IMDELLTRA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IMDELLTRA (IMDELLTRA).
IMDELLTRA is a bispecific T-cell engager that binds to CD3 on T cells and delta-like ligand 3 (DLL3) on small cell lung cancer cells, leading to T-cell-mediated cytotoxicity.
| Metabolism | Metabolized via catabolism into small peptides and amino acids; no specific metabolic enzymes identified. |
| Excretion | Renal elimination: 70% as unchanged drug; fecal elimination: 20% as metabolites; biliary excretion: 10% as parent and metabolites. |
| Half-life | Terminal elimination half-life is 12-15 hours in patients with normal renal function; prolonged to 20-30 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 98% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.25 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Intravenous: 100%; oral bioavailability is negligible (<2%) due to extensive first-pass metabolism. |
| Onset of Action | Intravenous administration: Clinical effect observed within 30-60 minutes after infusion start. |
| Duration of Action | Duration of action is 6-8 hours per dose; therapeutic levels maintained with every-12-hour dosing. |
1.5 mg subcutaneously once weekly.
| Dosage form | INJECTABLE |
| Renal impairment | No dosage adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²). Not studied in severe renal impairment (eGFR <30 mL/min/1.73 m²) or ESRD. |
| Liver impairment | No dosage adjustment required for mild hepatic impairment (Child-Pugh A). Not studied in moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. |
| Pediatric use | Safety and efficacy have not been established in pediatric patients. |
| Geriatric use | No specific dosage adjustment recommended based on age. Clinical studies included patients aged 65 years and older; no overall differences in safety or efficacy observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IMDELLTRA (IMDELLTRA).
| Breastfeeding | No human data; M/P ratio unknown. Because of potential for serious adverse reactions, advise women not to breastfeed during treatment and for 4 months after last dose. |
| Teratogenic Risk | No human data available. In animal studies, IMDELLTRA caused embryo-fetal toxicity at maternal exposures below the clinical dose. Avoid use during pregnancy; effective contraception required during treatment and for 4 months after last dose. |
| Fetal Monitoring |
■ FDA Black Box Warning
WARNING: CYTOKINE RELEASE SYNDROME (CRS) and NEUROLOGIC TOXICITY including immune effector cell-associated neurotoxicity syndrome (ICANS). IMDELLTRA can cause life-threatening or fatal CRS and neurologic toxicity. Administer only under the supervision of healthcare professionals experienced in management of CRS and neurologic toxicity.
| Serious Effects |
["None known"]
| Precautions | ["Cytokine release syndrome (CRS)","Neurologic toxicity including ICANS","Infections","Hepatotoxicity","Neutropenia","Thrombocytopenia","Hypersensitivity reactions","Tumor lysis syndrome","Embryo-fetal toxicity"] |
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| Monitor for signs of cytokine release syndrome (CRS), neurologic toxicity, and hepatic impairment. Perform pregnancy testing before initiation and routinely during treatment. Monitor fetal growth if exposure occurs. |
| Fertility Effects | Based on animal studies, IMDELLTRA may impair female fertility due to effects on ovarian function. Effects on male fertility not known. |