What is Lantidra?

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.

What is Lantidra used to treat?

Lantidra is used to treat adults with type 1 diabetes who are unable to approach target glycated hemoglobin (HbA1c) levels because of current repeated episodes of severe hypoglycemia (low blood sugar) despite intensive diabetes management and education.

Type 1 diabetes is a chronic disease that occurs when the immune system attacks and destroys the pancreatic beta cells that make insulin. People with type 1 diabetes have increased blood glucose levels and require regular insulin to survive.

Many people with type 1 diabetes have difficulty managing the required amount of insulin needed every day, and they may have repeated episodes of severe hypoglycemia, which can be dangerous if left untreated.

Lantidra potentially makes it easier for people with type 1 diabetes to manage their condition as the infused allogeneic islet beta cells can produce enough insulin to control blood glucose levels, eliminating the need for insulin therapy.

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.

Usual Adult Dose for Type 1 Diabetes

- 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).

Comments:
- Administer cells through the hepatic portal vein.
- The estimated tissue volume should not exceed 10 cc per transplant infusion.

Use:
- 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 in conjunction with concomitant immune suppression medicines.

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.

Before receiving Lantidra

Before you receive the infusion, tell your healthcare provider about all of your medical conditions.

For your Lantidra (islet cells) to survive, you must strictly follow the instructions for your immune suppression medicines. If you have any questions or problems about taking these medicines, ask your endocrinologist or transplant doctor for help.

Pregnancy

Do not get Lantidra if you are pregnant or want to become pregnant.

If you can become pregnant, you should use effective birth control after getting Lantidra. Talk with your doctor about the birth control regimens that may be right for you.

Immune suppression medicines can cause serious harm, including death, to you and your developing baby.

Some immune suppression medicines may cause formation of abnormal sperm. Ask your doctor if your immune suppression medicines can cause abnormal sperm. If so, and you have a female partner who can become pregnant, you should discuss this with your partner and use effective birth control before starting treatment with immune suppression medicines.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

It is not known if this medicine passes into your breast milk. Immune suppression medicines may be excreted into the breast milk.

If the immune suppression medicines have the potential to affect the ability of the patient to breast feed, breast feeding should be discontinued prior to starting the pre-procedural medications needed for administration of Lantidra.

Because immune suppression can increase your risk of infection, it is important that you:

• follow instructions from your transplant team about avoiding people who have infections, such as colds and flu.
• do not get immunization with live vaccines. Talk to your transplant team before getting any shots to prevent infections.

You can ask your transplant team if there are additional things you should avoid because of your specific immune suppression drugs.

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.

How will I receive Lantidra?

Lantidra islet cells are infused into your liver through a catheter that is placed into a large blood vessel going into your liver (called the hepatic portal vein). This is done under anesthesia. You will need to stay in the hospital for at least 24 hours.

Before receiving the infusion, you will need to start the immune suppression medicine. You will need to continue this medicine after the infusion to keep the islet cells alive. 

What should I avoid?

Because immune suppression can increase your risk of infection, it is important that you:

• follow instructions from your transplant team about avoiding people who have infections, such as colds and flu.
• do not get immunization with live vaccines. Talk to your transplant team before getting any shots to prevent infections.

You can ask your transplant team if there are additional things you should avoid because of your specific immune suppression drugs.

Dosing information

Usual Adult Dose for Type 1 Diabetes

- 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).

Comments:
- Administer cells through the hepatic portal vein.
- The estimated tissue volume should not exceed 10 cc per transplant infusion.

Use:
- 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 in conjunction with concomitant immune suppression medicines.