KRESLADI Suspension for infusion Ref.[116648] Active ingredients: Marnetegragene autotemcel

2.1 Dose

For autologous use only. For one-time single-dose intravenous use only.

The recommended minimum dose of KRESLADI is a single intravenous infusion of 2.8 × 10⁶ CD34+ cells/kg.

The dose is calculated based on the patient's weight prior to first apheresis.

See the Lot Information Sheet provided with the product shipment for additional information pertaining to dose. Up to two drug product lots may be administered to meet the minimum dose.

2.2 Preparation Before KRESLADI Infusion

Before mobilization, apheresis, and conditioning are initiated, confirm that autologous hematopoietic stem cell (HSC) transplantation is appropriate for the patient.

Consider administering ustekinumab prior to mobilization and apheresis and/or prior to KRESLADI infusion.

Mobilization and Apheresis

Administer granulocyte-colony-stimulating factor (G-CSF) and plerixafor for HSC mobilization followed by apheresis to obtain CD34+ cells for product manufacturing.

Weigh the patient prior to the first apheresis collection. Collect a recommended target number of CD34+ cells of 20 × 10⁶ CD34+ cells/kg.

Repeat additional cycles of mobilization and apheresis after at least 14 days to obtain more cells for KRESLADI manufacture if the minimum dose of 2.8 × 10⁶ CD34+ cells/kg is not met.

Back-Up CD34+ Cell Collection

Obtain and cryopreserve an additional collection of CD34+ cells of ≥2 × 10⁶ CD34+ cells/kg at the treatment center prior to initiating myeloablative conditioning and infusion with KRESLADI. Administer the back-up collection for rescue treatment if there is: 1) compromise of KRESLADI after initiation of conditioning and before KRESLADI infusion, 2) primary engraftment failure, or 3) loss of engraftment after infusion with KRESLADI.

Myeloablative Conditioning

Do not begin conditioning until KRESLADI has been received and stored at the treatment center and the availability of the back-up collection of CD34+ cells is confirmed.

Administer myeloablative conditioning before infusion of KRESLADI based on institutional guidelines. Consult the prescribing information for the conditioning agents prior to treatment.

Infuse KRESLADI 24-48 hours after completion of myeloablative conditioning.

Receipt and Storage of KRESLADI

• Ensure the availability of vapor phase of liquid nitrogen storage at less than or equal to -150°C (-238°F) at the treatment center.
• KRESLADI is shipped to the treatment center in the vapor phase of liquid nitrogen shipper.
• Confirm the patient's identity with the patient identifiers on the shipper and labels.
• If there are any concerns about the product or packaging upon receipt, contact Rocket Pharmaceuticals at 1-800-982-2410.
• Keep the infusion bag(s) in the metal cassette(s) and transfer KRESLADI from the vapor phase of liquid nitrogen shipper to the onsite vapor phase of liquid nitrogen storage (at ≤ -150°C (≤ -238°F) until ready for thaw and administration).

Preparation of KRESLADI for infusion

Confirm the infusion time in advance and adjust the start time of KRESLADI thaw such that it will be available for infusion when the patient and the healthcare provider are ready. Complete infusion of each bag of KRESLADI within 30 minutes of the start of thaw.

• Confirm patient identity: Prior to KRESLADI preparation, match the patient's identity with the patient identifiers on the KRESLADI cassette(s). Do not remove the KRESLADI infusion bag from the cassette if the information on the patient-specific label does not match the intended patient and contact Rocket Pharmaceuticals at 1-800-982-2410.
• Once patient identification is confirmed, remove the KRESLADI infusion bag(s) from the cassette(s) and check that the patient information on the cassette label(s) matches the bag label(s).
• A KRESLADI dose may be contained in one or two patient-specific infusion bags. Two infusion bags could be from two different drug product lots. Verify the number of bags received for the indicated dose of KRESLADI. Use the accompanying Lot Information Sheet to confirm that each infusion bag is within the expiration date prior to preparation of KRESLADI for infusion. If two infusion bags have been received, thaw and administer each infusion bag one at a time. Wait 1 to 2 hours after administration of the first bag before thawing of the second KRESLADI bag. Maintain the second infusion bag, if applicable, within the vapor phase of liquid nitrogen storage to maintain temperature less than or equal to -150°C (-238°F) until time to thaw.
• Inspect each infusion bag(s) for any breaches of integrity such as breaks or cracks before thawing. If the bag(s) is compromised, follow the local guidelines and call Rocket Pharmaceuticals at 1-800-982-2410.
• Place the infusion bag inside a sterile plastic bag per local institutional guidelines.
• Thaw KRESLADI at 37°C (98.6°F) in a water bath or dry-thaw method until there is no visible ice in the infusion bag. Thawing should take no longer than 5 minutes. Promptly remove the infusion bag once thawed and keep it at room temperature.
• Do not leave KRESLADI unattended and do not submerge the infusion ports if thawed in a water bath.
• 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. Most small clumps of cellular material should disperse with gentle manual mixing.
• Do not shake the bag.
• Do not filter, wash, spin down and/or resuspend KRESLADI in new media prior to infusion.
• Do not sample, alter, irradiate, or refreeze KRESLADI.

2.3 Administration

• Complete KRESLADI infusion within 30 minutes of the start of thaw.
• Do not use an in-line blood filter or infusion pump.
• Use central venous access for the infusion of KRESLADI.
  • Before infusion, confirm the patient's identity matches the patient identifiers on the KRESLADI infusion bag(s). Do not use KRESLADI if the information on the patient-specific label does not match the intended patient. Use the Lot Information Sheet to confirm the total number of infusion bags to be administered.
  • Prime the tubing of the infusion set with normal saline prior to infusion.
  • Expose the sterile port on the infusion bag by tearing off the protective wrap covering the port.
  • Connect the port to the primed infusion tubing and then connect the tubing to the patient's central venous access aseptically per institutional standard operating procedures.
  • Administer the entire contents of the KRESLADI bag by intravenous infusion. The time for infusion will vary but will usually be less than 10 minutes.
  • At the end of the infusion, flush the infusion bag and tubing with normal saline solution to ensure as many cells as possible are delivered to the patient. Consider the infusion volume in relation to the age and weight of the patient and the priming volume of the infusion tubing set.
  • If two infusion bags are provided, administer the contents of the first infusion bag completely before proceeding to thaw (following Section 2.2 steps 4 - 7) and infuse (following Section 2.3 steps 1 - 6) the contents of the second infusion bag. Wait 1 to 2 hours after administration of the first bag before thawing and infusion of the second bag.

KRESLADI contains human blood cells that are genetically modified with replication-incompetent, self-inactivating lentiviral vector (LVV). Follow universal precautions and local institutional biosafety guidelines for handling and disposal of KRESLADI to avoid potential transmission of infectious diseases.

After KRESLADI Administration

Follow standard procedures for patient monitoring and management after HSC transplantation after KRESLADI infusion.

• Irradiate any blood products required within the first 3 months after KRESLADI infusion.
• Patients treated with KRESLADI should not donate blood, organs, tissues, or cells at any time in the future.

• Keep the infusion bag(s) in the cassette(s) and store KRESLADI frozen in the vapor phase of liquid nitrogen at less than or equal to -150°C (≤ -238°F) until ready for thaw and administration.
• Thaw KRESLADI prior to infusion [see Dosage and Administration (2)].
• Do not re-freeze after thawing.
• Do not irradiate KRESLADI, as this could lead to inactivation.