Summary

Dosage and Administration

CARVYKTI is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive viable T cells in one infusion bag. The recommended dose range is 0.5-1.0x10⁶ CAR-positive viable T cells per kg of body weight with a maximum dose of 1x10⁸ CAR-positive viable T cells per single infusion. CARVYKTI is for autologous use only.¹

Pretreatment

Administer the lymphodepleting chemotherapy regimen: cyclophosphamide 300 mg/m² intravenously (IV) and fludarabine 30 mg/m² IV daily for 3 days.¹

Administer CARVYKTI infusion 2 to 4 days after the completion of the lymphodepleting chemotherapy regimen.¹ See Pretreatment below for information on the lymphodepleting chemotherapy regimen.

Premedication

Administer the following pre-infusion medications to all patients 30-60 minutes prior to CARVYKTI infusion¹:

• Antipyretics (oral or intravenous acetaminophen 650 to 1000 mg).
• Antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent).

Avoid prophylactic use of systemic corticosteroids because their use may interfere with the activity of CARVYKTI.¹

Receipt of CARVYKTI

See full details for receipt of CARVYKTI for infusion below.

Preparation of CARVYKTI for Infusion

Do not thaw the product until it is ready to be used. Coordinate the timing of CARVYKTI thaw and infusion. Confirm the infusion time in advance and adjust the start time for thaw so that CARVYKTI is available for infusion when the patient is ready. Once thawed, the CARVYKTI infusion must be completed within 2.5 hours at room/ambient temperature (20°C to 25°C).¹ See steps for preparation of CARVYKTI for infusion below.

Administration

Ensure that a minimum of two doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period.¹ See steps for administration of CARVYKTI for infusion below.

Monitoring After Infusion

Administer CARVYKTI at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare facility.¹

Monitor patients at least daily for 10 days following CARVYKTI infusion at a certified healthcare facility for signs and symptoms of cytokine release syndrome (CRS) and neurologic toxicities. Monitor periodically for 4 weeks for signs and symptoms of delayed neurologic toxicity.¹ See steps for monitoring after infusion of CARVYKTI below.

Product Labeling

Dosage and Administration

• For autologous use only. For intravenous use only.¹

Dose

• CARVYKTI is provided as a single dose for infusion containing a suspension of CAR-positive viable T cells in one infusion bag. The recommended dose range is 0.5-1.0×10⁶ CAR-positive viable T cells per kg of body weight, with a maximum dose of 1×10⁸ CAR-positive viable T cells per single infusion.¹

Administration

• CARVYKTI is for autologous use only. The patient’s identity must match the patient identifiers on the CARVYKTI cassette and infusion bag. Do not infuse CARVYKTI if the information on the patient-specific labels does not match the intended patient.¹

Preparing the Patient for CARVYKTI Infusion

• Confirm availability of CARVYKTI prior to starting the lymphodepleting chemotherapy regimen.¹

Pretreatment

• Administer the lymphodepleting chemotherapy regimen: cyclophosphamide 300 mg/m² IV and fludarabine 30 mg/m² IV daily for 3 days.¹
  • See the prescribing information of cyclophosphamide and fludarabine for information on dose adjustment in renal impairment.
• Lymphodepleting regimen must be delayed if a patient has serious adverse reactions from preceding bridging therapies (including clinically significant active infection, cardiac toxicity, and pulmonary toxicity) or active graft versus host disease in patient with prior allogeneic stem cell transplant. Consider repeating lymphodepleting regimen if CARVYKTI dosing is delayed by more than 14 days and patient has recovered from toxicity of the first lymphodepleting regimen.¹
• Administer CARVYKTI infusion 2 to 4 days after the completion of the lymphodepleting chemotherapy regimen.¹
• CARVYKTI infusion should be delayed if a patient has any of the following conditions¹:
  • Clinically significant active infection or inflammatory disorders.
  • Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning, except for Grade 3 nausea, vomiting, diarrhea, or constipation. CARVYKTI infusion should be delayed until resolution of these events to Grade ≤1.

Premedication

• Administer the following pre-infusion medications to all patients 30-60 minutes prior to CARVYKTI infusion¹:
  • Antipyretics (oral or intravenous acetaminophen 650 to 1000 mg).
  • Antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent).
• Avoid prophylactic use of systemic corticosteroids because their use may interfere with the activity of CARVYKTI.¹

Receipt of CARVYKTI

• All sites approved for infusion will support required storage conditions for vapor phase of liquid nitrogen.¹
• CARVYKTI is shipped directly to the cell laboratory or clinical pharmacy associated with the infusion center in the vapor phase of a liquid nitrogen shipper.¹
• Confirm the patient’s identity with the patient identifiers on the shipper.¹
• If the patient is not expected to be ready for same-day administration, before the shipper expires, transfer CARVYKTI to onsite vapor phase of liquid nitrogen storage.¹

