Brand Name
Pluvicto
Generic Name
177 Vipivotide Tetraxetan
View Brand Information FDA approval date: March 23, 2022
Classification: Radioligand Therapeutic Agent
Form: Injection
What is Pluvicto (177 Vipivotide Tetraxetan)?
PLUVICTO is indicated for the treatment of adult patients with prostate-specific membrane antigen -positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. PLUVICTO is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen -positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.
Approved To Treat
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Brand Information
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan)
1INDICATIONS AND USAGE
PLUVICTO is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy, and
- are considered appropriate to delay taxane-based chemotherapy, or
- have received prior taxane-based chemotherapy.
2DOSAGE FORMS AND STRENGTHS
Injection: 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan as a clear and colorless to slightly yellow solution in a single-dose vial.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Myelosuppression
- Renal Toxicity
4.1Clinical 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 PSMAfore and VISION studies (N = 756), the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes (83%), decreased hemoglobin (65%), fatigue (49%), dry mouth (46%), decreased platelets (40%), decreased estimated glomerular filtration rate (37%), nausea (35%), decreased neutrophils (31%), decreased calcium (29%), decreased sodium (27%), increased aspartate aminotransferase (26%), increased alkaline phosphatase (24%), arthralgia (22%), decreased appetite (21%), increased potassium (21%), constipation (21%), and back pain (21%).
PSMAfore
The safety of PLUVICTO was evaluated in the PSMAfore study in patients with progressive, PSMA-positive mCRPC previously treated with ARPI therapy, for whom it was considered appropriate to delay taxane-based chemotherapy by the investigator
Serious adverse reactions occurred in 20% of patients who received PLUVICTO. Serious adverse reactions in > 1% of patients who received PLUVICTO included anemia (1.8%), urinary tract infection (1.8%), hemorrhage (1.3%), and sepsis (1.3%).
Fatal adverse reactions occurred in 1.8% of patients who received PLUVICTO, including COVID-19 pneumonia, cardiac arrest, intestinal ischemia, and sepsis (0.4% each).
PLUVICTO was permanently discontinued due to adverse reactions in 6% of patients. Adverse reactions leading to permanent discontinuation of PLUVICTO in ≥ 1% of patients who received PLUVICTO were thrombocytopenia (1.8%) and dry mouth (1.3%).
Adverse reactions leading to a dose interruption of PLUVICTO occurred in 12% of patients. The most frequent (≥ 1%) adverse reactions leading to a dose interruption of PLUVICTO in patients who received PLUVICTO were COVID-19 (3.1%) and anemia (1.8%).
Adverse reactions leading to a dose reduction of PLUVICTO occurred in 3.5% of patients. The most frequent (≥ 0.5%) adverse reaction leading to a dose reduction of PLUVICTO in patients who received PLUVICTO was dry mouth (0.9%).
Table 3 and Table 4 summarize the incidence of adverse reactions and laboratory abnormalities, respectively, in PSMAfore.
Clinically relevant adverse reactions in < 10% of patients who received PLUVICTO included dysgeusia, abdominal pain, peripheral edema, headache, acute kidney injury, weight decreased, urinary tract infection, dry eye, dizziness, dry skin, oral fungal infection, gastroesophageal reflux disease, pyrexia, vertigo, stomatitis, dysphagia, esophagitis, pancytopenia, and bone marrow failure.
VISION
The safety of PLUVICTO was evaluated in the VISION study in patients with progressive, PSMA-positive mCRPC previously treated with ARPI therapy and taxane-based chemotherapy
Serious adverse reactions occurred in 37% of patients who received PLUVICTO plus BSoC. Serious adverse reactions in > 1% of patients who received PLUVICTO plus BSoC included musculoskeletal pain (4%), hemorrhage (4%), sepsis (3.2%), urinary tract infection (3%), anemia (2.8%), acute kidney injury (1.9%), pneumonia (1.7%), pyrexia (1.5%), pancytopenia (1.3%), spinal cord compression (1.1%), and pulmonary embolism (1.1%).
Fatal adverse reactions occurred in 3% of patients who received PLUVICTO plus BSoC, including sepsis (0.9%), pancytopenia (0.6%), hepatic failure (0.4%), intracranial hemorrhage (0.2%), subdural hematoma (0.2%), ischemic stroke (0.2%), COVID-19 (0.2%), and aspiration pneumonia (0.2%).
PLUVICTO was permanently discontinued due to adverse reactions in 12% of patients. Adverse reactions leading to permanent discontinuation of PLUVICTO in ≥ 1% of patients who received PLUVICTO plus BSoC were anemia (2.8%), thrombocytopenia (2.8%), and leukopenia (including neutropenia) (1.7%).
Adverse reactions leading to a dose interruption of PLUVICTO occurred in 16% of patients. The most frequent (≥ 3%) adverse reactions leading to a dose interruption of PLUVICTO in patients who received PLUVICTO plus BSoC were anemia (5%) and thrombocytopenia (3.6%).
Adverse reactions leading to a dose reduction of PLUVICTO occurred in 6% of patients. The most frequent (≥ 1%) adverse reactions leading to a dose reduction of PLUVICTO in patients who received PLUVICTO plus BSoC were thrombocytopenia (1.9%) and anemia (1.3%).
Table 5 and Table 6 summarize the incidence of adverse reactions and laboratory abnormalities, respectively, in VISION.
Clinically relevant adverse reactions in < 10% of patients who received PLUVICTO plus BSoC included acute kidney injury, dizziness, dysgeusia, headache, pyrexia, dry eye, oral fungal infection, vertigo, gastroesophageal reflux disease, stomatitis, pancytopenia, dry skin, dysphagia, esophagitis, and bone marrow failure.
5OVERDOSAGE
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.
6DESCRIPTION
PLUVICTO (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
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) 1,000 MBq/mL (27 mCi/mL) Injection is supplied as a sterile, clear, colorless to slightly yellow solution for intravenous use. 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.
6.1Physical 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 7.
6.2External Radiation
Table 8 summarizes the radioactive decay properties of lutetium-177.
7HOW SUPPLIED/STORAGE AND HANDLING
PLUVICTO Injection containing 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan 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 the date and time of administration (NDC# 69488-010-61). 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 the date and time of administration.
The product vial is enclosed within a lead shielded container (NDC# 69488-010-61) for protective shielding and placed in a plastic sealed container. The product is shipped in a type A package (NDC# 69488-010-61).
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.
8PATIENT COUNSELING 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
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
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
Embryo-Fetal Toxicity
Advise males that PLUVICTO can cause fetal harm
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
Infertility
Advise males of reproductive potential that PLUVICTO may cause temporary or permanent infertility
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©2025 Novartis
PLUVICTO
U.S. Patents 10398791; 10406240; 11318121; 12208102
T2025-17
9PRINCIPAL DISPLAY PANEL
PLUVICTO
1,000 MBq/mL (27 mCi/mL)
lutetium Lu 177 vipivotide tetraxetan injection
Intravenous use Single-dose vial
Sterile
NDC# 69488-010-61
Rx Only
NOVARTIS
