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Molecule

Flotufolastat f-18

Radioactive Diagnostic Agent
Available on request
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Flotufolastat f-18 is a radioactive diagnostic agent 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. MedsAcross supplies Flotufolastat f-18 for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Radioactive Diagnostic Agent, Positron Emitting Activity
US FDA first approval
Not recorded
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Identifiers
UNII 811W19E3OLCAS 2305060-41-5DrugBank DB17851Q120497866

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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. POSLUMA is a radioactive diagnostic agent 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.

Source: US FDA prescribing information

How it works

Flotufolastat F 18 binds to PSMA (IC50 = 4.4 nM) 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.

Source: US FDA prescribing information

Dosing overview

Recommended amount of radioactivity of POSLUMA is 296 MBq (8 mCi) administered as an intravenous bolus injection. Initiate imaging approximately 60 minutes after administration. Scanning should start from mid-thigh and proceed to base of skull. See full prescribing information for additional preparation, handling, administration, imaging, and radiation dosimetry information.

Source: US FDA prescribing information

Warnings and precautions

Risk of Image Misinterpretation: Image interpretation errors can occur with POSLUMA imaging. Interpretation of POSLUMA PET may differ depending on imaging readers in patients with suspected recurrence of prostate cancer. Consider multidisciplinary consultation and histopathological confirmation. Radiation risk: POSLUMA contributes to a patient's long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Source: US FDA prescribing information

Side effects

The most common adverse reactions (≥0.4%) are diarrhea, blood pressure increase, and injection site pain.

Source: US FDA prescribing information

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.

Source: US FDA prescribing information

Storage

Store POSLUMA at 20°C to 25°C (68°F to 77°F). Store POSLUMA in the original container in radiation shielding.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Flotufolastat f-18, sorted by availability.

MedicineManufacturerRegisterAvailability
Posluma 158 mCi/mL injectionIntravenousBlue Earth DiagnosticsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Posluma

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDANot recorded—
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Flotufolastat f-18 available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Flotufolastat f-18 and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Flotufolastat f-18 have?

The catalogue lists 1 brand names for Flotufolastat f-18, including Posluma.

Does Flotufolastat f-18 need cold chain shipping?

No listed presentation of Flotufolastat f-18 is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. POSLUMA prescribing information (Blue Earth Diagnostics). U.S. National Library of Medicine, DailyMed. Retrieved 25 July 2026

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