Lutetium lu-177 vipivotide tetraxetan
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Radioligand Therapeutic Agent
Dosing in kidney impairment
GBq (160 mCi). Grade ≥ 3 renal toxicity Permanently discontinue PLUVICTO. Recurrent renal toxicity after one dose reduction Permanently discontinue PLUVICTO. Dry mouth [see Adverse Reactions] Grade 2 Withhold PLUVICTO until improvement or return to baseline. Consider reducing PLUVICTO dose by 20% to
Kidneys 0.42 0.19 3.1 1.4 19
| Abbreviations: CLcr, creatinine clearance; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ULN, upper limit of normal. Grading according to most current Common Terminology Criteria for Adverse Events (CTCAE). | ||
| Adverse reaction | Severity | Dosage modification |
| Myelosuppression (Anemia, thrombocytopenia, leukopenia, or neutropenia) [see Warnings and Precautions (5.2)] | Grade 2 | Withhold PLUVICTO until improvement to Grade 1 or baseline. |
| Grade ≥ 3 | Withhold PLUVICTO until improvement to Grade 1 or baseline. Reduce PLUVICTO dose by 20% to 5.9 GBq (160 mCi). | |
| Recurrent Grade ≥ 3 myelosuppression after one dose reduction | Permanently discontinue PLUVICTO. | |
| Renal toxicity [see Warnings and Precautions (5.3)] | Defined as: Confirmed serum creatinine increase (Grade ≥ 2)Confirmed CLcr < 30 mL/min; calculate using Cockcroft-Gault with actual body weight | Withhold PLUVICTO until improvement. |
| Defined as: Confirmed ≥ 40% increase from baseline serum creatinine andConfirmed > 40% decrease from baseline CLcr; calculate using Cockcroft-Gault with actual body weight | Withhold PLUVICTO until improvement or return to baseline. Reduce PLUVICTO dose by 20% to 5.9 GBq (160 mCi). | |
| Grade ≥ 3 renal toxicity | Permanently discontinue PLUVICTO. | |
| Recurrent renal toxicity after one dose reduction | Permanently discontinue PLUVICTO. | |
| Dry mouth [see Adverse Reactions (6.1)] | Grade 2 | Withhold PLUVICTO until improvement or return to baseline. Consider reducing PLUVICTO dose by 20% to 5.9 GBq (160 mCi). |
| Grade 3 | Withhold PLUVICTO until improvement or return to baseline. Reduce PLUVICTO dose by 20% to 5.9 GBq (160 mCi). | |
| Recurrent Grade 3 dry mouth after one dose reduction | Permanently discontinue PLUVICTO. | |
| Gastrointestinal toxicity [see Adverse Reactions (6.1)] | Grade ≥ 3 (not amenable to medical intervention) | Withhold PLUVICTO until improvement to Grade 2 or baseline. Reduce PLUVICTO dose by 20% to 5.9 GBq (160 mCi). |
| Recurrent Grade ≥ 3 gastrointestinal toxicity after one dose reduction | Permanently discontinue PLUVICTO. | |
| Fatigue [see Adverse Reactions (6.1)] | Grade ≥ 3 | Withhold PLUVICTO until improvement to Grade 2 or baseline. |
| Electrolyte or metabolic abnormalities [see Adverse Reactions (6.1)] | Grade ≥ 2 | Withhold PLUVICTO until improvement to Grade 1 or baseline. |
| Other non-hematologic toxicity [see Adverse Reactions (6.1)] | Any unacceptable toxicity | Permanently discontinue PLUVICTO. |
| Any adverse reaction that requires treatment delay of > 4 weeks | Permanently discontinue PLUVICTO. | |
| Any recurrent Grade 3 or 4 or persistent and intolerable Grade 2 adverse reaction after one dose reduction | Permanently discontinue PLUVICTO. | |
| aRadiation absorbed dose estimates were derived using OLINDA v2.4 radiation dosimetry software, using measured time-activity data from patient imaging as input. Specific methods and software used for bone marrow and osteogenic cells dosimetry estimates are included below: *Estimated radiation absorbed dose based on activity measured in blood samples collected from patients, and dosimetry calculations using OLINDA v2.4. **Estimated radiation absorbed dose based on activity measured in patient imaging (voxelized analysis of measured activity in bone marrow regions approximately 1 cm adjacent to bone metastasis activity within the vertebrae T8-L5) from 81 individual volume of interest (VOI) collected from 28 patients, and dosimetry calculations using Hermia Voxel Dosimetry v3.1.0. | ||||||
