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Trade names | Lantidra |
Other names | donislecel-jujn |
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Routes of administration | Islet cell transplantation via intravenous infusion[1][2] |
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KEGG |
Donislecel, sold under the brand name Lantidra, is a cellular therapy medication used for the treatment of type 1 diabetes.[3][5] Donislecel is an allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells.[5] Donislecel is administered as a single infusion into the hepatic (liver) portal vein.[5]
The most common adverse reactions include nausea, fatigue, anemia, diarrhea, and abdominal pain.[5]
Donislecel was approved for medical use in the United States in June 2023.[3][5]
Donislecel is indicated for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia (low blood sugar) despite intensive diabetes management and education.[3][5]
The primary mechanism of action of donislecel is believed to be the secretion of insulin by the infused allogeneic islet beta cells.[5] In some people with type 1 diabetes, these infused cells can produce enough insulin, so the recipient no longer needs to take insulin (by injections or pump) to control their blood sugar levels.[5]
The most common adverse reactions include nausea, fatigue, anemia, diarrhea, and abdominal pain.[5]
The safety and effectiveness of donislecel was evaluated in two non-randomized, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and a maximum of three infusions.[5] Overall, 21 participants did not need to take insulin for a year or more, with eleven participants not needing insulin for one to five years and ten participants not needing insulin for more than five years.[5] Five participants did not achieve any days of insulin independence.[5]
The FDA granted marketing approval of Lantidra to CellTrans, Inc.[5]
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This article incorporates public domain material from the United States Department of Health and Human Services