About Lutathera®

Introducing Lutathera®

Lutetium (177Lu) Oxodotreotide

For full LUTATHERA® safety information please refer to your local Summary of Product Characteristics or prescribing information via adacap.com/our-products/.

Radioligand therapy (RLT) with LUTATHERA®

LUTATHERA® 370 MBq/mL solution for infusion is a radiolabeled somatostatin analogue (SSA) comprised of the radionuclide lutetium-177 and the peptide oxodotreotide.1,2 It is designed to deliver beta radiation directly to gastroenteropancreatic neuroendocrine tumor (GEP-NET) cells, disrupting them from within:1

  • Oxodotreotide is a SSA that binds with high affinity to the somatostatin receptor subtype 2 (SSTR2)1,2 – the most frequently expressed SSTR subtype in GEP-NETs3
  • Lutetium-177 is a β- emitting radionuclide with a mean radiation penetration range of 0.67mm and a maximum range of 2.2mm. This means that the radiation is mostly contained within the tumor, limiting damage to neighbouring healthy cells1

Before starting treatment with LUTATHERA®, somatostatin receptor (SSTR) imaging (scintigraphy or positron emission tomography [PET]) must confirm the overexpression of SSTRs in the tumour tissue, with the tumor uptake at least as high as normal liver uptake.1

LUTATHERA®’s mode of action

Moa diagram

LUTATHERA®’s mode of action

Moa diagram

For more information on the mode of action of LUTATHERA® please watch our video.

Theranostic concept

Theranostics is a treatment strategy that uses combinations of diagnostic and therapeutic agents which share a specific molecular target.5

Diagnostic agents can be used to determine the expression of disease-specific molecular markers, such as cell surface receptors or membrane transporters. Once expression is confirmed with the diagnostic agent, the patient can be treated with a therapeutic agent that targets the same specific molecular marker.5

Diagnostic and therapeutic agents that are used in this way are called theranostic pairs. These enable more accurate patient selection, prediction of treatment response, and response evaluation.5

LUTATHERA® and the diagnostic agent gallium (68Ga) edotreotide are one example of a theranostic pair in the management of GEP-NETs.5 Gallium (68Ga) edotreotide is a radiolabeled peptide that binds to SSTRs, and is used with positron emission tomography (PET) to image GEP-NETs.5,6 This process determines the level of SSTR expression on patients’ tumors, which helps identify suitable patients for SSTR-targeted treatment with LUTATHERA®.6

Alternative imaging techniques to PET, such as scintigraphy, are also able to confirm the overexpression of SSTRs in tumor tissue and therefore aid selection of appropriate patients for LUTATHERA® treatment.1

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GEP-NET, gastroenteropancreatic neuroendocrine tumor; PET, positron emission tomography; RLT, radioligand therapy; SSA, somatostatin analog; SSTR, somatostatin receptor; SSTR2, somatostatin receptor subtype 2.
References: 1. LUTATHERA® Summary of Product Characteristics. March 2022. 2. Strosberg J, El-Haddad G, Wolin E et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. New Engl J Med. 2017;376(2): 127–135. 3. Zamora V, Cabanne A, Salanova R et al. Immunohistochemical expression of somatostatin receptors in digestive endocrine tumours. Dig Liver Dis. 2010; 42(3): 220–225. 4. LUTATHERA® US Full Prescribing Information. May 2020. Available at: https://www.lutathera.com/wp-content/uploads/2020/06/Lutathera_USPI-20200528.pdf. Accessed: April 2022. 5. Marin JFG, Nunes RF, Coutinho AM et al. Theranostics in Nuclear Medicine: Emerging and Re-emerging Integrated Imaging and Therapies in the Era of Precision Oncology. Radiographics. 2020; 40(6): 1715–1740. 6. Ambrosini V, Kunikowska J, Baudin E et al. Consensus on molecular imaging and theragnostics in neuroendocrine neoplasms. Eur J Cancer. 2021;146: 56–73.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report upon local legislation or to use the pharmacovigilance link adacap.com/pharmacovigilance/.

LUTATHERA® indication

LUTATHERA® is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.1

LUTATHERA® contraindications1

LUTATHERA® is contraindicated in patients with:

  • Hypersensitivity to the active substance or to any of the following excipients: acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride, sodium hydroxide, water for injections
  • Established or suspected pregnancy or when pregnancy has not been excluded
  • Kidney failure with creatinine clearance <30mL/min

Refer to your local SmPC or prescribing information via adacap.com/our-products/ for further detail on contraindications.

