Lutetium Lu 177 Dotatate: uses, dosing, side effects & brands

Lutetium Lu 177 Dotatate is a medicine sold in the U.S. under one brand, for gastrointestinal neoplasms, pancreatic neoplasms and neuroendocrine tumors. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats: Gastrointestinal Neoplasms, Pancreatic Neoplasms and Neuroendocrine Tumors
Available as: Injectable
Sold as: Lutathera
Prescription?: Prescription only
Generic available?: Not in our catalog

How lutetium lu 177 dotatate is dosed

From the FDA label for Lutathera (application NDA208700). Other lutetium lu 177 dotatate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

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…

Lutetium Lu 177 Dotatate side effects

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…

Who shouldn’t take lutetium lu 177 dotatate

None. None. ( 4 )

Lutetium Lu 177 Dotatate drug interactions

Somatostatin Analogs : Discontinue long-acting analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. ( 2.3 , 7.1 ) 7.1 Somatostatin Analogs Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of LUTATHERA. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. Administer short- and long-acting octreotide during LUTATHERA treatment as recommended [see Dosage and Administration ( 2.3 )] . 7.2 Glucocorticoids Glucocorticoids can induce down-regulation of subtype 2 somatostatin receptors (SSTR2). Avoid repeated administration of high doses of glucocorticoids during treatment with LUTATHERA.

Every lutetium lu 177 dotatate product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Lutathera.

Lutetium Lu 177 Dotatate and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Lutetium Lu 177 dotatate is a radiolabeled somatostatin analog indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. No information is available on the use of lutetium Lu 177 dotatate during breastfeeding. The manufacturer recommends that breastfeeding be discontinued during lutetium Lu 177 dotatate therapy and for 2.5 months following the last dose, which would usually mean permanently discontinuing breastfeeding of the current infant.

Full LactMed record for lutetium lu 177 dotatate: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised July 17, 2025. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about lutetium lu 177 dotatate

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1 reports naming lutetium lu 177 dotatate, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

generalised tonic-clonic seizure1 reports
respiratory arrest1 reports

Read these as a signal, not a rate. A report does not mean lutetium lu 177 dotatate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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Frequently asked questions

What is lutetium lu 177 dotatate?

Lutathera (Lutetium Lu 177 Dotatate) is a medication used to treat Gastrointestinal Neoplasms, Pancreatic Neoplasms, Neuroendocrine Tumors.

Can you take lutetium lu 177 dotatate with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run lutetium lu 177 dotatate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does lutetium lu 177 dotatate come in?

Across the brands we track, lutetium lu 177 dotatate is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic lutetium lu 177 dotatate?

We do not currently list a generic-labelled lutetium lu 177 dotatate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page

APA: pharmaranks. (2026, July 24). Lutetium Lu 177 Dotatate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/lutetium-lu-177-dotatate
MLA: “Lutetium Lu 177 Dotatate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/lutetium-lu-177-dotatate.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for lutetium lu 177 dotatate on DailyMed (NIH) ↗.