Pharmaceutical particulars : מידע רוקחי

6.         PHARMACEUTICAL PARTICULARS
6.1        List of excipients

Cryostor CS10 (contains DMSO)
Sodium chloride
Human albumin
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.
Tecartus is stable for 1 year when stored frozen in the vapour phase of liquid nitrogen (≤ − 150°C).

Tecartus is stable at room temperature (20°C to 25°C) for up to 3 hours after thawing. However, Tecartus infusion must begin within 30 minutes of thaw completion and the total infusion time should not exceed 30 minutes.

6.4   Special precautions for storage

Tecartus must be stored in the vapour phase of liquid nitrogen (≤ − 150°C) and must remain frozen until the patient is ready for treatment to ensure viable live autologous cells are available for patient administration. Thawed product must not be refrozen.

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

6.5   Nature and contents of container and special equipment for use, administration or implantation

Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, containing approximately 68 mL of cell dispersion.

One cryostorage bag is individually packed in a shipping metal cassette.

6.6   Special precautions for disposal and other handling
Irradiation could lead to inactivation of the product.

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

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

Preparation prior to administration

•     Verify that the patient’s identity (ID) matches the patient identifiers on the Tecartus metal cassette.
•     The Tecartus infusion bag must not be removed from the metal cassette if the information on the patient-specific label does not match the intended patient.
•     Once the patient ID is confirmed, remove the infusion bag from the metal cassette.
•     Check that the patient information on the metal cassette label matches that on the bag label.
•     Inspect the infusion bag for any breaches of container integrity before thawing. If the bag is compromised, follow the local guidelines for handling of waste of human-derived material (and immediately contact Kite).


Thawing

•     Place the infusion bag inside a second bag.
•     Thaw Tecartus at approximately 37 °C using either a water bath or dry thaw method 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. Tecartus must not be washed, spun down, and/or re-suspended in new media prior to infusion. Thawing should take approximately 3 to 5 minutes.
•     Once thawed, Tecartus is stable at room temperature (20 °C – 25 °C) for up to 3 hours.
However, Tecartus infusion must begin within 30 minutes of thaw completion.

Administration

•     For autologous single use only.
•     Tocilizumab and emergency equipment must be available prior to infusion and during the monitoring period.
•     Central venous access is recommended for the administration of Tecartus.
•     Verify the patient ID again to match the patient identifiers on the Tecartus bag.
•     Prime the tubing with sodium chloride 9 mg/mL (0.9%) solution for injection (0.154 mmol sodium per mL) prior to infusion.
•     Infuse the entire content of the Tecartus bag within 30 minutes by either gravity or a peristaltic pump.
•     Gently agitate the bag during infusion to prevent cell clumping.
•     After the entire content of the bag is infused, rinse the tubing at the same infusion rate with sodium chloride 9 mg/mL (0.9%) solution for injection (0.154 mmol sodium per mL) to ensure all the treatment is delivered.

Precautions to be taken for the disposal of the medicinal product

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

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