Generic name: TAGRAXOFUSP 1000ug in 1mL
Dosage form: injection, solution
Medically reviewed by Drugs.com. Last updated on Feb 21, 2019.
- 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.
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.
|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)|
|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.|
1ELZONRIS 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
|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.
Preparation for Administration
Assure the following components required for dose preparation and administration are available prior to thawing ELZONRIS:
- One empty 10 mL sterile vial
- 0.9% Sodium Chloride Injection, USP (sterile saline)
- Three 10 mL sterile syringes
- One 1 mL sterile syringe
- One mini-bifuse Y-connector
- Microbore tubing
- One 0.2 micron polyethersulfone in-line filter
- 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:
- Step 1 - Prepare 10 mL of 100 mcg/mL ELZONRIS
- Using a sterile 10 mL syringe, transfer 9 mL of 0.9% Sodium Chloride Injection, USP to an empty sterile 10 mL vial.
- Gently swirl the ELZONRIS vial to mix the contents, remove the cap, and using a sterile 1 mL syringe, withdraw 1 mL of thawed ELZONRIS from the product vial.
- Transfer the 1 mL of ELZONRIS into the 10 mL vial containing the 0.9% Sodium Chloride Injection. Gently invert the vial at least 3 times to mix the contents. Do not shake vigorously.
- Following dilution the final concentration of ELZONRIS is 100 mcg/mL.
- Step 2 – Prepare the ELZONRIS infusion set.
- Calculate the required volume of diluted ELZONRIS (100 mcg/mL) according to patient’s weight.
- Draw up the required volume into a new syringe (if more than 10 mL of diluted ELZONRIS (100 mcg/mL) is required for the calculated patient dose, repeat step 1 with a second vial of ELZONRIS). Label the ELZONRIS syringe.
- Prepare a separate syringe with at least 3 mL of 0.9% Sodium Chloride Injection, USP (saline flush) to be used to flush the administration set once the ELZONRIS dose is delivered.
- Label the saline flush syringe.
- Connect the saline flush syringe to one arm of the Y-connector and ensure the clamp is closed.
- Connect the product syringe to the other arm of the Y-connector and ensure the clamp is closed.
- Connect the terminal end of the Y-connector to the microbore tubing.
- Remove the cap from the supply side of the 0.2 micron filter and attach it to the terminal end of the microbore tubing.
- Unclamp the arm of the Y-connector connected to the saline flush syringe. Prime the Y-connector up to the intersection (do not prime the full infusion set with saline). Re-clamp the Y-connector line on the saline flush arm.
- Remove the cap on the terminal end of the 0.2 micron filter and set it aside. Unclamp the arm of the Y-connector connected to the product syringe, and prime the entire infusion set, including the filter. Recap the filter, and re-clamp the Y-connector line on the product side. The infusion set is now ready for delivery for dose administration.
- 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.
- Establish venous access and maintain with sterile 0.9% Sodium Chloride Injection, USP.
- Administer the prepared ELZONRIS dose via infusion syringe pump over 15 minutes. The total infusion time will be controlled using a syringe pump to deliver the entire dose and the saline flush over 15 minutes.
- Insert the ELZONRIS syringe into the syringe pump, open the clamp on the ELZONRIS side of the Y-connector and deliver the prepared ELZONRIS dose.
- Once the ELZONRIS syringe has been emptied, remove it from the pump and place the saline flush syringe in the syringe pump.
- Open the clamp on the saline flush side of the Y-connector and resume infusion via the syringe pump at the pre-specified flow to push remaining ELZONRIS dose out of the infusion line to complete delivery.