Lutathera (lutetium lu 177 dotatate)
An approved treatment for Neuroendocrine Tumors.
The same compound appears under different names depending on the context. Here is how to identify Lutetium Lu 177 dotatate wherever you encounter it, plus the key facts at a glance.
- Generic name
- Lutetium Lu 177 dotatate
- Brand name
- Lutathera
- Development code
- 177Lu-DOTATATE
- Drug class
- Radiolabeled somatostatin analog (peptide receptor radionuclide therapy)
- Manufacturer
- Novartis (Advanced Accelerator Applications)
- How it's taken
- 7.
An IV radioactive treatment given 4 times, 8 weeks apart, for adults and children 12 and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Approved for adults on January 26, 2018 and for ages 12 and up on April 23, 2024.
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Where Lutetium Lu 177 dotatate fits
Usually used when gut or pancreatic NETs grow despite a somatostatin injection, as one of several options alongside daily pills such as everolimus, sunitinib and cabozantinib.
How Lutetium Lu 177 dotatate works
Many neuroendocrine tumor cells carry somatostatin receptors on their surface. Lutathera pairs a molecule that docks on those receptors with radioactive lutetium-177, so the radiation is delivered mostly to the tumor cells. A special PET scan must first show that the tumor has the receptors. An amino acid infusion given with each dose helps protect the kidneys.
Mechanism: Radioactive drug (radioligand) that attaches to somatostatin receptors on neuroendocrine tumor cells and delivers radiation directly to them
Side effects and safety
- Radiation exposure. Lutathera adds to lifetime radiation exposure, which raises long-term cancer risk. Radiation safety steps are followed during and after each dose.
- Low blood counts. Blood counts are checked, and doses are held, lowered or stopped if counts fall too far.
- Later blood cancers. Myelodysplastic syndrome (median onset 29 months) and acute leukemia (median 55 months) have occurred after treatment.
- Kidney and liver damage. Drinking fluids and urinating often around each dose helps protect the kidneys; kidney and liver tests are monitored.
- Hormone crisis. Tumors can release a burst of hormones, causing flushing, diarrhea, low blood pressure or wheezing.
- Pregnancy and fertility. Can harm an unborn baby, so effective birth control is used, and may cause infertility.
- A somatostatin receptor PET scan before starting
- Pregnancy check before starting
- Blood counts, kidney tests and liver tests before each dose and during treatment
- Watching for hormone crisis symptoms during and after each dose
Lutathera has no boxed warning and no contraindications. The label warns about radiation exposure, lowered blood counts, a later risk of myelodysplastic syndrome (median onset 29 months) and leukemia (median 55 months), kidney and liver damage, allergic reactions, hormone crises from the tumor (flushing, diarrhea, low blood pressure, wheezing), harm to an unborn baby and infertility. In the NETTER-1 trial, nausea (65% against 12% on octreotide alone), vomiting (53% against 10%) and tiredness (38% against 26%) were the most common side effects.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Lutetium Lu 177 dotatate
7.4 GBq (200 mCi) by IV infusion every 8 weeks, for 4 doses in total, given in a nuclear medicine center. An amino acid infusion starts 30 minutes before each dose and runs for at least 3 hours after it, with anti-nausea medicine beforehand. Long-acting octreotide 30 mg is injected 4 to 24 hours after each dose and then every 4 weeks until the disease progresses or for 18 months from the start of treatment.
Availability and cost
Only available as the brand-name product.
Help paying for Lutathera
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
People with private insurance may pay as little as $0 for Lutathera. The co-pay offer pays up to $15,000 over the whole course of treatment toward the drug's out-of-pocket cost, and you pay anything above that. It cannot be used with Medicare, Medicaid, TRICARE, VA, DoD or other federal or state programs, without insurance, or when the plan does not cover Lutathera.
For: private insurance · source - Free medicine program
Lutathera is on the medication list of the Novartis Patient Assistance Foundation, which gives medicine free to people who are uninsured, have government insurance or cannot afford their medicine. You must live in the US or a US territory, be treated as an outpatient by a licensed US provider and meet income limits. Call 1-800-277-2254.
For: no insurance, underinsured, Medicare · source - Insurance and case manager help
A dedicated team guides you through referral, financial help, what to expect with treatment and common questions, and works with your provider on insurance coverage.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: The $15,000 co-pay cap covers the whole course of treatment, not one year. Treatment costs such as administration fees may be extra. Hours are Monday to Friday, 8 AM to 8 PM ET.
