Effective Date: December 28, 2018
Stemline Therapeutics, Inc. ("Stemline" or "our") respects the privacy of visitors to BPDCNinfo.com (the "Site") and recognizes your need for appropriate protection and management of the personally identifiable information you may share with us.
This Privacy Notice ("Notice") sets forth Stemline's practices with regard to the collection, use, and disclosure of certain information we may gather when visitors use the Site. This Notice only applies to the Site and does not apply to information collected or received by other means.
Please read this entire Notice before using or submitting information to Stemline through this Site. By using this Site and submitting information through this Site to Stemline, you agree with the terms below.
Data Collection: Stemline collects personally identifiable information (such as your first and last name, home or other physical address, telephone number or email address, and any other information submitted to Stemline) when voluntarily submitted to Stemline.
Data Use: Stemline uses the information it gathers to operate its business. The information we collect or receive about you may be used by Stemline to contact you, to improve this Site, to provide you with information that you have requested, or to provide additional information which Stemline believes may be of interest to you. Stemline may also use this information to perform marketing studies or for other commercial purposes, including purposes for which it may receive compensation. Automated Information, and anonymized or aggregated information, may be shared with and used by us, by others acting on our behalf, or by third parties subject to their own privacy policies.
Data Sharing: Stemline may share information about you with our affiliates. We also may share information about you with third-party service providers who help us operate our business or provide services on our behalf. For example, we may share information with analytics companies, and with companies who help us promote our products and services, or help us customize advertisements, offers, or other communications with you.
In addition, Stemline may use and share the information it gathers in order to comply with applicable law, legal advice, and our policies, or for preventing fraud, theft, and injury to you, us, or others. Please note that other parties may collect personally identifiable information about your online activities over time and across different websites when you use this Site.
Stemline may also share information about you, including personally identifiable information, in connection with the sale or merger of our business, or the transfer of Stemline assets to a third party.
Security: While Stemline makes reasonable efforts to protect the information collected through this Site, please be aware that there is always some risk involved when submitting data over the Internet. We cannot guarantee that our Site is 100% safe from illegal tampering or "hacking." Any data transmitted over the Internet may be at risk. If you choose to contact us by email via the link on this Site, you should not include any confidential personal information and should never include a Social Security number, date of birth, any insurance/financial information, or any sensitive medical information.
Links to Third-Party Websites: As a convenience to our visitors, our Site may contain links to a number of other (non-Stemline) websites that we believe may offer useful information. Those websites may have their own privacy policies and this Notice does not apply to those websites. You should contact those websites directly for information on their privacy policies. We are not responsible for the privacy practices or the content of these third-party websites.
Children's Privacy: Our Site is not intended for children under the age of 13, and we do not knowingly collect information from children under 13.
Contact: If you have any questions about this Notice or Stemline's privacy practices, you may email us at email@example.com.
- 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.