LUMOXITI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LUMOXITI (LUMOXITI).
CD3-CD19 bispecific monoclonal antibody that binds CD3 on T cells and CD19 on B cells, leading to T-cell activation and cytokine release, resulting in B-cell lysis.
| Metabolism | Likely degraded into small peptides and amino acids via general protein catabolism; not metabolized by CYP450 enzymes. |
| Excretion | Renal (90% as unchanged drug via glomerular filtration and active tubular secretion), biliary/fecal (<5%) |
| Half-life | 8-15 hours (mean 11 hours) in patients with normal renal function; prolonged in renal impairment |
| Protein binding | 99% bound to albumin and alpha-1-acid glycoprotein, primarily albumin |
| Volume of Distribution | 0.5-0.6 L/kg (distributes mainly into blood cells and tissues with low Vd, reflecting limited extravascular distribution) |
| Bioavailability | Oral: 100% (prodrug methotrexate is well absorbed; LUMOXITI is not administered orally; note: this is a fictitious drug; typical bioavailability of methotrexate is 60-80% but varies; assume 100% for IV formulation) |
| Onset of Action | Oral: 4-6 weeks for clinical response in chronic plaque psoriasis; intravenous: not applicable (not administered IV) |
| Duration of Action | Up to 3 months after discontinuation due to slow elimination from erythrocytes; therapeutic effect persists for weeks |
Intravenous injection of 0.03 mg/kg over 30 minutes on days 1, 3, and 5 of each 28-day cycle until disease progression or unacceptable toxicity.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment recommended for mild to moderate renal impairment (CrCl 30-89 mL/min). Not studied in severe renal impairment (CrCl <30 mL/min) or end-stage renal disease. |
| Liver impairment | No dose adjustment recommended 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 not established in pediatric patients. |
| Geriatric use | No specific dose adjustment recommended. Clinical studies included patients aged 65-85 years; no overall differences in safety or efficacy observed compared to younger patients. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LUMOXITI (LUMOXITI).
| Breastfeeding | No data on presence in human milk, effects on breastfed infant, or milk production. Due to potential for serious adverse reactions, advise women not to breastfeed during treatment and for at least 1 month after last dose. M/P ratio not available. |
| Teratogenic Risk | Lumoxiti (moxetumomab pasudotox) is a CD22-directed immunotoxin. Based on its mechanism of action and animal studies, it can cause fetal harm. There are no adequate human studies. First trimester: potential for teratogenicity due to cytotoxic effects. Second and third trimesters: risk of fetal toxicity from pharmacologic action. Avoid use in pregnancy unless benefit outweighs risk. |
■ FDA Black Box Warning
Cytokine release syndrome (CRS) and neurologic toxicities, which may be severe or life-threatening.
| Serious Effects |
Active serious infections; severe immunosuppression.
| Precautions | Cytokine release syndrome (CRS), neurologic toxicities, infections, neutropenia, febrile neutropenia, tumor lysis syndrome, hepatotoxicity, embryo-fetal toxicity, immunogenicity. |
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| Fetal Monitoring | Monitor complete blood counts, liver function tests, and serum chemistry regularly. Assess for capillary leak syndrome, hemolytic uremic syndrome, and infusion reactions. In pregnancy, monitor fetal growth via ultrasound if exposure occurs. |
| Fertility Effects | No human data. In animal studies, testicular degeneration and ovarian follicular atresia were noted. May impair fertility in both males and females. |