Version May 2024
Note: 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.
Prostate cancer, metastatic, castration resistant (PSMA-positive): IV: 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses (Ref), or until disease progression or unacceptable toxicity.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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 impairment may be at greater risk of toxicity.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Kidney toxicity during treatment (refer also to "Dosing: Adjustment for Toxicity"):
≥ Grade 2 confirmed serum creatinine increase or confirmed CrCl <30 mL/minute: Withhold lutetium Lu 177 vipivotide tetraxetan until improvement.
≥40% confirmed 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.
Hepatotoxicity during treatment (refer also to "Dosing: Adjustment for Toxicity"): AST or ALT elevation >5 times ULN (in the absence of liver metastases): Permanently discontinue lutetium Lu 177 vipivotide tetraxetan.
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, discontinue 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 serious 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 (39%), decreased serum sodium (33%), increased serum potassium (24%), increased serum sodium (11%), weight loss (11%)
Gastrointestinal: Abdominal pain (11%), constipation (20%), decreased appetite (21%), diarrhea (19%; grades 3/4: <1%), nausea (35%; grades 3/4: 1%), vomiting (19%; grades 3/4: <1%), xerostomia (39%)
Genitourinary: Urinary tract infection (12%; serious: 3%)
Hematologic & oncologic: Anemia (32%; grades 3/4: 13%), decreased neutrophils (28%; grades 3/4: 5%), leukopenia (56%; grades 3/4: 7%), lymphocytopenia (85%; grades 3/4: 47%), thrombocytopenia (17%; grades 3/4: 8%)
Hepatic: Increased serum aspartate aminotransferase (28%)
Nervous system: Fatigue (43%)
Renal: Increased serum creatinine (24%)
1% to 10%:
Cardiovascular: Peripheral edema (10%), pulmonary embolism (1%)
Gastrointestinal: Dysgeusia (7%)
Hematologic & oncologic: Hemorrhage (serious: 4%), pancytopenia (<5%; grades ≥3: 1%)
Infection: Sepsis (3%)
Nervous system: Dizziness (8%), headache (7%), spinal cord compression (1%), vertigo (<5%)
Neuromuscular & skeletal: Musculoskeletal pain (serious: 4%)
Ophthalmic: Dry eye syndrome (<5%)
Renal: Acute kidney injury (9%; serious: 2%)
Respiratory: Pneumonia (serious: 2%)
Miscellaneous: Fever (7%)
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.
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, and household contacts. 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 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): $54,621.00
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 infusion 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 by using a disposable syringe fitted with a syringe shield and a disposable sterile needle. 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. Follow administration 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 prefilled 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 saline line. Once the infusion is complete, flush the line with ≥10 mL NS.
Vial method (with a peristaltic infusion pump):
Insert a 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 infusion pump.
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 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.
Prefill 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. Prefill 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 prefilled 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 infusion pump. Infuse an appropriate volume of lutetium Lu 177 vipivotide tetraxetan solution at ~25 mL/hour. When the correct lutetium Lu 177 vipivotide tetraxetan radioactivity has been delivered, stop the infusion pump and then change the position of the 3-way stopcock valve so that the infusion pump is in line with the sterile NS solution. Restart the infusion pump and infuse an IV flush of ≥10 mL NS solution through the IV catheter to the patient.
Prostate cancer, metastatic, castration resistant: Treatment of prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer in adults who have been treated with androgen receptor pathway inhibition and 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 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
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
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
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. Verify pregnancy status prior to initiating therapy in patients who could become pregnant. 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 to 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.
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