Blastic Plasmacytoid Dendritic Cell Neoplasm
Elzonris (tagraxofusp-erzs) is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). ELZONRIS (tagraxofusp-erzs) injection is a preservative-free, sterile, clear, colorless, 1,000 mcg in 1 mL solution supplied in a single-dose glass vial. Each carton contains one vial (NDC 72187-0401-1). These highlights do not include all the information needed to use
ELZONRIS� safely and effectively. See full prescribing information for
ELZONRIS.
ELZONRIS (tagraxofusp-erzs) injection, for intravenous use
Initial U.S. Approval: 2018
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)
INDICATIONS AND USAGE
ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. (1)
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. See full prescribing information for instructions on preparation and administration. (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mcg in 1 mL in a single-dose vial. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity: Monitor patients for signs/symptoms and treat appropriately. (5.2)
Hepatotoxicity: Monitor ALT and AST. Interrupt ELZONRIS if the transaminases rise to greater than 5 times the upper limit of normal. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ? 30%) are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia 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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2018
16.2 Storage and Handling
Store in freezer between -25�C and -15�C (-13�F and 5�F). Protect ELZONRIS from light by storing in the original package until time of use. Thaw vials at room temperature between 15�C and 25�C (59�F and 77�F) prior to preparation [see Preparation for Administration (2.3)]. Do not refreeze the vial once thawed. Do not use beyond expiration date on container.
