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Dose Administration

The first cycle of ELZONRIS should be administered in an inpatient setting, while the subsequent cycles can be administered in the inpatient setting or a suitable outpatient ambulatory care setting equipped with appropriate observation for patients with hematopoietic malignancies undergoing treatment.1

Administer once daily on days 1 to 5 of a 21-day cycle

Prepare to observe patients through at least 24 hours after the last infusion during cycle 1 in the inpatient setting1

15 minute IV infusion time

In cycle two and beyond, prepare to observe patients for at least 4 hours following each infusion for any adverse events1

Factors to consider before dose administration1

Prior to administration, ELZONRIS is diluted to 100 micrograms per milliliter according to the patient’s weight

Do not reuse excess ELZONRIS. Any excess material should be thrown away immediately following infusion

Administer ELZONRIS until disease progression or unacceptable toxicity occurs. Do not administer as an IV push or bolus

Refer to the Package Insert for a complete list of Warnings and Precautions and recommended dose modifications

Pre-medicate patients ~60 minutes prior to each infusion with1:

  • H1-histamine antagonist (eg, diphenhydramine hydrochloride)
  • Acetaminophen (paracetamol)
  • Corticosteroid (eg, 50 mg IV methylprednisolone or equivalent)
  • H2-histamine antagonist (eg, famotidine)

IV, intravenous

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  1. Reference:
  2. ELZONRIS [prescribing information]. New York, NY: Stemline Therapeutics, Inc.; July 2023.

This page is intended to be a practical guide. Use the checklists to keep track of the steps. Please note that selections are not stored. Your selections will be lost if you refresh/close the page.

Steps for dose administration1:

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Step 1

Prior to infusion, check the patient’s ID band, establish venous access, and maintain with sterile 0.9% Sodium Chloride Injection, USP.

Step 2

Insert the syringe containing the diluted ELZONRIS dose into the programmable syringe pump, following the pump’s instructions. Please refer to the manufacturer’s instructions for your pump to ensure proper use.

Step 3

The total infusion time will be controlled using a programmable pump to deliver the entire diluted ELZONRIS dose over 15 minutes. This time frame includes the 0.9% Sodium Chloride Injection, USP flush.

Step 4

The pump must have settings that enable you to input the total dose amount required for infusion and the time required for delivery.

Step 5

Before you connect the administration setup to the patient’s IV line, determine where you will place the 0.9% Sodium Chloride Injection, USP flush so it can be conveniently accessed upon completion of the diluted ELZONRIS dose.

Step 6

Attach the outlet of the in-line filter to the Y-connector of the patient’s IV line.

Step 7

Stop the patient’s running 0.9% Sodium Chloride Injection, USP line by clamping it and then start the infusion pump.

Run the infusion syringe pump until the diluted ELZONRIS-filled syringe is empty. This will take less than 15 minutes.

Step 8

A healthcare professional should closely observe the patient during infusion for any potential adverse or site reactions.

Step 9

Depending on the type of pump you are using, alarms may sound to indicate that the syringe is almost empty. Visually verify that the syringe is completely empty.

Step 10

When the diluted ELZONRIS-filled syringe is completely empty, remove it from the pump, following the pump’s instructions. Do not turn off the pump.

Clamp the ELZONRIS side of the Y-connector.

Step 11

Clamp the ELZONRIS side of the Y-connector.

Step 12

Open the clamp on the 0.9% Sodium Chloride Injection, USP flush side of the Y-connector.

Step 13

Place the 0.9% Sodium Chloride Injection, USP flush syringe in the programmable pump.

Then resume infusion via the programmable pump at the pre-specified flow rate to completely deliver the diluted ELZONRIS dose remaining in the microbore tubing line.

Step 14

You should ensure that the full recommended dose of diluted ELZONRIS has been sufficiently administered during the 15-minute time frame.

Step 15

When that has happened, remove the 0.9% Sodium Chloride Injection, USP flush syringe from the programmable pump. The 0.9% Sodium Chloride Injection, USP flush syringe will not be emptied entirely at the end of the 15-minute infusion, since it is just intended to push the remaining ELZONRIS dose out of the infusion line to complete dose delivery.

Power off the pump by following the pump’s instructions.

Step 16

Disconnect the in-line filter port from the patient’s IV line. Prepare to monitor the patient through at least 24 hours after the last infusion during Cycle 1 in the inpatient setting, and at least 4 hours following each infusion in the subsequent cycles for any adverse events.

Step 1

 Prior to infusion, check the patient’s ID band, establish venous access, and maintain with sterile 0.9% Sodium Chloride Injection, USP.

