Overview
11 DESCRIPTION Tagraxofusp-erzs, a CD123-directed cytotoxin, is a fusion protein comprised of a recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT). Tagraxofusp-erzs has an approximate molecular weight of 57,695 Daltons. Tagraxofusp-erzs is constructed by recombinant DNA technology and produced in Escherichia coli cells.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tagraxofusp-erzs is a CD123-directed cytotoxin composed of recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT) fusion protein that inhibits protein synthesis and causes cell death in CD123-expressing cells. 12.2 Pharmacodynamics The exposure-response relationships and the time course of pharmacodynamic response for ELZONRIS have not been fully characterized. 12.3 Pharmacokinetics Following administration of tagraxofusp-erzs 12 mcg/kg via 15-minute infusion in patients with BPDCN, the mean (SD) area under the plasma drug concentration over time curve (AUC) was 231 (123) hr·mcg/L and maximum plasma concentration (Cmax) was 162 (58.1) mcg/L. Distribution Mean (SD) volume of distribution of tagraxofusp-erzs is 5.1 (1.
Indications
- 1 INDICATIONS AND USAGE ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 )
Common Doses
- 12 mcg
- 3.2 g
- 50 mg
- 3.5 g
Dosage
2 DOSAGE AND ADMINISTRATION Premedicate with an H1-histamine antagonist, acetaminophen, corticosteroid and H2-histamine antagonist prior to each ELZONRIS infusion. ( 2.1 ) Administer ELZONRIS intravenously at 12 mcg/kg over 15 minutes once daily on days 1 to 5 of a 21-day cycle. ( 2.1 ) Administer the first cycle of ELZONRIS in the inpatient setting. Subsequent cycles may be administered in the inpatient or appropriate outpatient setting. ( 2.1 ) Additional important preparation and administration information is in full prescribing information.
Black Box Warning
WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. ( 5.1 )
Contraindications
- 4 CONTRAINDICATIONS None. None ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following serious adverse drug reactions are described elsewhere in the labeling: Capillary Leak Syndrome [see Warnings and Precautions ( 5.1 ) ] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [see Warnings and Precautions ( 5.3 ) ] Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.