Carvykti Injection, Suspension
Product Images NDC 57894-111

CAR-T cell therapy called ciltacabtagene autoleucel is a suspension meant for intravenous infusion. The medication guide included in the package should be given to each patient. One sterile bag containing a maximum of XI0? CA patient-specific infusion bag, with 5% DMSO, should be used for treatment. The medication should only be used for autologous purposes. The medication should be taken as per the prescribing information, and transportation and storage should be conducted in vapor phase of liquid nitrogen at -120°C (184°F). The medication should not be refrozen or refrigerated once it is thawed and should not be irradiated. Furthermore, the medication should not be used with leukodepleting filter. The CAR-T cells are cultured and genetically modified but not evaluated for infectious substances, and no US standard of potency is set. The information also includes the bag ID, lot, and expiration dates.*

CARVYKTI™ is a suspension for intravenous infusion for autologous use only. It contains a maximum of 1x10° CAR-positive viable T cells in 330 mL frozen suspension per patient-specific infusion bag, with 5% DMSO. It is cultured, genetically modified and not evaluated for infectious substances. Dosage instructions and storage guidelines are provided. The medication guide must be dispensed to each patient. The bag's identification, lot number, order ID, and patient information must be matched with the patient identifiers on the cassette and infusion bag upon receipt. Manufactured and marketed by Janssen Biotech and Legend Biotech, respectively. The NDC is 57894-111-02.*