Donislecel

LANTIDRA is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Use LANTIDRA in conjunction with concomitant immunosuppression. Use in conjunction with concomitant immunosuppression.

Pancreatic islets regulate blood glucose levels through secretion of multiple hormones in response to increases and decreases in blood glucose. Endocrine cells within pancreatic islets release insulin, glucagon, somatostatin, pancreatic peptide, and ghrelin. Insulin stimulates glucose uptake by peripheral tissues, glucagon mobilizes glucose from the liver into circulation, somatostatin inhibits both α- and β-cell secretions, pancreatic peptide inhibits pancreatic exocrine secretion, and ghrelin inhibits insulin secretion. The primary mechanism of action of LANTIDRA is believed to be secretion of insulin by infused (transplanted) β- cells.

For infusion into the hepatic portal vein only. Do not irradiate. Do not use leukodepleting filters. Do not use if product time exceeds 48-hours post product release or if temperature is not maintained between 15 and 25° C To be prepared and administered only by medical professionals experienced in islet cell transplantation. The recommended minimum dose is 5,000 equivalent islet number (EIN) per kg patient body weight for initial infusion (transplant) and 4,500 EIN/kg for subsequent infusions (same recipient). Administer cells through the hepatic portal vein using a 5 or 6 French angiographic catheter indicated for infusion of LANTIDRA. The estimated tissue volume should not exceed 10 cc per transplant infusion.

Do not administer LANTIDRA to patients who have concomitant diseases or conditions, including pregnancy, that contraindicate the procedure for LANTIDRA infusion or immunosuppression. LANTIDRA is contraindicated in patients for whom immunosuppression is contraindicated.

Risks from Concomitant Immunosuppression: Increased risk of severe infections including opportunistic infections, malignancy, and severe anemia. Monitor closely. Administer PCP and CMV prophylaxis. Procedural Complications: Liver laceration and hemorrhage have occurred. Monitor for bleeding, portal hypertension, and portal vein thrombosis during and immediately following infusion. Increased Risk of Graft Rejection: Patients with a positive T- and B-cell crossmatch between recipient serum and donor lymphocytes may be at increased risk for graft rejection. Transmission of Donor-Derived Infections: Monitor for signs of infection following infusion and treat accordingly. Panel Reactive Antibodies (PRA): Product administration may elevate PRA and negatively impact candidacy for renal transplant.

Ninety percent (90%) of subjects had at least one serious adverse reaction. The major causes were attributed to: Infusion procedure liver laceration/hematoma, hemorrhage, and intra-abdominal bleeding (13%) elevation of portal pressure (7%) Immunosuppression Infection (87%) Malignancy (37%) Ninety percent (90%) of subjects had at least one serious adverse reaction. The major causes are attributed to: Infusion procedure liver laceration/hematoma, hemorrhage, and intra-abdominal bleeding (13%) elevation of portal pressure (7%) Immunosuppression Infection (87%) Malignancy (37%)

Store in the insulated container at 15°C to 25°C for up to 48 hours from time of product release.