ASH Clinical News ACN_5.4_Full Issue_web | Page 38

Travel and VTE SIDEBAR Recommendations from the ASH Guidelines for VTE Prophylaxis in Long- Distance Travelers ≥5-hour-long flight. No symptomatic DVTs developed in either group, but wearing compression stockings did decrease signifi- cantly symptomless DVT compared with no stockings (p<0.001). No adverse effects from compression stockings were reported in studies that assessed tolerability. Most of the literature related to prophylactic use of LMWH is narrative or from systematic reviews, according to the guideline. Only one small randomized trial was found: LONFLIT3. 10 The study randomized 300 patients at high risk for VTE to receive either no prophylaxis, aspirin 400 mg, or LMWH (enoxaparin). Of the 249 patients who completed the study, no LMWH-treated patients experienced a DVT, compared with 4.82 percent of control patients and 3.6 percent of aspirin-treated patients. However, 60 percent of the DVTs were asymptomatic. 10 In her own practice, Dr. O’Connell commented, “in someone with a remote history of DVT from a provoking event like orthope- dic surgery, I would not suggest LMWH for every flight longer than four hours. On the other hand, for someone with a symptomatic and proximal DVT treated in the last year, I would consider a prophy- lactic dose of LMWH for a long flight, particularly if there was no provoking event.” Finally, the ASH guidelines recommend that, in patients at high Who is at increased risk? The following factors place people at an increased risk for developing VTE: • recent surgery • prior VTE • postpartum women • active malignancy • ≥2 risk factors, including combinations of the above with hormonal replacement therapy, obesity, or pregnancy The First and Only Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) FROM A DEADLY DISEASE RISES A DURABLE RESPONSE How long is “long-distance?” Long-distance travel is defined as travel longer than four hours in duration. Who should wear graduated compression stockings or take low- molecular-weight heparin (LMWH) or aspirin for VTE prophylaxis? In long-distance travelers without risk factors for VTE, the ASH guideline panel suggests not using these measures. However, the ASH guidelines panel suggests using graduated compression stockings or prophylactic LMWH for long- distance travelers who are at substantially increased VTE risk. What if a patient cannot wear graduated compression stockings or take LMWH? For long-distance travelers who are at an increased risk of VTE but who are unable or unwilling to use LMWH or graduated compression stockings (due to resource constraints or aversion to other indicated anticoagulants), the ASH guideline panel suggests using aspirin rather than no VTE prophylaxis. Source: Schunemann HJ, Cushman M, Burnett AE, et al. American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients. Blood Adv. 2018;2:3198-225. 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 36 ASH Clinical News