Prescription medicine
Lutetium oxodotreotide lu 177 Brand names: Lutathera, Bexlutry
Lutetium oxodotreotide lu 177 (Lutathera) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lutetium oxodotreotide lu 177 FDA label on DailyMed (effective January 15, 2026); every lutetium oxodotreotide lu 177 label on DailyMed.
Highlights of the record
FDA label of January 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLUTATHERA 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.
Forms and strengths
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,683 through July 30, 2026
What is lutetium oxodotreotide lu 177 used for?
From the label: indications and usageLUTATHERA 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.
Source: FDA drug label (Lutathera), Advanced Accelerator Applications USA, Inc, effective January 15, 2026 (SPL set 72d1a024-00b7-418a-b36e-b2cb48f2ab55), via openFDA; the full label on DailyMed
Is there a generic for lutetium oxodotreotide lu 177 (Lutathera)?
No generic lutetium oxodotreotide lu 177 is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lutetium oxodotreotide lu 177 label say about other medicines?
The lutetium oxodotreotide lu 177 label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Octreotide | drug interactions | Administer short- and long-acting octreotide during LUTATHERA treatment as recommended [see Dosage and Administration ( 2.3 )]. |
Source: FDA drug label (Lutathera), Advanced Accelerator Applications USA, Inc, effective January 15, 2026 (SPL set 72d1a024-00b7-418a-b36e-b2cb48f2ab55), via openFDA; the full label on DailyMed
What do FAERS reports show for lutetium oxodotreotide lu 177?
The FDA Adverse Event Reporting System holds 5,683 reports that list lutetium oxodotreotide lu 177 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 704 are coded as a death and 694 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2021 (1,352, against a median of 162 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Lutetium oxodotreotide lu 177 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other