| Absorbed dose per unit activity (Gy/GBq) N = 29 | Calculated absorbed dose for 7.4 GBq administration (Gy) | Calculated absorbed dose for 6 x 7.4 GBq (44.4 GBq cumulative activity) (Gy) | ||||
| Organ | Mean | SD | Mean | SD | Mean | SD |
| Adrenals | 0.033 | 0.026 | 0.25 | 0.19 | 1.5 | 1.1 |
| Brain | 0.0069 | 0.0051 | 0.051 | 0.038 | 0.30 | 0.23 |
| Esophagus | 0.025 | 0.026 | 0.18 | 0.19 | 1.1 | 1.2 |
| Eyes | 0.022 | 0.025 | 0.16 | 0.18 | 0.98 | 1.1 |
| Gallbladder wall | 0.028 | 0.026 | 0.21 | 0.19 | 1.3 | 1.2 |
| Heart wall | 0.17 | 0.12 | 1.3 | 0.88 | 7.8 | 5.3 |
| Kidneys | 0.42 | 0.19 | 3.1 | 1.4 | 19 | 8.4 |
| Lacrimal glands | 2.1 | 0.48 | 15 | 3.6 | 92 | 21 |
| Left colon | 0.58 | 0.14 | 4.3 | 1.0 | 26 | 6.1 |
| Liver | 0.093 | 0.050 | 0.69 | 0.37 | 4.1 | 2.2 |
| Lungs | 0.11 | 0.11 | 0.78 | 0.83 | 4.7 | 5.0 |
| Osteogenic cells: | ||||||
| -blood-based* | 0.036 | 0.029 | 0.26 | 0.21 | 1.6 | 1.3 |
| -image-based** | 0.048 | 0.038 | 0.36 | 0.28 | 2.1 | 1.7 |
| Pancreas | 0.027 | 0.026 | 0.20 | 0.19 | 1.2 | 1.2 |
| Prostate | 0.027 | 0.026 | 0.20 | 0.19 | 1.2 | 1.2 |
| Rectum | 0.56 | 0.14 | 4.1 | 1.1 | 25 | 6.3 |
| Red marrow: | ||||||
| -blood-based* | 0.035 | 0.020 | 0.26 | 0.15 | 1.5 | 0.91 |
| -image-based** | 0.055 | 0.046 | 0.41 | 0.34 | 2.5 | 2.1 |
| Right colon | 0.32 | 0.079 | 2.4 | 0.58 | 14 | 3.5 |
| Salivary glands | 0.63 | 0.37 | 4.6 | 2.7 | 28 | 16 |
| Small intestine | 0.071 | 0.031 | 0.52 | 0.23 | 3.1 | 1.4 |
| Spleen | 0.061 | 0.028 | 0.45 | 0.21 | 2.7 | 1.2 |
| Stomach wall | 0.025 | 0.026 | 0.19 | 0.19 | 1.1 | 1.2 |
| Testes | 0.023 | 0.025 | 0.17 | 0.19 | 1.0 | 1.1 |
| Thymus | 0.024 | 0.026 | 0.18 | 0.19 | 1.1 | 1.2 |
| Thyroid | 0.26 | 0.37 | 1.9 | 2.8 | 11 | 17 |
| Total body | 0.037 | 0.027 | 0.28 | 0.20 | 1.7 | 1.2 |
| Urinary bladder wall | 0.32 | 0.025 | 2.4 | 0.19 | 14 | 1.1 |
Dosing in liver impairment
Liver 0.093 0.050 0.69 0.37 4.1
Preparation and administration
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Your numbers for lutetium lu-177 vipivotide tetraxetan. Take vial strength, diluent, and limits from the label below.
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Preparation and Administration Preparation Instructions Use aseptic technique and radiation shielding when handling or administering PLUVICTO, using tongs as needed to minimize radiation exposure. Inspect the product visually under a shielded screen for particulate matter and discoloration prior to administration. Discard the vial if particulates and/or discoloration are present.
Do not inject the PLUVICTO solution directly into any other intravenous solution. Confirm the amount of radioactivity of PLUVICTO delivered to the patient with an appropriately calibrated dose calibrator prior to and after each PLUVICTO administration. Dispose of any unused medicinal product or waste material in accordance with local and federal laws.
Administration Instructions Prior to administration, flush the intravenous catheter used exclusively for PLUVICTO administration with ≥ 10 mL of 0.9% Sodium Chloride Injection, USP to ensure patency and to minimize the risk of extravasation. Manage cases of extravasation as per institutional guidelines. The recommended dosage of PLUVICTO may be administered intravenously as an injection using the syringe method, as an infusion using the gravity method, or as an infusion using the peristaltic pump method.
