ELZONRIS CONCENTRATE FOR SOLUTION FOR INFUSION 1000 MCG/ML [SIN17059P]

Product Info

ELZONRIS CONCENTRATE FOR SOLUTION FOR INFUSION 1000 MCG/ML

[SIN17059P]

Indication

4.1 Therapeutic Indications

ELZONRIS is a CD123-directed cytotoxin indicated as monotherapy for first-line treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults.

Due to the rarity of the disease, the efficacy and safety of ELZONRIS as first-line treatment of BPDCN in adult patients has been demonstrated in a limited number of patients [see Clinical Studies (5.1.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Dosing

4.2 Posology and method of administration

4.2.1 Recommended Dosage

• 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. The dose is calculated based on the patient’s actual weight.

• 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., famotidine), 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.

4.2.2 Dosage Modifications

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

  
  
  

  
  
  

4.2.3 Preparation for Administration

Assure the following components required for dose preparation and administration are available prior to thawing ELZONRIS:

• One infusion syringe pump

  • One empty 10 mL sterile vial

  • 0.9% Sodium Chloride Injection, USP

  • 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, USP. 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 to be used to flush the administration set once the ELZONRIS dose is delivered.

  • Label the 0.9% Sodium Chloride Injection, USP flush syringe.

  • Connect the 0.9% Sodium Chloride Injection, USP 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 0.9% Sodium Chloride Injection, USP flush syringe. Prime the Y-connector up to the intersection (do not prime the full infusion set with 0.9% Sodium Chloride Injection, USP). Re-clamp the Y-connector line on the 0.9% Sodium Chloride Injection, USP 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.

4.2.4 Administration

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

• Open the clamp on the 0.9% Sodium Chloride Injection, USP 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.

Contraindications

4.3 Contraindications

None.