Tecvayli

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

Administer pre-treatment medicinal products 1-3 hr prior to step-up dosing schedule: oral or IV dexamethasone 16 mg, diphenhydramine 50 mg or equiv, acetaminophen 650-1,000 mg or equiv. 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 (may be given between 2-7 days after step-up dose 1). 1st maintenance dose: 1.5 mg/kg single dose on day 5 (may be given between 2-7 days after step-up dose 2). Wkly dosing schedule: Subsequent maintenance dose: 1.5 mg/kg once wkly, 1 wk after 1st maintenance dose & wkly thereafter. Maintain min of 5 days between wkly maintenance dose. Patient w/ complete response or better for min of 6 mth Every-2-wk dosing schedule: Consider reducing dose frequency to 1.5 mg/kg every 2 wk. Duration of treatment: Patients should be treated until disease progression or unacceptable toxicity.

Hypersensitivity.

Not to be administered IV; in patients w/ active infection. Withhold treatment until cytokine release syndrome (CRS) is resolved; if CRS is suspected; immune effector cell-associated neurotoxicity syndrome (ICANS) & other neurologic toxicities occur; in patients who develop HBV reactivation. CRS; signs & symptoms including fever, hypoxia, chills, hypotension, tachycardia, headache & elevated liver enzymes; potential life-threatening complications may include cardiac dysfunction, adult resp distress syndrome, neurologic toxicity, renal &/or hepatic failure, & disseminated intravascular coagulation. Serious or life-threatening neurologic toxicities including ICANS. Severe, life-threatening, or fatal infections, new or reactivated viral infections; progressive multifocal leukoencephalopathy. HBV reactivation; fulminant hepatitis, hepatic failure. Hypogammaglobulinaemia. Reduced immune response to vaccines. Neutropenia & febrile neutropenia. Monitor patients who received treatment w/in step-up dosing schedule & after experiencing grade 2 or higher CRS for 48 hr; for signs & symptoms of neurologic toxicities during treatment; infection prior to & during treatment; clinical & lab signs of HBV reactivation while receiving treatment, & for at least 6 mth following end of treatment. Monitor Ig levels; CBC at baseline & periodically during treatment. Consider antiviral prophylaxis for prevention of HZV reactivation prior to treatment. Not recommended to have vaccination w/ live virus vaccines for at least 4 wk prior to start of & during treatment, & at least 4 wk after treatment. Avoid driving or operating heavy or potentially dangerous machinery during & for 48 hr after completing 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 final dose. In clinical studies, male patients w/ a female partner of childbearing potential used effective contraception during treatment & for 3 mth after last dose. Not recommended during pregnancy. Advise patients not to breast-feed during treatment & for at least 5 mth after last dose.

Pneumonia, COVID-19, URTI; neutropenia, thrombocytopenia, lymphopenia, anaemia, leukopenia; CRS, hypogammaglobulinaemia; hypercalcaemia, hypokalaemia, hypophosphataemia, hypomagnesaemia, decreased appetite; peripheral neuropathy, headache; haemorrhage, HTN; dyspnoea, cough; diarrhoea, vomiting, nausea, constipation; musculoskeletal pain; pyrexia, inj site reaction, pain, oedema, fatigue; increased blood alkaline phosphatase. Sepsis, cellulitis; febrile neutropenia, hypofibrinogenaemia; hyperamylasaemia, hyperkalaemia, hyponatraemia, hypocalcaemia, hypoalbuminaemia; ICANS, encephalopathy; hypoxia; increased blood creatinine, lipase, γ-glutamyltransferase & INR, transaminase elevation, prolonged aPTT.

Concomitant use w/ CYP450 substrates w/ narrow therapeutic index eg, ciclosporin.

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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