When using the gravity or peristaltic pump method, infuse PLUVICTO directly from its original container. Use the syringe method or the peristaltic pump method when administering a reduced dose of PLUVICTO following a dosage modification for an adverse reaction. When using the gravity method for a reduced dose, adjust the PLUVICTO dose before the administration to avoid the delivery of an incorrect volume of PLUVICTO.
Intravenous Methods of Administration Instructions for the Syringe Method Withdraw an appropriate volume of PLUVICTO solution to deliver the desired radioactivity by using a disposable syringe fitted with a syringe shield and a disposable sterile needle that is 9 cm, 18 gauge (long needle). To aid the withdrawal of the solution, a filtered 2.5 cm, 20 gauge needle (short venting needle) can be used to reduce the resistance from the pressurized vial.
Ensure that the short needle does not touch the PLUVICTO solution in the vial. Administer PLUVICTO to the patient by slow intravenous push within approximately 1 to 10 minutes (either with a syringe pump or manually without a syringe pump) via an intravenous catheter that is primed with 0.9% Sodium Chloride Injection, USP and that is used exclusively for PLUVICTO administration to the patient.
If using a syringe pump, fit the syringe into the shielded pump and include a 3-way stopcock valve between the syringe and an intravenous catheter primed with 0.9% Sodium Chloride Injection, USP and used for PLUVICTO administration to the patient. When the desired PLUVICTO radioactivity 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 0.9% Sodium Chloride Injection, USP.
Restart the syringe pump. After the flush of the syringe has been completed, perform an intravenous flush of ≥ 10 mL of 0.9% Sodium Chloride Injection, USP through the intravenous catheter to the patient. Instructions for the Gravity Method Insert a 2.5 cm, 20 gauge needle (short needle) into the PLUVICTO vial and connect via a catheter to 500 mL 0.9% Sodium Chloride Injection, USP (used to transport the PLUVICTO solution during the infusion).
Ensure that the short needle does not touch the PLUVICTO solution in the vial and do not connect the short needle directly to the patient. Do not allow the 0.9% Sodium Chloride Injection, USP to flow into the PLUVICTO vial prior to the initiation of the PLUVICTO infusion and do not inject the PLUVICTO solution directly into the 0.9% Sodium Chloride Injection, USP.
Insert a second needle that is 9 cm, 18 gauge (long needle) into the PLUVICTO vial, ensuring that the long needle touches and is secured to the bottom of the PLUVICTO vial during the entire infusion. Connect the long needle to the patient by an intravenous catheter that is primed with 0.9% Sodium Chloride Injection, USP and that is used exclusively for the PLUVICTO infusion into the patient.
Use a clamp or an infusion pump to regulate the flow of the 0.9% Sodium Chloride Injection, USP via the short needle into the PLUVICTO vial (the 0.9% Sodium Chloride Injection, USP entering the vial through the short needle will carry the PLUVICTO solution from the vial to the patient via the intravenous catheter connected to the long needle within approximately 30 minutes).
During the infusion, ensure that the level of solution in the PLUVICTO vial remains constant. Disconnect the vial from the long needle line and clamp the 0.9% Sodium Chloride Injection, USP line once the level of radioactivity is stable for at least five minutes. Follow the infusion with an intravenous flush of ≥ 10 mL of 0.9% Sodium Chloride Injection, USP through the intravenous catheter to the patient.
Instructions for the Peristaltic Pump Method Insert a filtered 2.5 cm, 20 gauge needle (short venting needle) into the PLUVICTO vial. Ensure that the short needle does not touch the PLUVICTO solution in the vial and do not connect the short needle directly to the patient or to the peristaltic pump. Insert a second needle that is 9 cm, 18 gauge (long needle) into the PLUVICTO vial, ensuring that the long needle touches and is secured to the bottom of the PLUVICTO vial during the entire infusion.
Connect the long needle and a 0.9% Sodium Chloride Injection, USP 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 instructions. Prime the line by opening the 3-way stopcock valve and pumping the PLUVICTO solution through the tubing until it reaches the exit of the valve.
Prime the intravenous catheter which will be connected to the patient by opening the 3-way stopcock valve to the 0.9% Sodium Chloride Injection, USP and pumping the 0.9% Sodium Chloride Injection, USP until it exits the end of the catheter tubing. Connect the primed intravenous catheter to the patient and set the 3-way stopcock valve such that the PLUVICTO solution is in line with the peristaltic pump.
Infuse an appropriate volume of PLUVICTO solution at approximately 25 mL/h to deliver the desired radioactivity. When the desired PLUVICTO 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 0.9% Sodium Chloride Injection, USP.
