The First and Only Treatment for
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
FROM A DEADLY DISEASE
RISES A DURABLE RESPONSE
INDICATION
• 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
IMPORTANT SAFETY INFORMATION
Boxed 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
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
• ELZONRIS can cause capillary leak syndrome (CLS), which may
be life-threatening or fatal if not properly managed. The overall
incidence of CLS in clinical trials was 55% in patients receiving
ELZONRIS, including 46% in Grades 1 or 2, 6% in Grade 3,
1% in Grade 4, and 2 fatal events. Common signs and
symptoms (incidence ≥ 20%) associated with CLS that were
reported during treatment with ELZONRIS include
hypoalbuminemia, edema, weight gain, and hypotension
• Before initiating therapy with ELZONRIS, ensure that the patient
has adequate cardiac function and serum albumin is ≥ 3.2 g/dL
• During treatment with ELZONRIS, ensure that serum albumin
levels are ≥ 3.5 g/dL and have not been reduced by ≥ 0.5 g/dL
from the albumin value measured prior to dosing initiation of
the current cycle. Monitor serum albumin levels prior to the
initiation of each dose or more often as indicated clinically
thereafter. Additionally, assess patients for other signs or
symptoms of CLS, including weight gain, new onset or
worsening edema including pulmonary edema, hypotension,
or hemodynamic instability
• Counsel patients to seek immediate medical attention should
signs or symptoms of CLS occur at any time
Copyright 2019 - Stemline Therapeutics, Inc. All rights reserved. 1/2019 US-ELZ-1800028