Access and eligibility
For people 12 and older with gastroenteropancreatic NETs that show somatostatin receptors on a PET scan. Kidney function, blood counts and liver tests must allow treatment.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
NETTER-1 (NCT01578239) randomized 229 people with progressive midgut NETs to Lutathera plus long-acting octreotide or high-dose octreotide alone. The tumor grew or the person died in 23% on Lutathera against 69% on octreotide; median progression-free survival was not reached on Lutathera against 8.5 months, a hazard ratio of 0.21, meaning about a 79% lower risk of the tumor growing or death. In the ERASMUS study of 360 people with GEP-NETs in the Netherlands, 17% had their tumors shrink by the study's criteria.
Development history
Developed by Advanced Accelerator Applications, now part of Novartis. The FDA approved Lutathera on January 26, 2018 for adults with somatostatin receptor-positive GEP-NETs and extended it to children 12 and older on April 23, 2024. Two more versions of lutetium-177 dotatate were approved in September 2026: Curium's Bexlutry and Lantheus's Bravnetsa.
Explore Neuroendocrine Tumors trials
Other Neuroendocrine Tumors treatments
Somatostatin injections (lanreotide, octreotide) are usually first. When tumors grow, options include Lutathera, everolimus, sunitinib (pancreatic NETs), cabozantinib, liver-directed treatments and chemotherapy, chosen by tumor site, grade and receptor status. Newer radioactive drugs, including ITM-11 and actinium-225 dotatate, are in trials.
Common questions about Lutetium Lu 177 dotatate
▸What is Lutetium Lu 177 dotatate (Lutathera)?
An IV radioactive treatment given 4 times, 8 weeks apart, for adults and children 12 and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Approved for adults on January 26, 2018 and for ages 12 and up on April 23, 2024.
▸How does Lutetium Lu 177 dotatate work?
Many neuroendocrine tumor cells carry somatostatin receptors on their surface. Lutathera pairs a molecule that docks on those receptors with radioactive lutetium-177, so the radiation is delivered mostly to the tumor cells. A special PET scan must first show that the tumor has the receptors. An amino acid infusion given with each dose helps protect the kidneys.
▸What are the side effects of Lutetium Lu 177 dotatate?
Lutathera has no boxed warning and no contraindications. The label warns about radiation exposure, lowered blood counts, a later risk of myelodysplastic syndrome (median onset 29 months) and leukemia (median 55 months), kidney and liver damage, allergic reactions, hormone crises from the tumor (flushing, diarrhea, low blood pressure, wheezing), harm to an unborn baby and infertility. In the NETTER-1 trial, nausea (65% against 12% on octreotide alone), vomiting (53% against 10%) and tiredness (38% against 26%) were the most common side effects.
▸How is Lutetium Lu 177 dotatate taken?
7.4 GBq (200 mCi) by IV infusion every 8 weeks, for 4 doses in total, given in a nuclear medicine center. An amino acid infusion starts 30 minutes before each dose and runs for at least 3 hours after it, with anti-nausea medicine beforehand. Long-acting octreotide 30 mg is injected 4 to 24 hours after each dose and then every 4 weeks until the disease progresses or for 18 months from the start of treatment.
▸Is Lutetium Lu 177 dotatate FDA approved?
Yes, Lutetium Lu 177 dotatate (Lutathera) is FDA approved (2018) for the treatment of Neuroendocrine Tumors.
▸How many Lutathera treatments do you get?
4, given by IV every 8 weeks, about 8 months in all. Each infusion is given in a nuclear medicine center with an amino acid infusion to protect the kidneys, and long-acting octreotide injections continue alongside it.
▸Who can get Lutathera?
People 12 and older with gastroenteropancreatic neuroendocrine tumors whose PET scan shows somatostatin receptors, with blood counts, kidney and liver tests that allow it. It is not approved for lung NETs.
▸What did the NETTER-1 trial show?
In 229 people with progressive midgut NETs, the tumor grew or the person died in 23% on Lutathera plus octreotide against 69% on high-dose octreotide alone, with about a 79% lower risk of the tumor growing or death.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-01. LUTATHERA (lutetium Lu 177 dotatate) injection: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d1a024-00b7-418a-b36e-b2cb48f2ab55
- U.S. Food and Drug Administration · 2024-04-23. FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETs. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-dotatate-pediatric-patients-12-years-and-older-gep-nets
- ClinicalTrials.gov. NETTER-1: Lutathera versus high-dose octreotide in midgut NETs. https://clinicaltrials.gov/study/NCT01578239