TZIELD 2 MG / 2 ML — DIN 02557347
TEPLIZUMAB : 2 MG / 2 ML · SANOFI-AVENTIS CANADA INC · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is TZIELD?
TZIELD 2 MG / 2 ML contains TEPLIZUMAB : 2 MG / 2 ML. It is listed in the Health Canada Drug Product Database under DIN 02557347, held by SANOFI-AVENTIS CANADA INC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 20-Aug-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 TZIELD used for?
TZIELD (Teplizumab) is indicated to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes. Patients selected for TZIELD treatment should have a diagnosis of Stage 2 type 1 diabetes, confirmed by documenting at least two positive pancreatic islet cell autoantibodies and dysglycemia without overt hyperglycemia. The clinical history of the patient should not suggest type 2 diabetes.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Teplizumab cost around the world?
Teplizumab is listed on 3 of the national price registers Nexara ingests. Each country publishes on a different basis, so 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; United Arab Emirates 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 |
|---|---|---|---|
| United Arab Emirates | public | 1 | 1 |
| Norway | max AUP (pharmacy retail) | 1 | 1 |
| Saudi Arabia | public | 1 | 1 |
3 pack listings across 3 brand entries and 2 price bases, refreshed 07 Sep 2026. Ranges span every Teplizumab 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.
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 | 2 MG / 2 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | TZIELD is supplied in Type I borosilicate glass vial with a butyl rubber stopper and an aluminum seal with a coloured polypropylene flip-off cap. Each pack contains 1 vial. |
| Storage | Refrigerate TZIELD vials at 2°C to 8°C in the original carton to protect from light. Store upright. Do not freeze or shake the vials. The product does not contain preservative. The diluted product should be used immediately. If not used immediately, store the diluted solution at room temperature [15°C to 30°C] and complete infusion within 4 hours of the start of preparation. Discard the infusion solution if not administered within 4 hours of preparation. |
| 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, because this listing covers more than one of them.
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 | Teplizumab |
|---|---|
| ATC code | A10XX01 |
| 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) | 02557347 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2557347 |
| Brand name | TZIELD |
| Generic / active ingredient | TEPLIZUMAB : 2 MG / 2 ML |
| Market authorization holder | SANOFI-AVENTIS CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | A10XX01 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A10XX |
| Current status | MARKETED |
| Status date | 20-Aug-2025 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Administer TZIELD by intravenous infusion over a minimum of 30 minutes, once daily for 14 consecutive days. The dose is based on body surface area (BSA). Recommended Dosing Schedule: • Day 1: 65 mcg/m² • Day 2: 125 mcg/m² • Day 3: 250 mcg/m² • Day 4: 500 mcg/m² • Days 5 through 14: 1,030 mcg/m² Do not administer two doses on the same day. Premedication: Prior to TZIELD infusion for at least the first 5 days of dosing, premedicate with (1) a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, and (2) an antihistamine, and (3) (optional) an antiemetic. Administer additional doses of premedication if needed. Preparation for intravenous administration: 1. Dilute TZIELD prior to use. 2. Inspect TZIELD visually before use; it should be clear and colourless. Do not use if particulate matter or colouration is seen. 3. Prepare using aseptic technique. Each vial is for single use only. 4. Prepare a sterile glass vial or PVC infusion bag with 18 mL of 0.9% sodium chloride injection. 5. Remove 2 mL of TZIELD from the vial and slowly add to the 18 mL of 0.9% sodium chloride injection. Mix gently by slowly inverting the vial or rocking the infusion bag. The resulting 20 mL diluted solution contains 100 mcg/mL of teplizumab. 6. Withdraw the volume of diluted TZIELD solution required for that day's calculated dose from the 100 mcg/mL solution. 7. Slowly add contents of the syringe containing the TZIELD dose to a 25 mL 0.9% sodium chloride injection PVC infusion bag. Gently rock the infusion bag to ensure the solution mixes sufficiently. Do not shake. 8. Discard unused portion of remaining diluted TZIELD solution. 9. Start the TZIELD infusion within 2 hours of preparation. If not used immediately, store the diluted solution at room temperature [15°C to 30°C] and complete infusion within 4 hours of the start of preparation. Discard if not administered within 4 hours. Missed Dose: If a planned infusion is missed, resume dosing by administering all remaining doses on consecutive days to complete the 14-day treatment course.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
TZIELD is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to teplizumab or any of its excipients.
Warnings and precautions
Vaccinations: Administer all age-appropriate vaccinations prior to starting TZIELD. Inactivated or mRNA vaccinations are not recommended within 2 weeks prior to TZIELD treatment, during treatment, or 6 weeks after completion of treatment. Live-attenuated vaccinations are not recommended within 8 weeks prior to TZIELD treatment, during treatment, or up to 52 weeks after treatment. Driving and Operating Machinery: Fatigue has been reported. Patients should be cautioned not to drive, operate dangerous machinery or engage in activities requiring alertness or physical coordination if experiencing these effects. Hematologic (Lymphopenia): In clinical trials, 80% of patients treated with TZIELD developed lymphopenia. Severe lymphopenia (<0.5 X 10^9 cells/L lasting 1 week or longer) occurred in 0.9% of patients. Monitor white blood cell counts during treatment. Discontinue TZIELD if prolonged severe lymphopenia develops. Immune (Cytokine Release Syndrome - CRS): CRS has been observed in 6% of patients treated with TZIELD. Manifestations included fever, nausea, fatigue, headache, myalgia, arthralgia, increased ALT, AST, and total bilirubin. To mitigate CRS, premedicate with antipyretics, antihistamines, and/or antiemetics. Monitor liver enzymes and bilirubin. Discontinue TZIELD if ALT or AST ≥3x ULN and bilirubin >2x ULN (unless Gilbert's syndrome). To treat CRS, medicate with antipyretics, antihistamines, and/or antiemetics. Consider temporarily pausing dosing for 1-2 days or discontinuing treatment if severe CRS develops. Hypersensitivity Reactions: Acute hypersensitivity reactions (serum sickness, angioedema, urticaria, rash, vomiting, bronchospasm) occurred. Discontinue use and treat promptly if severe hypersensitivity reactions occur. Serious Infections: Bacterial and viral infections have occurred. TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor for signs and symptoms of infection during and after treatment. Treat appropriately and discontinue TZIELD if serious infection develops.
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.
2 · Same class — other molecules in ATC A10XX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Teplizumab | TZIELD | 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.
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 TZIELD called?
Also recorded in Canada as: 2 ML teplizumab-mzwv 1 MG/ML Injection [Tzield] (US), 2 ML teplizumab-mzwv 1 MG/ML Injection (US), TEPLIZUMAB-MZWV (US), TEPLIZUMAB-ZWWV (US), TEPLIZUMAB (GLOBAL).
The same molecule, Teplizumab, 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 |
|---|---|---|
| Teizeild | Latin | Norway |
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.