Posluma (flotufolastat F 18) is an imaging agent used to detect and locate prostate cancer during PET (positron emission tomography) scans. Posluma contains an imaging agent (18F radioscope) which is designed to specifically bind to Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells which means physicians can accurately identify and locate the prostate cancer cells within the body. Posluma is a Radiohybrid PSMA-targeted PET Imaging Agent.

Posluma received FDA approval based on the results of two phase 3 trials, LIGHTHOUSE (NCT04186819) and SPOTLIGHT (NCT04186845), it was originally called 18F-rhPSMA-7.3 during clinical trials and development.

What is Posluma used for?

Posluma is FDA-approved to be used as a radioactive diagnostic agent during PET scan for PSMA-positive lesions in men with prostate cancer who have:

• suspected metastasis and are candidates for initial definitive therapy
• suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Radiation Risks. This medicine contributes to a patient’s long-term cumulative radiation exposure.

Risk of Image Misinterpretation. The interpretation of Posluma PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. 

How is Posluma administered?

Patients should drink sufficient water to ensure they are well-hydrated before their PET study.

Patients should empty their bladder immediately before imaging.

Posluma is given as an intravenous injection (injection into a vein) approximately 60 minutes before the PET scan which usually takes approximately 20 minutes, depending on the number of bed positions and time per bed position.

It is important to drink and urinate as often as possible during the first hours after having this medicine to reduce radiation exposure.

Patients should drink sufficient water to ensure they are well-hydrated before their PET study.

Patients should empty their bladder immediately before imaging.

Posluma is given as an intravenous injection (injection into a vein) approximately 60 minutes before the PET scan which usually takes approximately 20 minutes, depending on the number of bed positions and time per bed position.

It is important to drink and urinate as often as possible during the first hours after having this medicine to reduce radiation exposure.

The recommended Poslum adult dose is 296 MBq (8 mCi) as an intravenous bolus injection.

• The necessary volume to administer should be calculated based on calibration time and required dose.
• The recommended maximum volume of undiluted Posluma is 5 mL.
• Posluma may be diluted with 0.9% Sodium Chloride Injection, USP.
• Assay the dose in a dose calibrator before administration.

Post Administration Instructions

• After the injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection to ensure full dose delivery.

Posulma side effects include:

• diarrhea 
• blood pressure increase  
• injection site pain. 

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in a change in the absorption of this medicine into prostate cancer. It has not been established what the effect of these therapies has on the performance of Posluma PET.