Dosing and Administration
Premedication and Concomitant Medications
Somatostatin Analogs1 | |
| Before initiating LUTATHERA treatment, discontinue long-acting SSAs (eg, long-acting octreotide) at least 4 weeks prior to initiating LUTATHERA. Administer short-acting octreotide as needed; discontinue at least 24 hours prior to initiating LUTATHERA. |
| During treatment with LUTATHERA, administer long-acting octreotide 30 mg IM between 4 to 24 hours after each dose of LUTATHERA. Do not administer long-acting octreotide within 4 weeks prior to each subsequent dose of LUTATHERA. Short-acting octreotide may be given for symptomatic management during treatment with LUTATHERA but must be withheld at least 24 hours before each dose of LUTATHERA. |
| Following treatment with LUTATHERA, continue long-acting octreotide 30 mg IM every 4 weeks after completing LUTATHERA until disease progression or for 18 months following treatment initiation at the discretion of the physician. |
Antiemetics and Amino Acids
Patients treated with LUTATHERA in the NETTER-1 trial received an amino acid solution for renal protection.1,2
Premedication with antiemetics should be administered prior to the start of the amino acid solution infusion1
Initiate an IV infusion of a sterile amino acid solution containing L-lysine and L-arginine 30 minutes before the start of the LUTATHERA infusion. Use a 3-way valve to administer the amino acid solution using the same venous access as LUTATHERA or administer the amino acid solution through a separate venous access in the patient’s other arm. Continue the infusion during and for at least 3 hours after completion of the infusion of LUTATHERA1
– Do not decrease the dose of the amino acid solution if a reduced dose of LUTATHERA is administered1For more information about the amino acid solution, please refer to the full Prescribing Information for LUTATHERA
Hypersensitivity Prophylaxis
Premedicate patients who have had prior grade 1/2 hypersensitivity reactions to LUTATHERA. Do not re-challenge patients who experience grade 3/4 hypersensitivity reactions to LUTATHERA.1
Treatment Regimen
Before initiating LUTATHERA: Discontinue long-acting SSAs (eg, long-acting octreotide) for at least 4 weeks prior to initiating LUTATHERA. Administer short-acting octreotide as needed; discontinue at least 24 hours prior to initiating LUTATHERA.1
During LUTATHERA treatment: Administer long-acting octreotide 30 mg IM between 4 to 24 hours after each LUTATHERA dose. Do not administer long-acting octreotide within 4 weeks prior to each subsequent LUTATHERA dose. Short-acting octreotide may be given for symptomatic management during LUTATHERA treatment but must be withheld for at least 24 hours before each LUTATHERA dose.1
Following treatment with LUTATHERA, continue long-acting octreotide 30 mg IM every 4 weeks after completing LUTATHERA until disease progression or for 18 months following treatment initiation at the discretion of the physician.1
Long-acting SSAs should be discontinued at least 4 weeks prior to initiating LUTATHERA.1
Short-acting octreotide may be given for symptomatic management during treatment with LUTATHERA but must be withheld for at least 24 hours before each dose of LUTATHERA.1
LUTATHERA dosage should be modified based on hematologic, renal, hepatic, hypersensitivity, or other adverse reactions (see full Prescribing Information).1
For reduced dose administration instructions, refer to section 2.5 (Preparation and Administration) of the full Prescribing Information
aAdminister long-acting octreotide 30 mg IM between 4 to 24 hours after each dose of LUTATHERA. Do not administer long-acting octreotide within 4 weeks prior to each subsequent dose of LUTATHERA.1
– The interval between infusions may be extended up to 16 weeks in the case of a dose modification due to an adverse reaction.1 Permanently discontinue LUTATHERA in patients who experience grade 3/4 hypersensitivity reactions. Please see the Prescribing Information for additional information on dose modifications.
