Posluma FDA Approval History

Last updated by Melisa Puckey, BPharm on May 31, 2023.

FDA Approved: Yes (First approved May 25, 2023)
Brand name: Posluma
Generic name: flotufolastat F 18
Dosage form: Injection
Company: Blue Earth Diagnostics
Treatment for: Positron Emission Tomography Imaging, Diagnosis and Investigation

Posluma (flotufolastat F 18) a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

• Posluma is indicated for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial therapy, or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. PET imaging with Posluma can help identify the location and extent of the prostate cancer, providing clinically valuable information to guide patient management.
• Posluma is an optimized, targeted radiohybrid diagnostic imaging agent. Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use.
• Posluma is administered as an intravenous bolus injection. Imaging should be initiated approximately 60 minutes after administration. Scanning should start from mid-thigh and proceed to the base of the skull.
• Warnings and precautions associated with Posluma include image interpretation errors and unintentional radiation exposure.
• Common adverse reactions include diarrhea, blood pressure increase, and injection site pain.

Development timeline for Posluma

Further information

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