TECLISTAMAB

Teclistamab received its initial approval from the United States Food and Drug Administration (FDA) on October 20, 2022. Results from the 2023 MajesTEC-1 trial demonstrated its efficacy in patients with relapsed or refractory multiple myeloma, with an overall response rate (ORR) of 63% and a complete response (CR) rate of 39.4%.

Teclistamab is a prescription medication used to treat multiple myeloma in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. It is indicated for individuals whose multiple myeloma has relapsed or is resistant to previous treatments.

Teclistamab is administered via intravenous infusion, which means it is delivered directly into a vein through an IV drip. This typically takes place in a healthcare setting, such as a clinic or hospital, where healthcare professionals can monitor the patient.

Common side effects of Teclistamab include: Fever Upper respiratory tract infections Pain in your joints and muscles Tiredness and weakness Headache Diarrhea Serious side effects of Teclistamab are: Severe infections Cytokine release syndrome (CRS) Neurological symptoms Blood clots

Teclistamab carries a warning for potential severe cytokine release syndrome (CRS). Patients should be closely monitored for signs of CRS, especially during the initial doses. Additionally, there is a risk of severe infections due to the immune system's activation, which requires regular monitoring and appropriate treatment of any signs of infection.

Infections: Evaluate patients for infection risks before initiating teclistamab. Regularly monitor for signs of infections during treatment and initiate appropriate prophylactic or therapeutic measures as needed. Neurotoxicity: Screen patients for neurological conditions prior to treatment and monitor for symptoms of neurotoxicity, such as encephalopathy or altered mental status, throughout therapy. Address any neurological symptoms immediately. Hematologic Toxicity: Regularly check blood cell counts during treatment. Monitor for signs of cytopenias and manage as necessary to prevent complications related to low blood cell levels. Pregnancy and Contraception: Assess pregnancy status before starting treatment. Advise patients to use effective contraception during treatment and for a period after completing therapy, as teclistamab may cause harm to a developing fetus.

Inform your doctor of any medical conditions, particularly if you have a history of severe infections or neurological disorders. Monitor for signs of infection and report symptoms immediately. Keep track of your blood cell counts and notify your healthcare provider of any unusual bleeding or associated symptoms. Teclistamab infusions must be administered only in a healthcare setting and must not be self-administered. Report any adverse effects or concerns to your healthcare team and attend all scheduled follow-up appointments.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf https://pubmed.ncbi.nlm.nih.gov/35661166/ https://www.jnj.com/media-center/press-releases/tecvayli-teclistamab-cqyv-biweekly-dosing-approved-by-the-u-s-fda-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma