Dosing & Administration

About PLUVICTO¹ 

PLUVICTO is a ready-to-use solution for single use only. To ensure there is no product mixing, the intravenous (IV) catheter should only be used to administer PLUVICTO during the infusion.²

• How PLUVICTO is supplied: Colorless type I glass, 30-mL single-dose vial. The product vial is in a lead-shielded container 

• Volume: Solution volume is adjusted from 7.5 mL to 12.5 mL to provide a total of 7.4 GBq (200 mCi) of radioactivity at the date and time of administration

PLUVICTO dosing schedule²

Administered every 6 weeks for up to 6 treatments

• PLUVICTO solution for injection contains 7.4 GBq (200 mCi) (at time of use)

• Administered once every 6 weeks for up to 6 treatments, or until disease progression, or unacceptable toxicity

• Slow IV injection (1 to 10 minutes) or infusion

GBq, gigabecquerel; mCi, millicurie.

Setup and administration of PLUVICTO^2,3

General Information

• PLUVICTO is administered intravenously

• Nuclear medicine health care professionals may use methods deemed appropriate and safe

• Prior to administration with PLUVICTO, a saline flush with ≥10 mL of 0.9% sterile sodium chloride must be administered to ensure patency of the IV line and minimize the risk of extravasation

• Manage cases of extravasation as per your institutional guidelines

• PLUVICTO will be administered slowly by intravenous route and followed by a saline flush

Important note regarding use of PLUVICTO²

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:

Any unused medicinal product or waste material should be disposed of in accordance with local and federal laws.

PLUVICTO is supplied as a single-dose vial containing 7.4 GBq (200 mCi) ± 10% of lutetium Lu 177 vipivotide tetraxetan²

Shelf Life

• The shelf life of PLUVICTO is 120 hours (5 days) from the date and time of calibration
   

Special Precautions for Storage

• Store below 30ºC (86ºF). Do not freeze

• Store in the original package to protect from ionizing radiation (lead shielding)

• Storage of radiopharmaceuticals should be in accordance with local and federal laws on radioactive materials

• Do not use PLUVICTO after the expiration date and time stated on the label after “EXP”
   

Special Precautions for Handling

• PLUVICTO is a radiopharmaceutical and should be handled with appropriate safety measures to minimize radiation exposure

• Use waterproof gloves and effective radiation shielding when handling PLUVICTO
   

Special Precautions for Disposal

• Dispose of any unused medicinal product or waste material in accordance with local and federal laws, as per radiation safety officer guidance

• Lutetium-177 is prepared using 2 different sources of stable isotopes (either lutetium-176 or ytterbium-176) that require different waste management. Consult the product batch release certificate to identify the source of stable isotopes used and apply appropriate waste management

Helpful tools for administering PLUVICTO and patient counseling