Version July 2025
Gastroenteropancreatic neuroendocrine tumors : Children ≥12 years and Adolescents: IV: 7.4 GBq (200 mCi) every 8 weeks (±1 week) for a total of 4 doses; in combination with an amino acid infusion and long-acting octreotide.
Supportive therapy medications for lutetium Lu 177 dotatate administration:
Somatostatin analogs:
Preparation for lutetium Lu 177 dotatate therapy: Discontinue long-acting somatostatin analogs (eg, long-acting octreotide) at least 4 weeks prior to initiating lutetium Lu 177 dotatate therapy. Administer short-acting octreotide in the interim as needed; discontinue at least 24 hours prior to initiating lutetium Lu 177 dotatate therapy.
Concomitant with lutetium Lu 177 dotatate therapy: Administer long-acting octreotide 30 mg IM between 4 to 24 hours after each lutetium Lu 177 dotatate dose. Do not administer long-acting octreotide within 4 weeks of each subsequent lutetium Lu 177 dotatate dose; short-acting octreotide may be given for symptomatic management, but discontinue at least 24 hours before each lutetium Lu 177 dotatate dose. Continue long-acting octreotide 30 mg IM every 4 weeks after completion of the full course of lutetium Lu 177 dotatate treatment until disease progression or for 18 months following treatment initiation as directed by the health care provider.
Amino acid solution: To decrease radiation dose to the kidneys, initiate amino acid IV infusion 30 minutes before administering lutetium Lu 177 dotatate. The solution should contain L-lysine HCl (18 to 25 g) and L-arginine HCl (18 to 25 g) in a total volume of 1 to 2 L with an osmolality of <1,200 mOsmol/kg. Continue the infusion during and for at least 3 hours after completion of the lutetium Lu 177 dotatate dose; do not decrease the dose of the amino acid solution if the dose of lutetium Lu 177 dotatate is reduced.
Antiemetic: Administer antiemetics before the recommended amino acid solution.
Hypersensitivity reaction prophylaxis: Premedicate if a prior grade 1 or 2 hypersensitivity reaction occurred with lutetium Lu 177 dotatate administration.
Dosage adjustment for toxicity:
Children ≥12 years and Adolescents: IV:
|
Adverse reactions |
Description/severity |
Dosage modification |
|---|---|---|
|
a Dosage adjustment not required for grade 3 or 4 hematologic toxicity related solely to lymphopenia. | ||
|
Anemia/neutropenia |
Grade 3 or 4 (first occurrence) |
Withhold lutetium Lu 177 dotatate dose until ≤ grade 2. Resume therapy at a reduced dose of 3.7 GBq (100 mCi) in patients with complete or partial resolution. If the reduced dose does not result in ≥ grade 3 anemia or neutropenia, increase to lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) for the next dose. Permanently discontinue lutetium Lu 177 dotatate for ≥ grade 3 anemia or neutropenia requiring a treatment delay of ≥16 weeks. |
|
Grade 3 or 4 (recurrent) |
Permanently discontinue lutetium Lu 177 dotatate. | |
|
Thrombocytopenia |
Grade 2, 3, or 4 (first occurrence) |
Withhold lutetium Lu 177 dotatate dose until grade 0 or 1. Resume therapy at a reduced dose of 3.7 GBq (100 mCi) in patients with complete or partial resolution. If the reduced dose does not result in ≥ grade 2 thrombocytopenia, increase to lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) for the next dose. Permanently discontinue lutetium Lu 177 dotatate for ≥ grade 2 thrombocytopenia requiring a treatment delay of ≥16 weeks. |
|
Grade 2, 3, or 4 (recurrent) |
Permanently discontinue lutetium Lu 177 dotatate. | |
|
Hypersensitivity reactions (including anaphylaxis and allergic reaction) |
Grade 3 or 4 (first occurrence) |
Permanently discontinue lutetium Lu 177 dotatate. |
|
Any other adverse reactiona |
Grade 3 or 4 (first occurrence) |
Withhold lutetium Lu 177 dotatate dose until ≤ grade 2. Resume therapy at a reduced dose of 3.7 GBq (100 mCi) in patients with complete or partial resolution. If the reduced dose does not result in ≥ grade 3 adverse reaction, increase to lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) for the next dose. Permanently discontinue lutetium Lu 177 dotatate for ≥ grade 3 adverse reactions requiring a treatment delay of ≥16 weeks. |
|
Grade 3 or 4 (recurrent) |
Permanently discontinue lutetium Lu 177 dotatate. | |
Note: Calculate CrCl using the Cockcroft-Gault equation with actual body weight.
