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Lantidra Product Information

Additional Product Information can be located in the Package Insert.

What is Lantidra?

Lantidra (donislecel) is a breakthrough treatment approved for adults with type 1 diabetes (T1D) who experience severe hypoglycemia despite intensive diabetes management and education. Lantidra is the first allogeneic cellular therapy made from donor pancreatic islet cells for the treatment of T1D. The primary mechanism of action of Lantidra is via secretion of insulin by the infused allogeneic islet beta cells. In some patients with type 1 diabetes, these infused cells can produce enough insulin, so the patient no longer needs to take insulin (by injections or pump) to control their blood sugar levels. Lantidra is administered as a single infusion into the hepatic (liver) portal vein. An additional infusion of Lantidra may be performed depending on the patient’s response to the initial dose.

Lantidra consists of a suspension of allogeneic pancreatic islets in Connaught Medical Research Laboratories (CMRL) 1066 transplant medium buffered with HEPES (2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid; 10 mM final concentration) and supplemented with human serum albumin (0.5% final concentration). Lantidra™ is contained in one 1,000 mL infusion bag filled with a supplied volume of 400 mL, containing not more than 10 cc of estimated packed islet tissue. The 1,000 mL fusion bag is aseptically connected to a smaller 750 mL bag containing 200 mL of supplied volume for use in rinsing the 1,000 mL bag and line following transplant to assure complete transfer of islets to the patient.

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How is Lantidra  Product Quality Assessed?

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Quality control (QC) assessments are performed to confirm potency, identity, safety, and purity of the isolated islets. QC testing is performed in compliance with rigorous FDA standards to ensure high quality pancreatic islets are produced.

QC assessments include viability, purity, and glucose-stimulation insulin secretion assays. QC assessment results are verified and approved by the CellTrans Quality Control Unit before release of each Lantidra lot for transplantation.

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What are the Benefits of Lantidra?

The benefits of Lantidra outweigh the risks in patients with brittle T1D who have failed state-of-the-art insulin therapy based upon the totality of evidence from the Lantidra clinical program and published literature, including the following factors:

 

  • Islet transplantation is effective at restoring good glycemic control in most patients, and this beneficial effect persists for at least several years.

  • Islet transplantation improves patient quality of life, allowing patients to perform activities that they could not do prior to receiving an islet transplant.​​

 

  • Islet transplantation may slow or reverse many debilitating secondary complications and comorbidities of T1D (e.g., atherosclerosis, retinopathy).

 

  • Even with partial graft function, islet transplantation can lead to improved glycemic control, reduced reliance on exogenous insulin, and improved quality of life.

 

  • Lantidra and the transplantation procedure are generally safe. The islet transplantation procedure is minimally invasive, with lower procedural risk than whole pancreas transplantation.

 

  • Most risks associated with islet transplant are associated with immunosuppressant drugs, which are already approved for use in transplant recipients based upon their own favorable benefit-risk profiles.

 

  • Brittle T1D is a debilitating disease that is not well-managed with standard-of-care insulin therapy, and the risk of these patients remaining on an ineffective treatment is significant. While whole pancreas transplantation is an option in some of these patients, for others, the risks associated with an open surgical technique are too high.

 

  • More than 2 decades of experience demonstrate the safety and effectiveness of islet transplantation for patients with brittle T1D.

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