Dotatate

Lutetium Lu 177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 somatostatin receptors (SSTR2). Upon binding to somatostatin receptor expressing cells, including malignant somatostatin receptor-positive tumors, the compound is internalized.

• LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

• None. None.contraindicated

Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA. ( 2.1 ) Administer 7.4 GBq (200 mCi) every 8 weeks (± 1 week) for a total of 4 doses. ( 2.2 ) Administer long-acting octreotide 30 mg intramuscularly 4 to 24 hours after each LUTATHERA dose and short-acting octreotide for symptomatic management. ( 2.3 ) Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing LUTATHERA until disease progression or for 18 months following treatment initiation. ( 2.3 ) Administer antiemetics before recommended amino acid solution. ( 2.3 ) Initiate recommended intravenous amino acid solution 30 minutes before LUTATHERA infusion; continue during and for at least 3 hours after LUTATHERA infusion. Do not decrease dose of amino acid solution if LUTATHERA dose is reduced. ( 2.3 ) 2.1 Important Safety Instructions LUTATHERA is a radiopharmaceutical; handle with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.1 )] . Use waterproof gloves and effective radiation shielding when handling LUTATHERA. Radiopharmaceuticals, including LUTATHERA, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA [see Use in Specific Populations ( 8.1 , 8.3 )] .

Risk From Radiation Exposure : Minimize radiation exposure during and after treatment with LUTATHERA consistent with institutional good radiation safety practices and patient management procedures. ( 2.1 , 5.1 ) Myelosuppression : Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue based on the severity. ( 2.4 , 5.2 ) Secondary Myelodysplastic Syndrome (MDS) and Leukemia : Median time to onset: MDS is 29 months; acute leukemia is 55 months. ( 5.3 ) Renal Toxicity : Advise patients to hydrate and to urinate frequently before, on the day of and the day after administration of LUTATHERA. Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue based on the severity. ( 2.3 , 2.4 , 5.4 ) Hepatotoxicity : Monitor transaminases, bilirubin, serum albumin and INR. ( 2.4 , 5.5 ) Hypersensitivity Reactions : Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis. Permanently discontinue LUTATHERA based on severity. ( 2.3 , 2.4 , 5.6 ) Neuroendocrine Hormonal Crisis : Monitor for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms. ( 5.7 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) Risk of Infertility : LUTATHERA may cause infertility. ( 5.9 , 8.3 ) 5.1 Risk From Radiation Exposure LUTATHERA contributes to a patient’s overall long-term cumulative radiation exposure.

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.2 )] Secondary Myelodysplastic Syndrome and Leukemia [see Warnings and Precautions ( 5.3 )] Renal Toxicity [see Warnings and Precautions ( 5.4 )] Hepatotoxicity [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Neuroendocrine Hormonal Crisis [see Warnings and Precautions ( 5.7 )] Most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in WARNINGS AND PRECAUTIONS reflect exposure to LUTATHERA in 111 patients with advanced, progressive midgut neuroendocrine tumors (NETTER-1). Safety data in WARNINGS AND PRECAUTIONS were also obtained in an additional 22 patients in a non-randomized pharmacokinetic sub-study of NETTER-1 and in a subset of patients (811 of 1214) with advanced somatostatin receptor-positive tumors enrolled in ERASMUS [see Warnings and Precautions ( 5 )] .

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, LUTATHERA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on LUTATHERA use in pregnant women. No animal studies using lutetium Lu 177 dotatate have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from LUTATHERA, can cause fetal harm. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of lutetium Lu 177 dotatate in human milk, or its effects on the breastfed child or milk production. No lactation studies in animals were conducted. Because of the potential risk for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LUTATHERA and for 2.5 months after the last dose. 8.3 Females and Males of Reproductive Potential Based on mechanism of action, LUTATHERA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] .

Metabolism

The pharmacokinetics (PK) of lutetium Lu 177 dotatate have been characterized in patients with progressive, somatostatin receptor-positive neuroendocrine tumors. The mean blood exposure (area under the curve) of lutetium Lu 177 dotatate at the recommended dose is 41 ng.h/mL [coefficient of variation (CV) 36%].

• Jun 1, 2016NDANDA208547Aaa Usa Inc
• Jan 26, 2018NDANDA208700Aaa Usa Inc
• Sep 3, 2020NDANDA213227Curium

1. 1Ill-defined Disorder1,54127%
2. 2General Physical Health Deterioration1,11719%
3. 3Death4337.5%
4. 4Malignant Neoplasm Progression3415.9%
5. 5Nausea3185.5%
6. 6Platelet Count Decreased2283.9%
7. 7Covid-191963.4%
8. 8Fatigue1933.3%
9. 9Diarrhoea1893.3%
10. 10Disease Progression1723.0%
11. 11Laboratory Test Abnormal1713.0%
12. 12Illness1662.9%
13. 13Vomiting1572.7%
14. 14Abdominal Pain1562.7%
15. 15Malaise1432.5%

The 10 most recently updated of 225 ClinicalTrials.gov registrations naming Dotatate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 18 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT06991738updated 2026-06-12
• Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
  Recruiting · Phase 2 · Interventional · 80 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT02019706updated 2026-06-12
• [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers
  Recruiting · Phase 1 · Interventional · 120 enrolled · National Cancer Institute (NCI)
  NCT06479811updated 2026-06-12
• Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
  Recruiting · Phase 2 · Interventional · 70 enrolled · National Cancer Institute (NCI)
  NCT04665739updated 2026-06-11
• NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
  Active not recruiting · Phase 1 · Interventional · 31 enrolled · Novartis Pharmaceuticals
  NCT06379217updated 2026-06-10
• A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients
  Not yet recruiting · Observational · 4,023 enrolled · Novartis Pharmaceuticals
  NCT07635316updated 2026-06-09
• The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
  Recruiting · Phase 2 · Interventional · 54 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT04927416updated 2026-06-08
• 177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer
  Recruiting · Phase 2 · Interventional · 10 enrolled · OHSU Knight Cancer Institute
  NCT04529044updated 2026-06-05
• Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).
  Recruiting · Phase 1 · Phase 2 · Interventional · 25 enrolled · Fundación de investigación HM
  NCT06607692updated 2026-06-04
• Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
  Recruiting · Phase 2 · Interventional · 146 enrolled · Institut du Cancer de Montpellier - Val d'Aurelle
  NCT04954820updated 2026-06-04

Frequently asked questions

How does Dotatate work?

Lutetium Lu 177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 somatostatin receptors (SSTR2). Upon binding to somatostatin receptor expressing cells, including malignant somatostatin receptor-positive tumors, the compound is internalized.

What is Dotatate used for?

According to FDA labeling, Dotatate carries indications including: LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTATHERA is a radiolabeled somatostatin analog indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Dotatate?

Dotatate is marketed under brand names including Lutathera.

What are the contraindications for Dotatate?

Dotatate labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.