Lutetium-177 dotatate (Lutathera)_Dosage, benefits & legal status
Also known as Lutathera, 177Lu-DOTATATE, Lu-177 dotatate, lutetium Lu 177 dotatate, lutetium (177Lu) oxodotreotide
How it compares with RYZ101, the same peptide carrying actinium-225, is covered in the ACTION-1 trial report.
A peptide used as a delivery van: it finds tumour cells with somatostatin receptors and irradiates them from the inside.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Lutetium-177 dotatate (Lutathera)?
Plain language first. The technical label stays, but it never stands alone.Overview
The peptide is the targeting system and the radiation is the treatment. In the NETTER-1 trial it cut the risk of tumour growth or death by 79% against high-dose octreotide in gut tumours, though the final survival gain (48.0 against 36.3 months) was not statistically significant. It is given in hospital as four infusions, 8 weeks apart.
Lutetium-177 dotatate is octreotate, an eight-residue cousin of octreotide, with a DOTA cage on its front end holding one atom of radioactive lutetium-177. The peptide homes to somatostatin receptor 2 on neuroendocrine tumour cells and is pulled inside, and the lutetium's beta radiation damages DNA in that cell and its near neighbours. Novartis sells it as Lutathera through its Advanced Accelerator Applications unit.
What it's used for
A hospital radiation treatment for neuroendocrine tumours of the gut and pancreas that carry somatostatin receptors, in adults and children aged 12 and over.
How does Lutetium-177 dotatate (Lutathera) work?
What it does in the body, and where.Lutathera uses the peptide as a homing device and lutetium-177 as the payload.
- 01Finding the tumourMost well-differentiated gut and pancreatic neuroendocrine tumours are covered in somatostatin receptor 2. The octreotate peptide binds it strongly and almost nowhere else: in lab tests it was over 300 times more selective for subtype 2 than for the others.
- 02Pulled insideBinding makes the cell swallow the receptor and the drug with it, trapping the lutetium inside the tumour cell.
- 03RadiationLutetium-177 gives off beta particles that travel up to about 2 mm, damaging DNA in the cell and its neighbours. Unbound drug leaves through the kidneys within hours, so an amino acid infusion is given to protect them.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Midgut tumours after octreotide
FDA-approved- Human trialNETTER-1, 229 people: progression or death in 23% against 69% (HR 0.21); median progression-free survival 8.5 months on high-dose octreotide and not reached on Lutathera.
- No dataFinal overall survival 48.0 against 36.3 months, not statistically significant (HR 0.84).
- No dataResponse rate is 18% against 3% in the NEJM paper and 13% against 4% in the US label, counted differently.
First treatment, grade 2 and 3
FDA-approved- Human trialNETTER-2, 226 people: median progression-free survival 22.8 against 8.5 months (HR 0.276); severe side effects 35% against 27%.
- No dataSurvival data were immature, and the EU first-line application was withdrawn in 2025.
Long-term safety
FDA-approved- Human observationIn the 1,214-person Rotterdam series, myelodysplastic syndrome occurred in 2.0% and acute leukaemia in 0.5%, after a median of 29 and 55 months.
- Human observationKidney failure in under 1%, 3 to 36 months after treatment.
It has not been shown to extend life: NETTER-1's final survival difference (48.0 against 36.3 months) was not significant, and the 'HR 0.52' or 'HR 0.40' figures are interim analyses. The response rate is 18% in the NEJM paper and 13% in the US label. Lutetium-177's 6.6-day half-life is physical decay; the drug leaves the blood with a half-life of about 71 hours. The peptide is octreotate, not octreotide: tyrosine at position 3 and a threonine acid end. DOTATOC, used in lutetium-177 edotreotide, is a third molecule. NETTER-2 was positive for progression, but no regulator has granted a specific first-line approval, and the EU application was withdrawn. The '13% kidney failure' in NETTER-1 is a grouped term that includes milder creatinine rises.
The published record
Papers and trials about Lutetium-177 dotatate (Lutathera)
386 papers tagged human · 218 not reviews or lab · 25 clinical trial publications
105 registered trials · 8 with posted results
Furthest stage reached: Approved in the US
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count. 475 papers and 100 trials indexed in detail.
At a glance
Four things to know about Lutetium-177 dotatate (Lutathera)
Evidence
FDA-approved
Category
Sexual and hormonal
Common vial
Varies
Half-life
About 71 hours in blood (lutetium-177 decays over 6.6 days)
How much, and do you cycle it?