Restart the peristaltic pump and infuse an intravenous flush of ≥ 10 mL of 0.9% Sodium Chloride Injection, USP through the intravenous catheter to the patient.
| aRadiation absorbed dose estimates were derived using OLINDA v2.4 radiation dosimetry software, using measured time-activity data from patient imaging as input. Specific methods and software used for bone marrow and osteogenic cells dosimetry estimates are included below: *Estimated radiation absorbed dose based on activity measured in blood samples collected from patients, and dosimetry calculations using OLINDA v2.4. **Estimated radiation absorbed dose based on activity measured in patient imaging (voxelized analysis of measured activity in bone marrow regions approximately 1 cm adjacent to bone metastasis activity within the vertebrae T8-L5) from 81 individual volume of interest (VOI) collected from 28 patients, and dosimetry calculations using Hermia Voxel Dosimetry v3.1.0. | ||||||
| Absorbed dose per unit activity (Gy/GBq) N = 29 | Calculated absorbed dose for 7.4 GBq administration (Gy) | Calculated absorbed dose for 6 x 7.4 GBq (44.4 GBq cumulative activity) (Gy) | ||||
| Organ | Mean | SD | Mean | SD | Mean | SD |
| Adrenals | 0.033 | 0.026 | 0.25 | 0.19 | 1.5 | 1.1 |
| Brain | 0.0069 | 0.0051 | 0.051 | 0.038 | 0.30 | 0.23 |
| Esophagus | 0.025 | 0.026 | 0.18 | 0.19 | 1.1 | 1.2 |
| Eyes | 0.022 | 0.025 | 0.16 | 0.18 | 0.98 | 1.1 |
| Gallbladder wall | 0.028 | 0.026 | 0.21 | 0.19 | 1.3 | 1.2 |
| Heart wall | 0.17 | 0.12 | 1.3 | 0.88 | 7.8 | 5.3 |
| Kidneys | 0.42 | 0.19 | 3.1 | 1.4 | 19 | 8.4 |
| Lacrimal glands | 2.1 | 0.48 | 15 | 3.6 | 92 | 21 |
| Left colon | 0.58 | 0.14 | 4.3 | 1.0 | 26 | 6.1 |
| Liver | 0.093 | 0.050 | 0.69 | 0.37 | 4.1 | 2.2 |
| Lungs | 0.11 | 0.11 | 0.78 | 0.83 | 4.7 | 5.0 |
| Osteogenic cells: | ||||||
| -blood-based* | 0.036 | 0.029 | 0.26 | 0.21 | 1.6 | 1.3 |
| -image-based** | 0.048 | 0.038 | 0.36 | 0.28 | 2.1 | 1.7 |
| Pancreas | 0.027 | 0.026 | 0.20 | 0.19 | 1.2 | 1.2 |
| Prostate | 0.027 | 0.026 | 0.20 | 0.19 | 1.2 | 1.2 |
| Rectum | 0.56 | 0.14 | 4.1 | 1.1 | 25 | 6.3 |
| Red marrow: | ||||||
| -blood-based* | 0.035 | 0.020 | 0.26 | 0.15 | 1.5 | 0.91 |
| -image-based** | 0.055 | 0.046 | 0.41 | 0.34 | 2.5 | 2.1 |
| Right colon | 0.32 | 0.079 | 2.4 | 0.58 | 14 | 3.5 |
| Salivary glands | 0.63 | 0.37 | 4.6 | 2.7 | 28 | 16 |
| Small intestine | 0.071 | 0.031 | 0.52 | 0.23 | 3.1 | 1.4 |
| Spleen | 0.061 | 0.028 | 0.45 | 0.21 | 2.7 | 1.2 |
| Stomach wall | 0.025 | 0.026 | 0.19 | 0.19 | 1.1 | 1.2 |
| Testes | 0.023 | 0.025 | 0.17 | 0.19 | 1.0 | 1.1 |
| Thymus | 0.024 | 0.026 | 0.18 | 0.19 | 1.1 | 1.2 |
| Thyroid | 0.26 | 0.37 | 1.9 | 2.8 | 11 | 17 |
| Total body | 0.037 | 0.027 | 0.28 | 0.20 | 1.7 | 1.2 |
| Urinary bladder wall | 0.32 | 0.025 | 2.4 | 0.19 | 14 | 1.1 |
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO can cause fetal harm [see Clinical Pharmacology (12.1)] . There are no available data on PLUVICTO use in pregnant females. No animal studies using lutetium Lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radioactive emissions, including those from PLUVICTO, can cause fetal harm.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.