YESCARTA 200000000 CELLS
AXICABTAGENE CILOLEUCEL : 200000000 CELLS · DIN 02485648 · GILEAD SCIENCES CANADA INC
Health Canada status: MARKETED
What is YESCARTA?
YESCARTA 200000000 CELLS contains AXICABTAGENE CILOLEUCEL : 200000000 CELLS. It is listed in the Health Canada Drug Product Database under DIN 02485648, held by GILEAD SCIENCES CANADA INC, supplied as SUSPENSION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 27-Nov-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 YESCARTA used for?
Adults with: 1. Refractory/relapsed DLBCL or HGBL after 1st-line therapy. 2. Relapsed/refractory LBCL after 2+ lines of therapy. 3. Relapsed/refractory Grade 1-3a Follicular Lymphoma (FL) after 2+ lines.
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 | 02485648 |
|---|---|
| Brand name | YESCARTA |
| Generic / active ingredient | AXICABTAGENE CILOLEUCEL : 200000000 CELLS |
| Manufacturer | GILEAD SCIENCES CANADA INC |
| Strength | 200000000 CELLS |
| Dosage form | SUSPENSION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L01XL03 AXICABTAGENE CILOLEUCEL |
| AHFS class | 26:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 27-Nov-2019 |
| Original market date | 2019-11-27 00:00:00 |
How is it administered?
Single IV infusion. Target dose: 2 x 10^6 CAR-positive viable T cells/kg (max 2 x 10^8 cells). Requires lymphodepleting chemotherapy (cyclophosphamide/fludarabine) and premedication.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Thawed YESCARTA may be stored at room temperature (20°C to 25°C) for up to 3 hours. Do NOT refreeze. (Note: Product is typically stored frozen in the vapor phase of liquid nitrogen).
How is it supplied?
Patient-specific single infusion bag containing approximately 68 mL of cell suspension.
Contraindications
Hypersensitivity to any ingredient in the formulation, including non-medicinal ingredients (e.g., DMSO, gentamicin) or component of the container.
Warnings and precautions
Serious Warnings: Cytokine Release Syndrome (CRS) and Neurologic Toxicities (ICANS), both potentially fatal. Risk of secondary malignancies, prolonged cytopenias, and serious infections.
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.