Carvykti Ciltacabtagene autoleucel Suspension for IV Infusion

1. Indications and Usage
Multiple Myeloma:
Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
2. Dosage and Administration
Route of Administration:
Intravenous Infusion ONLY. Do not administer as an IV push or bolus.
Dosing:
Recommended Dose: 1.0 × 10⁶ CAR-positive viable T cells per kg of actual body weight.
Pre-infusion: Administer lenalidomide maintenance (if on treatment) until at least 3 days before lymphodepleting chemotherapy.
Lymphodepletion:
Administer lymphodepleting chemotherapy (e.g., fludarabine and cyclophosphamide) approximately 3 days before CAR-T cell infusion.
3. Mechanism of Action
BCMA Targeting:
Ciltacabtagene autoleucel is a CD19-negative, BCMA-directed CAR-T cell therapy.
Cytotoxicity:
The CAR structure binds to BCMA on myeloma cells, resulting in T-cell activation and killing of BCMA-expressing tumor cells.
4. Safety and Warnings
Cytokine Release Syndrome (CRS):
Can cause severe and life-threatening CRS. Monitor vital signs closely. Have tocilizumab (IL-6 receptor antagonist) and corticosteroids ready.
Neurologic Toxicity (ICANS):
Risk of immune effector cell-associated neurotoxicity syndrome (ICANS). Monitor for encephalopathy, tremors, or seizures.
Infections:
Risk of severe and fatal infections (bacterial, viral, fungal). Screen for HBV, HCV, and HIV prior to T-cell collection.
Hypogammaglobulinemia:
Prolonged immunoparesis may occur. Monitor immunoglobulin levels.
Adverse Reactions
Most Common:
Fatigue, musculoskeletal pain, fever, cough, diarrhea, nausea, upper respiratory tract infection, and hypogammaglobulinemia.
6. Drug Interactions
Live Vaccines:
Avoid the use of live viral vaccines during treatment and until immune recovery.
Immunosuppressants:
High-dose corticosteroids or other immunosuppressants may reduce the efficacy of ciltacabtagene autoleucel.
7. Pharmaceutical Information
Chemical Composition:
Product Type: Genetically modified autologous T cells.
Storage:
Store frozen at -90°C to -60°C. Do not thaw prior to administration.