Pluvicto

Q: Who makes Pluvicto?

Pluvicto is listed by 1 labeler in the FDA NDC directory, including Novartis Pharmaceuticals Corporation.

lutetium Lu 177 vipivotide tetraxetan · Injection, Solution · Intravenous

Prescription (Rx) Radioligand Therapeutic Agent

Uses

1 INDICATIONS AND USAGE PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. ( 1.1 ) Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. ( 1.2 ) 1.1 Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer PLUVICTO is indicated in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. 1.2 Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer PLUVICTO is indicated for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.

Dosage and administration

Select patients for treatment using LOCAMETZ ® or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors. ( 2.2 ) mAPMN/S Prostate Cancer : The recommended dosage of PLUVICTO in combination with ARPI is 7.4 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. ( 2.3 ) mAPMR Prostate Cancer : The recommended dosage of PLUVICTO is 7.4 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. ( 2.3 ) Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions. ( 2.4 ) 2.1 Important Safety Instructions PLUVICTO is a radiopharmaceutical; handle with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.1)] . Use waterproof gloves and effective radiation shielding when handling PLUVICTO. Radiopharmaceuticals, including PLUVICTO, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. 2.2 Patient Selection Select patients with metastatic prostate cancer for treatment with PLUVICTO using LOCAMETZ or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors. Additional selection criteria were used in clinical studies [see Clinical Studies (14)] . 2.3 Recommended Dosage Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer The recommended dosage of PLUVICTO in combination with ARPI is 7.4 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. Refer to the Prescribing Information for ARPI for recommended dosing information. Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer The recommended dosage of PLUVICTO is 7.4 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. Patients receiving PLUVICTO for metastatic prostate cancer should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. 2.4 Dosage Modifications for Adverse Reactions Recommended dosage modifications of PLUVICTO for adverse reactions are provided in Table 1. Management of adverse reactions may require temporary dose interruption, dose reduction, or permanent discontinuation of treatment with PLUVICTO. If a treatment delay due to an adverse reaction persists for > 4 weeks, consider permanent discontinuation of PLUVICTO. The dose of PLUVICTO may be reduced by 20% to 5.9 GBq (160 mCi) once; do not re-escalate dose. If a patient has further adverse reactions that would require an additional dose reduction, treatment with PLUVICTO must be discontinued. Table 1: Recommended Dosage Modifications of PLUVICTO for Adverse Reactions 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 and Confirmed > 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. 2.5 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.

Dosage forms and strengths

Injection: 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan at calibration time as a clear and colorless to slightly yellow solution in a single-dose vial containing 7.4 GBq (200 mCi) ± 10% at administration time. Injection: 1,000 MBq/mL (27 mCi/mL) at calibration time in a single-dose vial containing 7.4 GBq (200 mCi) ± 10% at administration time. ( 3 )

Contraindications

None. None. ( 4 )

