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An Approach to Treating BPDCN Patients with Prior or Concomitant Hematologic Malignancies

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An Approach to Treating BPDCN Patients with Prior or Concomitant Hematologic Malignancies

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Learn about the effects of a therapy in patients with blastic plasmacytoid dendritic cell neoplasm and prior or concomitant hematologic malignancies.

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  • Overview

    Since up to 20 percent of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) have prior or concomitant hematologic malignancies (PCHM), a subgroup analysis of a pivotal trial evaluated the efficacy and safety of the treatment option TAGRAXOFUSP in this patient population. This report found that the response rates and adverse effects seen in patients with BPDCN who also presented with a PCHM were consistent with findings from previous studies focusing on BPDCN patients without a PCHM.1 Dive further into the findings with Dr. Charles Turck and Dr. James McCloskey.

  • INDICATION

    ELZONRIS is a CD123-directed cytotoxin indicated 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

    • Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8/122) of patients, Grade 4 in 1% (1/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range - 1 to 46 days), and all but 5 patients experienced an event in Cycle 1.
    • Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability.

    Hypersensitivity Reactions

    • ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur.

    Hepatotoxicity

    • Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption.
    • Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved.

    ADVERSE REACTIONS:
    Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and 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.

    Reference:

    1. Pemmaraju N, et al. Tagraxofusp, a CD123-directed therapy, in patients with blastic plasmacytoid dendritic cell neoplasm and prior or concomitant hematologic malignancies: subgroup analysis of a pivotal trial. Poster presented at: 65th ASH Annual Meeting & Exposition. December 10-13, 2022: New Orleans, LA.

     

    MAT-US-TAG-00052 / Copyright 2023- Stemline Therapeutics, Inc.
    All rights reserved. 12/2023

Schedule27 Feb 2024