• Pancreatic, thyroid, and other endocrine cancers

Lutathera Generic Name & Formulations

General Description

Lutetium Lu 177 dotatate 370 MBq/mL (10mCi/mL); soln for IV inj; preservative-free.

Pharmacological Class

Somatostatin analogue.

How Supplied

Single-dose vial—1

Generic Availability


Mechanism of Action

Lutetium Lu 177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 receptors (SSRT2). Upon binding to somatostatin receptor expressing cells, including malignant somatostatin receptor-positive tumors, the compound is internalized. The beta emission from Lu 177 induces cellular damage by formation of free radicals in somatostatin receptor-positive cells and in neighboring cells.

Lutathera Indications


Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Lutathera Dosage and Administration


Administer antiemetics before amino acid solution. Give IV amino acid solution (L-lysine and L-arginine) 30mins prior to, during and for ≥3hrs after Lutathera infusion; do not reduce solution dose even if Lutathera dose is reduced. Discontinue long-acting somatostatin analogues (eg, long-acting octreotide) for ≥4wks before starting Lutathera; give short-acting octreotide as needed; discontinue ≥24hrs prior to starting Lutathera. Premedicate those with prior Grade 1 or 2 hypersensitivity reactions to Lutathera; do not rechallenge if Grade 3 or 4 reactions occur. Administer Lutathera 7.4 GBq (200mCi) as an IV infusion every 8 weeks for a total of 4 doses. Give concomitant long-acting octreotide 30mg IM between 4–24hrs after each dose. Do not give long-acting octreotide within 4 weeks of each subsequent dose. Continue long-acting octreotide 30mg IM every 4 weeks after completing Lutathera until disease progression or for up to 18 months following treatment initiation. Dose modifications for adverse reactions: see full labeling.


Not established.

Lutathera Contraindications

Not Applicable

Lutathera Boxed Warnings

Not Applicable

Lutathera Warnings/Precautions


Should be used by physicians trained and experienced in radiopharmaceuticals. Handle with appropriate safety measures to minimize radiation exposure during and after Lutathera. Increased risk for cancer with long-term cumulative radiation exposure. Monitor closely for hypersensitivity reactions during and after infusion for a minimum of 2hrs in a setting where cardiopulmonary resuscitation medication/equipment are available. Discontinue infusion at 1st signs/symptoms of a severe hypersensitivity reaction; permanently discontinue if Grade 3 or 4 reactions occur. Monitor CBCs, serum creatinine, CrCl, transaminases, bilirubin, serum albumin, and INR during therapy; withhold, reduce dose, or permanently discontinue based on severity of reaction. Advise patients to hydrate and urinate frequently before, on the day of, and the day after administration. Monitor for signs/symptoms of tumor-related hormonal disease (eg, flushing, diarrhea, hypotension, bronchoconstriction, others); give IV somatostatin analogues, fluids, corticosteroids, and electrolytes as indicated. Mild or moderate renal impairment: assess renal function more frequently. Severe hepatic or renal impairment (CrCl <30mL/min) or ESRD: not studied. Risk of infertility. Embryo-fetal toxicity. Advise to use effective contraception during and for 7 months (females of reproductive potential) or 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2.5 months after the last dose).

Lutathera Pharmacokinetics


Mean blood exposure (AUC): 41 ng.h/mL (coefficient of variation [CV] 36%).

Mean maximum blood concentration (Cmax): 10 ng/mL (CV 50%).


Mean volume of distribution: 460 L (CV 54%).

Non-radioactive lutetium Lu 175 dotate is 43% bound to human plasma proteins.

Coadministration of amino acids reduced the median radiation dose to the kidneys by 47% (34–59%) and increased the mean beta-phase blood clearance of lutetium Lu 177 dotatate by 36%.


Primarily renal with cumulative excretion of 44% within 5 hours, 58% within 24 hours, and 65% within 48 hours following administration. 

Half-life: 71 ± 28 hours.

Mean clearance: 4.5 L/h (CV 31%).

Lutathera Interactions


Efficacy may be affected by somatostatin and its analogues (see Adult dosing). Avoid concomitant repeated high-doses of glucocorticoids.

Lutathera Adverse Reactions

Adverse Reactions

Lymphopenia, increased GGT, vomiting, nausea, increased AST/ALT, hyperglycemia, hypokalemia; myelosuppression, secondary myelodysplastic syndrome, leukemia, renal toxicity, hepatotoxicity, hypersensitivity reactions, neuroendocrine hormonal crisis.

Lutathera Clinical Trials

See Literature

Lutathera Note

Not Applicable

Lutathera Patient Counseling

See Literature