Warnings and precautions

Risk From Radiation Exposure : Minimize radiation exposure during and after treatment with PLUVICTO consistent with institutional good radiation safety practices and patient treatment procedures. Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation. ( 5.1 ) Myelosuppression : Perform complete blood counts. Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity. ( 2.4 , 5.2 ) Renal Toxicity : Advise patients to remain well hydrated and to urinate frequently. Perform kidney function laboratory tests. Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity. ( 2.4 , 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. ( 5.4 , 8.1 , 8.3 ) Infertility : PLUVICTO may cause temporary or permanent infertility. ( 5.5 , 8.3 ) 5.1 Risk From Radiation Exposure PLUVICTO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Minimize radiation exposure to patients, medical personnel, and others during and after treatment with PLUVICTO consistent with institutional good radiation safety practices, patient treatment procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home. Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation. Before the patient is released, inform patients about the necessary radioprotection precautions to follow to minimize radiation exposure to others [see Patient Counseling Information (17)] . After each administration of PLUVICTO, advise patients to: Limit close contact (less than 3 feet) with others for 2 days or with children and pregnant women for 7 days. Refrain from sexual activity for 7 days. Sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days. 5.2 Myelosuppression PLUVICTO can cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia. In the PSMAddition study, Grade 3 or 4 decreased leukocytes (7%), decreased neutrophils (4.4%), decreased hemoglobin (4.3%), and decreased platelets (1.1%) occurred in patients treated with PLUVICTO. In the PSMAfore study, Grade 3 or 4 decreased hemoglobin (7%), decreased leukocytes (4.4%), decreased neutrophils (3.5%), and decreased platelets (2.7%) occurred in patients treated with PLUVICTO. One death occurred due to bone marrow failure during long-term follow-up in a patient who received PLUVICTO. In the VISION study, Grade 3 or 4 decreased hemoglobin (15%), decreased platelets (9%), decreased leukocytes (7%), and decreased neutrophils (4.5%) occurred in patients treated with PLUVICTO. Grade ≥ 3 pancytopenia occurred in 1.1% (which includes two fatal events) of patients treated with PLUVICTO. Two deaths (0.4%) occurred due to intracranial hemorrhage and subdural hematoma in association with thrombocytopenia, one death (0.2%) occurred due to sepsis and concurrent neutropenia, and one death (0.2%) occurred due to bone marrow failure in patients treated with PLUVICTO. Perform complete blood counts before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO based on the severity of myelosuppression [see Dosage and Administration (2.4)] . 5.3 Renal Toxicity PLUVICTO can cause severe renal toxicity. In the PSMAddition study, Grade 3 or 4 acute kidney injury (1.6%) occurred in patients treated with PLUVICTO. In the PSMAfore study, Grade 3 or 4 acute kidney injury (1.3%) occurred in patients treated with PLUVICTO. In the VISION study, Grade 3 or 4 acute kidney injury (3.4%) occurred in patients treated with PLUVICTO. Advise patients to remain well hydrated and to urinate frequently before and after administration of PLUVICTO. Perform kidney function laboratory tests, including serum creatinine and calculated creatinine clearance (CLcr), before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO based on the severity of renal toxicity [see Dosage and Administration (2.4)] . 5.4 Embryo-Fetal Toxicity 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)] . No animal studies using lutetium Lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from PLUVICTO, can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose [see Use in Specific Populations (8.1, 8.3)] . 5.5 Infertility PLUVICTO may cause infertility in males. The recommended cumulative dose of 44.4 GBq of PLUVICTO results in a radiation absorbed dose to the testes within the range where PLUVICTO may cause temporary or permanent infertility [see Use in Specific Populations (8.3)] .