Children ≥12 years and Adolescents: IV:
Baseline kidney impairment:
CrCl ≥30 mL/minute: No dosage adjustment necessary. Monitor renal function more frequently; patients may be at a greater risk of toxicity.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
End-stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Nephrotoxicity during treatment:
If any of the following occur (first occurrence): CrCl <40 mL/minute or 40% increase in serum creatinine from baseline or 40% decrease in CrCl from baseline:
Withhold lutetium Lu 177 dotatate dose until resolution or return to baseline. Resume therapy at a reduced dose of 3.7 GBq (100 mCi) in patients with resolution or return to baseline. If the reduced dose does not result in recurrent renal toxicity, administer lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) for the next dose. Permanently discontinue lutetium Lu 177 dotatate for renal toxicity requiring a treatment delay of ≥16 weeks, or for recurrent renal toxicity.
Children ≥12 years and Adolescents: IV:
Baseline liver impairment:
Mild or moderate impairment: No dosage adjustment is necessary.
Severe impairment (total bilirubin >3 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hepatotoxicity during treatment:
If any of the following occur (first occurrence): Total bilirubin >3 times ULN (grade 3 or 4) or serum albumin <30 g/L with INR >1.5:
Withhold lutetium Lu 177 dotatate dose until resolution or return to baseline; resume therapy at a reduced dose of 3.7 GBq (100 mCi) in patients with resolution or return to baseline. If the reduced dose does not result in recurrent hepatotoxicity, administer lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) for the next dose. Permanently discontinue lutetium Lu 177 dotatate for hepatotoxicity requiring a treatment delay of ≥16 weeks, or for recurrent hepatotoxicity.
(For additional information see "Lutetium Lu-177 dotatate: Drug information")
Note: Premedications and concomitant medications are required.
Gastroenteropancreatic neuroendocrine tumors: IV: 7.4 GBq (200 mCi) every 8 weeks (±1 week) for a total of 4 doses (Ref).
Premedication and concomitant medications:
Somatostatin analogs: Discontinue long-acting somatostatin analogs (eg, long-acting octreotide) at least 4 weeks prior to initiating lutetium Lu 177 dotatate therapy. Administer short-acting octreotide in the interim as needed, but discontinue at least 24 hours prior to initiating lutetium Lu 177 dotatate therapy. During lutetium Lu 177 dotatate therapy, administer long-acting octreotide 30 mg IM between 4 to 24 hours after each lutetium Lu 177 dotatate dose. Do not administer long-acting octreotide within 4 weeks of each subsequent lutetium Lu 177 dotatate dose; short-acting octreotide may be given for symptomatic management, but discontinue at least 24 hours before each lutetium Lu 177 dotatate dose. Continue long-acting octreotide 30 mg IM every 4 weeks after completion of the full course of lutetium Lu 177 dotatate treatment until disease progression or for 18 months following treatment initiation as directed by the healthcare provider.
Antiemetic: Administer antiemetics before the recommended amino acid solution.
Amino acid solution: Initiate an IV infusion of a sterile amino acid solution 30 minutes before administering lutetium Lu 177 dotatate. The solution should contain L-lysine (between 18 to 25 g) and L-arginine (between 18 to 25 g) in a total volume of 1 to 2 L and have an osmolarity of <1,050 mOsmol/L. Continue the infusion during and for at least 3 hours after completion of the lutetium Lu 177 dotatate dose; do not decrease the dose of the amino acid solution if the dose of lutetium Lu 177 dotatate is reduced. See "Administration".
Hypersensitivity reaction: Premedicate if a prior grade 1 or 2 hypersensitivity reaction occurred with lutetium Lu 177 dotatate administration. Do not rechallenge if a grade 3 or 4 hypersensitivity reaction occurred with a prior infusion.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: Calculate CrCl using the Cockcroft-Gault equation with actual body weight.
