| [Dear_________,] |
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| I want to inform you about an important article on a treatment for a deadly hematologic cancer: |
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Tagraxofusp in Blastic Plasmacytoid Dendritic-Cell Neoplasm
Pemmaraju
N, Lane AA, Sweet KL, et al. N Engl J Med. 2019;380(17):1628-1637. |
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VISIT HERE TO READ OR DOWNLOAD THIS ARTICLE:
https://stemline.com/pipeline/scientific-presentations/ |
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| See full Prescribing Information |
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| At the time of publication, certain authors were paid consultants or employees of Stemline Therapeutics. Additional information is included in the disclosure section of this article. |
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| Note: By accessing this article, you acknowledge that Stemline may report the transfer of value associated
with receipt of this journal article, as required by all applicable national, territorial and/or state transparency
laws and regulations. |
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| INDICATION |
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ELZONRIS® (tagraxofusp-erzs) 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
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| IMPORTANT SAFETY INFORMATION |
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| Boxed WARNING: CAPILLARY LEAK SYNDROME |
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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 |
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| WARNINGS AND PRECAUTIONS |
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| Capillary Leak Syndrome |
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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 |
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Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is ≥ 3.2 g/dL |
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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 |
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Counsel patients to seek immediate medical attention should signs or symptoms of CLS occur at any time |
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| Hypersensitivity Reactions |
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ELZONRIS can cause severe hypersensitivity reactions. Grade 3 or higher events were reported in 10% of patients in clinical trials. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur. If the reaction is severe, discontinue ELZONRIS permanently |
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| Hepatotoxicity |
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Elevations in liver enzymes can occur with ELZONRIS. Grade 3 or higher elevations in liver enzymes occurred in approximately 40% of patients in clinical trials |
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Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Temporarily withhold ELZONRIS if the transaminases rise to greater than 5 times the upper limit of normal (ULN) and resume treatment upon normalization or when resolved |
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| ADVERSE REACTIONS: |
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| The most common adverse reactions in the clinical trials (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, and weight increase. The most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, sodium, and increases in glucose, ALT, and AST. |
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Please see full Prescribing Information, including
Boxed WARNING. |
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| To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. |
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ELZONRIS® is a registered trademark of Stemline Therapeutics, Inc.
Copyright 2019 - Stemline Therapeutics, Inc.
750 Lexington Avenue, New York, NY 10022
All rights reserved. 7/2019 US-ELZ-00029 |
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| If you do not wish to receive promotional emails regarding ELZONRIS, click here. |
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| VISIT ELZONRIS.COM/HCP FOR MORE INFORMATION. |
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