Tecelra Dosage

Recommended Dose

The recommended dose is between 2.68 x 109 to 10 x 109 MAGE-A4 T cell receptor (TCR) positive T cells administered as a single intravenous infusion.

TECELRA is provided as a single dose for infusion in one or more infusion bag(s). Verify the number of bags received for the indicated dose prior to preparation for infusion.

Preparation and Administration

Receipt of TECELRA

Plan for TECELRA to arrive prior to beginning lymphodepleting chemotherapy.

Ensure storage conditions in vapor phase of liquid nitrogen (≤ -130°C).

TECELRA is shipped directly to the healthcare facility in the vapor phase of a liquid nitrogen shipper. Upon receipt of TECELRA confirm the patient’s identifiers on the metal cassette and product bag.

Inspect the product for obvious signs of damage and contact Adaptimmune at 1-855-24MYADAP (1-855-246-9232) if any anomalies are identified at the time of receipt.

Transfer TECELRA in the original packaging, containing the cassette(s) protecting the infusion bag(s), to onsite storage at ≤ -130°C before the shipper expires.

Store TECELRA in a manner that is consistent with How Supplied/Storage and Handling (16). If unforeseen circumstances prevent proper storage of TECELRA consistent with How Supplied/Storage and Handling (16), contact Adaptimmune at 1- 855-24MYADAP (1-855-246-9232) to arrange for return shipment.

Preparing Patient for TECELRA Administration

Confirm availability of TECELRA at the healthcare facility prior to starting the lymphodepleting chemotherapy regimen.

Match the patient’s identity with the patient identifiers on the TECELRA cassette(s) and infusion bag(s). Do not infuse TECELRA if the information on the patient-specific label(s) does not match the intended patient.

Administer a lymphodepleting chemotherapy regimen of fludarabine 30 mg/m2/day intravenously for 4 days starting on the seventh day before TECELRA infusion (Day-7 to Day -4) and cyclophosphamide 600 mg/m2/day intravenously for 3 days starting the seventh day before TECELRA infusion (Day -7 to Day -5).

Refer to fludarabine prescribing for information on fludarabine dosage in patients with renal impairment.

Short-acting or pegylated granulocyte-colony stimulating factor (G-CSF) may be administered at the discretion of the physician, and according with institutional standards, from 24 hours after last day of lymphodepleting chemotherapy (from Day -3) until resolution of neutropenia.

Premedication

Premedicate with an H1-antihistamine and acetaminophen according to institutional standard practice, approximately 30-60 minutes prior to TECELRA infusion.

Avoid prophylactic systemic corticosteroids, as it may interfere with the activity of TECELRA.

Preparation of TECELRA for Administration

Do not thaw the product until it is ready to be used. Coordinate the timing of TECELRA thaw and infusion. Confirm infusion time in advance and adjust the start time of TECELRA thaw such that it will be available for infusion when the patient is ready.

A TECELRA dose may be contained in one or more infusion bag(s). Verify the number of bags received for the indicated dose prior to preparation of TECELRA for infusion. If more than one bag will be infused for the treatment dose, thaw and administer the contents of each infusion bag completely before proceeding to thaw and infuse the contents of the next infusion bag.

1. Confirm patient identity. Prior to TECELRA preparation, match the patient’s identity with the patient identifiers on each TECELRA cassette. Do not remove the TECELRA infusion bag(s) from the cassette(s) if the information on the patient-specific label does not match the patient’s identity. Contact Adaptimmune at 1-855-24MYADAP (1-855-246-9232) if there are any discrepancies between the labels and the patient identifiers.

2. Once patient identity is confirmed, remove TECELRA infusion bag(s) from the cassette(s) and check that the patient identifiers on the cassette label match the patient identifiers on the bag label. Contact Adaptimmune at 1-855-24MYADAP (1-855-246-9232) if there are any discrepancies between the patient identifiers on the cassette and bag labels.

3. Inspect the infusion bag for any breaches of container integrity such as breaks or cracks before thawing. If the bag is compromised, do not infuse the contents and call Adaptimmune at 1-855-24MYADAP (1-855-246-9232)

4. Place the infusion bag inside a second sealable ,preferably sterile bag per institutional standard practice.

5. Thaw the infusion bag at approximately 37°C using a water bath or dry thaw method, until there is no visible ice in the infusion bag.

6. Gently mix the contents of the bag by massaging, to disperse visible cell clumps. Small clumps of cellular material should disperse with gentle manual massaging. Do not infuse TECELRA if clumps are not dispersed. Call Adaptimmune at 1- 855-24MYADAP (1-855-246-9232).

7. Keep TECELRA at ambient temperature (20°C to 25°C) once thawed. Do not pre-filter into a different container, wash, spin down, or resuspend TECELRA in new media prior to infusion.

8. Administer within one hour.

TECELRA Administration

9. Do not use a leukodepleting filter.

10. Follow universal precautions and local biosafety guidelines for handling and disposal of TECELRA to avoid potential transmission of infectious diseases, due to the presence of human blood cells that are genetically modified with replication incompetent, self-inactivating lentiviral vector.

11. Confirm patient identity with the patient identifiers on the infusion bag(s). Do not infuse TECELRA if the information on the patient-specific label does not match the intended patient. Call Adaptimmune at 1-855-24MYADAP (1-855-246-9232). Prime the tubing of the infusion set with 0.9% sodium chloride solution prior to infusion.

12. Administer the TECELRA infusion bag via intravenous infusion within one hour. Administer the entire contents of the TECELRA infusion bag.

13. After the entire contents of the TECELRA infusion bag are infused, rinse the infusion bag with approximately 50mL 0.9% sodium chloride solution to ensure all product is delivered.

14. If more than one infusion bag has been received, administer the content of each infusion bag completely before proceeding to thaw and infuse the content of the next infusion bag, following steps 1-14 for all subsequent infusion bags.