Renal impairment prior to treatment initiation:
CrCl ≥30 mL/minute: No dosage adjustment necessary. Monitor renal function more frequently; patients may be at a greater risk of toxicity.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
End-stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Renal toxicity during treatment:
CrCl <40 mL/minute, or 40% increase from baseline serum creatinine, or 40% decrease from baseline CrCl: Withhold lutetium Lu 177 dotatate dose until resolution or return to baseline; resume therapy at a reduced dose of 3.7 GBq (100 mCi) in patients with resolution or return to baseline. If the reduced dose does not result in renal toxicity, administer lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) for the next dose. Permanently discontinue lutetium Lu 177 dotatate for renal toxicity requiring a treatment delay of ≥16 weeks, or for recurrent renal toxicity.
Hepatic impairment prior to treatment initiation:
Mild or moderate impairment: No dosage adjustment is necessary.
Severe impairment (bilirubin >3 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hepatotoxicity during treatment:
Bilirubin >3 times ULN (grade 3 or 4) or albumin <30 g/L with INR >1.5: Withhold lutetium Lu 177 dotatate dose until resolution or return to baseline; resume therapy at a reduced dose of 3.7 GBq (100 mCi) in patients with resolution or return to baseline. If the reduced dose does not result in hepatotoxicity, administer lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) for the next dose. Permanently discontinue lutetium Lu 177 dotatate for hepatotoxicity requiring a treatment delay of ≥16 weeks, or for recurrent hepatotoxicity.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse drug reactions are reported for adults from combination therapy trials with octreotide.
>10%:
Cardiovascular: Flushing (14%), hypertension (12%), peripheral edema (16%)
Dermatologic: Alopecia (12%)
Endocrine & metabolic: Hyperglycemia (82%), hyperkalemia (19%), hypernatremia (17%), hyperuricemia (34%), hypocalcemia (32%), hypoglycemia (15%), hypokalemia (26%)
Gastrointestinal: Abdominal pain (26%), decreased appetite (21%), diarrhea (26%), nausea (65%), vomiting (53%)
Hematologic & oncologic: Anemia (81%), leukopenia (55%; grades 3/4: 2%), lymphocytopenia (90%; grades 3/4: 44%), neutropenia (26%; grades 3/4: 3%), thrombocytopenia (53%; grades 3/4: 1%)
Hepatic: Increased gamma-glutamyl transferase (66%), increased serum alanine aminotransferase (43%), increased serum alkaline phosphatase (65%), increased serum aspartate aminotransferase (50%), increased serum bilirubin (30%)
Nervous system: Anxiety (12%), dizziness (17%), fatigue (38%), headache (17%)
Neuromuscular & skeletal: Back pain (13%), limb pain (11%)
Renal: Increased serum creatinine (85%), kidney failure (13%)
Respiratory: Cough (11%)
1% to 10%:
Cardiovascular: Atrial fibrillation (5%)
Gastrointestinal: Constipation (10%), dysgeusia (8%)
Genitourinary: Urotoxicity (8%; radiation related)
Hematologic & oncologic: Myelodysplastic syndrome (2%)
Neuromuscular & skeletal: Myalgia (5%), neck pain (5%)
Miscellaneous: Fever (8%)
Postmarketing: Hypersensitivity: Hypersensitivity reaction (including angioedema)
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to lutetium Lu 177 dotatate or any component of the formulation; severe renal impairment (CrCl <30 mL/minute); pregnancy.
Concerns related to adverse effects:
• Bone marrow suppression: Myelosuppression (anemia, thrombocytopenia, and neutropenia [all grades]) occurred more frequently in patients receiving lutetium Lu 177 dotatate versus long-acting octreotide. In a clinical study, the platelet nadir occurred at a median of 5.1 months following the first lutetium Lu 177 dotatate dose. Over two-thirds of patients who developed thrombocytopenia recovered to baseline or normal platelet levels with a median platelet recovery time of 2 months.
• Hepatotoxicity: Hepatic effects have occurred with lutetium Lu 177 dotatate administration; hepatic tumor hemorrhage, edema, or necrosis, and intrahepatic congestion and cholestasis have been reported very rarely. Patients with hepatic metastasis may have an increased risk of hepatotoxicity due to radiation exposure from lutetium Lu 177 dotatate infusion.
