin | Bahrain, Saudi Arabia |
| Enhertu | Latin | Saudi Arabia |
| Equituz | Latin | South Africa |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.