Version May 2024
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 (Strosberg 2017).
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.
Hematologic toxicity
Anemia or neutropenia (grade 3 or 4): 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, administer 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, or for recurrent grade 3 or 4 anemia or neutropenia.
Thrombocytopenia (grade 2, 3, or 4): Withhold lutetium Lu 177 dotatate dose until ≤ grade 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, administer 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, or for recurrent grade 2, 3, or 4 thrombocytopenia.
Note: Dose modifications are not required for hematological toxicities grade 3 or 4 due to lymphopenia.
Hypersensitivity reactions (including allergic reaction and anaphylaxis): Discontinue lutetium Lu 177 dotatate infusion when signs/symptoms consistent with a severe hypersensitivity reaction occur and initiate appropriate management. Permanently discontinue lutetium Lu 177 dotatate for grade 3 or 4 hypersensitivity reactions.
Nonhematologic toxicity:
Grade 3 or 4 toxicity: 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 toxicity, administer lutetium Lu 177 dotatate at 7.4 GBq (200 mCi) for the next dose. Permanently discontinue lutetium Lu 177 dotatate for ≥ grade 3 adverse reaction requiring a treatment delay of ≥16 weeks, or for recurrent grade 3 or 4 toxicity.
Refer to adult dosing.
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%), renal failure syndrome (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: Angioedema, hypersensitivity reaction
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.
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): $67,075.20
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Lutathera: 370 MBq/mL (10 mCi/mL) (1 ea)
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. 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.
Gastroenteropancreatic neuroendocrine tumors: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults, including foregut, midgut, and hindgut neuroendocrine tumors.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 diminish the therapeutic effect 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 (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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
Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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 enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
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.
It is not known if lutetium Lu 177 dotatate is present in breast milk. Due to the potential for serious adverse events in the breastfed infant, the manufacturer does not recommend breastfeeding during therapy or for 2.5 months after the last dose.
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; administer in a setting where cardiopulmonary resuscitation medication and equipment are available.
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.
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