Sodium Pantothenate

Lantidra is an allogeneic pancreatic islet cellular therapy for the treatment of type 1 diabetes mellitus in adults whose symptoms are not well controlled. Lantidra is a cellular suspension of pancreatic islets (islets of Langerhans) manufactured from the pancreas of a single deceased donor. The cellular suspension is infused into your hepatic portal vein. Pancreatic islets are regions of the pancreas that contain different types of endocrine cells, including beta cells. The beta cells are the endocrine cells that synthesize, store, and release the blood glucose-regulating hormone insulin. Lantidra is thought to work in the treatment of type 1 diabetes via the secretion of insulin by the infused (transplanted) pancreatic beta cells.

Lantidra is an allogeneic pancreatic islet cellular therapy for the treatment of type 1 diabetes mellitus in adults whose symptoms are not well controlled. Lantidra is a cellular suspension of pancreatic islets (islets of Langerhans) manufactured from the pancreas of a single deceased donor. The cellular suspension is infused into your hepatic portal vein. Pancreatic islets are regions of the pancreas that contain different types of endocrine cells, including beta cells. The beta cells are the endocrine cells that synthesize, store, and release the blood glucose-regulating hormone insulin. Lantidra is thought to work in the treatment of type 1 diabetes via the secretion of insulin by the infused (transplanted) pancreatic beta cells.

Lantidra requires continuing use of immune suppression medicines that suppress your immune system. You should not get the infusion if you cannot have these medicines because the islet cells will not survive.

Injury can occur during the delivery of Lantidra into the large blood vessel going to your liver (the hepatic portal vein). You have a higher risk of infections and cancer because of the immune suppression needed to keep the islet cells alive. In some cases, the immune suppression will be stopped because of these side effects and the islet cells will die and stop making insulin. You can make antibodies from your islet cell infusion that can make it harder to get a match for transplants, such as a kidney transplant. These side effects should be considered when assessing the benefits and risks. Common side effects include nausea, fatigue, anemia, diarrhea and abdominal pain. You can ask your doctor for information that is written for health professionals. Call your doctor about any side effects that concern you.

Lantidra is only for adult patients with type 1 diabetes who have repeated episodes of severe hypoglycemia, those that they need help from someone to treat, and cannot get their HbA1c at the goal set by their endocrinologist and diabetes team, despite intensive diabetes management and education. Lantidra is a cell therapy that is infused (transplanted) into your liver. Talk to your transplant doctor or endocrinologist about your risks from the infusion procedure and the long-term immune suppression medicine that you will need to use after you get the infusion. Risks from the infusion can include: damage to the liver with severe bleeding that may require blood transfusions or prolonged hospitalization. risk of viruses from the organ donor. the infusion may be stopped if the procedure increases pressure in the blood vessels of your liver. If this happens, all of the cells may not be infused. You will need to take medicines that suppress your immune system regularly for your transplant to survive. Risks of long-term immune suppression are increased risk of infection, including serious infection, organ failure, and death, and increased risk of certain cancers, including skin and lymph node cancer (lymphoma). Regular follow up appointments are needed. Call your doctor right away if you have any symptoms of an infection, including: fever sweats or chills cough or flu-like symptoms muscle ache stiff neck warm, red, or painful areas on your skin confusion Follow instructions for regular skin exams and notify your endocrinologist and transplant team if you are told you have skin cancer. You will need to continue to take insulin and check your blood glucose (sugar) as instructed by your endocrinologist and transplant team. Insulin independence is not immediate and can take several weeks to occur. Following treatment with Lantidra, not every patient becomes insulin independent and some patients who become insulin independent may need to restart insulin. Monitor your blood glucose levels after getting Lantidra. Not all patients are able to stop taking insulin after getting the infusion. Do not stop taking insulin without talking to your doctor. It is very important to follow your doctor’s instructions for blood glucose monitoring and keep your follow-up appointments to decrease the chance of serious and life-threatening high glucose or diabetic ketoacidosis.

Lantidra is only for adult patients with type 1 diabetes who have repeated episodes of severe hypoglycemia, those that they need help from someone to treat, and cannot get their HbA1c at the goal set by their endocrinologist and diabetes team, despite intensive diabetes management and education. Lantidra is a cell therapy that is infused (transplanted) into your liver. Talk to your transplant doctor or endocrinologist about your risks from the infusion procedure and the long-term immune suppression medicine that you will need to use after you get the infusion. Risks from the infusion can include: damage to the liver with severe bleeding that may require blood transfusions or prolonged hospitalization. risk of viruses from the organ donor. the infusion may be stopped if the procedure increases pressure in the blood vessels of your liver. If this happens, all of the cells may not be infused. You will need to take medicines that suppress your immune system regularly for your transplant to survive. Risks of long-term immune suppression are increased risk of infection, including serious infection, organ failure, and death, and increased risk of certain cancers, including skin and lymph node cancer (lymphoma). Regular follow up appointments are needed. Call your doctor right away if you have any symptoms of an infection, including: fever sweats or chills cough or flu-like symptoms muscle ache stiff neck warm, red, or painful areas on your skin confusion Follow instructions for regular skin exams and notify your endocrinologist and transplant team if you are told you have skin cancer. You will need to continue to take insulin and check your blood glucose (sugar) as instructed by your endocrinologist and transplant team. Insulin independence is not immediate and can take several weeks to occur. Following treatment with Lantidra, not every patient becomes insulin independent and some patients who become insulin independent may need to restart insulin. Monitor your blood glucose levels after getting Lantidra. Not all patients are able to stop taking insulin after getting the infusion. Do not stop taking insulin without talking to your doctor. It is very important to follow your doctor’s instructions for blood glucose monitoring and keep your follow-up appointments to decrease the chance of serious and life-threatening high glucose or diabetic ketoacidosis.

5 to 10 mg (7.5 (7.5)) As recommended. PO —

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

There are no known interactions between Lantidra and other drugs. You can ask your doctor or pharmacist if there are any interactions between your specific Immune suppression medicines and other drugs.

Store in a well closed container.