TERMS AND CONDITIONS OF WEBSITE USE
Please read the following terms and conditions of use carefully before using this website. Your use of this website is subject to, and constitutes acceptance of, the conditions included in this notice.
General. This website is provided by Stemline for the convenience of visitors to our website. Nothing on this website should be construed as an offer to form a binding contract, or as granting any license or transfer of intellectual property. Your use of this site is at your own risk. Notwithstanding any other provision herein, Stemline reserves the right, in the event of a violation of these terms and conditions, to protect its rights, property, and interests to the maximum extent of the law.
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Dated Information. While Stemline may periodically update or correct information presented on this website, such information may include typographical errors and/or technical inaccuracies and/or omissions. Stemline makes no representation or warranty as to the accuracy of any information at this website and expressly disclaims any obligation to update such information. Stemline also reserves the right to make additions, deletions, or modifications to any information at any time and from time to time without any prior notice.
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Changes to this Notice. Stemline may revise these terms at any time without prior notice. You are bound by any such revisions and should, therefore, visit this page each time you access this website to review the then-current conditions applicable to your use of this website.
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750 Lexington Ave.
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This website contains information related to general medical conditions and is provided for educational purposes only. It is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. Research and clinical trial information provided on this website includes investigational treatments which have not been approved for sale by the U.S. Food and Drug Administration.
© 2018 Stemline Therapeutics, Inc.
- 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
- 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
- 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
- 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
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.
Please see full Prescribing Information, including Boxed WARNING.
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.