Concerned about elevated PSA levels?

What is Axumin? 

Axumin^® (fluciclovine F 18) injection is a diagnostic imaging agent (sometimes called a radiotracer). Axumin is used along with a positron emission tomography (PET) imaging scan for men who have had prior treatment for prostate cancer and now have prostate specific antigen (PSA) levels that are elevated.

IMPORTANT SAFETY INFORMATION

What do I need to know about Axumin?

• As with all diagnostic imaging tests such as x-rays, bone scans and computed tomography (CT) scans, it is possible that the physician (a radiologist or nuclear medicine physician) that reviews your Axumin PET/CT scan can interpret your results incorrectly. This means that a negative Axumin PET/CT scan does not rule out that you have recurrent prostate cancer, and a positive Axumin PET/CT scan does not confirm that you have recurrent prostate cancer.
• How well Axumin works seems to be affected by PSA levels. As PSA levels go up, an Axumin PET/CT scan is better able to identify recurrent prostate cancer.
• Serious reactions including anaphylaxis, a severe, potentially life-threatening allergic reaction, may occur in patients who receive Axumin.
• Axumin adds to your long-term overall radiation exposure, which can lead to an increased risk of cancer.

What are the possible side effects of Axumin?

Most commonly reported adverse reactions are:

• Injection site pain
• Injection site redness
• Unusual taste in the mouth

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Axumin. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.