Version July 2025
Dosage guidance:
Clinical considerations: Select patients for treatment with lutetium Lu 177 vipivotide tetraxetan based on prostate-specific membrane antigen (PSMA) expression in tumors (utilizing Gallium Ga 68 PSMA-11 or other appropriate PSMA positron emission tomography [PET]).
Prostate cancer, metastatic, castration resistant, PSMA positive (previously treated): IV: 7.4 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: CrCl calculated using the Cockcroft-Gault equation with actual body weight.
Altered kidney function prior to treatment initiation:
CrCl 30 to 89 mL/minute: No dosage adjustment is recommended; however, monitor kidney function frequently, as patients with mild or moderate kidney impairment may be at greater risk of toxicity.
CrCl <30 to 15 mL/minute and end-stage kidney disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Kidney toxicity during treatment:
Confirmed ≥ grade 2 SCr increase or confirmed CrCl <30 mL/minute: Withhold lutetium Lu 177 vipivotide tetraxetan until improvement.
Confirmed ≥40% increase from baseline serum creatinine and confirmed >40% decrease from baseline CrCl: Withhold lutetium Lu 177 vipivotide tetraxetan until improvement or return to baseline, then reduce dose to 5.9 GBq (160 mCi).
≥ Grade 3 kidney toxicity: Permanently discontinue lutetium Lu 177 vipivotide tetraxetan.
Recurrent kidney toxicity after one dose reduction: Permanently discontinue lutetium Lu 177 vipivotide tetraxetan.
Hepatic impairment prior to treatment initiation: There are no dosage adjustments provided in the manufacturer's labeling.
Note: Adverse reaction management may require temporary dose interruption, delay (extending the dosing interval from every 6 weeks up to every 10 weeks), dose reduction, or permanent discontinuation. If a treatment delay due to an adverse reaction persists for >4 weeks, consider permanent discontinuation of lutetium Lu 177 vipivotide tetraxetan. The lutetium Lu 177 vipivotide tetraxetan dose may be reduced one time by 20% (to 5.9 GBq [160 mCi]); do not re-escalate dose. If further adverse reactions occur that would necessitate an additional dose reduction, permanently discontinue lutetium Lu 177 vipivotide tetraxetan.
|
Adverse reaction |
Severity |
Dosage modification |
|---|---|---|
|
a ECOG = Eastern Cooperative Oncology Group. | ||
|
Hematologic toxicity | ||
|
Myelosuppression (anemia, thrombocytopenia, leukopenia, or neutropenia) |
Grade 2 |
Withhold lutetium Lu 177 vipivotide tetraxetan until improvement to grade 1 or baseline. |
|
≥ Grade 3 |
Withhold lutetium Lu 177 vipivotide tetraxetan until improvement to grade 1 or baseline, then resume with the dose reduced to 5.9 GBq (160 mCi). | |
|
Recurrent ≥ grade 3 myelosuppression (after one dose reduction) |
Permanently discontinue lutetium Lu 177 vipivotide tetraxetan. | |
|
Nonhematologic toxicity | ||
|
Dry mouth |
Grade 2 |
Withhold lutetium Lu 177 vipivotide tetraxetan until improvement or return to baseline. Consider reducing dose to 5.9 GBq (160 mCi). |
|
Grade 3 |
Withhold lutetium Lu 177 vipivotide tetraxetan until improvement or return to baseline, then resume with the dose reduced to 5.9 GBq (160 mCi). | |
|
Recurrent grade 3 dry mouth (after one dose reduction) |
Permanently discontinue lutetium Lu 177 vipivotide tetraxetan. | |
|
Electrolyte or metabolic abnormalities |
≥ Grade 2 |
Withhold lutetium Lu 177 vipivotide tetraxetan until improvement to grade 1 or baseline. |
|
Fatigue |
≥ Grade 3 |
Withhold lutetium Lu 177 vipivotide tetraxetan until improvement to grade 2 or baseline. |
|
GI toxicity |
≥ Grade 3 (not amenable to medical intervention) |
