Generic name: lutetium Lu 177 dotatate
Dosage form: injection
Drug class: Therapeutic radiopharmaceuticals

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 26, 2025.

What is Lutathera?

Lutathera (Lutetium Lu 177 dotatate) is a targeted radiotherapy used to treat advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a type of cancer that begins in the pancreas or gastrointestinal (GI) tract. Lutathera works by delivering targeted radiation directly to the cancer cells, helping kill cancer cells and slow tumor progression.

Lutathera belongs to a class of medicines called peptide receptor radionuclide therapy (PRRT).

Patients usually receive Lutathera through IV infusion every 8 weeks, for a total of four doses. As part of the Lutathera treatment regime, you will be given medications to prevent nausea (antiemetics) and an infusion of amino acids (L-lysine and L-arginine) to protect kidney function. A long-acting octreotide injection is also administered within 4–24 hours after each Lutathera dose.

Lutathera FDA approval and indication

Lutathera FDA approval was received on January 26, 2018, following positive results from the NETTER-1 (NCT01578239) clinical trial, which demonstrated Lutathera increased progression-free survival (PFS) and overall response rate (ORR). 

Lutathera's FDA approval is for the treatment of 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.

Lutathera Clinical Success Rate in NETTER-2 Trials

Further Lutathera success rate was measured in the next clinical trial, NETTER-2 (NCT03972488), with a:

• Median progression-free survival (PFS): 22.8 months (vs. 8.5 months in the control group)
• Overall response rate (ORR): 43.0% (vs. 9.3% in the control group).

How Lutathera Works

Lutathera mechanism of action is as a radiolabeled somatostatin analog, meaning it combines a targeting molecule (similar to natural somatostatin) with a radioactive substance to treat the tumor from within.

Lutathera is a targeted radioactive therapy designed to treat certain tumors that have somatostatin receptors on the surface of many neuroendocrine tumor cells. These receptors act like docking stations for the drug.

Once Lutathera finds and attaches to these receptors, it delivers a small, controlled dose of radiation directly to the tumor, helping to destroy the cancer cells while minimizing damage to healthy tissue.

Lutathera Works in Three Key Steps:

1. Targeting the Tumor
   Lutathera recognizes and binds to somatostatin receptor type 2 (SSTR2), commonly found on neuroendocrine tumor cells.
2. Delivering Radiation
   It carries a radioactive component called Lutetium-177, which emits energy that penetrates the tumor cells.
3. Destroying Cancer Cells
   The radiation causes damage inside the cancer cells, leading to the tumor cells' death.

Lutathera side effects

Common side effects of Lutathera

Common Lutathera 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 Lutathera 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.

Lutathera 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 Lutathera 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 Lutathera.

Both men and women using Lutathera 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.

Lutathera may cause other types of cancer, such as leukemia. Ask your doctor about this risk.

Breastfeeding

Do not breastfeed while receiving Lutathera, and for at least 4 months after your last dose.

Pregnancy

You should not use Lutathera cancer treatment if you are pregnant or planning a pregnancy.

Lutathera 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 Lutathera.

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 Lutathera may harm the baby if a pregnancy does occur.

How is Lutathera given?

Lutathera treatment

Lutathera is administered as an infusion into a vein once every 8 weeks for a total of 4 doses by your HCP (healthcare provider). It must be administered slowly, and can take 30 to 40 minutes to complete.

General Lutathera treatment information

After each infusion, you will be given another medicine called octreotide (LAR), 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 Lutathera, 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.

Lutathera dose information

Lutathera dose: 7.4 GBq (200 mCi) every 8 weeks (± 1 week) for a total of 4 doses (adult and pediatric patients 12 years and older).

Dose modifications: Dose may be modified depending of the severity of side effects. For more information on dosage modifications, see the Lutathera Dosage page.

Administer premedications and concomitant medications as recommended.

Lutathera premedications and concomitant medications

Somatostatin Analogs

• Before starting Lutathera treatment. Discontinue long-acting somatostatin analogs (e.g., long-acting octreotide) at least 4 weeks before starting Lutathera. Short-acting octreotide may be administered as needed, but should be discontinued at least 24 hours before starting Lutathera.
• During Lutathera treatment. Long-acting octreotide 30 mg should be administered intramuscularly 4 to 24 hours after each Lutathera dose, and short-acting octreotide can be administered for symptomatic management. 
• Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing Lutathera until disease progression or for 18 months after starting treatment.

Antiemetics

• Administer antiemetics before the recommended amino acid solution. 

Intravenous amino acid solution

• Start the recommended intravenous amino acid solution 30 minutes before Lutathera infusion; continue during and for at least 3 hours after Lutathera infusion. Do not decrease the dose of amino acid solution if the Lutathera dose is reduced. 

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 Lutathera is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What other drugs will affect Lutathera?

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 Lutathera, 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.

Lutathera Prescribing Information

HCPs and patients often use the Lutathera 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 Lutathera Package Insert or the  FDA label.

Company

Lutathera Novartis AG ( registered trademark)

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

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