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.2)] Renal Toxicity [see Warnings and Precautions (5.3)] Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased neutrophils, nausea, decreased platelets, decreased estimated glomerular filtration rate, increased aspartate aminotransferase, decreased sodium, increased magnesium, increased potassium, decreased calcium, and increased alkaline phosphatase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the pooled safety population for the PSMAddition, PSMAfore and VISION studies (N = 1320), the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes (86%), decreased hemoglobin (68%), fatigue (51%), dry mouth (46%), decreased neutrophils (35%), nausea (35%), decreased platelets (33%), decreased estimated glomerular filtration rate (28%), increased aspartate aminotransferase (25%), decreased sodium (22%), increased magnesium (22%), increased potassium (21%), decreased calcium (21%), and increased alkaline phosphatase (20%). Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer PSMAddition The safety of PLUVICTO in combination with ARPI was evaluated in the PSMAddition study in patients with PSMA-positive mAPMN/S prostate cancer [see Clinical Studies (14.1)] . Patients could have been treated with ARPI in the metastatic setting for up to 45 days prior to consent. Patients received at least one dose of either PLUVICTO 7.4 GBq (200 mCi) administered every 6 weeks in combination with ARPI (N = 564) or ARPI alone (N = 565). Among patients who received PLUVICTO in combination with ARPI, the median duration of exposure to PLUVICTO was 8.3 months (range, 1.3 to 11.2) and the median number of doses of PLUVICTO received was 6 (range, 1 to 6). The median cumulative administered activity of PLUVICTO was 43.4 GBq (range, 7.1 to 47.3). Serious adverse reactions occurred in 32% of patients who received PLUVICTO in combination with ARPI. Serious adverse reactions in > 1% of patients included acute kidney injury (1.6%), pneumonia and sepsis (1.4% each), anemia, basal cell carcinoma, general physical health deterioration, and syncope (1.1% each). Fatal adverse reactions occurred in 2.7% of patients who received PLUVICTO in combination with ARPI, including general physical health deterioration (0.5%), respiratory failure and sudden death (0.4% each), arrhythmia, cardiac arrest, congestive heart failure, cholangiocarcinoma, COVID-19, malignant neoplasm of unknown primary site, multiple organ dysfunction syndrome, and subdural hemorrhage (0.2% each). PLUVICTO was permanently discontinued due to adverse reactions in 8% of patients who received PLUVICTO in combination with ARPI. The most frequent (≥ 1%) adverse reaction leading to permanent discontinuation of PLUVICTO was anemia (1.1%). Adverse reactions leading to a dose interruption of PLUVICTO occurred in 12% of patients who received PLUVICTO in combination with ARPI. The most frequent (≥ 1%) adverse reactions leading to a dose interruption of PLUVICTO were neutropenia (2%), leukopenia, and COVID-19 (1.2% each). Adverse reactions leading to a dose reduction of PLUVICTO occurred in 3.9% of patients who received PLUVICTO in combination with ARPI. The most frequent (≥ 1%) adverse reaction leading to a dose reduction of PLUVICTO was dry mouth (1.1%). Table 3 and Table 4 summarize the incidence of adverse reactions and laboratory abnormalities, respectively, in PSMAddition. Table 3: Adverse Reactions (≥ 10%) in Patients With PSMA-Positive mAPMN/S Prostate Cancer Who Received PLUVICTO in Combination With ARPI or ARPI in PSMAddition Abbreviation: ARPI, androgen receptor pathway inhibitors. a Includes multiple similar terms. Adverse reactions PLUVICTO in combination with ARPI (N = 564) ARPI (N = 565) All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades 3 or 4 (%) General disorders Fatigue a 51 1.4 41 1.8 Decreased appetite 14 0.9 7 0.2 Gastrointestinal disorders Dry mouth a 46 0 3.7 0 Nausea 34 0.2 9 0 Constipation 18 0 16 0 Vomiting a 14 0.7 3.7 0 Diarrhea 12 0.2 10 0 Nervous system disorders Dysgeusia a 13 0 4.1 0 Headache 12 0 9 0.4 Clinically relevant adverse reactions in < 10% of patients who received PLUVICTO in combination with ARPI included abdominal pain, dizziness, acute kidney injury, dry eye, dry skin, stomatitis, gastroesophageal reflux disease, vertigo, eye irritation, oral fungal infection, dysphagia, and esophagitis. Table 4: Select Laboratory Abnormalities (≥ 10%) That Worsened From Baseline in Patients With PSMA-Positive mAPMN/S Prostate Cancer Who Received PLUVICTO in Combination With ARPI or ARPI (Between Arm Difference of ≥ 5% All Grades) in PSMAddition Abbreviation: ARPI, androgen receptor pathway inhibitors. a The denominator used to calculate the rate for each laboratory parameter varied from 563 to 564 based on the number of patients with a baseline value and at least one post-treatment value. b The denominator used to calculate the rate for each laboratory parameter varied from 557 to 558 based on the number of patients with a baseline value and at least one post-treatment value. c No Grade 4 laboratory abnormalities worsening from baseline were reported.

Use in specific populations

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. 8.2 Lactation Risk Summary The safety and efficacy of PLUVICTO have not been established in females. There are no data on the presence of lutetium Lu 177 vipivotide tetraxetan in human milk or its effects on the breastfed child or on milk production. 8.3 Females and Males of Reproductive Potential Contraception Males Advise males with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose [see Clinical Pharmacology (12.1), Nonclinical Toxicology (13.1)] . Infertility The recommended cumulative dose of 44.4 GBq of PLUVICTO results in a radiation absorbed dose to the testes within the range where PLUVICTO may cause temporary or permanent infertility. 8.4 Pediatric Use The safety and effectiveness of PLUVICTO in pediatric patients have not been established. 8.5 Geriatric Use Of the 564 patients who received at least one dose of PLUVICTO in combination with ARPI in the PSMAddition study, 379 patients (67%) were 65 years of age or older and 115 patients (20%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 43% of patients ≥ 75 years of age and in 29% of younger patients. Grade ≥ 3 adverse reactions occurred in 59% of patients ≥ 75 years of age and in 49% of younger patients. Of the 227 patients who received at least one dose of PLUVICTO in the PSMAfore study, 177 patients (78%) were 65 years of age or older and 83 patients (37%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 20% of patients ≥ 75 years of age and in 20% of younger patients. Grade ≥ 3 adverse reactions occurred in 39% of patients ≥ 75 years of age and in 34% of younger patients. Of the 529 patients who received at least one dose of PLUVICTO plus BSoC in the VISION study, 387 patients (73%) were 65 years of age or older and 143 patients (27%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 41% of patients ≥ 75 years of age and in 35% of younger patients. Grade ≥ 3 adverse reactions occurred in 56% of patients ≥ 75 years of age and in 53% of younger patients. 8.6 Renal Impairment Exposure of lutetium Lu 177 vipivotide tetraxetan is expected to increase with the degree of renal impairment [see Clinical Pharmacology (12.3)] . No dose adjustment is recommended for patients with mild (baseline CLcr 60 to 89 mL/min by Cockcroft-Gault) to moderate (CLcr 30 to 59 mL/min) renal impairment; however, patients with mild to moderate renal impairment may be at greater risk of toxicity. Frequently monitor renal function and adverse reactions in patients with mild to moderate renal impairment [see Dosage and Administration (2.4)] . The pharmacokinetics and safety of PLUVICTO have not been studied in patients with severe (CLcr 15 to 29 mL/min) renal impairment or end-stage renal disease.

