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Lutetium (177lu) Vipivotide Tetraxetan

Pluvicto · ATC code V10XX

Key facts
Active substance
Lutetium (177lu) Vipivotide Tetraxetan
Drug class
Lutetium chloride lu-177
ATC code
V10XX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Pluvicto 1 000 MBq/mL solution for injection/infusion
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-27

Key facts

Lutetium (177Lu) vipivotide tetraxetan is a PSMA-targeted radiopharmaceutical used to treat adults with PSMA-positive metastatic castration-resistant prostate cancer.

What it is used for

  • With androgen deprivation therapy (with or without AR pathway inhibition) for adults with progressive PSMA-positive metastatic castration-resistant prostate cancer previously treated with AR pathway inhibition and taxane-based chemotherapy

Dosing

  • 7,400 MBq intravenously every 6 weeks (±1 week) for up to a total of 6 doses, unless disease progression or unacceptable toxicity
  • Only by persons authorised to handle radiopharmaceuticals in designated settings; patients selected by PSMA imaging
  • Continue medical castration with a GnRH analogue in patients not surgically castrated
  • For adverse reactions the dose may be reduced once by 20% to 5,900 MBq, without re-escalation; discontinue if a delay persists beyond 4 weeks
  • Blood counts, kidney and liver tests before and during treatment; not recommended with creatinine clearance below 50 mL/min

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Contributes to long-term cumulative radiation exposure, which is associated with increased cancer risk; radiation protection for patients, staff and others
  • Myelosuppression, including fatal cases; monitor blood counts and withhold, reduce or discontinue as needed
  • Renal toxicity; patients should increase fluids and void often
  • Limit close contact after each dose, especially with children and pregnant women (details in the full text)

Side effects

  • Most common: fatigue (48.0%), dry mouth (39.3%), nausea (35.7%), anaemia (31.9%), decreased appetite (21.4%), constipation (20.2%)
  • Most common grade 3 to 4: anaemia (12.9%), thrombocytopenia (7.9%), lymphopenia (7.8%), fatigue (6.6%)

Interactions

  • No clinical drug interaction studies were performed

Pregnancy and breastfeeding

  • Not indicated for use in females; radioactive emissions can cause foetal harm
  • Men should not father a child and should use a condom during treatment and for 14 weeks after the last dose

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • PluvictoNovartis Europharm Limited · EMEA/H/C/005483

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Pluvicto
Liechtenstein
Pluvicto
Norway
Pluvicto

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Pluvicto – EPAR, Product Information (OF THE TEXT 11. DOSIMETRY Radiation dose to specific organs,). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/pluvicto-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC V10XX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.