• Hypersensitivity reactions: Hypersensitivity reactions, including angioedema, have been reported.
• Neuroendocrine hormonal crisis: Neuroendocrine hormonal crises (eg, flushing, diarrhea, bronchospasm, hypotension) have occurred (rarely) following the lutetium Lu 177 dotatate dose. Reactions typically occurred during or within 24 hours after the initial dose. Hypercalcemia was reported in a small number of patients.
• Renal toxicity: Renal failure has occurred following lutetium Lu 177 dotatate administration; the time to renal failure ranged from 3 to 36 months following infusion in one clinical trial. Some patients had underlying renal impairment or other risk factors for renal failure such as diabetes or hypertension. Administer concomitantly with a recommended amino acid solution before, during, and after lutetium Lu 177 dotatate infusion to decrease proximal tubule reabsorption (and decrease radiation exposure to the kidneys); do not decrease the dose of the amino acid solution if lutetium Lu 177 dotatate is dose reduced. Patients should hydrate and urinate frequently during and after lutetium Lu 177 dotatate infusion. Patients with baseline mild or moderate renal impairment may be at increased risk for renal toxicity following lutetium Lu 177 dotatate administration.
• Secondary malignancies: In clinical trials, myelodysplastic syndrome (MDS) and leukemia have been reported in a small percentage of patients who received lutetium Lu 177 dotatate. In one study, the median time to development was 29 months (range: 9 to 45 months) and 55 months (range: 32 to 125 months) for MDS and leukemia, respectively. Long-term cumulative radiation exposure is associated with an increased risk for cancer.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients, health care personnel, and household contacts. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. Radiation may be detected in the urine for up to 30 days following lutetium Lu 177 dotatate infusion; administration of this agent contributes to the patient's long-term cumulative radiation exposure which is associated with an increased cancer risk. Risks of radiation associated with lutetium Lu 177 dotatate are increased in pediatric patients.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Lutathera: 370 MBq/mL (10 mCi/mL) (1 ea)
No
Solution (Lutathera Intravenous)
370 mbq/ml (per each): $71,770.46
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Lutathera: 370 MBq/mL (10 mCi/mL) (1 ea)
Radiopharmaceutical; use appropriate precautions for handling and disposal. Administer in a setting where cardiopulmonary resuscitation medication and equipment are available.
IV: Administer as an IV infusion; do not administer as an IV bolus. Flush catheter with ≥10 mL NS to ensure patency and decrease extravasation risk prior to administration of lutetium Lu 177 dotatate. Three methods of administration may be used at recommended dose: gravity, peristaltic pump, or syringe pump method. If administering a reduced dose (ie, following an adverse reaction), administer by peristaltic or syringe pump method; when using the gravity method for a reduced dose, adjust the dose before administration to avoid delivery of an incorrect volume. Refer to product labeling for further details. Monitor for signs/symptoms of hypersensitivity during infusion and for at least 2 hours after infusion. Premedicate before infusion for patients who have had prior grade 1 or 2 hypersensitivity reactions with lutetium Lu 177 dotatate. Refer to manufacturer labeling for administration methods details and institutional protocol.
Amino acid solution: IV infusion: Administer antiemetic prior to amino acid infusion initiation. Use a 3-way valve to administer the amino acid solution starting 30 minutes prior to the lutetium Lu 177 dotatate infusion using the same venous access as the lutetium Lu 177 dotatate infusion, or administer the amino acid solution through a separate venous access in the patient's other arm. Continue the amino acid infusion during and for at least 3 hours after completion of the lutetium Lu 177 dotatate infusion.
IV: Administer as an IV infusion; do not administer as an IV bolus. Administer via the gravity, peristaltic pump, or syringe pump method when administering recommended dosage; for reduced dosages following an adverse reaction, administer by peristaltic or syringe pump method; when using the gravity method for a reduced dose, adjust the dose before administration to avoid delivery of an incorrect volume. Refer to product labeling for further details. Prior to administration, flush IV catheter with ≥10 mL of NS to ensure patency and decrease the risk of extravasation. Monitor for signs/symptoms of hypersensitivity during infusion and for at least 2 hours after infusion. Premedicate before infusion for patients who have had prior grade 1 or 2 hypersensitivity reactions with lutetium Lu 177 dotatate.
