Brand Name

Posluma

Generic Name
Flotufolastat F-18
View Brand Information
FDA approval date: May 25, 2023
Classification: Radioactive Diagnostic Agent
Form: Injection

What is Posluma (Flotufolastat F-18)?

POSLUMA is indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen level. POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen level.

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Brand Information

POSLUMA (flotufolastat F-18)
1INDICATIONS AND USAGE
POSLUMA is indicated 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.
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
2DOSAGE FORMS AND STRENGTHS
Injection: 296 MBq/mL to 5,846 MBq/mL (8 mCi/mL to 158 mCi/mL) as flotufolastat F 18 gallium in approximately 25 mL at end of synthesis supplied as a clear, colorless solution in a multiple-dose vial.
3CONTRAINDICATIONS
None.
4DRUG INTERACTIONS
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.
5OVERDOSAGE
In the event of an overdose of POSLUMA, maintain hydration of the patient and frequent voiding to minimize radiation exposure. A diuretic might also be considered. If possible, an estimate of the radiation effective dose administered to the patient should be made.