The range, and whether you take breaks.7.4 GBq every 8 weeks, 4 doses (label), every 8 weeks, for 4 doses. One course of 4 doses, 8 weeks apart FDA label
The label caps treatment at 4 doses (29.6 GBq). Long-acting octreotide then continues every 4 weeks until progression or for up to 18 months from the start.
How long does it stay in the body?
The half-life, and where the figure comes from.About 71 hours in blood (lutetium-177 decays over 6.6 days)FDA label
Blood terminal half-life 71 hours, plus or minus 28. The radioactivity itself halves every 6.647 days whether or not the drug has left the body. Most unbound drug leaves in the urine: 58% within 24 hours, and urine stays radioactive for up to 30 days.
Source: Lutathera prescribing information sections 11 and 12.3
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What does it cost?
Typical dose and cost, in plain numbers.Lutetium-177 dotatate (Lutathera) is not reconstituted
It is not supplied as a powder measured in milligrams, so there is no water-to-powder math and no draw to calculate here. Doses are written in GBq.
Typical dose: 7.4 GBq every 8 weeks, 4 doses (label)
7.4 GBq (200 mCi) by intravenous infusion over 30 to 40 minutes every 8 weeks, for 4 doses (29.6 GBq in total). An amino acid infusion of lysine and arginine starts 30 minutes before and runs for at least 3 hours after, cutting the kidney radiation dose by about half. Long-acting octreotide is stopped 4 weeks before the first dose and given again 4 to 24 hours after each one. After side effects the dose drops to 3.7 GBq. Prepared and given only in a licensed nuclear medicine unit; the vial calculator does not apply.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Lutetium-177 dotatate (Lutathera) keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 38% charged residues, 50% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Pregnancy: radiation can harm a fetus. Women need contraception during treatment and for 7 months after, men with female partners for 4 months
- Breastfeeding, during treatment and for 2.5 months after the last dose
- Severe kidney impairment (creatinine clearance under 30), not studied
- Long-acting octreotide or lanreotide in the 4 weeks before a dose, since they block the same receptor
- Repeated high-dose steroids, since they can switch off the target receptor
Stop and get help
- Fever, repeated infections, unusual bruising or bleeding, possible bone marrow suppression
- Flushing, diarrhoea, wheezing, a racing heart or very low blood pressure within a day of a dose, a possible hormone crisis
- Swelling of the face or throat or trouble breathing during the infusion
- Passing much less urine, or new swelling of the legs
Common effects
- Nausea in 65% and vomiting in 53%, against 12% and 10% on high-dose octreotide
- Low lymphocyte counts in 90%, severe in 44%
- Low platelets in 53% against 17%, and anaemia in 81% against 55%
- Bone marrow cancer (myelodysplastic syndrome) in 2.3% in NETTER-1; in the larger Rotterdam series it appeared a median of 29 months after treatment
- Hair thinning in 12% against 2%
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Lutetium-177 dotatate (Lutathera) approved?
And where the numbers on this page come from.Yes. Lutetium-177 dotatate (Lutathera) is FDA approved and available on prescription in the United States. It is also approved in the European Union, the United Kingdom, Japan, Canada, and Switzerland.
- Approval statusFDA-approved
- RouteInto a vein (30 to 40 minute infusion), in a nuclear medicine unit
- Checked13 October 2026
- Approved outside the USEuropean Union, United Kingdom, Japan, Canada, Switzerland: EU authorisation 26 September 2017 (adults, progressive grade 1 and 2 gut and pancreatic tumours), recommended by NICE in England in 2018; Japan 23 June 2021 for somatostatin receptor-positive neuroendocrine tumours; Canada 9 January 2019; Switzerland 22 November 2024. Also approved in the US.This does not change the United States position above.
