Pluvicto Update for 2025
The US Food and Drug Administration (FDA) recently approved lutetium Lu 177 vipivotide tetraxetan (also known by the trade name PLUVICTO®) 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 who are considered appropriate to delay taxane-based chemotherapy. The approval of PLUVICTO® in patients who are considered appropriate to delay taxane-based chemotherapy is based on the PSMAfore study.
IMPORTANT SAFETY INFORMATION
What is PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan)?
PLUVICTO is a prescription treatment used to treat adults with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) already treated with:
• hormone therapy or
• hormone therapy and chemotherapy
What is the most important information I should know about PLUVICTO?
Use of PLUVICTO involves exposure to radioactivity. Long-term, accruing radiation exposure is associated with an increased risk for cancer. Drink plenty of water and urinate as often as possible during the first hours after administration.
To minimize radiation exposure to others following administration of PLUVICTO, limit close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days. Refrain from sexual activity for 7 days, and sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from pregnant women for 15 days.
PLUVICTO may cause serious side effects, including:
Low level of blood cell counts. Tell your doctor right away if you develop any new or worsening symptoms, including:
Tiredness or weakness
Pale skin
Shortness of breath
Bleeding or bruising more easily than normal or difficulty stopping bleeding
Frequent infections with signs such as fever, chills, sore throat, or mouth ulcers
Kidney problems. You should stay well-hydrated before and after treatment. Tell your doctor right away if you develop any new or worsening urinary symptoms.
All radiopharmaceuticals, including PLUVICTO, have the potential to cause harm to an unborn baby.
You should use effective contraception during treatment with PLUVICTO and for 14 weeks after your last dose
PLUVICTO may cause temporary or permanent infertility.
Click here to view or download the PLUVICTO Patient Advocacy Toolkit Document
We also invite you to visit www.pluvicto.com. On the site, you will find educational and support resources that patients with PSMA+ mCRPC may find helpful while using PLUVICTO®. The website is for reference by patients during their treatment journey.