Download Axumin® (fluciclovine F 18) injection Resources

    Download the complete formulary kit or choose one or more of the individual components below.

    • Disease Overview: Brief summary of biochemically recurrent prostate cancer, current imaging paradigms, and the unmet clinical need in PET/CT imaging.
    • Clinical Summary: A detailed summary of the Axumin clinical studies, including the rationale, study background, and clinical endpoints. Also includes a description of the product’s mechanism of action (MOA).
    • Clinical Bibliography: A list of publications describing the safety and efficacy of Axumin.
    • Indication and ISI: Full Axumin Indication and Important Safety Information (ISI).
    • Dosing and Administration Guide: Detailed instructions for dosing and administration, including positioning patients, recommended timing for PET/CT imaging, and approximate timing for image acquisition.
    • Safety Data Sheet: Health and safety precautions for the preparation, handling, and use of Axumin.
    • Coding Sheet: Relevant product, procedure, and diagnosis coding information applicable for billing purposes.
    • Ordering Information: Information to order Axumin for your facility and the list of services our sales representatives can provide.

     

    Download all imager resources or choose one or more of the individual components below.

    • Press Release Template: Customizable press release template to announce Axumin®(fluciclovine F 18) injection availability at your imaging center.
    • Direct Mail Template: Customizable template to raise awareness of Axumin®(fluciclovine F 18) injection availability to referring physicians.
    • Patient Brochure: Downloadable patient brochure with space on the back for your imaging center's location information.

     

    Reimbursement tip sheet

    Download a checklist with useful tips for prior-authorization, pre-determination, and appeals.

    Payer worksheet

    Blue Earth has developed a worksheet to help you keep track of the Axumin coverage policies and billing requirements of your local payers

    Patient benefit verification form

    To enroll a patient for Axumin reimbursement support services, healthcare professionals must download, complete, and submit the Axumin Patient Benefit Verification Form.

    Scheduling sheet

    For use by referring physicians when scheduling a patient for Axumin imaging. Provides the relevant information required by the imaging facility. Download the Scheduling Sheet and/or the companion Scheduling Tip Sheet.

    Sample claim forms

    Download examples of Axumin claim information entered into CMS-1500 and UB04 forms to use as a reference when submitting claims.

    Patient brochure

    Download the Axumin patient brochure in English or Spanish.

     

    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.