KYMRIAH 600000000 CELLS
TISAGENLECLEUCEL : 600000000 CELLS · DIN 02480514 · NOVARTIS PHARMACEUTICALS CANADA INC
Health Canada status: MARKETED
What is KYMRIAH?
KYMRIAH 600000000 CELLS contains TISAGENLECLEUCEL : 600000000 CELLS. It is listed in the Health Canada Drug Product Database under DIN 02480514, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as SUSPENSION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 24-May-2019. 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 KYMRIAH used for?
Pediatric/young adult B-cell ALL (up to 25 years); Adult relapsed/refractory large B-cell lymphoma (DLBCL); Adult relapsed/refractory follicular lymphoma (FL) (NOC/c).
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 | 02480514 |
|---|---|
| Brand name | KYMRIAH |
| Generic / active ingredient | TISAGENLECLEUCEL : 600000000 CELLS |
| Manufacturer | NOVARTIS PHARMACEUTICALS CANADA INC |
| Strength | 600000000 CELLS |
| Dosage form | SUSPENSION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L01XL04 TISAGENLECLEUCEL |
| AHFS class | 26:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 24-May-2019 |
| Original market date | 2019-05-24 00:00:00 |
How is it administered?
Single-dose IV infusion. B-cell ALL (<=50kg): 0.2-5.0 x 10^6 cells/kg; (>50kg): 0.1-2.5 x 10^8 cells. DLBCL/FL: 0.6-6.0 x 10^8 cells. Administer 2-14 days after lymphodepleting chemotherapy.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Cryopreserved in the vapor phase of liquid nitrogen (<= -120°C). Thawed product must be infused within 30 minutes.
How is it supplied?
Patient-specific infusion bag(s) containing 10 mL to 50 mL of cell suspension.
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation, including dimethyl sulfoxide (DMSO) or dextran 40.
Warnings and precautions
Serious Warnings: Cytokine release syndrome (CRS) and Neurological toxicities (ICANS). Risk of secondary malignancies (T-cell origin). Driving restricted for 8 weeks post-infusion.
Who else supplies TISAGENLECLEUCEL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TISAGENLECLEUCEL appears in 6 registered pack listings across 5 markets, published on 4 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.