Tecvayli

Monotherapy for the treatment of relapsed & refractory multiple myeloma in adults who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, & an anti-CD38 Ab & have demonstrated disease progression on the last therapy.

SC Step-up dosing schedule: Step-up dose 1: 0.06 mg/kg single dose on day 1. Step-up dose 2: 0.3 mg/kg single dose on day 3. 1st maintenance dose: 1.5 mg/kg single dose on day 5. Wkly dosing schedule: Subsequent maintenance dose: 1.5 mg/kg once wkly, 1 wk after the 1st maintenance dose & wkly thereafter. Patient w/ a complete response or better for a min of 6 mth Every-2-wk dosing schedule: Consider reducing dose frequency to 1.5 mg/kg every 2 wk.

Hypersensitivity.

Risk of cytokine release syndrome (CRS); serious or life-threatening neurologic toxicities, including immune effector cell-associated neurotoxicity syndrome; hepatitis B reactivation. Reports of severe, life-threatening or fatal infections; hypogammaglobulinaemia; neutropenia & febrile neutropenia. Administer pre-treatment medicinal products (corticosteroids, antihistamine & antipyretics) prior to each dose of step-up dosing schedule to reduce CRS risk. Monitor patients for signs & symptoms of neurologic toxicities during treatment & treat promptly. Monitor patients for signs & symptoms of infection prior to & during treatment, & treat appropriately. Tecvayli step-up dosing schedule should not be administered in patients w/ active infection. Patients w/ evidence of +ve HBV serology should be monitored for clinical & lab signs of HBV reactivation while receiving Tecvayli, & for at least 6 mth following the end of treatment. Monitor Ig levels during treatment. Immune response to vaccines may be reduced. Vaccination w/ live virus vaccines is not recommended for at least 4 wk prior to start of treatment, during treatment & least 4 wk after treatment. Monitor CBC at baseline & periodically during treatment. Monitor patients w/ neutropenia for signs of infection. Major influence on the ability to drive & use machines. Do not drive or operate heavy machinery during step-up dosing schedule & for 48 hr after completing the step-up dosing schedule & in the event of new onset of any neurological symptoms. Women of childbearing potential should use effective contraception during treatment & for 5 mth after the final dose. In clinical studies, male patients w/ a female partner of childbearing potential used effective contraception during treatment & for 3 mth after the last dose. Not recommended for pregnant women. Advise patients not to breast-feed during treatment & for at least 5 mth after the last dose.

Hypogammaglobulinaemia, cytokine release syndrome, neutropenia, anaemia, musculoskeletal pain, fatigue, thrombocytopenia, inj site reaction, URTI, lymphopenia, diarrhoea, pneumonia, nausea, pyrexia, headache, cough, constipation, pain.

Toxicity or medicinal product conc (eg, cyclosporine) should be monitored from initiation of step-up schedule up to 7 days after the 1st maintenance dose or during a CRS event, in patients who are receiving concomitant CYP450 substrates w/ narrow therapeutic index. The dose of the concomitant medicinal product should be adjusted as needed.

Targeted Cancer Therapy

L01FX24 - teclistamab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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