Withhold lutetium Lu 177 vipivotide tetraxetan until improvement to grade 2 or baseline, then resume with the dose reduced to 5.9 GBq (160 mCi). |
|
Recurrent ≥ grade 3 GI toxicity (after one dose reduction) |
Permanently discontinue lutetium Lu 177 vipivotide tetraxetan. | |
|
Other nonhematologic toxicity |
Any unacceptable toxicity |
Permanently discontinue lutetium Lu 177 vipivotide tetraxetan. |
|
Any adverse reaction that requires treatment delay of >4 weeks |
Permanently discontinue lutetium Lu 177 vipivotide tetraxetan. | |
|
Any recurrent grade 3 or 4 or persistent and intolerable grade 2 adverse reaction (after one dose reduction) |
Permanently discontinue lutetium Lu 177 vipivotide tetraxetan. | |
|
Canadian labeling: Additional adverse reactions (not in US labeling) | ||
|
Fracture (weight-bearing bones) |
Any |
Withhold lutetium Lu 177 vipivotide tetraxetan until the fracture has been adequately stabilized/treated and ECOGa performance status has stabilized. |
|
Spinal cord compression |
Any |
Withhold lutetium Lu 177 vipivotide tetraxetan until the compression has been adequately treated, neurological sequela have stabilized, and ECOGa performance status has stabilized. |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Endocrine & metabolic: Decreased serum calcium (18% to 34%), decreased serum sodium (11% to 34%), hypermagnesemia (19%), increased serum potassium (24%), increased serum sodium (11%), weight loss (11%)
Gastrointestinal: Abdominal pain (12%), constipation (20% to 22%), decreased appetite (21% to 22%), diarrhea (17% to 19%; grades 3/4: <1%), nausea (32% to 36%; grades 3/4: 1%), vomiting (11% to 19%; grades 3/4: <1%), xerostomia (39% to 61%)
Genitourinary: Urinary tract infection (12%)
Hematologic & oncologic: Decreased hemoglobin (64% to 67%; grade 3: 7% to 15%), decreased neutrophils (28% to 38%; grades 3/4: 4% to 5%), decreased platelet count (30% to 45%; grades 3/4: 3% to 9%), lymphocytopenia (78% to 85%; grades 3/4: 27% to 47%)
Hepatic: Increased serum alkaline phosphatase (31%), increased serum aspartate aminotransferase (29%)
Nervous system: Fatigue (48% to 53%)
Neuromuscular & skeletal: Arthralgia (20% to 22%), back pain (14% to 24%), ostealgia (11%)
Renal: Decreased estimated GFR (eGFR) (23% to 43%)
1% to 10%:
Cardiovascular: Peripheral edema (10%)
Dermatologic: Xeroderma (<10%)
Endocrine & metabolic: Decreased serum potassium (6%)
Gastrointestinal: Dysgeusia (<10%), dysphagia (<10%), esophagitis (<10%), gastroesophageal reflux disease (<10%), oral candidiasis (<10%), stomatitis (<10%)
Hematologic & oncologic: Bone marrow failure (<10%), leukopenia (grades 3/4: 4% to 7%), pancytopenia (<10%; grades ≥3: 1%)
Infection: Sepsis (1% to 3%)
Nervous system: Dizziness (<10%), headache (<10%), vertigo (<10%)
Ophthalmic: Dry eye syndrome (<10%)
Renal: Acute kidney injury (<10%)
Miscellaneous: Fever (<10%)
Frequency not defined:
Cardiovascular: Pulmonary embolism
Hematologic & oncologic: Hemorrhage
Nervous system: Spinal cord compression
Neuromuscular & skeletal: Musculoskeletal pain
Respiratory: Pneumonia
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to lutetium Lu 177 vipivotide tetraxetan or any component of the formulation.
Concerns related to adverse effects:
• Bone marrow suppression: Lutetium Lu 177 vipivotide tetraxetan may cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia; grade 3 and 4 events have occurred, as well as ≥ grade 3 pancytopenia (with fatal cases). Deaths due to sepsis and concurrent neutropenia and thrombocytopenia-associated intracranial hemorrhage and subdural hematoma were reported.