Gravity method:
Insert a 2.5 cm, 20-gauge needle (short needle) into the lutetium Lu 177 dotatate vial and connect via a catheter to a 500 mL sterile NS solution. Do not allow the short needle to touch the lutetium Lu 177 dotatate solution in the vial and do not connect this short needle to the patient. Do not allow NS to flow into the lutetium Lu 177 dotatate vial prior to infusion initiation and do not inject lutetium Lu 177 dotatate directly into the NS solution.
Insert a separate 9 cm, 18-gauge (long needle) into the lutetium Lu 177 dotatate vial; ensure that this long needle touches and is secured to the bottom of the lutetium Lu 177 dotatate vial during the entire infusion. Connect the long needle to the patient by an IV catheter that is prefilled with sterile NS solution and that is used only for the lutetium Lu 177 dotatate infusion into the patient.
Use a clamp or an infusion pump to regulate the flow of the NS solution via the short needle into the lutetium Lu 177 dotatate vial at a rate of 50 to 100 mL/hour for 5 to 10 minutes, and then 200 to 300 mL/hour for an additional 25 to 30 minutes. The NS solution (entering the vial through the short needle) will carry the lutetium Lu 177 dotatate solution from the vial to the patient through the IV catheter connected to the long needle (over a total duration of 30 to 40 minutes).
During the infusion, ensure that the level of solution in the lutetium Lu 177 dotatate vial remains constant. Once the level of radioactivity is stable for at least 5 minutes, disconnect the vial from the long needle line and clamp the NS line. Once the infusion is complete, flush the line with 25 mL NS.
Peristaltic pump method:
Insert a filtered 2.5 cm, 20-gauge needle (short venting needle) into the lutetium Lu 177 dotatate vial. Do not allow the short needle to touch the lutetium Lu 177 dotatate solution in the vial and do not connect this short needle directly to the patient or the peristaltic pump.
Insert a separate 9 cm, 18-gauge (long needle) into the lutetium Lu 177 dotatate vial; ensure that this long needle touches and is secured to the bottom of the lutetium Lu 177 dotatate vial during the entire infusion.
Connect the long needle and sterile NS solution to a 3-way stopcock valve via appropriate tubing. Connect the output of the 3-way stopcock valve to tubing installed on the input side of the peristaltic infusion pump according to manufacturer's instruction.
Prime the line by opening the 3-way stopcock valve and pumping the lutetium Lu 177 dotatate infusion through the tubing until it reaches the exit of the valve. Prime the IV catheter that will be connected to the patient by opening the 3-way stopcock valve to the sterile NS solution and pumping the sterile NS solution until it exits the end of the catheter tubing.
Connect the primed IV catheter to the patient and set the 3-way stopcock valve so that the lutetium Lu 177 dotatate infusion is in line with the peristaltic pump. Infuse an appropriate volume of lutetium Lu 177 dotatate over 30 to 40 minutes to administer the desired radioactivity. When the correct volume of lutetium Lu 177 dotatate infusion has been delivered, stop the peristaltic pump and then change the position of the 3-way stopcock valve so that the peristaltic pump is in line with the sterile NS solution. Restart the peristaltic pump and infuse an IV flush of 25 mL NS solution through the IV catheter to the patient.
Syringe pump method:
Use a disposable syringe fitted with a syringe shield and a disposable sterile 9 cm, 18-gauge (long needle) to withdraw the appropriate volume of lutetium Lu 177 dotatate to deliver the desired radioactivity; a filtered 2.5 cm, 20-gauge (short venting needle) may be used to aid in the withdrawal and reduce the resistance of the pressurized vial; ensure the short needle does not touch the lutetium Lu 177 dotatate solution in the vial.
Connect the syringe into the shielded pump and include a 3-way stopcock valve between the syringe and IV catheter prefilled with NS for lutetium Lu 177 dotatate for administration to the patient. Infuse an appropriate volume of lutetium Lu 177 dotatate over 30 to 40 minutes to administer the desired radioactivity.
