Detailed interpretation of the instructions for use of Teritusumab/Telicat

Teritusumab (Teclistamab-cqyv ) is an innovative bispecific B cell maturation antigen (BCMA)-directed CD3 T cell-engaging antibody, specifically developed for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). Such patients usually have received multiple lines of treatment including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies, but still experience disease progression. Through its unique immune mechanism, TECVAYLI fills the gap in the efficacy of traditional therapies and brings new hope for the treatment of drug-resistant myeloma.

This drug is given by injection under the skin, usually into the abdomen or thigh by a healthcare professional. In order to reduce the risk of initial adverse reactions, an ascending dose dosing strategy is adopted. Use the lowest starting dose (0.06 mg/kg) on u200bu200bthe first day, increase to the second incremental dose (0.3 mg/kg) on u200bu200bthe fourth day, enter the formal treatment phase (1.5 mg/kg) on u200bu200bthe seventh day, and then administer once a week until disease progression or unacceptable toxicity. If the patient achieves complete remission (CR) or better for 6 consecutive months and the condition is stable, the dosing frequency can be adjusted to once every two weeks. This flexible dose adjustment mechanism can take into account both efficacy and safety, which is a major advantage of the teritusumab treatment regimen.

The incremental phase is particularly critical, aiming to gradually activate the patient'sT cell immune response to avoid inducing severe cytokine release syndrome (CRS) in a short period of time. Therefore, patients usually need to be hospitalized for at least 48 hours of observation during the escalation period, so that the medical team can promptly monitor and intervene in possible immune-related adverse events. If adverse reactions occur during the incremental phase, the second incremental or formal treatment dose can be appropriately delayed for 2 to 7 days depending on the condition to improve tolerance and safety.

In terms of pharmacological mechanism,TECVAYLI is designed through a bispecific antibody, one end of which binds to the CD3 receptor expressed on the surface of T cells, and the other end recognizes BCMA on the surface of malignant plasma cells, thereby accurately "drawing" T cells and tumor cells into close contact. At this time, T cells are activated and release perforin and granzymes, which directly induce lysis and apoptosis of BCMA-positive tumor cells. This mechanism of action is independent of the traditional T cell receptor antigen recognition pathway (that is, it does not rely on MHC-I molecules), so it is also effective against previous immunosuppression or antigen-escape myeloma. For this reason, teritolumab is considered a new milestone in immunotherapy for multiple myeloma.

In actual treatment, the adverse reactions of teritusumab are relatively controllable, but close monitoring is required. Common side effects include fever, fatigue, muscle or bone pain, upper respiratory tract infection, injection site redness and swelling, nausea and diarrhea. Most of these symptoms are mild to moderate and reversible, and usually resolve with supportive care. More serious but rare adverse events are cytokine release syndrome (CRS) and neurotoxic reactions (ICANS), but their incidence can be significantly reduced through dose escalation strategies and preventive drugs. In laboratory tests, common grade 3 to 4 abnormalities include leukopenia, lymphocyte or platelet reduction, and mild liver function changes. Clinicians will dynamically adjust the dose based on the test results.

In terms of storage, Teritolumab needs to be kept refrigerated at 2°C to 8°C, avoiding freezing and direct sunlight. Medications should be stored in their original packaging to maintain stability and out of the reach of children. Before each use, medical staff must strictly abide by the preparation and dilution guidelines to ensure the quality and safety of the medicinal solution.

Reference materials:https://www.tecvayli.com/