Posluma
Generic name: flotufolastat F 18
Dosage form: intravenous injection
What is Posluma?
Posluma, also known as flotufolastat F 18, is a type of imaging agent utilized in PET (positron emission tomography) scans to detect and locate prostate cancer. It contains a specialized imaging agent called 18F radioscope, which specifically binds to Prostate-Specific Membrane Antigen (PSMA) found on prostate cancer cells. This enables physicians to accurately identify and locate prostate cancer cells within the body. Posluma is classified as a Radiohybrid PSMA-targeted PET Imaging Agent.
The FDA granted approval to Posluma based on the findings of two phase 3 trials known as LIGHTHOUSE (NCT04186819) and SPOTLIGHT (NCT04186845). During its clinical trials and development phase, Posluma was initially referred to as 18F-rhPSMA-7.3.
What is Posluma used for?
Posluma has obtained FDA approval as a radioactive diagnostic agent utilized in PET scans for identifying PSMA-positive lesions in men with prostate cancer who meet the following criteria:
- Individuals with suspected metastasis who are eligible for initial definitive therapy.
- Individuals with suspected recurrence, indicated by elevated serum prostate-specific antigen (PSA) levels.
Warning
Radiation Exposure Risks: Posluma increases a patient's long-term cumulative radiation exposure.
Risk of Image Interpretation: The interpretation of Posluma PET scans may vary among different imaging readers, particularly in the region of the prostate/prostate bed. To mitigate the risk of false positive interpretations, it is advisable to seek multidisciplinary consultation and obtain histopathological confirmation when clinical decision-making relies solely on uptake in the prostate/prostate bed region or when uptake is interpreted as borderline.
How is Posluma administered?
Patients are advised to consume an adequate amount of water to ensure proper hydration prior to their PET study.
Before imaging, patients should empty their bladder.
Posluma is administered through an intravenous injection (injection into a vein) approximately 60 minutes before the PET scan, which typically lasts around 20 minutes, varying based on the number of bed positions and the time allocated per bed position.
To minimize radiation exposure, it is crucial to drink fluids and urinate frequently during the initial hours following the administration of this medication.
Dosing information
The recommended adult dose of Posluma is 296 MBq (8 mCi), to be administered as a bolus injection into a vein.
- The volume required for administration should be calculated considering the calibration time and the desired dose.
- The maximum recommended volume of undiluted Posluma is 5 mL.
- If necessary, Posluma can be diluted with 0.9% Sodium Chloride Injection, USP.
- Before administering the dose, it is important to measure it accurately using a dose calibrator.
Post Administration Instructions
- Following the injection, it is necessary to administer an intravenous flush of sterile 0.9% Sodium Chloride Injection to ensure the complete delivery of the dose.
What are the side effects of Posluma?
Posluma may cause the following side effects:
- Diarrhea
- Increase in blood pressure
- Pain at the injection site
Interactions
Androgen deprivation therapy (ADT) and other treatments that target the androgen pathway, including androgen receptor antagonists, can potentially affect the absorption of this medication in prostate cancer. The impact of these therapies on the performance of Posluma PET has not been determined.
Storage
Store Posluma at a temperature between 20 °C and 25 °C (68°F and 77 °F). Keep it in the original container within a radiation shielding environment. The expiration date and time can be found on the container label. It is recommended to use the solution within 10 hours from the end of synthesis. Any unused solution should be disposed of following applicable regulations.
Company
Marketed by Blue Earth Diagnostics Ltd., Oxford, OX4 4GA, UK.
