| {{customText[Learn more about managing Capillary Leak Syndrome (CLS) in patients receiving ELZONRIS|Managing Capillary Leak Syndrome (CLS) in patients receiving ELZONRIS]}} | | | | Dear {{accFname}} {{accLname}}, | | {{customText[Prior to our upcoming meeting, I thought it would be useful to send the following information about managing CLS in patients with BPDCN receiving ELZONRIS™ (tagraxofusp-erzs). We can discuss this important subject in greater depth when we meet, but please reach out in advance if you have any questions.|Thank you for taking the time to discuss how to manage CLS in patients with BPDCN receiving ELZONRIS™ (tagraxofusp-erzs). I have summarized a few key points from our meeting, so that you have the information we discussed in one place. If you have any questions about ELZONRIS or want to discuss this new treatment further, please don't hesitate to reach out.|Sorry I wasn’t able to reach you. I would like to provide you with some information about managing CLS in patients receiving ELZONRIS™ (tagraxofusp-erzs), the first and only treatment now approved for BPDCN. Please let me know when you would like to meet and discuss ELZONRIS further.]}} | | {{customText[Best regards,|Thank you,|Until then,]}} | | {{userName}} | | {{user.Title}} | | {{userEmailAddress}} | | {{user.Phone}} | | Stemline Therapeutics, Inc. | | |  |  |
| | The First and Only Approved Treatment for Blastic
Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in adults and in pediatric patients 2 years and older | | | ELZONRIS™ (tagraxofusp-erzs) and CLS | | In clinical studies, ELZONRIS was shown to cause CLS, which in some cases may be life-threatening or fatal. | | Assess all patients appropriately before and throughout ELZONRIS treatment1 | | • | Before initiating therapy with ELZONRIS (first dose of first cycle), ensure patient has adequate cardiac function* and serum albumin ≥ 3.2 g/dL, and weigh patient to establish baseline weight for subsequent dose | | • | During treatment with ELZONRIS, assess patients for common signs/symptoms of CLS, including: weight gain ≥ 1.5 kg from the previous day’s predose weight; new onset or worsening edema, including pulmonary edema; hypotension or hemodynamic instability; and serum albumin < 3.5 g/dL or reduced by ≥ 0.5 g/dL from the albumin value measured prior to ELZONRIS dosing initiation of the current cycle |
| | Monitor patients during ELZONRIS administration1 | | | | Cycle 1 must be administered in the inpatient setting | | — | Observe patients for at least 24 hours after the last infusion of the first cycle |
| | Subsequent cycles may be administered in an inpatient setting or an appropriate outpatient setting |
| |
| | Counsel patients upon discharge1 | | • | Advise patients of the risk of CLS, and to contact their health care professional for signs and symptoms associated with CLS including new or worsening edema, weight gain, shortness of breath, and/or hypotension after infusion. Advise patients to weigh themselves daily |
| | CLS management guidelines1 | | | | TIME OF PRESENTATION | CLS SIGN/ SYMPTOM | RECOMMENDED ACTION | ELZONRIS DOSING MANAGEMENT |
| | Prior to first
dose of ELZONRIS in cycle 1 | Serum albumin < 3.2 g/dL | Administer ELZONRIS when serum albumin ≥ 3.2 g/dL. |
| | During ELZONRIS dosing | Serum albumin < 3.5 g/dL | Administer 25g intravenous albumin (q12h or more frequently as practical) until serum albumin is ≥ 3.5 g/dL AND not more than 0.5 g/dL lower than the value measured prior to dosing initiation of the current cycle. | Interrupt ELZONRIS dosing until the relevant CLS sign/symptom has resolvedª | | Serum albumin reduced by ≥ 0.5 g/dL from the albumin value measured prior to ELZONRIS dosing initiation of the current cycle | | A predose body weight that is increased by ≥ 1.5 kg over the previous day’s predose weight | Administer 25g intravenous albumin (q12h or more frequently as practical), and manage fluid status as indicated clinically (e.g., generally with intravenous fluids and vasopressors if hypotensive and with diuretics if normotensive or hypertensive), until body weight increase has resolved (i.e. the increase is no longer ≥ 1.5 kg greater than the previous day's predose weight). | | Edema, fluid overload and/or hypotension | Administer 25g intravenous albumin (q12h or more frequently as practical) until serum albumin is ≥ 3.5 g/dL.
Administer 1 mg/kg of methylprednisolone (or an equivalent) per day, until resolution of CLS sign/symptom or as indicated clinically.
Aggressive management of fluid status and hypotension if present, which could include intravenous fluids and/or diuretics or other blood pressure management, until resolution of CLS sign/symptom or as clinically indicated. |
|
| | | | ª | ELZONRIS administration may resume in the same cycle if all CLS signs/symptoms have resolved and the patient did not require measures to treat hemodynamic instability. ELZONRIS administration should be held for the remainder of the cycle if CLS signs/symptoms have not resolved or the patient required measures to treat hemodynamic instability (e.g. required administration of intravenous fluids and/or vasopressors to treat hypotension) (even if resolved), and ELZONRIS administration may only resume in the next cycle if all CLS signs/symptoms have resolved, and the patient is hemodynamically stable. |
|  | | VISIT ELZONRIS.COM/HCP FOR MORE INFORMATION. | | | |
| |
|
|
| | | 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 |
| | Hypersensitivity Reactions | | • | 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 |
| | Hepatotoxicity | | • | 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 |
| | ADVERSE REACTIONS: | | 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. |  | For more information about Stemline ARC, call 1-833-4-STEMLINE (1-833-478-3654) from 8:00 AM to 8:00 PM ET, Monday through Friday or visit StemlineARC.com. | | * | In clinical studies, patients had a normal left ventricular ejection fraction ≥ institutional lower limit of normal as measured by multigated acquisition scan or 2-dimensional echocardiography within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram.2 |
| References: 1. ELZONRIS [prescribing information]. New York, NY, US: Stemline Therapeutics, Inc.; 2018. 2. Data on file. Stemline Therapeutics, Inc. | Copyright 2019 - Stemline Therapeutics, Inc.
750 Lexington Avenue, New York, NY 10022
All rights reserved. 2/2019 US-ELZ-1900021 | If you do not wish to receive promotional emails regarding ELZONRIS™, unsubscribe here. |
|
|
|
|
|
