PDCN)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribinginformation are not listed.
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FULL PRESCRIBING INFORMATION
WARNING: CAPILLARY LEAK SYNDROME
Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receivingELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings andPrecautions (5.1)].
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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
• Administer ELZONRIS at 12 mcg/kg intravenously over 15 minutes once daily on days 1 to 5 of a 21-daycycle. The dosing period may be extended for dose delays up to day 10 of the cycle. Continue treatmentwith ELZONRIS until disease progression or unacceptable toxicity.
• Prior to the first dose of the first cycle, ensure serum albumin is greater than or equal to 3.2 g/dL beforeadministering ELZONRIS.
• Premedicate patients with an H1-histamine antagonist (e.g., diphenhydramine hydrochloride), H2-histamineantagonist (e.g., ranitidine), corticosteroid (e.g., 50 mg intravenous methylprednisolone or equivalent) andacetaminophen (or paracetamol) approximately 60 minutes prior to each ELZONRIS infusion.
• Administer Cycle 1 of ELZONRIS in the inpatient setting with patient observation through at least 24 hoursafter the last infusion.
• Administer subsequent cycles of ELZONRIS in the inpatient setting or in a suitable outpatient ambulatorycare setting that is equipped with appropriate monitoring for patients with hematopoietic malignanciesundergoing treatment. Observe patients for a minimum of 4 hours following each infusion.
2.2 Dose Modifications
Monitor vital signs and check albumin, transaminases, and creatinine prior to preparing each dose ofELZONRIS. See Table 1 for recommended dose modifications and Table 2 for CLS management guidelines.
Table 1. Recommended ELZONRIS Dose ModificationsParameter Severity Criteria Dose Modification
Serum albumin
Serum albumin ≤ 3.5 g/dL or reduced ≥ 0.5 g/dLfrom value measured prior to initiation of the currentcycle
See CLS Management Guidelines (Table 2)
Body weight Body weight increase ≥ 1.5 kg over pretreatmentweight on prior treatment day See CLS Management Guidelines (Table 2)
Aspartate
aminotransferase (AST)
or alanine
aminotransferase (ALT)
ALT or AST increase > 5 times the upper limit of
normal
Withhold ELZONRIS until transaminase
elevations are ≤ 2.5 times the upper limit of
normal.
Serum creatinine Serum creatinine > 1.8 mg/dL (159 micromol/L) or
creatinine clearance ≤ 60 mL/minute
Withhold ELZONRIS until serum creatinine
resolves to ≤ 1.8 mg/dL (159 micromol/L) or
creatinine clearance ≥ 60 mL/minute.
Parameter Severity Criteria Dose Modification
Systolic blood pressure Systolic blood pressure ≥ 160 mmHg or ≤ 80 mmHg Withhold ELZONRIS until systolic blood
pressure is < 160 mmHg or > 80 mmHg.
Heart rate Heart rate ≥ 130 bpm or ≤ 40 bpm Withhold ELZONRIS until heart rate is
< 130 bpm or > 40 bpm.
Body temperature Body temperature &g |
