Dosage Information for Tecartus: Its form, strength, administration methods, and additional details
In the field of advanced gene and cell therapies, Tecartus (brexucabtagene autoleucel) stands out as a significant development in the treatment of certain types of lymphoma and leukemia in adults. This personalized therapy is administered as a single dose of engineered T cells, tailored to the patient's body weight or lymphocyte count.
The administration process involves several steps:
- Leukapheresis: The patient's T cells are collected through a leukapheresis procedure.
- Cell Engineering: The collected T cells are sent to a manufacturing facility, where they are genetically modified to express the CAR targeting CD19 (for Tecartus).
- Lymphodepleting Chemotherapy: Before the infusion of Tecartus, patients typically receive a lymphodepleting chemotherapy regimen (commonly fludarabine and cyclophosphamide) to optimize CAR T cell expansion in the body.
- Single Infusion: After chemotherapy, the patient receives a single infusion of the CAR T-cell product.
- Monitoring: Intensive monitoring follows for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which are known toxicities with CAR T-cell therapies including Tecartus.
Tecartus is indicated for adult patients with relapsed or refractory mantle cell lymphoma after two or more prior therapies and for adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). Its efficacy and safety profile have been shown even in patients with CNS involvement, although toxicity management is critical.
After the infusion, patients are advised to avoid driving, using heavy machinery, or engaging in other potentially dangerous activities for eight weeks due to potential side effects. They must also stay nearby the treatment facility for four weeks to receive prompt treatment in case of serious side effects.
If being treated for MCL, the patient will stay at the treatment center for monitoring at least one week after the infusion. If being treated for ALL, the patient will stay for at least two weeks. Before the infusion, medications such as acetaminophen (Tylenol) and an antihistamine (Benadryl) are given to reduce the risk of infusion reactions.
Additional resources for information about Tecartus can be found in the "More about Tecartus" and "cancer hub" articles on Medical News Today's website. The Tecartus infusion is preceded by a 3-day chemotherapy treatment at the treatment center, and the therapy is administered by IV infusion at a healthcare facility certified to give Tecartus.
The maximum dosage of Tecartus for MCL is 200 million modified T cells per kilogram (kg) of body weight, and for ALL it is 100 million modified T cells per kg of body weight. The dosage of Tecartus will be determined by the doctor based on the condition being treated.
Tecartus starts to work after the infusion, and the time from infusion to when the doctor may see an effect can vary from 28-90 days. The single-dose nature aligns with typical administration of advanced gene and cell therapies.