Detection of recurrent prostate cancer, in a single visit

Axumin® (fluciclovine F 18) injection: Image Acquisition Timeline

Start scanning in just 3-5 minutes. Total scan time is typically 20-30 minutes.

Axumin injection image acquisition timeline

    Axumin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration. The recommended dose is 370 MBq (10 mCi) administered as an intravenous bolus injection.1

     

    1. Inspect Axumin visually for particulate matter and discoloration before administration.
    2. Do not use the drug if the solution contains particulate matter or is discolored.
    3. Use aseptic technique and radiation shielding when withdrawing and administering Axumin.
    4. Calculate the necessary volume to administer based on calibration time and date, using a suitably calibrated instrument. The recommended maximum volume of injection of undiluted Axumin is 5 mL. 
      1. Axumin may be diluted with Sodium Chloride Injection, 0.9%.
    5. Injection into the right arm is preferred as stasis in the left axillary vein may be misinterpreted as a metastatic lymph node (Virchow’s node). If the right arm cannot be used, beware of the possibility of image interpretation error.
    6. After the Axumin injection, administer an intravenous flush of sterile Sodium Chloride Injection, 0.9% to ensure full delivery of the dose.
    7. Dispose of any unused drug in a safe manner in compliance with applicable regulations.

    Patient Preparation Prior to PET/CT Imaging: Advise the patient to avoid any significant exercise for at least one day prior to PET/CT imaging, and not to eat or drink for at least 4 hours (other than small amounts of water for taking medications) prior to administration of Axumin.1

    Codes that may be required when submitting claims for Axumin and related procedures

    Download the Axumin patient brochure, “What to Expect.”

    Position the patient supine with arms above the head.1 If the patient cannot tolerate this position for the duration of the study, an alternate position for the patient’s arms may be used. 

    Begin PET scanning 3 to 5 minutes after completion of the Axumin injection.1 Following intravenous administration, the tumor-to-normal tissue contrast is highest between 4 and 10 minutes after injection with a 61% reduction in mean tumor uptake at 90 minutes after injection.1

    • If scanning is started early, the biodistribution may be altered (e.g., increased blood pool) and this should be taken into account during image interpretation.1
    • If scanning is started late, the biodistribution may be altered (e.g., increased muscle uptake) and this should be taken into account during image interpretation.1

    High quality CT acquisition for anatomic correlation and attenuation correction is recommended. It is recommended that image acquisition should start from mid-thigh and proceed to the base of the skull.1 Typical total scan time is between 20 to 30 minutes.1 Identification of tumor location is based on fluciclovine F 18 uptake in comparison with tissue background. For larger lesions (≥1 cm), uptake equal to or greater than bone marrow is considered suspicious for prostate cancer recurrence. For small lesions (<1 cm), focal uptake greater than blood pool should be considered suspicious for prostate cancer recurrence.1

     

    Image Interpretation Training

    Blue Earth Diagnostics has partnered with the Society of Nuclear Medicine and Molecular Imaging to deliver training on how to interpret Axumin Images. Visit the online learning site.

    References:

    1. Axumin [package insert]. Oxford, UK: Blue Earth Diagnostics Ltd; 2016.

    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.