Trodelvy Caution For Usage

Preparation and Administration: Reconstitution: TRODELVY is a hazardous drug.
Follow applicable special handling and disposal procedures.
Calculate the required dose (mg) of TRODELVY based on the patient's body weight at the beginning of each treatment cycle (or more frequently if the patient's body weight changed by more than 10% since the previous administration) [see Recommended Dose and Schedule under Dosage & Administration].
Allow the required number of vials to warm to room temperature.
Using a sterile syringe, slowly inject 20 mL of 0.9% Sodium Chloride Injection, USP, into each 180 mg TRODELVY vial. Each vial contains overfill to compensate for liquid loss during preparation and after reconstitution, the total resulting volume delivers a concentration of 10 mg/mL.
Gently swirl vials and allow to dissolve for up to 15 minutes. Do not shake. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be free of visible particulates, clear and yellow. Do not use the reconstituted solution if it is cloudy or discolored.
Use immediately to prepare a diluted TRODELVY infusion solution.
Dilution: Calculate the required amount of the reconstituted TRODELVY solution needed to obtain the appropriate dose according to the patient's body weight.
Determine the final volume of the infusion solution to deliver the appropriate dose at a TRODELVY concentration range of 1.1 mg/mL to 3.4 mg/mL (the total volume should not exceed 500 mL for patients weighing less than or equal to 170 kg). For patients whose body weight exceeds 170 kg, divide the total calculated dose between two 500 mL infusion bags. The 2 bags should be infused sequentially over the total calculated infusion time of TRODELVY in order to deliver the full dose.
Use 0.9% Sodium Chloride Injection, USP only since the stability of the reconstituted TRODELVY solution has not been determined with other infusion-based solutions. Use polyvinyl chloride, polypropylene or ethylene/propylene copolymer infusion bag.
Withdraw and discard the volume of 0.9% Sodium Chloride Injection, USP from the final infusion bag that is necessary to achieve the indicated TRODELVY concentration following the addition of the calculated amount of reconstituted TRODELVY solution.
Withdraw the calculated amount of the reconstituted TRODELVY solution from the vial(s) using a syringe. Discard any unused portion remaining in the vial(s).
To minimize foaming, slowly inject the calculated amount of reconstituted TRODELVY solution into the infusion bag. Do not shake the contents.
If not used immediately, the infusion bag containing TRODELVY solution can be stored refrigerated 2°C to 8°C for up to 4 hours protected from light. After refrigeration, administer diluted solution within 6 hours (including infusion time).
Do Not Freeze or Shake.