Product Description
1. Technical Specifications
| Attribute |
Details |
| Brand Name |
Yescarta |
| Generic Name |
Axicabtagene Ciloleucel |
| Strength |
Patient-specific, individualized cellular product (CAR-T infusion) |
| Dosage Form |
Suspension for intravenous infusion (cryopreserved) |
| Packaging Size |
Single infusion bag per patient (dose varies by patient weight/product) |
| Packaging Type |
Cryopreserved infusion bag |
| Medicine Type |
Anticancer (Cellular Therapy CAR-T cell therapy) |
| Manufacturer |
Kite Pharma, a Gilead Company |
| Distributed By |
Authorized CAR-T therapy centers / specialized transplant hospitals |
2. Product Description
Yescarta (Axicabtagene Ciloleucel) is a genetically modified autologous T-cell immunotherapy (CAR-T therapy).
It involves collecting a patients own T-cells, engineering them with a chimeric antigen receptor (CAR) targeting CD19, and reinfusing them to recognize and destroy CD19-expressing malignant B-cells.
This therapy provides a personalized and highly targeted immunotherapy for relapsed or refractory B-cell malignancies.
3. Product Highlights
| Attribute |
Details |
| Therapeutic Category |
Anticancer CAR-T Cell Immunotherapy |
| Application Area |
Relapsed/refractory large B-cell lymphoma, follicular lymphoma |
| Mechanism of Action |
Autologous CAR-T cells bind CD19 on B-cells cytotoxic destruction |
| Administration |
Single IV infusion (following lymphodepleting chemotherapy) |
| Storage Conditions |
Stored frozen in vapor phase of liquid nitrogen ( -150 C); thawed prior to infusion |
4. Therapeutic Uses
Yescarta is indicated for the treatment of:
-
Relapsed or refractory large B-cell lymphoma (LBCL) after 2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
-
Relapsed or refractory follicular lymphoma (FL) after 2 lines of systemic therapy.
5. Side Effects
Common:
-
Fever, chills
-
Fatigue, weakness
-
Nausea, diarrhea
-
Headache
-
Muscle/joint pain
-
Cough
Serious / Severe:
-
Cytokine Release Syndrome (CRS): fever, hypotension, hypoxia, multi-organ dysfunction
-
Neurologic Toxicities (ICANS): confusion, tremor, seizures, encephalopathy
-
Serious infections due to prolonged cytopenias
-
Hypogammaglobulinemia (increased infection risk)
-
Prolonged low blood counts (anemia, neutropenia, thrombocytopenia)
6. Precautions
-
Hospital Administration Only: Must be given at certified CAR-T treatment centers.
-
Cytokine Release Syndrome: Monitor closely; treat promptly with tocilizumab corticosteroids.
-
Neurological Monitoring: Observe for confusion, seizures, or cerebral edema.
-
Infection Risk: Prophylactic antimicrobials may be required; monitor for reactivation of hepatitis B or CMV.
-
Blood Counts: Regular CBC monitoring due to prolonged cytopenias.
-
Pregnancy & Breastfeeding: Contraindicated; safety not established.
-
Vaccination: Live vaccines should be avoided for at least 6 weeks prior and after therapy.
Pioneering Immunotherapy for LymphomaYescarta (Axicabtagene Ciloleucel) represents a breakthrough in treating adults with difficult-to-treat large B-cell lymphoma following at least two previous systemic therapies. By harnessing the patients own immune system, this CAR-T cell therapy offers targeted destruction of cancer cells, potentially improving outcomes for patients with limited options.
Strict Administration and Storage GuidelinesThis therapy is administered exclusively in a hospital setting under the supervision of experienced physicians. The product is cryopreserved and must be stored at or below -150C. Importantly, the vial must be thawed immediately prior to administration and infused right away, ensuring the viability of the modified T-cells for optimal therapeutic effect.
Patient Monitoring and SafetyYescarta requires rigorous monitoring during and after infusion due to the risk of cytokine release syndrome and neurological toxicities. Patients must be screened for infections before treatment and closely observed for adverse reactions post-infusion. These precautions are vital for patient safety and treatment efficacy.
FAQs of Axicabtagene Ciloleucel injection:
Q: How is Axicabtagene Ciloleucel (Yescarta) administered to patients?
A: Axicabtagene Ciloleucel is given as a single intravenous infusion in a hospital setting under the supervision of a physician experienced in CAR-T cell therapy. The dosage is based on the patients weight, as determined by the healthcare provider.
Q: What benefits does Yescarta offer to adults with lymphoma?
A: Yescarta provides a personalized cancer treatment by targeting CD19-expressing cancer cells in patients with relapsed or refractory large B-cell lymphoma after two or more prior therapies, potentially improving the chance for remission when other treatments have failed.
Q: When should patients expect to receive Yescarta after approval for therapy?
A: Once a patient is eligible and has completed the necessary screening, their T-cells are collected and modified. The infusion is scheduled once the genetically modified cells are prepared, and administration occurs in a hospital after cryopreserved cells are thawed.
Q: Where should Yescarta be stored before use?
A: Yescarta must be stored at or below -150C in a cryopreserved state. The product should only be thawed immediately prior to its intravenous infusion and not refrozen or stored at higher temperatures.
Q: What precautions must be followed during and after administration of this therapy?
A: Patients must undergo rigorous monitoring for cytokine release syndrome and neurological toxicities during and after infusion. Pre-infusion screening for active infections and close observation post-infusion for adverse reactions are mandatory.
Q: What is the process for preparing and using Axicabtagene Ciloleucel?
A: Patients T-cells are collected and genetically modified to recognize CD19 antigens on cancer cells. The cells are then cryopreserved and shipped back for hospital administration, where the vial is thawed just before intravenous infusion.
Q: Who should not receive Axicabtagene Ciloleucel injection?
A: Patients with known hypersensitivity to any component of the formulation should not receive this therapy. It is also not recommended during active infections or where contraindicated by the treating physician.
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