Contact Blue Earth Diagnostics, Inc.

US Corporate Headquarters

Blue Earth Diagnostics Inc.

25 Burlington Mall Road, Suite 206

Burlington, MA USA 01803

1-855-AXUMIN1(1-855-298-6461)

bedus@blueearthdx.com

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Media Contact

Priscilla Harlan, Vice President

Corporate Communications

p.harlan@blueearthdx.com

Pharmacovigilance/Adverse Event Reporting

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

For Medical Information

Click here for Blue Earth Medical Information or call 
1-855-AXUMIN1(1-855-298-6461), and press "3"

Medical Education Requests

imegrants@blueearthdx.com

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.