Pregnancy

Pediatric use

8.4 Pediatric Use The safety and effectiveness of PLUVICTO in pediatric patients have not been established.

Geriatric use

8.5 Geriatric Use Of the 564 patients who received at least one dose of PLUVICTO in combination with ARPI in the PSMAddition study, 379 patients (67%) were 65 years of age or older and 115 patients (20%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 43% of patients ≥ 75 years of age and in 29% of younger patients. Grade ≥ 3 adverse reactions occurred in 59% of patients ≥ 75 years of age and in 49% of younger patients. Of the 227 patients who received at least one dose of PLUVICTO in the PSMAfore study, 177 patients (78%) were 65 years of age or older and 83 patients (37%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 20% of patients ≥ 75 years of age and in 20% of younger patients. Grade ≥ 3 adverse reactions occurred in 39% of patients ≥ 75 years of age and in 34% of younger patients. Of the 529 patients who received at least one dose of PLUVICTO plus BSoC in the VISION study, 387 patients (73%) were 65 years of age or older and 143 patients (27%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 41% of patients ≥ 75 years of age and in 35% of younger patients. Grade ≥ 3 adverse reactions occurred in 56% of patients ≥ 75 years of age and in 53% of younger patients.

Overdosage

In the event of administration of a radiation overdosage with PLUVICTO, reduce the radiation absorbed dose to the patient by increasing the elimination of the radionuclide from the body by frequent micturition or by forced diuresis and frequent bladder voiding. Estimate the effective radiation dose that was applied and treat with additional supportive care measures as clinically indicated.

Description

(lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent. Lutetium Lu 177 vipivotide tetraxetan is a PSMA-binding ligand bound to a DOTA chelator radiolabeled with lutetium-177. The chemical name is 2-[4-[2-[[4-[[(2S)-1-[[(5S)-5-carboxy-5-[[(1S)-1,3-dicarboxy propyl]carbamoylamino]pentyl]amino]-3-naphthalen-2-yl-1-oxopropan-2-yl]carbamoyl]cyclohexyl]methylamino]-2-oxoethyl]-4,7,10-tris(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]acetate; lutetium-177(3+). The molecular mass is 1216.06 g/mol and the molecular formula is C 49 H 68 177 LuN 9 O 16 . The chemical structure for lutetium Lu 177 vipivotide tetraxetan is shown below: PLUVICTO Injection containing 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan at calibration time is supplied as a sterile, clear, colorless to slightly yellow solution for intravenous use containing 7.4 GBq (200 mCi) ± 10% of lutetium Lu 177 vipivotide tetraxetan at administration time. Each single-dose vial contains acetic acid (0.30 mg/mL), sodium acetate (0.41 mg/mL), gentisic acid (0.39 mg/mL), sodium ascorbate (50.0 mg/mL), pentetic acid (0.10 mg/mL), and water for injection (q.s. to 1 mL). The pH range of the solution is 4.5 to 7.0. Chemical Structure of lutetium 11.1 Physical Characteristics Lutetium-177 decays to a stable hafnium-177 with a physical half-life of 6.647 days by emitting beta-minus radiation with a maximum energy of 498 keV (79%) and photonic radiation (γ) of 208 keV (11%) and 113 keV (6.4%). The main radiations of lutetium-177 are detailed in Table 9. Table 9: Lutetium-177 Main Radiations Radiation Energy (keV) Iβ - % Iγ% β - 176.5 12.2 β - 248.1 0.05 β - 384.9 9.1 β - 497.8 78.6 γ 71.6 0.15 γ 112.9 6.40 γ 136.7 0.05 γ 208.4 11.0 γ 249.7 0.21 γ 321.3 0.22 11.2 External Radiation Table 10 summarizes the radioactive decay properties of lutetium-177. Table 10: Physical Decay Chart: Lutetium-177 Physical Half-life = 6.647 days Hours Fraction remaining 0 1.000 1 0.996 2 0.991 5 0.979 10 0.958 24 (1 day) 0.901 48 (2 days) 0.812 72 (3 days) 0.731 120 (5 days) 0.594 168 (7 days) 0.482 336 (14 days) 0.232 720 (30 days) 0.044 1080 (45 days) 0.009

