Lutetium Lu 177 dotatate

Brand name: Lutathera
Dosage form: infusion
Drug class: Therapeutic radiopharmaceuticals

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 25, 2025.

What is Lutetium Lu 177 dotatate?

Lutetium Lu 177 dotatate (Lutathera) is a targeted radiotherapy used to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which are neuroendocrine tumors (NETs) that develop in the gastrointestinal tract. Lutetium Lu 177 dotatate delivers targeted radiation directly to the neuroendocrine tumors to slow the tumor progression for longer. The treatment is given every 8 weeks for 4 doses.

Lutetium Lu 177 dotatate brand name is Lutathera by Novartis AG.

Lutetium Lu 177 dotatate FDA approval is for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are:

• in the foregut, midgut, and hindgut
• somatostatin receptor-positive 
• for adults and children aged 12 years and older.

How does Lutetium Lu 177 dotatate work?

Lutetium Lu 177 dotatate is a targeted treatment designed for certain types of tumors that have somatostatin receptors on their surface. These receptors act like docking stations that Lutetium Lu 177 dotatate can latch onto. Once the drug attaches, it delivers a small, controlled dose of radiation directly to the tumor cells.

Lutetium Lu 177 dotatate works in three key steps:

• Finding the Tumor: Lutathera recognizes and binds to somatostatin receptors (SSTR2), which are commonly found on neuroendocrine tumor cells.
• Delivering Radiation: The drug carries a radioactive component, Lutetium-177, which emits energy that damages the tumor from the inside.
• Targeted Cell Destruction: The radiation damage causes tumor cells to die.

Lutetium Lu 177 dotatate mechanism of action is radiolabeled somatostatin analog. It is from a class of medicines called peptide receptor radionuclide therapy (PRRT).

 Lutetium Lu 177 dotatate success rate

Lutetium Lu 177 dotatate success rate was measured in the clinical trial NETTER-2 (NCT03972488).

Lutetium Lu 177 dotatate patients had a: 

• 43.0% overall response rate (ORR) compared to the control group of 9.3%
• 22.8 months median progression-free survival (PFS),  compared to 8.5 months in the control group.

Lutetium Lu 177 dotatate side effects

Common side effects of lutetium Lu 177 dotatate

Common lutetium Lu 177 dotatate side effects may include:

• Nausea 65%
• Vomiting 53%
• Tiredness - fatigue 38%
• Diarrhea 26%
• Abdominal pain 26%
• Decreased appetite 21%
• Headache 17%
• Dizziness 17%

These were the common side effects that occurred in 15% or more of Lutathera patients in the  NETTER-1 clinical trial. Laboratory abnormalities were also a common side effect of this medicine, including lymphopenia, anemia, leukopenia, thrombocytopenia, neutropenia, increased creatinine, hyperglycemia, hyperuricemia, increased GGT, increased alkaline phosphatase and many more.

Serious lutetium Lu 177 dotatate side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Lutetium Lu 177 dotatate treatment may cause other serious side effects. Call your doctor at once if you have:

• little or no urination;
• flushing (warmth, redness, or tingly feeling);
• diarrhea;
• a light-headed feeling, like you might pass out;
• wheezing, chest tightness, trouble breathing;
• low blood cell counts -fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• low potassium level - eg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness, or limp feeling.

Your Lutetium Lu 177 dotatate cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

Embryo-Fetal Toxicity: Do not become pregnant or breastfeed a baby while receiving lutetium Lu 177 dotatate.

Both men and women using lutetium Lu 177 dotatate should use effective birth control to prevent pregnancy. Lutathera can harm an unborn baby or cause birth defects if the mother or father is using this medicine

Other warnings include:

• Risk from radiation exposure
• Myelosuppression
• Secondary myelodysplastic syndrome (MDS) and leukemia 
• Renal toxicity 
• Hepatotoxicity
• Hypersensitivity reactions
• Neuroendocrine hormonal crisis 
• Risk of Infertility.

Before taking this medicine

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• diabetes;
• high blood pressure; or
• any type of radiation treatment.

Lutetium Lu 177 dotatate may cause other types of cancer, such as leukemia. Ask your doctor about this risk.

Breastfeeding

Do not breastfeed while receiving lutetium Lu 177 dotatate, and for at least 4 months after your last dose.

Pregnancy

You should not use lutetium Lu 177 dotatate cancer treatment if you are pregnant or planning a pregnancy.

Lutetium Lu 177 dotatate treatment can harm an unborn baby or cause birth defects if the mother or the father is receiving this medicine.

• If you are a woman, use effective birth control to prevent pregnancy while you are receiving this medicine and for at least 7 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is receiving lutetium Lu 177 dotatate.

Fertility 

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because lutetium Lu 177 dotatate may harm the baby if a pregnancy does occur.

How is lutetium Lu 177 dotatate given?

Lutetium Lu 177 dotatate is given as an infusion into a vein. A healthcare provider will give you this injection once every 8 weeks for a total of 4 doses.

Lutetium Lu 177 dotatate must be given slowly, and the infusion can take 30 to 40 minutes to complete.

After each infusion, you will be given another medicine called octreotide, which is injected into a muscle. Octreotide injections are usually given once every 4 weeks for up to 18 months.

You may be given other medications to help prevent serious side effects or allergic reactions. Keep using these medicines for as long as your doctor has prescribed.

Drink plenty of fluids while being treated with this medicine. You should urinate often, to help keep your kidneys working properly.

You will need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

For up to 30 days after you are treated with lutetium Lu 177 dotatate, your urine will contain radiation. To prevent the spread of this radiation, use a toilet rather than a urinal, and sit on the toilet while urinating.

Always wash your hands after using the bathroom. Avoid handling any clean-up of your stools or urine without wearing latex rubber gloves. If another person is handling your urine, they should wear gloves, eye protection, and a mask to cover the nose and mouth.

When cleaning any spills of bodily fluid, use only disposable cleaning cloths that can be flushed down a toilet. Ask your doctor or health department how to dispose of any bodily fluid spills that cannot be flushed down a toilet.

Wash any soiled clothing separately from the laundry of other people in your home.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Lutathera.

What happens if I overdose?

Since lutetium Lu 177 dotatate is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What other drugs will affect lutetium Lu 177 dotatate?

Somatostatin Analogs: Discontinue long-acting analogs at least 4 weeks and short-acting octreotide at least 24 hours before each Lutathera dose.

Other drugs may affect lutetium Lu 177 dotatate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

This list of interactions may not be complete and other interactions may occur.

Lutetium Lu 177 dotatate Prescribing Information

HCPs and patients often use the Lutetium Lu 177 dotatate Prescribing Information for more detailed information about this medicine. The Lutathera PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Prescribing Information (PI) is also known as the Lutetium Lu 177 dotatate Package Insert or the  FDA label.

Company

Lutathera Novartis AG ( registered trademark)

Distributed by: Advanced Accelerator Applications USA, Inc., Millburn, NJ 07041. 

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer