Elzonris

ELZONRIS- tagraxofusp injection, solution
Stemline Therapeutics, Inc.

WARNING: CAPILLARY LEAK SYNDROME

Capillary Leak Syndrome (CLS) which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

  • Administer ELZONRIS at 12 mcg/kg intravenously over 15 minutes once daily on days 1 to 5 of a 21-day cycle. The dosing period may be extended for dose delays up to day 10 of the cycle. Continue treatment with ELZONRIS until disease progression or unacceptable toxicity.
  • Prior to the first dose of the first cycle, ensure serum albumin is greater than or equal to 3.2 g/dL before administering ELZONRIS.
  • Premedicate patients with an H1-histamine antagonist (e.g., diphenhydramine hydrochloride), H2-histamine antagonist (e.g., ranitidine), corticosteroid (e.g., 50 mg intravenous methylprednisolone or equivalent) and acetaminophen (or paracetamol) approximately 60 minutes prior to each ELZONRIS infusion.
  • Administer Cycle 1 of ELZONRIS in the inpatient setting with patient observation through at least 24 hours after the last infusion.
  • Administer subsequent cycles of ELZONRIS in the inpatient setting or in a suitable outpatient ambulatory care setting that is equipped with appropriate monitoring for patients with hematopoietic malignancies undergoing treatment. Observe patients for a minimum of 4 hours following each infusion.

2.2 Dose Modifications

Monitor vital signs and check albumin, transaminases, and creatinine prior to preparing each dose of ELZONRIS. See Table 1 for recommended dose modifications and Table 2 for CLS management guidelines.

Table 1. Recommended ELZONRIS Dose Modifications
Parameter Severity Criteria Dose 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 (Table 2)
Body weight Body weight increase ≥ 1.5 kg over pretreatment weight on prior treatment day See CLS Management Guidelines (Table 2)
Aspartate aminotransferase (AST) or alanine aminotransferase (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/minute Withhold ELZONRIS until serum creatinine resolves to ≤ 1.8 mg/dL (159 micromol/L) or creatinine clearance ≥ 60 mL/minute.
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.
Table 2. CLS Management Guidelines

1 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.

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 resolved1.
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.

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