Mechanism of action

12.1 Mechanism of Action Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent. The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177 which is linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer. Upon binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage which can lead to cell death.

How supplied

Injection containing 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan at calibration time is a sterile, preservative-free and clear, colorless to slightly yellow solution for intravenous use supplied in a clear, colorless Type I glass 30 mL single-dose vial containing 7.4 GBq (200 mCi) ± 10% of lutetium Lu 177 vipivotide tetraxetan at administration time (NDC# 0078-1217-61). The solution volume in the vial can range from 7.5 mL to 12.5 mL in order to provide a total of 7.4 GBq (200 mCi) of radioactivity at administration time. The product vial is enclosed within a lead shielded container (NDC# 0078-1217-61) for protective shielding and placed in a plastic sealed container. The product is shipped in a type A package. The shelf life is 120 hours (5 days) from the date and time of calibration. Store below 30°C (86°F). Do not freeze. Store in the original package to protect from ionizing radiation (lead shielding). Store PLUVICTO in accordance with local and federal laws on radioactive materials. Do not use PLUVICTO after the expiration date and time which are stated on the label. Dispose of any unused medicinal product or waste material in accordance with local and federal laws. Lutetium-177 for PLUVICTO may be prepared using two different sources of stable nuclides (either lutetium-176 or ytterbium-176) that require different waste management. Lutetium-177 for PLUVICTO is prepared using ytterbium-176 (“non-carrier added”) unless otherwise communicated on the product batch release certificate.

Patient information

Risk From Radiation Exposure Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation. Before the patient is released, inform patients about the necessary radioprotection precautions to follow to minimize radiation exposure to others. After each administration of PLUVICTO, advise patients to: Limit close contact (less than 3 feet) with others for 2 days or with children and pregnant women for 7 days. Refrain from sexual activity for 7 days. Sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days [see Warnings and Precautions (5.1)] . Myelosuppression Advise patients to contact their healthcare provider for any signs or symptoms of myelosuppression, such as tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty to stop bleeding, or frequent infections with signs, such as fever, chills, sore throat or mouth ulcers [see Warnings and Precautions (5.2)] . Renal Toxicity Advise patients to remain well hydrated and to urinate frequently before and after administration of PLUVICTO. Advise patients to contact their healthcare provider for any signs or symptoms of renal toxicity, such as passing urine less often than usual or passing much smaller amounts of urine than usual [see Warnings and Precautions (5.3)] . Embryo-Fetal Toxicity Advise males that PLUVICTO can cause fetal harm [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)] . Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose [see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)] . Infertility Advise males of reproductive potential that PLUVICTO may cause temporary or permanent infertility [see Warnings and Precautions (5.5), Use in Specific Populations (8.3)] . Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 ©2026 Novartis PLUVICTO ® is a registered trademark of Novartis AG and/or its affiliates. U.S. Patents 10398791; 10406240; 11318121; 11951190; 12208102 T2026-26

Label text from the FDA structured product label by Novartis Pharmaceuticals Corporation (revised Aug 12, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Lutetium Lu-177 Vipivotide Tetraxetan in 1 product

Pluvicto NDC products (1)

NDC	Strength & form	Labeler	Type
0078-1217	Lutetium Lu-177 Vipivotide Tetraxetan 27 mCi/mL Injection, Solution	Novartis Pharmaceuticals Corporation	NDA

Frequently asked questions

What is Pluvicto used for?

What are the side effects of Pluvicto?

Who makes Pluvicto?

Pluvicto is listed by 1 labeler in the FDA NDC directory, including Novartis Pharmaceuticals Corporation.