When the correct volume of lutetium Lu 177 dotatate infusion has been delivered, stop the syringe pump and then change the position of the 3-way stopcock valve to flush the syringe with 25 mL of NS solution. Restart the syringe pump. After the flush of the syringe has completed, infuse an IV flush of 25 mL NS solution through the IV catheter to the patient.
Antiemetics: Administer antiemetics prior to amino acid solution.
Amino acid solution: Use a 3-way valve to administer the amino acid solution using the same venous access as the lutetium Lu 177 dotatate infusion, or administer the amino acid solution through a separate venous access in the patient's other arm. Continue the amino acid infusion during and for at least 3 hours after completion of the lutetium Lu 177 dotatate infusion.
Store at <25°C (77°F). The shelf life is 72 hours; discard appropriately at 72 hours. Store in original container; the product vial is in a lead shielded container placed in a plastic sealed container. Do not freeze.
Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) including foregut, midgut, and hindgut neuroendocrine tumors (FDA approved in ages ≥12 years and adults).
Lutathera may be confused with Lutera
Lutetium Lu 177 dotatate may be confused with Lutetium Lu 177 vipivotide tetraxetan.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and health care personnel. Use under supervision of experienced personnel. Use waterproof gloves and effective radiation shielding when handling.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
Corticosteroids (Systemic): May decrease therapeutic effects of Lutetium Lu 177 Dotatate. Management: Avoid repeated use of high-doses of corticosteroids during treatment with lutetium Lu 177 dotatate. Use of corticosteroids is still permitted for the treatment of neuroendocrine hormonal crisis. The effects of lower corticosteroid doses is unknown. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Somatostatin Analogs: May decrease therapeutic effects of Lutetium Lu 177 Dotatate. Specifically, the therapeutic effect of Lutetium Lu 177 Dotatate may be diminished if the timing of Somatostatin Analog administration is not carried out as recommended. Management: Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to lutetium Lu 177 dotatate dose. Administer short and long-acting octreotide during treatment as recommended. See full interaction monograph Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Evaluate pregnancy status prior to initiating therapy. Patients who could become pregnant should use effective contraception during therapy and for 7 months after the last dose. Patients with partners who could become pregnant should use effective contraception during therapy and for 4 months after the last dose.
Radiation associated with lutetium Lu 177 dotatate therapy may cause infertility in males and females, which may be temporary or permanent.
Based on the mechanism of action, lutetium Lu 177 dotatate may cause fetal harm if exposure occurs during pregnancy.
Monitor blood cell counts; serum creatinine and creatinine clearance (monitor more frequently in patients with baseline renal impairment); transaminases, bilirubin, and albumin. Verify pregnancy status prior to initiating therapy in patients who could become pregnant. Monitor for signs/symptoms of neuroendocrine hormonal crisis (eg, flushing, diarrhea, bronchospasm, hypotension) and secondary malignancies (myelodysplastic syndrome and leukemia). Monitor closely for signs/symptoms of hypersensitivity reactions (including angioedema and anaphylaxis) during and for a minimum of 2 hours following lutetium Lu 177 dotatate administration.
Lutetium Lu 177 dotatate is a beta- and gamma-emitting radionuclide which binds to somatostatin receptors (Strosberg 2017). It binds with highest affinity to subtype 2 receptors (SSRT2); after binding to somatostatin-expressing cells, the lutetium Lu 177 dotatate compound is internalized. Beta emission induces cellular damage by forming free radicals in somatostatin receptor-positive and surrounding cells.
Distribution: 460 L; lutetium Lu 177 dotatate distributes into kidneys, tumor lesions, liver, spleen, and (in some patients) pituitary gland and thyroid within 4 hours after administration. The maximum penetration into tissue is 2.2 mm (mean penetration: 0.67 mm).
Protein binding: Non-radioactive form of lutetium dotatate: 43% to plasma proteins.
Half-life elimination: Mean terminal blood half-life: 71 ± 28 hours.
Excretion: Primarily renal; prolonged elimination in the urine is expected; however, >99% of lutetium Lu 177 dotatate will be eliminated within 14 days after administration.
Clearance: 4.5 L/hour.
