Axumin® (fluciclovine F 18) Injection: First F 18 amino acid agent for PET imaging in recurrent prostate cancer

Fluciclovine F 18:

  • Is a synthetic amino acid PET imaging agent labeled with F 18 (molecular weight 132)1
  • Is recognized and taken up by amino acid transporters that are upregulated in many cancer cells, including prostate cancer1
  • Is taken up preferentially by prostate cancer cells, compared with surrounding normal tissues1
  • Is not metabolized or incorporated into newly synthesized proteins2
  • Limited urinary activity may facilitate delineation of lesions directly adjacent to the urinary bladder3
Graphic illustrating the Axumin mechanism of action

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

Adapted from Fuchs BC. Semin Cancer Biol. 2005.4

References:

  1. Axumin [package insert]. Oxford, UK: Blue Earth Diagnostics Ltd; May 2021.
  2. Schuster DM, Nanni C, Fanti S, et al. Anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid: physiologic uptake patterns, incidental findings, and variants that may simulate disease. J Nucl Med. 2014;55(12):1986-1992.
  3. Pernthaler B, Kulnik R, Gstettner C, Salamon S, Aigner RM, Kvaternik H. A prospective head-to-head comparison of 18F-fluciclovine with 68Ga-PSMA-11 in biochemical recurrence of prostate cancer in PET/CT. Clin Nucl Med. 2019;44(10):e566-e573.
  4. Fuchs BC, Bode BP. Amino acid transporters ASCT2 and LAT1 in cancer: partners in crime? Semin Cancer Biol. 2005;15(4):254-266.

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.