This page/content is for Great Britain healthcare professionals only.
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 (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.2
Dosing and administration
Please refer to the Pluvicto SmPC for full information about dosing and administration.
Pluvicto is a ready-to-use solution. It may be administered intravenously as 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 (using a peristaltic infusion pump). 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.2
Great Britain posology: Pluvicto is administered every 6 weeks (± 1 week) for a total of 6 doses.
One dose of Pluvicto contains 7.4 GBq (200 mCi) – at time of use.§2
There are three alternative ways to administer Pluvicto:2
- Using a syringe (with or without pump)
- Gravity method (with or without pump)
- Peristatic infusion pump from vial
Pluvicto is a ready-to-use solution for single use only.
To ensure there is no product mixing, the intravenous catheter should only be used to administer Pluvicto during the infusion.2
Always use the principles of ALARA (as low as reasonably achievable).
ALARA is the guiding principle of radiation safety. It means that even a small radiation dose should be avoided if there is no benefit to receiving it.
It includes 3 basic protective measures:
TIME
Minimise time spent near radioactive source
DISTANCE
Maximise distance to radioactive source
SHIELDING
Use shielding between yourself and the radioactive source and use waterproof gloves when handling Pluvicto
Safety profile and efficacy
The efficacy and safety of Pluvicto + BSoC were assessed in the VISION trial.1
Pluvicto mechanism of action
Pluvicto targets PSMA-positive cells, including prostate cancer cells.2
The most common ADRs (≥20%) occurring at a higher incidence in patients who received Pluvicto + BSoC compared to BSoC alone include: fatigue, dry mouth, nausea, anaemia, decreased appetite and constipation.
*In VISION, a randomised, open-label, multicentre, phase 3 clinical trial (n=831), Pluvicto prolonged overall survival, imaging-based progression-free survival, and maintained quality of life for longer when used alongside best standard of care compared to best standard of care alone.
†Alternate primary endpoints: Overall survival was improved by 4 months vs BSoC (HR 0.62, 95% CI, 0.52–0.74; p<0.001), radiographic progression-free survival was improved by 5.3 months vs BSoC (HR 0.40, 99.2% CI, 0.29–0.57; p<0.001).
‡Secondary endpoint: Quality of life measured as FACT-P total score was maintained by 3.5 months more vs BSoC (HR 0.54, 95% CI, 0.45–0.66; nominal p-value with non-inferential analysis <0.001), quality of life measured as BPI-SF pain intensity was maintained by 3.7 months more vs BSoC (HR 0.52, 95% CI, 0.43–0.63, nominal p-value with non-inferential analysis <0.001).
§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.2
ALARA, as low as reasonably achievable; AR, androgen receptor; BSoC, best standard of care; mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen; SmPC, Summary of Product Characteristics.
References:
- Sartor O, et al. N Engl J Med 2021;385(12):1091–1103
- Pluvicto® Great Britain Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/13965/smpc [Accessed March 2023].