HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ELZONRISTM 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 lifethreateningor fatal if not properly managed, can occur in
patients receiving ELZONRIS.
INDICATIONS AND USAGE
ELZONRIS is a CD123-directed cytotoxin for the treatment of blasticplasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatricpatients 2 years and older.
DOSAGE AND ADMINISTRATION
• Premedicate with an H1-histamine antagonist, acetaminophen,corticosteroid and H2-histamine antagonist prior to each ELZONRISinfusion.
• Administer ELZONRIS intravenously at 12 mcg/kg over 15 minutes oncedaily on days 1 to 5 of a 21-day cycle.
• Administer the first cycle of ELZONRIS in the inpatient setting.
Subsequent cycles may be administered in the inpatient or appropriateoutpatient setting.
• Additional important preparation and administration information is in fullprescribing information. See full prescribing information for instructionson preparation and administration.
DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mcg in 1 mL in a single-dose vial.
CONTRAINDICATIONS
• None.
WARNINGS AND PRECAUTIONS
• Hypersensitivity: Monitor patients for signs/symptoms and treatappropriately.
• Hepatotoxicity: Monitor ALT and AST. Interrupt ELZONRIS if thetransaminases rise to greater than 5 times the upper limit of normal.
ADVERSE REACTIONS
Most common adverse reactions (incidence≥ 30%) are capillary leaksyndrome, nausea, fatigue, peripheral edema, pyrexia and weight increase.
Most common laboratory abnormalities (incidence≥50%) are decreasesin albumin, platelets, hemoglobin,calcium, and sodium, and increases inglucose, ALT and AST.
To report SUSPECTED ADVERSE REACTIONS, contact StemlineTherapeutics, Inc. at 877-332-7961 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed
Revised: 12/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CAPILLARY LEAK SYNDROME
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
2.2 Dose Modifications
2.3 Preparation for Administration
2.4 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Capillary Leak Syndrome
5.2 Hypersensitivity Reactions
5.3 Hepatotoxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of
Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 First-Line Treatment of Blastic Plasmacytoid
Dendritic Cell Neoplasm (BPDCN)
14.2 Relapsed or Refractory Blastic Plasmacytoid
Dendritic Cell Neoplasm (B |
