lutathera peptide FAQ

In April 2024, the FDA expanded its approval of Lutathera to include children 12 and older with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This approval was based on a small study involving nine adolescents with somatostatin receptor-positive tumors, including some with GEP-NETs. They received Lutathera every eight weeks for up to four doses, the same as the adult dosage. The safety of Lutathera in children 12 and older was found to be similar to that in adults. Talk with your health care provider about whether Lutathera is the right choice for your child.

Somatostatin analogs, like octreotide, can interfere with how well Lutathera works because both medicines attach to the same receptors (special surface proteins) on tumor cells. To prevent this, your health care provider will have you stop long-acting somatostatin analogs at least four weeks before each Lutathera dose and short-acting versions at least 24 hours before. Shortly after each Lutathera dose is given, these medications can be used as directed to help manage symptoms. Also, high doses of steroids (glucocorticoids), such as prednisone, can reduce the number of receptors that Lutathera targets on tumors. So it is important to avoid frequent or high-dose steroids during Lutathera treatment to ensure the medicine works as well as possible.

Lutathera is typically given as an intravenous (IV) infusion for a total of four doses, given eight weeks apart. Your health care provider will give you medications before, during, and after each dose to help reduce the side effects. Your experience may vary, but the following guidelines are provided by the maker of Lutathera. Before treatment. Long-acting octreotide must be stopped at least four weeks before starting Lutathera. Short-acting octreotide may be continued as needed, but it should be stopped 24 hours before your Lutathera treatment. You will likely receive an injection of long-acting octreotide four to 24 hours after each Lutathera dose to help manage symptoms. It is important to avoid long-acting octreotide within four weeks before the next Lutathera dose. Short-acting octreotide may also be used for symptom control but must be stopped 24 hours before each infusion. Medications during treatment. Shortly before your Lutathera dose, you will receive anti-nausea medication (antiemetics) and an amino acid solution to protect your kidneys. You will get the amino acid solution through an IV starting 30 minutes before the Lutathera infusion and continue for at least three hours after. If you get serious side effects, your health care provider may adjust your dosage or treatment plan. Monitoring for reactions. Your health care team will monitor you closely for at least two hours after each infusion to check for any allergic reactions. Your treatment will take place in a hospital or other health care facility where you can be monitored and, in case of serious reactions, receive care right away. Some people have a short stay in the hospital to receive Lutathera, especially for their first dose. After treatment. For the first two days after your Lutathera dose, your urine (pee) will contain high levels of radioactive material. These hygiene tips can help reduce the risk of radiation exposure to those around you:

A cost assistance program is available from Novartis, the maker of Lutathera, that may reduce the amount you pay. Whether you qualify to enroll may depend on the type of insurance you have or if you are uninsured. Visit www.lutathera.com/patient-support/novartis-patient-support for more information about Lutathera costs and copay savings. You can also call the drugmaker at 844-638-7222 to connect with a representative for financial support information and other resources.

Your health care provider will track your progress with regular imaging scans and tests to see how well Lutathera is working and whether your tumors are shrinking or staying the same size. Even if your tumors do not shrink, the medicine may still be working. It is designed to slow tumor growth. But individual results can vary. In clinical trials, some people had a stable disease, meaning their tumors stopped growing for a while, while others saw their disease progress. In a few cases, the tumors disappeared and were no longer visible on scans. Ask your health care team when to get your first imaging scan after Lutathera treatment and how often they plan to recheck you.

Somatostatin receptors are found on many types of cells, but some neuroendocrine tumors(NETs) have more somatostatin receptors than normal. This makes them a target for treatments like Lutathera. Lutathera works by targeting a specific type of somatostatin receptors, called subtype 2 somatostatin receptors, or SSTR2 for short. After Lutathera attaches to these receptors, the medicine gets absorbed into the cell and releases a dose of radiation that damages the tumor cell and nearby cells. This can help slow or stop the growth of NETs.

The safety and effectiveness of Lutathera was studied in two clinical trials. One study, NETTER-1, involved 229 adults with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Everyone had tumors with the following traits when they joined the study:

An ideal way to manage neuroendocrine tumors (GEP-NETs) is early surgical removal, before the tumors spread. But many people are diagnosed after the tumors have already spread, making complete removal impossible. When complete surgical removal is not an option, medications usually become a key part of managing GEP-NETs. A type of medicine called a somatostatin analog, such as octreotide, is typically prescribed to help slow or stop GEP-NETs from producing hormones, which can reduce symptoms like diarrhea. They also help to control tumor growth. But if your tumors continue to grow while you’re using this type of medicine, Lutathera may be considered as a treatment option. Lutathera works differently from octreotide. While octreotide helps control hormone production and symptoms, Lutathera is designed to target and deliver radiation directly into tumor cells. It binds to specific receptors on the tumors and releases radiation inside the cells, which helps slow or stop tumor growth. This makes Lutathera a more targeted treatment for tumors that continue to grow despite treatment with somatostatin analogs like octreotide.

To find out if Lutathera is right for treating your gastroenteropancreatic neuroendocrine tumors (GEP-NETs), your health care provider will do scans to see exactly where your tumors are and other tests to learn more about them. The FDA approved Lutathera for adults and children ages 12 years and older to treat GEP-NETs that meet the following criteria. Somatostatin receptor-positive. This means the tumor cells have high levels of somatostatin receptors. A somatostatin receptor is a protein on the surface of cells that connects to a hormone called somatostatin, which helps regulate other hormones in the body. Gut tumors. This medicine is approved for treating GEP-NETs found in certain areas of the digestive tract, including the esophagus, stomach, pancreas, or intestines. Your health care provider may describe the affected area as the foregut, midgut, or hindgut. Your health care provider can review your test results along with your health history to see if Lutathera is right for you.

Lutathera is typically given as an intravenous (IV) infusion once every eight weeks for a total of four doses. You will receive your doses at a hospital, clinic, or treatment center. The Lutathera infusion usually takes 30 to 40 minutes. Lutathera is a type of radionuclide therapy. It must be prepared and given by health care providers who are specially trained and experienced to safely handle medicines that have radioactive components (radiopharmaceuticals). You cannot store or use it at home.

The main benefit of Lutathera is that it can help slow the growth of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Two clinical trials support Lutathera as an effective treatment for GEP-NETs. Some of the main results of these studies are described below. The NETTER-1 clinical trial showed that Lutathera and octreotide worked better than octreotide alone to slow tumor growth.