Molecule
Fluciclovine f-18 is a radioactive diagnostic agent indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. MedsAcross supplies Fluciclovine 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
From the regulator-approved product information. Each section names its source.
Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
Source: US FDA prescribing information
Fluciclovine F 18 is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters, such as LAT-1 and ASCT2, which are upregulated in prostate cancer cells. Fluciclovine F 18 is taken up to a greater extent in prostate cancer cells compared with surrounding normal tissues.
Source: US FDA prescribing information
Use appropriate radiation safety handling measures. Aseptically withdraw Axumin from its container and administer 370 MBq (10 mCi) as a bolus intravenous injection. Initiate imaging 3 minutes to 5 minutes after administration. Scanning should start from mid-thigh and proceed to base of skull, with a total scan time of approximately 20 minutes to 30 minutes. The (radiation absorbed) effective dose associated with 370 MBq (10 mCi) of injected activity of Axumin is approximately 8 mSv (0.8 rem) in an adult.
Source: US FDA prescribing information
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Source: US FDA prescribing information
Image interpretation errors can occur with Axumin imaging. Radiation risk: Axumin 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
Most commonly reported adverse reactions are injection site pain, erythema, and dysgeusia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical trial database for Axumin includes data from 877 subjects including 797 males diagnosed with prostate cancer. Most patients received a single administration of Axumin, a small number of subjects (n = 50) received up to five administrations of the drug. The mean administered activity was 370 MBq (range, 163 MBq to 485 MBq). Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin.
Source: US FDA prescribing information
Store Axumin at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Store Axumin within 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.
1 presentations of Fluciclovine f-18, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Axumin 221 mCi/mL injectionIntravenous | Blue Earth Diagnostics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 27 May 2016 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Fluciclovine f-18 and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fluciclovine f-18, including Axumin.
Yes. The US FDA first approved Fluciclovine f-18 on 27 May 2016, according to Drugs@FDA.
No listed presentation of Fluciclovine f-18 is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fluciclovine f-18 is classified under ATC code V09IX12 (Fluciclovine f-18).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.