Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

CryoStor CS10 freeze media (contains DMSO)
Sodium chloride
Sodium gluconate
Sodium acetate trihydrate
Potassium chloride
Magnesium chloride
Water for injections

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Abecma is stable for 12 months when stored in the vapour phase of liquid nitrogen (≤ -130°C).
Each bag must be infused within 1 hour from start of thaw. After thawing, the volume of the product intended for infusion should be kept at room temperature (20°C – 25°C).

6.4   Special precautions for storage

Abecma must be stored in the vapour phase of liquid nitrogen (≤ -130°C) and must remain frozen until the patient is ready for treatment to ensure viable cells are available for patient administration.
Thawed medicinal product should not be refrozen.

For storage conditions after thawing of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Ethylene vinyl acetate cryopreservation bag(s) with sealed addition tube containing 10-30 mL (50 mL bag), 30-70 mL (250 mL bag) or 55-100 mL (500 mL bag) of cell dispersion.

Each cryopreservation bag is individually packed in a metal cassette.

One individual treatment dose is comprised of one or more infusion bags of the same size and fill volume.

6.6   Special precautions for disposal and other handling

Precautions to be taken before handling or administering the medicinal product 
Abecma must be transported within the facility in closed, break-proof, leak-proof containers.

This medicinal product contains human blood cells. Healthcare professionals handling Abecma must take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

Preparation prior to administration

Prior to Abecma infusion, it must be confirmed that the patient’s identity matches the patient identifiers on the Abecma cassette(s), the infusion bag(s) and the release for infusion certificate (RfIC). The Abecma infusion bag must not be removed from the cassette if the information on the patient-specific label does not match the intended patient. The company must be contacted immediately if there are any discrepancies between the labels and the patient identifiers.

If more than one infusion bag has been received for treatment, thaw each infusion bag one at a time.
The timing of thaw of Abecma and infusion should be coordinated. The infusion start time should be confirmed in advance and adjusted for thaw so that Abecma is available for infusion when the patient is ready.

Thawing

•     Remove the Abecma infusion bag from the cassette and inspect the infusion bag for any breaches of container integrity such as breaks or cracks before thawing. If the infusion bag appears to have been damaged or to be leaking, it should not be infused and should be disposed of according to local guidelines on handling of waste of human-derived material. •     Place the infusion bag inside a second sterile bag.
•     Thaw Abecma at approximately 37°C using an approved thaw device or water bath until there is no visible ice in the infusion bag. Gently mix the contents of the bag to disperse clumps of cellular material. If visible cell clumps remain, continue to gently mix the contents of the bag.
Small clumps of cellular material should disperse with gentle manual mixing. Do not wash, spin down and/or resuspend Abecma in new media prior to infusion.

Administration

•     Prime the tubing of the infusion set with sodium chloride 9 mg/mL (0.9%) solution for injection prior to infusion.
•     Infuse Abecma within 1 hour from start of thaw as quickly as tolerated by gravity flow. •     After the entire content of the infusion bag is infused, rinse the tubing with sodium chloride 9 mg/mL (0.9%) solution for injection at the same infusion rate to ensure all product is delivered.
•     Follow the same procedure for all subsequent infusion bags for the identified patient. 
Measures to take in case of accidental exposure

In case of accidental exposure local guidelines on handling of human-derived material must be followed. Work surfaces and materials which have potentially been in contact with Abecma must be decontaminated with appropriate disinfectant.

Precautions to be taken for disposal of the medicinal product

Unused medicinal product and all material that has been in contact with Abecma (solid and liquid waste) must be handled and disposed of as potentially infectious waste in accordance with local guidelines on handling of human-derived material.


7.    REGISTRATION HOLDER

Bristol Myers Squibb (Israel) Ltd.
18 Aharon Bart
P.O Box 3361,
Kiryat Arie
Petach Tikva 4951448

8.    MANUFCTURER
Celgene Corporation
Building S12 556 Morris Ave
Summit, NJ, 07901
USA