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Prescribing information (external link)
Pluvicto®▼ (lutetium [177Lu] vipivotide tetraxetan) is indicated for the treatment of adult patients with:1
Prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have progressed on or after treatment with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy
PSMA-positive mCRPC who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes
Pluvicto Summary of Product Characteristics (SmPC) can be found here
Pluvicto is available in the United Kingdom to eligible private patients.
Please refer to the Pluvicto SmPC for full information about dosing and administration.1
Pluvicto is a ready-to-use solution. Be aware that treatment with Pluvicto contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer.1
Posology: Pluvicto is administered intravenously every 6 weeks (± 1 week) for a total of 6 doses.1
Treatment monitoring1
Laboratory test should be performed before and during treatment with Pluvicto.
Haematology (haemaglobin, white blood cell count, absolute neutrophil count, platelet count)
Kidney function (serum creatinine, calculated creatinine clearance)
Liver function (alanaine aminotransferase, aspartate aminotransferase, alkaline phosphatase, blood serum albumin, total blood bilirubin)
One dose of Pluvicto contains 7400 MBq at the time of use.1
Management of severe or intolerable ADRs may require temporary dose interruption, dose reduction or permanent discontinuation of treatment with Pluvicto. Please refer to the Pluvicto SmPC for further information regarding dose modifications.
There are 3 ways to administer Pluvicto:1
As an injection using the syringe method
As an infusion using the gravity method
As an infusion using the peristaltic pump method
For more information on the 3 administration methods, please watch the videos below.
Prescribing Information for Pluvicto can be found at the top of the page.
Pluvicto should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings and after evaluation of the patient by a qualified physician.1
Radiopharmaceuticals, including Pluvicto, should be used by or under the control of healthcare professionals who are qualified by specific training and experience in the appropriate use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorised to license the use of radiopharmaceuticals.1
Pluvicto is a radiopharmaceutical and should be handled with appropriate safety measures to minimise radiation exposure. Waterproof gloves and effective radiation shielding should be used when handling Pluvicto. Radiation exposure to patients, medical personnel and others should be minimised during and after treatment with Pluvicto consistent with institutional good radiation safety practices, patient management procedures and instructions to the patient for follow-up radiation protection at home.1
The safety profile of Pluvicto was evaluated in two trials, PSMAfore and VISION. In PSMAfore, the most common (≥20%) adverse drug reactions (ADRs) occurring in patients who received Pluvicto include: dry mouth (60.8%), fatigue (52.9%), nausea (31.7%), anaemia (27.3%), constipation (22.0%), and decreased appetite (21.6%). The most common grade 3 to 4 ADRs (≥5%) occurring in patients who received Pluvicto include: anaemia (6.2%).1
In VISION, the most common (≥20%) ADRs occurring at a higher incidence in patients who received Pluvicto + BSoC compared to BSoC alone include: fatigue (48.0%), dry mouth (39.3%), nausea (35.7%), anaemia (31.9%), decreased appetite (21.4%) and constipation (20.2%). The most common grade 3 to 4 ADRs (≥5%) occurring at a higher incidence in patients who received Pluvicto + BSoC compared to BSoC alone include: anaemia (12.9%), thrombocytopenia (7.9%), lymphopenia (7.8%) and fatigue (6.6%).1
The data from the PSMAfore and VISION trials cannot be extrapolated to any other lutetium PSMA therapy.
For further information, please refer to the Pluvicto SmPC.
ADR, adverse drug reaction; 177Lu, lutetium-177; AR, androgen receptor; ARPI, androgen receptor pathway inhibitor; BSoC, best standard of care; mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen; RLT, radioligand therapy; SmPC, summary of product characteristics.
Reference
Pluvicto®▼ (lutetium [177Lu] vipivotide tetraxetan) Summary of Product Characteristics.
UK | February 2026 | FA-11470171-1
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.