YESCARTA 200000000 CELLS
AXICABTAGENE CILOLEUCEL : 200000000 CELLS · DIN 02485648 · GILEAD SCIENCES CANADA INC
Health Canada status: MARKETED
Overview
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. Nexara Health is a licensed Canadian wholesale distributor and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
Product details
| 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 |
| Original market date | 2019-11-27 00:00:00 |
Indications
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.
Dosage and administration
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.
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.
Storage and handling
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).
Packaging
Patient-specific single infusion bag containing approximately 68 mL of cell suspension.
Canadian availability and sourcing
Nexara Health supplies this product to licensed Canadian healthcare buyers. 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.