• Kidney toxicity: Lutetium Lu 177 vipivotide tetraxetan may cause severe kidney toxicity; grade 3 or 4 acute kidney injury and increased creatinine have been observed. Patients should be well hydrated and urinate frequently before and after lutetium Lu 177 vipivotide tetraxetan administration.
Special populations:
• Older age: A higher incidence of ≥ grade 3 or serious adverse events were reported in patients ≥75 years of age (compared to patients <75 years of age).
Other warnings/precautions:
• Appropriate use: Select patients for treatment with lutetium Lu 177 vipivotide tetraxetan based on prostate-specific membrane antigen (PSMA) expression in tumors. Refer to Gallium Ga 68 PSMA-11 monograph for further information.
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients, health care personnel, household contacts, and others. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority. Following lutetium Lu 77 vipivotide tetraxetan administration, patients should limit close contact (<3 feet) with household contacts and others for 2 days or with children and people who are pregnant for 7 days; advise patients to refrain from sexual activity for 7 days; patients should sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from people who are pregnant for 15 days. Administration of this agent contributes to the patient's long-term 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]:
Pluvicto: 1000 MBq/mL (1 ea)
No
Solution (Pluvicto Intravenous)
1000 mbq/ml (per each): $58,444.48
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:
Pluvicto: 1000 MBq/mL (1 ea)
IV: Administer as a slow IV push or an IV infusion. May administer via an injection (using a disposable syringe fitted with a syringe shield with or without a syringe pump), as an infusion using the gravity method (with or without an infusion pump), or as an infusion using the vial (with a peristaltic pump) when administering recommended initial dosage; for reduced dosages following an adverse reaction, administer only by the syringe method or the vial method (using gravity method for reduced doses may result in incorrect volume). Refer to product labeling for further details. Flush infusion line with at least 10 mL NS prior to lutetium Lu 177 vipivotide tetraxetan administration to assess catheter patency and to minimize risk of extravasation. Do not infuse other medications through the same IV line. Advise patients to increase oral fluid intake and to void frequently to reduce bladder radiation.
Per the study protocol, mild nausea and vomiting may occur with lutetium Lu 177 vipivotide tetraxetan administration; antiemetic treatment with an oral or IV serotonin antagonist and/or dexamethasone is recommended prior to infusion (Ref).
Syringe method (with or without a syringe pump):
Withdraw the appropriate lutetium Lu 177 vipivotide tetraxetan volume (for desired radioactivity) by using a disposable syringe fitted with a syringe shield and a disposable sterile, 9 cm, 18-gauge (long) needle; a filtered 2.5 cm, 20-gauge (short) needle may also be used to reduce resistance (ensure short needle does not touch solution in vial). Administer by slow IV push over ~1 to 10 minutes (either with a syringe pump or manually without a syringe pump) via an IV catheter that is prefilled with NS and that is used solely for lutetium Lu 177 vipivotide tetraxetan administration.
If using a syringe pump, fit the syringe into the shielded pump and include a 3-way stopcock valve between the syringe and an IV catheter that is primed with NS and that is used solely for lutetium Lu 177 vipivotide tetraxetan administration. Stop the syringe pump and change the position of the 3-way stopcock to flush the syringe with 25 mL of NS when the desired dose of lutetium Lu 177 vipivotide tetraxetan has been delivered.
Follow administration (either with a syringe pump or manually without a syringe pump) with an IV flush ≥10 mL NS through the IV catheter.
Gravity method (with or without an infusion pump):
Insert a 2.5 cm, 20-gauge (short) needle into the lutetium Lu 177 vipivotide tetraxetan 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 vipivotide tetraxetan 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 vipivotide tetraxetan vial prior to infusion initiation and do not inject lutetium Lu 177 vipivotide directly into the NS solution.
Insert a separate 9 cm, 18-gauge (long) needle into the lutetium Lu 177 vipivotide tetraxetan vial; ensure that this long needle touches and is secured to the bottom of the lutetium Lu 177 vipivotide tetraxetan vial during the entire infusion. Connect the long needle to the patient by an IV catheter that is primed with sterile NS solution and that is used only for the lutetium Lu 177 vipivotide tetraxetan infusion into the patient.
