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A CLS Alert Kit is available to healthcare professionals treating and monitoring patients receiving ELZONRIS on an inpatient or outpatient basis, indicating that the patient is a "CAPILLARY LEAK SYNDROME RISK." Kit contains patient alert bracelet, alert sign (to be placed in inpatient room), and chart sticker.

Both the grade and timing of CLS are well characterized1,2

one cycle

In the clinical trial, CLS occurred almost exclusively in cycle 1 of treatment1

CLS recurrence is rare

CLS recurrence is rare1,2

CLS appeared in a median of 6 days and resolved in a median of 6 days

In the long-term follow-up, CLS appeared in a median of 6 days and resolved in a median of
6 days2

Common signs and symptoms associated with CLS that were reported during treatment with ELZONRIS include1:

  • Hypoalbuminemia
  • Edema, including pulmonary edema
  • Weight gain
  • Hypotension
  • Hemodynamic instability

CLS incidence in patients receiving ELZONRIS in clinical trials1

Overall incidence of CLS was 53% (65/122)

  • 43% incidence of Grade 1 or 2 events (52/122)
  • 7% incidence of Grade 3 events (8/122)
  • 1% incidence of Grade 4 events (1/122)
  • 3% incidence of Grade 5 events (4/122)
  • Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death.

CLS was managed per recommended CLS management guidelines described below and in Table 2 of the full Prescribing Information.


CLS assessment for patients on ELZONRIS1

Assess all patients appropriately before and throughout ELZONRIS treatment

  • Before initiating therapy with ELZONRIS (first dose of first cycle):
    • Ensure patient has adequate cardiac function*
    • Ensure patient has serum albumin ≥3.2 g/dL
    • Weigh patient to establish baseline weight for dose
  • During treatment with ELZONRIS:
    • Monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as clinically indicated thereafter
    • Assess patients for signs or 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
      • Serum albumin <3.5 g/dL or reduction of ≥0.5 g/dL from the albumin value measured prior to ELZONRIS dosing initiation of the current cycle

Observe patients during ELZONRIS administration

  • Cycle 1
    • The first cycle must be administered in the inpatient setting
      • Observe patients for at least 24 hours after the last infusion of the first cycle

  • Subsequent cycles
    • Subsequent cycles may be administered in an inpatient setting or an appropriate outpatient setting

Counsel patients upon discharge

  • Advise patients of the risk of CLS, and to contact their healthcare provider if they experience signs or 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

*In the clinical studies, patients had a 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.3

Guidance for CLS management in patients1

Follow the CLS Management Guidelines found in Section 2.2 (Table 2) of the full Prescribing Information

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 abumin <3.5 g/dL Administer 25 g 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 resolved
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 25 g intravenous albumin (q12h or more frequently as practical) and manage fluid status as clinically indicated (eg, generally with intravenous fluids and vasopressors if hypotensive and with diuretics if normotensive or hypertensive) until body weight increase has resolved (ie, the increase is no longer 1.5 kg greater than the previous day’s predose weight)
Edema, fluid overload, and/or hypotension

Administer 25 g 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 clinically indicated

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

ELZONRIS dose is held1:

  • 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 (eg, 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

CLS, capillary leak syndrome; q12h, every 12 hours.

See how to properly prepare ELZONRIS
  1. References:
  2. ELZONRIS [prescribing information]. New York, NY: Stemline Therapeutics, Inc.; July 2023.
  3. Pemmaraju N, et al. Long-term benefits of tagraxofusp for patients with blastic plasmacytoid dendritic cell neoplasm. J Clin Oncol. 2022;40(26):3032-3036.
  4. Data on file. Stemline Therapeutics, Inc.

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.

IMPORTANT SAFETY INFORMATION

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.