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Posluma Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Multi-dose vial (25mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Flotufolastat F 18 binds to PSMA expressed on cells, including prostate cancer cells, and is internalized. Prostate cancer cells usually overexpress PSMA. Fluorine-18 is a ß+ emitting radionuclide that can be detected using positron emission tomography.
Posluma Indications
Indications
For positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level.
Posluma Dosage and Administration
Adult
Give as IV bolus inj. 296MBq (8mCi); max volume 5mL (undiluted). Follow with NaCl 0.9% IV flush. Acquire images ~60mins after inj. The radiation absorbed dose from 296MBq (8mCi) dose is 4.1mSv.
Children
Not established.
Posluma Contraindications
Not Applicable
Posluma Boxed Warnings
Not Applicable
Posluma Warnings/Precautions
Warnings/Precautions
Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. Risk for image misinterpretation and other errors; clinical correlation recommended. Contributes to patient's overall long-term cumulative radiation exposure. Advise to hydrate prior to and post-inj; void frequently after. Pregnancy, nursing mothers: not indicated for females.
Posluma Pharmacokinetics
See Literature
Posluma Interactions
Interactions
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway may affect flotufolastat F 18 uptake.
Posluma Adverse Reactions
Adverse Reactions
Diarrhea, BP increase, inj site pain.
Posluma Clinical Trials
See Literature
Posluma Note
Not Applicable
Posluma Patient Counseling
See Literature
