IMDELLTRA 10 MG — DIN 02551578
TARLATAMAB 10 MG · AMGEN CANADA INC · Powder For Solution · wholesale supply in Canada
Health Canada status: MARKETED
What is IMDELLTRA?
IMDELLTRA 10 MG contains TARLATAMAB 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02551578, held by AMGEN CANADA INC, supplied as Powder For Solution for Intravenous administration. Health Canada currently lists it as marketed, status dated 28-Nov-2024. 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 IMDELLTRA used for?
IMDELLTRA™ (tarlatamab for injection) is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy including platinum-based chemotherapy. This indication is issued market authorization with conditions based on objective response rate (ORR) and duration of response (DOR). An improvement in survival has not yet been established.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Tarlatamab cost around the world?
Tarlatamab is listed on 2 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. Norway publishes a max AUP (pharmacy retail); Saudi Arabia publishes a public. 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 |
|---|---|---|---|---|
| Norway | max AUP (pharmacy retail) | 1 | 2 | NOK███.██ |
| Saudi Arabia | public | 1 | 2 | SAR███.██ |
4 pack listings across 2 brand entries and 2 price bases, refreshed 07 Sep 2026. Ranges span every Tarlatamab 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 Tarlatamab 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 Tarlatamab — 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 |
|---|---|---|---|---|
| AMGEN CANADA INC | 2 | 2 | IMDELLTRA | 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 | 10 MG |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Pack configuration (monograph) | 1 mg package includes 1 vial of 1 mg Imdelltra and 2 vials of 7 mL IV Solution Stabilizer. 10 mg package contains 1 vial of 10 mg Imdelltra and 2 vials of 7 mL IV Solution Stabilizer. |
| Storage | Store Imdelltra and IV Solution Stabilizer vials in the original package refrigerated at 2°C to 8°C and protect from light until time of use. Do NOT freeze. Store lyophilized Imdelltra and IV Solution Stabilizer (IVSS) vials for a maximum of 24 hours at room temperature in the original carton to protect from light. Prepared Imdelltra solution in the IV bag can be stored refrigerated (2°C to 8°C) for up to 7 days, or at room temperature (20°C to 25°C) for up to 8 hours. Keep out of reach and sight of children. |
| 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 | Tarlatamab |
|---|---|
| ATC code | L01FX33 |
| 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) | 02551578 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2551578 |
| Brand name | IMDELLTRA |
| Generic / active ingredient | TARLATAMAB 10 MG |
| Market authorization holder | AMGEN CANADA INC |
| Health Canada schedule | SCHEDULE D, PRESCRIPTION |
| ATC code | L01FX33 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01FX |
| Current status | MARKETED |
| Status date | 28-Nov-2024 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Administer Imdelltra according to the step-up dosing schedule to reduce the incidence and severity of cytokine release syndrome (CRS). Administer concomitant medication as recommended to reduce the risk of CRS reactions. Imdelltra should only be administered by a healthcare professional with appropriate medical support to manage CRS and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS). Monitor patients for 24 hours from the start of Imdelltra infusion on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Recommend patients to remain within 1 hour of an appropriate healthcare setting for 48 hours from the start of the Imdelltra infusion following Cycle 1 Day 1 and Cycle 1 Day 8 doses accompanied by a caregiver. Ensure patients are well hydrated prior to administration of Imdelltra. Prior to administration of Imdelltra evaluate complete blood count, liver enzymes and bilirubin before each dose, and as clinically indicated. Imdelltra should not be administered to patients with active infection. The recommended dosage and schedule of Imdelltra is: Day 1: 1 mg, Day 8: 10 mg, Day 15: 10 mg, and then 10 mg every 2 weeks thereafter. Treat patients until disease progression or unacceptable toxicity. If a dose is delayed, restart therapy based on recommendations for dosage delay. No dosage reduction for Imdelltra is recommended.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Imdelltra is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Cytokine Release Syndrome (CRS), which may be serious or life-threatening, can occur in patients receiving Imdelltra. Initiate treatment with Imdelltra using the step-up dosing schedule to reduce the incidence and severity of CRS. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be serious or life-threatening, can occur in patients receiving Imdelltra. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold Imdelltra until CRS or neurologic toxicity resolves or permanently discontinue based on severity. Imdelltra may have an influence on the ability to drive or operate machinery. Patients experiencing symptoms that might affect their ability to drive or use machines (e.g., symptoms of ICANS, such as seizures, depressed level of consciousness) should be advised not to drive or use machines in the event of any symptoms until resolved. Tumour Lysis Syndrome (TLS) has been reported. Monitoring for signs or symptoms of TLS is particularly important for patients with a high tumor burden, rapidly proliferating tumors, or reduced renal function. Patients at increased risk for TLS are advised to receive adequate hydration and prophylactic treatment with a uric acid-lowering agent. Regular monitoring of blood chemistries is recommended. Imdelltra can cause cytopenias including neutropenia, thrombocytopenia, and anemia. Patients should be closely monitored for signs and symptoms of cytopenias. Imdelltra can cause hepatotoxicity. Monitor liver enzymes and bilirubin prior to treatment with Imdelltra, before each dose, and as clinically indicated. Imdelltra can cause serious infections including life-threatening and fatal infections. Monitor patients for signs and symptoms of infection prior to and during treatment with Imdelltra and treat as clinically indicated. Hypersensitivity reactions, including severe reactions, have been reported. Monitor patients for signs and symptoms of hypersensitivity during treatment with Imdelltra and manage as clinically indicated.
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 |
|---|---|---|---|---|---|
| IMDELLTRA | 1 MG | Powder For Solution | AMGEN CANADA INC | MARKETED | 02551551 |
2 · Same class — other molecules in ATC L01FX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Polatuzumab Vedotin | POLIVY | 2 | 2 | Yes |
| Teclistamab | TECVAYLI | 2 | 2 | Yes |
| Belantamab Mafodotin | BLENREP | 2 | 2 | Yes |
| Glofitamab | COLUMVI | 2 | 2 | Yes |
| Talquetamab | TALVEY | 2 | 2 | Yes |
| Tarlatamab | IMDELLTRA | 2 | 2 | Yes |
| Elranatamab | ELREXFIO | 2 | 2 | Yes |
| Enfortumab Vedotin | PADCEV | 2 | 2 | Yes |
| Epcoritamab | EPKINLY | 2 | 2 | Yes |
| Blinatumomab | BLINCYTO | 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 |
|---|---|---|---|
| L01FD | Pertuzumab · Trastuzumab · Trastuzumab Deruxtecan · Trastuzumab Emtansine | 18 | 16 |
| L01FG | Bevacizumab · Ramucirumab | 14 | 14 |
| L01FF | Atezolizumab · Avelumab · Cemiplimab · Dostarlimab · Durvalumab · +3 more | 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 IMDELLTRA called?
Also recorded in Canada as: tarlatamab-dlle 1 MG Injection [Imdelltra] (US), tarlatamab-dlle 10 MG Injection [Imdelltra] (US), tarlatamab-dlle 1 MG Injection (US), tarlatamab-dlle 10 MG Injection (US), TARLATAMAB-DLLE (US), tarlatamab (GLOBAL).
The same molecule, Tarlatamab, 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 |
|---|---|---|
| Imdylltra | Latin | Norway, Saudi Arabia |
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.