ZYNLONTA® FOR INJECTION 10MG/VIAL [SIN17098P]

Product Info

ZYNLONTA® FOR INJECTION 10MG/VIAL

[SIN17098P]

1 INDICATIONS AND USAGE

ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

This indication is approved based on overall response rate [see Clinical Studies (14.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

ZYNLONTA as an intravenous infusion administered over 30 minutes on Day 1 of each cycle (every 3 weeks). Administer intravenous infusion as follows:

• 0.15 mg/kg every 3 weeks for 2 cycles.

• 0.075 mg/kg every 3 weeks for subsequent cycles.

2.2 Recommended Premedication

Unless contraindicated, administer dexamethasone 4 mg orally or intravenously twice daily for 3 days beginning the day before administering ZYNLONTA. If dexamethasone administration does not begin the day before ZYNLONTA, dexamethasone should begin at least 2 hours prior to administration of ZYNLONTA.

2.3 Dosage Modifications and Delays

Recommended Dosage Modifications for Adverse Reactions

Recommendations for Dosage Delays
If dosing is delayed by more than 3 weeks due to toxicity related to ZYNLONTA, reduce subsequent doses by 50%. If toxicity reoccurs following dose reduction, consider discontinuation.
Note: If toxicity requires dose reduction following the second dose of 0.15 mg/kg (Cycle 2), the patient should receive the dose of 0.075 mg/kg for Cycle 3.

2.4 Reconstitution and Administration Instructions

Reconstitute and further dilute ZYNLONTA prior to intravenous infusion. Use appropriate aseptic technique.
ZYNLONTA is a hazardous drug. Follow applicable special handling and disposal procedures.¹

Dose calculation
Calculate the total dose (mg) required based on the patient’s weight and prescribed dose [see Dosage and Administration (2.1)].

• For patients with a body mass index (BMI) ≥35 kg/m², calculate the dose based on an adjusted body weight (ABW) as follows:
  ABW in kg = 35 kg/m²× (height in meters)²

• More than one vial may be needed to achieve the calculated dose.

• Convert the calculated dose (mg) to volume using 5 mg/mL, which is the concentration of ZYNLONTA after reconstitution.

Reconstitution of lyophilized ZYNLONTA

• Reconstitute each ZYNLONTA vial using 2.2 mL of Sterile Water for Injection, USP with the stream directed toward the inside wall of the vial to obtain a final concentration of 5 mg/mL.

• Swirl the vial gently until the powder is completely dissolved. Do not shake. Do not expose to direct sunlight.

• Inspect the reconstituted solution for particulate matter and discoloration. The solution should appear clear to slightly opalescent, colorless to slightly yellow. Do not use if the reconstituted solution is discolored, is cloudy, or contains visible particulates.

• Use reconstituted ZYNLONTA immediately. If not used immediately, store the reconstituted solution in the vial for up to 4 hours refrigerated at 2°C to 8°C (36°F to 46°F) or room temperature 20°C to 25°C (68°F to 77°F). Do not freeze.

• The product does not contain a preservative. Discard unused vial after reconstitution if the recommended storage time is exceeded.

Dilution in infusion bag

• Withdraw the required volume of reconstituted solution from the ZYNLONTA vial using a sterile syringe. Discard any unused portion left in the vial.

• Add the calculated dose volume of ZYNLONTA solution into a 50 mL infusion bag of 5% Dextrose Injection, USP.

• Gently mix the intravenous bag by slowly inverting the bag. Do not shake.

• If not used immediately, store the diluted ZYNLONTA infusion solution refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours or at room temperature 20°C to 25°C (68°F to 77°F) for up to 8 hours. Discard diluted infusion bag if storage time exceeds these limits. Do not freeze.

• No incompatibilities have been observed between ZYNLONTA and intravenous infusion bags with product-contacting materials of polyvinylchloride (PVC), polyolefin (PO), and PAB® (copolymer of ethylene and propylene).

Administration

• Administer by intravenous infusion over 30 minutes using a dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2- or 0.22-micron pore size) and catheter.

• Extravasation of ZYNLONTA has been associated with irritation, swelling, pain, and/or tissue damage, which may be severe [see Adverse Reactions (6.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Monitor the infusion site for possible subcutaneous infiltration during drug administration.

• Do not mix ZYNLONTA with or administer as an infusion with other drugs.

15 REFERENCES

1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

4 CONTRAINDICATIONS

None