Step 2

 Insert the syringe containing the diluted ELZONRIS dose into the programmable syringe pump, following the pump’s instructions. Please refer to the manufacturer’s instructions for your pump to ensure proper use.

Step 3

 The total infusion time will be controlled using a programmable pump to deliver the entire diluted ELZONRIS dose over 15 minutes. This time frame includes the 0.9% Sodium Chloride Injection, USP flush.

Step 4

 The pump must have settings that enable you to input the total dose amount required for infusion and the time required for delivery.

Step 5

 Before you connect the administration setup to the patient’s IV line, determine where you will place the 0.9% Sodium Chloride Injection, USP flush so it can be conveniently accessed upon completion of the diluted ELZONRIS dose.

Step 6

 Attach the outlet of the in-line filter to the Y-connector of the patient’s IV line.

Step 7

Stop the patient’s running 0.9% Sodium Chloride Injection, USP line by clamping it and then start the infusion pump.

Run the infusion syringe pump until the diluted ELZONRIS-filled syringe is empty. This will take less than
15 minutes.

Step 8

 A healthcare professional should closely observe the patient during infusion for any potential adverse or site reactions.

Step 9

 Depending on the type of pump you are using, alarms may sound to indicate that the syringe is almost empty. Visually verify that the syringe is completely empty.

Step 10

When the diluted ELZONRIS-filled syringe is completely empty, remove it from the pump, following the pump’s instructions. Do not turn off the pump.

Step 11

 Clamp the ELZONRIS side of the Y-connector.

Step 12

Open the clamp on the 0.9% Sodium Chloride Injection, USP flush side of the Y-connector.

Step 13

Place the 0.9% Sodium Chloride Injection, USP flush syringe in the programmable pump.

Then resume infusion via the programmable pump at the pre-specified flow rate to completely deliver the diluted ELZONRIS dose remaining in the microbore tubing line.

Step 14

 You should ensure that the full recommended dose of diluted ELZONRIS has been sufficiently administered during the 15-minute time frame.

Step 15

When that has happened, remove the 0.9% Sodium Chloride Injection, USP flush syringe from the programmable pump. The 0.9% Sodium Chloride Injection, USP flush syringe will not be emptied entirely at the end of the 15-minute infusion, since it is just intended to push the remaining ELZONRIS dose out of the infusion line to complete dose delivery.

Power off the pump by following the pump’s instructions.

Step 16

 Disconnect the in-line filter port from the patient’s IV line. Prepare to monitor the patient through at least 24 hours after the last infusion during Cycle 1 in the inpatient setting, and at least
4 hours following each infusion in the subsequent cycles for any adverse events.

IV, intravenous.

See long term efficacy

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See long term efficacy

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Well-defined dose modification guidelines have been established for ELZONRIS administration1

Parameter Severity criteria Dosage modification
Serum albumin Serum albumin <3.5 g/dL or reduced ≥0.5 g/dL from value measured prior to initiation of the current cycle See CLS Management Guidelines
Body weight Body weight increase ≥1.5 kg over pretreatment weight on prior treatment day See CLS Management Guidelines
AST or ALT ALT or AST increase >5 times the upper limit of normal Withhold ELZONRIS until transaminase elevations are ≤2.5 times the upper limit of normal
Serum creatinine Serum creatinine >1.8 mg/dL (159 micromol/L) or creatinine clearance <60 mL/min Withhold ELZONRIS until serum creatinine resolves to ≤1.8 mg/dL (159 micromol/L) or creatinine clearance ≥60 mL/min
Systolic blood pressure Systolic blood pressure ≥160 mmHg or ≤80 mmHg Withhold ELZONRIS until systolic blood pressure is <160 mmHg or >80 mmHg
Heart rate Heart rate ≥130 bpm or ≤40 bpm Withhold ELZONRIS until heart rate is <130 bpm or >40 bpm
Body temperature Body temperature ≥38°C Withhold ELZONRIS until body temperature is <38°C
Hypersensitivity reactions Mild or moderate Withhold ELZONRIS until resolution of any mild or moderate hypersensitivity reaction. Resume ELZONRIS at the same infusion rate
Severe or life-threatening Discontinue ELZONRIS permanently
Ensure the patient meets all requirements prior to ELZONRIS administration1

ALT, alanine aminotransferase; AST, aspartate aminotransferase; CLS, capillary leak syndrome.

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Explore the mechanism of action of ELZONRIS, a CD123-targeted molecule
  1. Reference:
  2. ELZONRIS [prescribing information]. New York, NY: Stemline Therapeutics, Inc.; July 2023.

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.