Use a clamp or infusion pump to regulate the flow of the NS solution via the short needle into the lutetium Lu 177 vipivotide tetraxetan vial. The NS solution (entering the vial through the short needle) will carry the lutetium Lu 177 vipivotide tetraxetan from the vial to the patient through the IV catheter connected to the long needle within ~30 minutes.
During the infusion, ensure that the level of solution in the lutetium Lu 177 vipivotide tetraxetan 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 ≥10 mL NS.
Vial method (with a peristaltic pump):
Insert a filtered 2.5 cm, 20-gauge needle (short venting needle) into the lutetium Lu 177 vipivotide tetraxetan vial. Do not allow the short needle to touch the lutetium Lu 177 vipivotide tetraxetan solution in the vial and do not connect this short needle directly to the patient or peristaltic pump.
Insert a second separate 9 cm, 18-gauge (long) needle into the lutetium Lu 177 vipivotide tetraxetan vial; ensure that this long needle touches and is secured to the bottom of the lutetium Lu 177 vipivotide tetraxetan 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 pump according to manufacturer's instruction.
Prime the line by opening the 3-way stopcock valve and pumping the lutetium Lu 177 vipivotide tetraxetan 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 vipivotide tetraxetan infusion is in line with the peristaltic pump. Infuse an appropriate volume of lutetium Lu 177 vipivotide tetraxetan solution at ~25 mL/hour to deliver the desired radioactivity. When the correct lutetium Lu 177 vipivotide tetraxetan radioactivity 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 ≥10 mL NS solution through the IV catheter to the patient.
Prostate cancer, metastatic, castration resistant, PSMA positive: Treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer in adults who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy or have received previous taxane-based chemotherapy.
Lutetium Lu 177 vipivotide tetraxetan may be confused with lutetium Lu 177 dotatate.
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.
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
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
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
Patients with partners who could become pregnant should use effective contraception during treatment and for 14 weeks after the last dose of lutetium Lu 177 vipivotide tetraxetan. Following administration of lutetium Lu 177 vipivotide tetraxetan, refrain from sexual activity for 7 days.
Lutetium Lu 177 vipivotide tetraxetan is absorbed into the testes. Following exposure to the recommended cumulative dose, fertility may be temporarily or permanently impaired.
Animal reproduction studies have not been conducted. Based on the mechanism of action, in utero exposure to lutetium Lu 177 vipivotide tetraxetan may cause fetal harm.
Pregnant persons should avoid close contact with treated patients. Patients undergoing treatment should limit close contact (<3 feet) to pregnant persons for 7 days after a dose of lutetium Lu 177 vipivotide tetraxetan. In addition, patients undergoing treatment should not sleep in the same bedroom as pregnant persons for 15 days after a dose of lutetium Lu 177 vipivotide tetraxetan.
It is not known if lutetium Lu 177 vipivotide tetraxetan is present in breast milk.
Prostate-specific membrane antigen (PSMA) expression (in tumors). CBC before and during treatment; serum creatinine and creatinine clearance before and during treatment; LFTs. Monitor hydration status and for signs/symptoms of infection and myelosuppression.
Following lutetium Lu 77 vipivotide tetraxetan administration, patients should limit close contact (<3 feet) with household contacts for 2 days or with children and people who are pregnant for 7 days; advise patients to refrain from sexual activity for 7 days; patients should sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from people who are pregnant for 15 days.
Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent. The radionuclide lutetium-177 is linked to a moiety that binds to prostate-specific membrane antigen (PSMA), a transmembrane glutamate carboxypeptidase that is highly expressed on prostate cancer cells (Sartor 2021). When lutetium Lu 177 vipivotide tetraxetan binds to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to the PSMA-expressing cells, resulting in DNA damage and cell death.
Distribution: Vd: 123 L; lutetium Lu 177 vipivotide tetraxetan distributes in the GI tract, liver, lungs, kidneys, heart wall, bone marrow, and salivary glands within 2.5 hours after administration.
Protein binding: Plasma: 60% to 70%.
Half-life elimination: 41.6 hours.
Excretion: Primarily renal; Clearance: 2.04 L/hour.
Altered kidney function: Lutetium Lu 177 vipivotide tetraxetan exposure increased with decreasing CrCl.
