BISPECIFIC BCMA-DIRECTED CD3 T-CELL ENGAGER
Overview
Tecvayli is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsed or refractory multiple myeloma. It may be used in combination with daratumumab hyaluronidase-fihj in people who have received at least one prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent, or as a single treatment in individuals who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Tecvayli is also known by its drug name, teclistamab-cqyv.
Tecvayli is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. Scientists believe it works by attaching to both BCMA on myeloma cells and CD3 on T cells (immune cells), bringing the immune system’s T cells close to the cancer cells so they can recognize and destroy them.
How do I take it?
Prescribing information states that Tecvayli is given as a subcutaneous (under the skin) injection by a healthcare professional. Treatment begins with a step-up dosing schedule followed by regular maintenance injections. Individuals are typically hospitalized for 48 hours after the first two step-up doses and monitored closely near a healthcare facility during the early treatment period. The medication should be administered exactly as prescribed by a health care provider.
Side effects
Common side effects of Tecvayli when used as monotherapy include pyrexia (fever), cytokine release syndrome (a strong immune response that can cause fever and inflammation), musculoskeletal pain (muscle and bone pain), injection site reactions, fatigue (extreme tiredness), upper respiratory tract infection (such as cold-like symptoms), nausea, headache, pneumonia (lung infection), and diarrhea.
Common side effects of Tecvayli when used in combination with daratumumab hyaluronidase-fihj include hypogammaglobulinemia (low levels of antibodies in the blood), upper respiratory tract infection, cytokine release syndrome, cough, diarrhea, musculoskeletal pain, COVID-19 infection, pneumonia, injection site reactions, fatigue, pyrexia (fever), headache, nausea, gastroenteritis (inflammation of the stomach and intestines), and decreased body weight.
The most common Grade 3 to 4 laboratory abnormalities seen with Tecvayli, whether used alone or with daratumumab hyaluronidase-fihj, include decreased lymphocytes (a type of white blood cell), decreased neutrophils (infection-fighting white blood cells), decreased total white blood cells, decreased hemoglobin (a protein in red blood cells that carries oxygen), and decreased platelets (cells that help blood clot).
Rare but serious side effects may include cytokine release syndrome (a severe inflammatory reaction), neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS), hepatotoxicity (liver damage), severe infections, neutropenia (low levels of infection-fighting white blood cells), hypersensitivity reactions including severe injection-related reactions, and embryo-fetal toxicity (harm to an unborn baby).
For more information about this treatment, visit:
Tecvayli (Teclistamab-Cqyv) Injection, for Subcutaneous Use — Janssen Biotech
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