Preparation of CARVYKTI for Infusion

• Do not thaw the product until it is ready to be used. Coordinate the timing of CARVYKTI thaw and infusion. Confirm the infusion time in advance and adjust the start time for thaw so that CARVYKTI is available for infusion when the patient is ready. Once thawed, the CARVYKTI infusion must be completed within 2.5 hours at room/ambient temperature (20°C to 25°C).¹
• Prior to thawing the product, confirm that tocilizumab and emergency equipment are available prior to the infusion and during the recovery period.¹

1. Confirm patient identity: Prior to CARVYKTI preparation, match the patient’s identity with the patient identifiers on the CARVYKTI cassette. Do not remove the CARVYKTI infusion bag from the cassette if the information on the patient-specific label does not match the intended patient. Contact Janssen Biotech, Inc. at 1-800-526-7736 if there are any discrepancies between the labels and the patient identifiers.¹
2. Once patient identification is confirmed, remove the CARVYKTI product bag from the cassette and check that the patient information on the cassette label matches the patient information on the bag label.¹
3. Inspect the product bag for any breaches of container integrity, such as breaks or cracks before and after thawing. Do not administer if the bag is compromised, and contact Janssen Biotech, Inc. at 1-800-526-7736.¹
4. Place the infusion bag inside a sealable plastic bag (preferably sterile) prior to thawing.¹
5. Thaw CARVYKTI at 37°C±2°C using either a water bath or dry thaw method until there is no visible ice in the infusion bag. Total time from start of thaw until completion of thawing should be no more than 15 minutes.¹
6. Remove the infusion bag from the sealable plastic bag and wipe dry. 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 pre-filter into a different container, wash, spin down, or resuspend CARVYKTI in new media prior to infusion.¹
7. Do not re-freeze or refrigerate thawed product.¹

Administration

• For autologous infusion only.¹
  • Once thawed, administer the entire contents of the CARVYKTI bag by IV infusion within 2.5 hours using infusion sets fitted with an in-line filter.¹
  • CARVYKTI may be administered via gravity or IV pump at an infusion rate that is suitable for administration to the patient in accordance with site/local procedure.²
• Do NOT use a leukocyte-depleting filter.¹
  • A non-leukocyte depleting filter is commonly referred to as a blood filter. All blood and cell products must be administered through a filter in order to remove cell clots and thrombi. Standard blood filters, with a pore size of 170–260 μm, trap large aggregates and clots.³
  • CARVYKTI is an engineered T cell product derived from a patient’s blood. To ensure the engineered T cells are not filtered out during infusion, while preventing potential agglomerates and clots of material from being infused to the patient, a non-leukocyte depleting filter (blood filter) must be used. If agglomerates/thrombi enter the bloodstream, there is a potential for the formation of clots, which can lead to pulmonary embolism.³
  • In the CARTITUDE-1 study, cilta-cel was administered using an infusion set with a blood filter pore size of 170 μm or larger.⁴
  • Blood filters are also available as microagglomerate filters which have a pore size range of 10–40 μm. CARVYKTI has not been evaluated for administration with microagglomerate filters and therefore they must NOT be used during infusion.³
• Ensure that a minimum of two doses of tocilizumab and emergency equipment are available prior to infusion and during the recovery period.¹
• Central venous access may be utilized for the infusion of CARVYKTI and is encouraged in patients with poor peripheral access.¹

1. Confirm the patient’s identity with the patient identifiers on the infusion bag. Do not infuse CARVYKTI if the information on the patient-specific label does not match the intended patient.¹
2. Prime the tubing of the infusion set with normal saline prior to infusion.¹
3. Once thawed, administer the entire contents of the CARVYKTI bag by intravenous infusion within 2.5 hours using infusion sets fitted with an in-line filter.¹
4. Gently mix the contents of the bag during CARVYKTI infusion to disperse cell clumps.¹
5. After the entire content of the product bag is infused, flush the administration line, inclusive of the in-line filter, with normal saline with a volume equal or greater to the total hold up volume of the primary administration set used inclusive of the drip tube, to ensure that all product is delivered.¹

• CARVYKTI contains human blood cells that are genetically modified with replication-incompetent, self-inactivating, lentiviral vector. Follow universal precautions and local biosafety guidelines for handling and disposal of CARVYKTI to avoid potential transmission of infectious diseases.¹

Monitoring After Infusion

• Administer CARVYKTI at a REMS-certified healthcare facility.¹
• Monitor patients at least daily for 10 days following CARVYKTI infusion at a certified healthcare facility for signs and symptoms of CRS and neurologic toxicities. Monitor periodically for 4 weeks for signs and symptoms of delayed neurologic toxicity.¹
• Instruct patients to remain within proximity of a certified healthcare facility for at least 4 weeks following infusion.¹
• Instruct patients to refrain from driving or hazardous activities for at least 8 weeks following infusion.¹

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 10 February 2025.