Axumin® (fluciclovine F 18) injection was specifically developed to enhance PET/CT imaging

Axumin is indicated for Positron Emission Tomography—Computed Tomography (PET/CT) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.1

Axumin contains fluciclovine, a fluorine 18 (F 18) labeled synthetic amino acid analog with a 109.7 minute half-life1

Fluciclovine F 18 is taken up to a greater extent in prostate cancer cells than in surrounding normal tissues, enabling the visualization of recurrent prostate cancer.1,2

It is transported into cells by amino acid transporters, such as ASCT2 and LAT1, which are upregulated in prostate cancer.1

Mechanism of action for Axumin

Axumin mechanism of action: Increased uptake of fluciclovine into prostate cancer cells by upregulated amino acid transporters, such as ASCT2 and LAT1.1-4

References:

  1. Axumin [package insert]. Oxford, UK: Blue Earth Diagnostics Ltd; 2016.
  2. Schuster DM, Savir-Baruch B, Nieh PT, et al. Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and111In-capromab pendetide SPECT/CT. Radiology. 2011:259(3):852-861.
  3. Fuchs BC, Bode BP. Amino acid transporters ASCT2 and LAT1 in cancer: Partners in Crime? Sem Cancer Biol. 2005;15:254-266.
  4. Okudaira H, Oka S, Ono M, et al. Accumulation of Trans-1-Amino-3-[18F]Fluorocyclobutanecarboxylic Acid in Prostate Cancer due to Androgen-Induced Expression of Amino Acid Transporters. Mol Imaging Biol. 2014;16:756-764.

INDICATION

Axumin® (fluciclovine F 18) injection is 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.

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
  • Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
  • Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Axumin full Prescribing Information.