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G, grade; GEP-NET, gastroenteropancreatic neuroendocrine tumor.
Reference: 1. LUTATHERA® Summary of Product Characteristics. March 2022.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report upon local legislation or to use the pharmacovigilance link adacap.com/pharmacovigilance/.

Dosing and administration

LUTATHERA® is a ready-to-use radiopharmaceutical medicinal product for single intravenous (IV) use only.1 The recommended treatment regimen in adults consists of 4 infusions of 7.4GBq each (total LUTATHERA® administered is 29.6GBq). The recommended interval between each administration is 8 weeks.1

Management of severe or intolerable adverse drug reactions may require temporary dose interruption, extending dosing interval from 8 weeks up to 16 weeks, dose reduction, or discontinuation of treatment with LUTATHERA®.1
Consult the SmPC before initiating treatment with LUTATHERA®.

DOSING diagram
The recommended infusion method for administration of LUTATHERA® is the gravity method as it enables LUTATHERA® infusion directly from the original container. Treating physicians may use other methods deemed appropriate and safe, including the use of infusion pumps, particularly when dose reduction is required. During the administration, the recommended radiation safety precaution measures should be undertaken regardless of the infusion method.1
GBq, gigabecquerel; SmPC, Summary of Product Characteristics; SSA, somatostatin analog.

Hear from Prof. Dr. Ken Herrmann about the importance of being compliant with LUTATHERA®’s recommended dosing regimen in our video.

Being compliant with the LUTATHERA® dosing regimen

Administration procedure1

  • Antiemetic premedication* should be administered at least 30 minutes prior to the start of the amino acid solution infusion to reach full antiemetic efficacy of the selected product, according to the respective product information
    • In case of severe nausea or vomiting during amino acid solution infusion, an antiemetic of a different pharmacological class can be administered
  • Amino acid solution* administration should be initiated 30 minutes before LUTATHERA® infusion, with an infusion rate of 250-500mL/h (depending on volume). Amino acid solution must be administered intravenously for 4 hours for full renal protection
  • LUTATHERA® infusion should start 30 minutes after the beginning of the amino acid solution infusion, with the infusion rate of approximately 400mL/h (this infusion rate is the reference rate; the infusion should start at a lower rate of <100mL/h for the first 5-10 minutes and should then be increased depending on the patient’s venous status). LUTATHERA® should be administered over 30 ± 10 minutes

Radiopharmaceuticals should be received, used and administered only by authorised personnel in designated clinical settings. Radiopharmaceutical receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.1

Amino acid solution preparation1

The amino acid solution can be prepared as a compounded product, in compliance with the hospital’s sterile medicinal product preparation good practices and according to the composition specified below:

DOSING diagram

Alternatively, some commercially available amino acid solutions can be used if compliant with the specification described below:

DOSING diagram
*Not provided with LUTATHERA®. **Equivalent to 20.0g lysine. †Equivalent to 20.7g arginine. ‡Equivalent to 14.4-20.0g lysine. §Equivalent to 14.9-20.7g arginine.

Concomitant administration of SSAs1

Administration of long-acting SSAs should be avoided within 30 days prior to LUTATHERA® administration. If necessary, patients may be treated with short-acting SSAs up to 24 hours before each LUTATHERA® infusion.

Treatment monitoring1

Before starting treatment with LUTATHERA®, SSTR imaging (scintigraphy or PET) must confirm the overexpression of SSTRs in the tumor tissue, with the tumor uptake at least as high as normal liver uptake.

Prior to each administration and during treatment, biological tests are required to re-assess the patient’s condition and adapt the treatment protocol if necessary (dose, infusion interval, number of infusions).

Minimum laboratory tests needed before each infusion are:

  • Hematology (hemoglobin, white blood cell count, platelet count)
  • Kidney function (serum creatinine and creatinine clearance)
  • Liver function (alanine aminotransferase, aspartate aminotransferase, albumin, bilirubin)

These tests should be performed:

  • At least once within 2-4 weeks prior to LUTATHERA® administration, and shortly before administration
  • Every 4 weeks for at least 3 months after the last infusion of LUTATHERA® and every 6 months thereafter, to detect possible delayed adverse reactions

Dosing may need to be modified based on the test results.

Refer to your local SmPC or prescribing information via adacap.com/our-products/ for full eligibility criteria and further detail on special warnings and precautions such as renal and hepatic function, evidence of bone metastases or other important circumstances where benefit and risk must be carefully assessed.

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GBq, gigabecquerel; IV, intravenous; SmPC, Summary of Product Characteristics; SSTR, somatostatin receptor.
Reference: 1. LUTATHERA® Summary of Product Characteristics. March 2022.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report upon local legislation or to use the pharmacovigilance link adacap.com/pharmacovigilance/.