Why Axumin
When faced with a negative or equivocal PSMA PET scan, don’t hesitate to make Axumin your immediate next step.
Not an actual patient.
Not all prostate cancer lesions express PSMA
~10% to 20%
of prostate malignancies lack prostate-specific membrane antigen (PSMA) expression, including neuroendocrine prostate cancer tumors1-3
Up to 42%
of cases of recurrent prostate cancer had no detectable PSMA4
In a retrospective analysis of 60 patients with metastatic castration-resistant prostate cancer (mCRPC),* 27% (16/60) of mCRPC and 42% (16/38) of castration-sensitive prostate cancer (CSPC) tissues sampled had no detectable membranous PSMA.4
*38 patients also had matched, same-patient diagnostic CSPC tissue samples.
Axumin does not rely on PSMA expression to visualize disease5
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Axumin is a synthetic amino acid taken up by transporters upregulated in prostate cancer cells.5
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Taken up preferentially by prostate cancer cells, compared with surrounding normal tissues5
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Not metabolized or incorporated into newly synthesized proteins6,7
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Limited urinary activity may facilitate delineation of lesions directly adjacent to the urinary bladder8
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PSMA ligands bind to cells that express PSMA, which is overexpressed on prostate cancer cells.9,10
= Axumin
= PSMA ligands
Axumin is the first and only synthetic amino acid for PET imaging in recurrent prostate cancer5
Explore the unique mechanism of action of Axumin that makes its use critical in cases of negative or equivocal PSMA PET.
Axumin may detect what PSMA PET may not11
PSA 0.3. pT3a N0 at diagnosis. Surgery 4 years prior to scan.
If PSMA PET fails to provide answers, make progress with Axumin11
References: 1. Bakht MK, Yamada Y, Ku SY, et al. Landscape of prostate-specific membrane antigen heterogeneity and regulation in AR-positive and AR-negative metastatic prostate cancer. Nat Cancer. 2023;4(5):699-715. doi:10.1038/s43018-023-00539-6 2. Bakht MK, Derecichei I, Li Y, et al. Neuroendocrine differentiation of prostate cancer leads to PSMA suppression. Endocr Relat Cancer. 2018;26(2):131-146. doi:10.1530/ERC-18-0226 3. Ulaner GA. Fundamentals of Oncologic PET/CT. Elsevier; 2019. 4. Paschalis A, Sheehan B, Riisnaes R, et al. Prostate-specific membrane antigen heterogeneity and DNA repair defects in prostate cancer. Eur Urol. 2019;76(4):469-478. doi:10.1016/j.eururo.2019.06.030 5. Axumin. Package insert. Blue Earth Diagnostics Ltd; 2022. 6. 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. doi:10.2967/jnumed.114.143628 7. Okudaira H, Shikano N, Nishii R, et al. Putative transport mechanism and intracellular fate of trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid in human prostate cancer. J Nucl Med. 2011;52(5):822-829. doi:10.2967/jnumed.110.086074 8. 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. doi:10.1097/ RLU.0000000000002703 9. Gallium Ga 68 Gozetotide. Package insert. University of California, San Francisco; 2022. 10. Pylarify. Package insert. Progenics Pharmaceuticals Inc; 2023. 11. Mallak N, Obala G, Lim JY. Role of 18F-fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT. Presented at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) conference; June 21-24, 2025; New Orleans, LA.
INDICATION | IMPORTANT SAFETY INFORMATION
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.