- DoseFrom the drug label. The manufacturer tested this range and a regulator reviewed it.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesLutathera prescribing information (DailyMed, revised 10/2024)Drugs@FDA, NDA 208700FDA, Lutathera approved for patients 12 and older (23 Apr 2024)EMA, Lutathera EPAREMA, withdrawal of the Lutathera first-line extensionStrosberg J et al., New England Journal of Medicine 2017;376:125-135 (NETTER-1)Strosberg JR et al., Lancet Oncology 2021;22:1752-1763 (NETTER-1 final survival)Singh S et al., Lancet 2024;403:2807-2817 (NETTER-2)ClinicalTrials.gov, NETTER-1 (NCT01578239)FDA GSRS substance record, lutetium Lu 177 dotatate (UNII AE221IM3BB)
What has happened recently
Authorised in the EU on 26 September 2017, four months before the US. FDA-approved on 26 January 2018 under NDA 208700, with priority review and orphan status, as the first peptide receptor radionuclide therapy in the US, for adults; extended to children aged 12 and over on 23 April 2024, based on safety data from 9 adolescents (4 with these tumours) and efficacy carried over from adults. The US indication does not specify a line of treatment. In the EU, a first-line extension based on NETTER-2 was withdrawn in May 2025 after the CHMP signalled that it could not be approved, and the adolescent extension was not pursued. Also approved in Japan (2021, for neuroendocrine tumours beyond the gut and pancreas), Canada (2019) and Switzerland (2024), and recommended by NICE in England. Novartis acquired the maker, Advanced Accelerator Applications, in January 2018. No generic exists.
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What else is like Lutetium-177 dotatate (Lutathera)?
Others in Sexual and hormonal, side by side.If you're weighing Lutetium-177 dotatate (Lutathera), it's worth reading Octreotide (Sandostatin), Pasireotide (Signifor), and PT-142 in the same class.
A peptide used as a delivery van: it finds tumour cells with somatostatin receptors and irradiates them from the inside.
- Dose
- 7.4 GBq every 8 weeks, 4 doses (label)
- How often
- Every 8 weeks, for 4 doses
An approved hormone blocker since 1988: it lowers growth hormone instead of raising it.
- Dose
- 50 to 500 mcg three times daily, or a 10 to 40 mg monthly depot (label)
- How often
- Two to four times daily, or every 4 weeks (depot)
A ring-shaped six-residue drug for Cushing's disease and acromegaly, traded for a high rate of diabetes.
- Dose
- 0.3 to 0.9 mg twice daily, or 10 to 60 mg monthly LAR (label)
- How often
- Twice daily (Signifor) or every 28 days (Signifor LAR)
A Palatin-style code number with no published compound behind it.
- Dose
- Research only
- How often
- Not established
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
Sources
- Lutathera prescribing information (DailyMed, revised 10/2024)(2024)Dose, amino acid kidney protection, warnings (radiation, bone marrow, MDS and leukaemia, kidney, liver, hormone crisis, infertility). Blood terminal half-life 71 hours; lutetium-177 physical half-life 6.647 days. NETTER-1 side effect tables.
- Drugs@FDA, NDA 208700(2026)Approved 26 January 2018 as a new molecular entity with priority review and orphan status; paediatric supplement 23 April 2024.
- FDA, Lutathera approved for patients 12 and older (23 Apr 2024)(2024)First radiopharmaceutical approved for children 12 and over with these tumours, based on NETTER-P safety and dosimetry, with efficacy extrapolated from adults.
- EMA, Lutathera EPAR(2026)EU authorisation 26 September 2017 for progressive, well-differentiated grade 1 and 2 gut and pancreatic neuroendocrine tumours in adults.
- EMA, withdrawal of the Lutathera first-line extension(2025)Withdrawn 9 May 2025; the CHMP's provisional view was that a survival effect had not been established.
- Strosberg J et al., New England Journal of Medicine 2017;376:125-135 (NETTER-1)(2017)229 people with progressing midgut tumours: 20-month progression-free survival 65.2% against 10.8% on high-dose octreotide (HR 0.21); response 18% against 3%.
- Strosberg JR et al., Lancet Oncology 2021;22:1752-1763 (NETTER-1 final survival)(2021)Median overall survival 48.0 against 36.3 months, HR 0.84, p=0.30, not significant; 36% of the control arm later had radioligand therapy.
- Singh S et al., Lancet 2024;403:2807-2817 (NETTER-2)(2024)226 people with newly diagnosed grade 2 or 3 tumours: median progression-free survival 22.8 against 8.5 months (HR 0.276); response 43.0% against 9.3%.
- ClinicalTrials.gov, NETTER-1 (NCT01578239)(2021)Phase 3, 231 enrolled, completed, results posted.
- FDA GSRS substance record, lutetium Lu 177 dotatate (UNII AE221IM3BB)(2026)INN lutetium (177Lu) oxodotreotide; CAS 437608-50-9; C65H87N14O19S2.Lu, MW 1609.55.
Beyond these, 575 records are indexed. Browse the records