Source: FDA, National Drug Code (US) Revision Year: 2020
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.
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:
| 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. | ||
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.
Assure the following components required for dose preparation and administration are available prior to thawing ELZONRIS:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Thawed ELZONRIS appearance should be a clear, colorless liquid that may contain a few white to translucent particles.
Prior to dose preparation thaw at room temperature, between 15°C and 25°C (59°F and 77°F), for 15 to 30 minutes in original carton, and verify thaw visually. Thawed vials may be held at room temperature for approximately 1 hour prior to dosage preparation. Do not force thaw. Do not refreeze vial once thawed.
Use aseptic technique for preparation of the ELZONRIS dose.
A 2-step process is required for preparation of the final ELZONRIS dose:
Administer ELZONRIS within 4 hours. During this 4-hour window, the prepared dose should remain at room temperature.
Do not reuse excess ELZONRIS. Any excess material should be thrown away immediately following infusion.
Store in freezer between -25°C and -15°C (-13°F and 5°F). Protect ELZONRIS from light by storing in the original package until time of use. Thaw vials at room temperature between 15°C and 25°C (59°F and 77°F) prior to preparation [see Preparation for Administration (2.3)]. Do not refreeze the vial once thawed. Do not use beyond expiration date on container.
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