Liso-cel PHA
What is the maximum number of vials per carton for each liso-cel component?
Up to 4 vials per carton.
Which two medications are recommended for premedication before liso-cel and ide-cel infusion?
Acetaminophen and diphenhydramine (or another H1-antihistamine).
What is the shelf life for Ide-cel?
The shelf life for commercial ide-cel drug product is 12 months.
What is the color of the box containing liso-cel vials?
Blue
What should be available prior to liso-cel and ide-cel infusion and during recovery?
Two doses of tocilizumab and emergency equipment.
Is visual inspection and return of liso-cel vials to the cryochamber allowed upon receipt?
No, this is considered a process excursion.
What are the recommended storage conditions for liso-cel and ide-cel at the site?
Frozen in vapor phase of liquid nitrogen (≤ -130°C).
Why are multiple infusion bags needed to deliver the total ide-cel dose?
The manufactured volume of ide-cel will vary among individual patients to achieve the recommended dose range. Different bag sizes are needed to accommodate patient-to patient variability
After removing the polyaluminum cover from a liso-cel vial, what must be done to the septum?
Swab with alcohol wipe and allow to air dry.
What is COI ?
Chain of Identity (COI) describes the ability to link a patient to their cells from the time of leukapheresis collection through product administration.
What is the purpose of the RFI Certificate in liso-cel administration?
Indicates correct product volumes and patient identifiers.
How quickly must the transfer of liso-cel and ide-cel to on-site storage be completed?
Within less than 2 minutes by two qualified staff.
When will sites know the patient-specific dose?
For commercial product, the patient specific dose will be known once the Release for Infusion (RFI) certificate is uploaded to the Cell Therapy 360 portal CAR T Cell Therapy Site after QA completes product release. For an out-of specification product, the ordering physician will know the dose after an initial scheduling notification is sent out.
What precaution must be taken with the tubing lines during liso-cel vial preparation?
Only cut the tubing line with a filter.
What type of filter is allowed for administration of Liso-cel and Ide-cel?
A non-leukodepleting filter
What information does the barcode on liso-cel vial labels include?
NDC barcode and internal manufacturing site tracking.
What safety equipment must be used when handling liso-cel and ide-cel from LN2 storage?
Waterproof thermal gloves, safety glasses with side shields, and a lab coat.
Where can Ide-cel be thawed?
Ide-cel is thawed immediately prior to infusion, which may occur at bedside. Product may also be thawed in a cell therapy lab and transported to bedside in an insulated room temperature carrier
What is the order in which the Liso-cel components are given?
CD8 first followed by the CD4 Component
What type of IV line can Ide-cel and Liso-cel be given through?
The IV can be either a peripheral line or central line
Where can liso-cel thawing and preparation occur?
Cellular therapy lab, pharmacy, bedside, or during transport to bedside.
What is the longest time after the END of lymphodepleting chemotherapy that a patient can receive their cells without requiring another round of lymphodepleting chemotherapy?
Idecel and Lisocel must be infused no more than 7 days from the planned infusion day.
What is the target temperature for a water bath or dry thaw unit for thawing Ide-cel?
A target of 37°C +/- 1°C is acceptable for thawing of ide-cel.
What type of needle is used to prepare the dose for Liso-cel?
20-gauge, 1- to 1.5-inch needle
What is the recommended action if LN2 shipper temperature goes above -130°C?
Do not initiate liso-cel or ide-cel infusion and call Bristol Myers Squibb.