bContinue long-acting octreotide 30 mg IM every 4 weeks after completing LUTATHERA until disease progression or for 18 months following treatment initiation at the discretion of the physician.1
Infusion Schedule and Procedures
1. Pretreatment Antiemetic:
Premedication with antiemetics should be administered prior to the start of the amino acid solution infusion1
2. Concomitant Amino Acid Infusion1
Initiate an IV infusion of a sterile amino acid solution containing L-lysine and L-arginine 30 minutes before the start of the LUTATHERA infusion. Use a 3-way valve to administer the amino acid solution using the same venous access as LUTATHERA or administer the amino acid solution through a separate venous access in the patient’s other arm. Continue the infusion during and for at least 3 hours after the completion of the infusion of LUTATHERA1
– Do not decrease the dose of the amino acid solution if a reduced dose of LUTATHERA is administered1
Amino Acid Solution | |
Characteristic1 | Specification |
L-lysine HCI | Between 18 and 25 gc |
L-arginine HCI | Between 18 and 25 gd |
Volume | 1 to 2 L |
Osmolality | <1200 mOsmol/kg |
cEquivalent to 14.4 g to 20 g L-lysine.1
dEquivalent to 14.9 g to 20.7 g L-arginine.1
3. Hypersensitivity Prophylaxis1
Premedicate patients who have had prior grade 1/2 hypersensitivity reactions to LUTATHERA. Do not rechallenge patients who experience grade 3/4 hypersensitivity reactions to LUTATHERA
4. Administration of LUTATHERA Using the Gravity Method
7.4 GBq (200 mCi) of LUTATHERA is administered IV over 30 to 40 minutes with the gravity method1
– Do not inject LUTATHERA directly into any other IV solutionThe gravity method, peristaltic pump method, or the syringe pump method may be used for the administration of the recommended dosage. Use the peristaltic pump or syringe pump method when administering a reduced dose of LUTATHERA following a dosage modification for an adverse reaction. When using the gravity method for a reduced dose, adjust the LUTATHERA dose before the administration to avoid the delivery of an incorrect volume of LUTATHERA1
– For instructions on how to use the gravity method, peristaltic pump method, or the syringe pump method to administer LUTATHERA, please refer to the full Prescribing Information
Patient Management
Patient Management Before and During Treatment With LUTATHERA
Prescribing Information Directions |
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General Recommendationse |
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eThese are general recommendations provided by representatives from the NANETS and the SNMMI who collaborated to develop a practical consensus guideline for the administration of lutetium Lu 177 dotatate. This guidance is not required per the LUTATHERA package insert and is designed to provide practical guidance on how to safely treat patients with this therapy.2
Preparing your patient for treatment with LUTATHERA
The treatment center will provide patients with detailed instructions regarding their treatment procedures, including preparation and ways to avoid or minimize radiation exposure to household contacts
Dose Modifications
Recommended Dosage Modifications of LUTATHERA for Adverse Reactions1 |
Adverse | Thrombocytopenia |
Severity of | First occurrence of grade 2, 3, or 4 |
Dose |
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Adverse | Anemia and neutropenia |
Severity of | First occurrence of grade 3 or 4 |
Dose |
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Adverse | Renal toxicity |
Severity of | First occurrence of:
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Dose |
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Adverse | Hepatotoxicity |
Severity of | First occurrence of:
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Dose |
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Adverse | Hypersensitivity reactionsg |
Severity of | First occurrence of grade 3 or 4 |
Dose |
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Adverse | Any other adverse reactionh |
Severity of | First occurrence of grade 3 or 4 |
Dose |
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fGrading of severity is defined in the most current Common Terminology Criteria for Adverse Events (CTCAE).1
gIncluding allergic reaction and anaphylaxis.1
hNo dose modification required for hematological toxicities of grade 3 or grade 4 solely due to lymphopenia.
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; GBb, gigabecquerel; HCI, hydrochloride; IM, intramuscular; IV, intravenous; mCi, millicurie; NANETS, North American Neuroendocrine Tumor Society; SNMMI, Society of Nuclear Medicine and Molecular Imaging; SSA, somatostatin analog; WBC, white blood cell.