Medical Editor: John P. Cunha, DO, FACOEP
Axumin (fluciclovine F 18) injection is a radioactive diagnostic agent 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. Common side effects of Axumin include:
- injection site pain and redness, and
- changes in taste
A physician will determine the dose of Axumin used. The (radiation absorbed) effective dose associated with 370 MBq (10 mCi) of injected activity of Axumin is approximately 8 mSv (0.8 rem) in an adult. Axumin may interact with other drugs. Tell your doctor all medications and supplements you use. Axumin is not indicated for use in women, therefore it is unlikely to be used during pregnancy or while breastfeeding.
Our Axumin (fluciclovine F 18) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical trial database for Axumin includes data from 877 subjects including 797 males diagnosed with prostate cancer. Most patients received a single administration of Axumin, a small number of subjects (n = 50) received up to five administrations of the drug. The mean administered activity was 370 MBq (range, 163 to 485 MBq).
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.
Read the entire FDA prescribing information for Axumin (Fluciclovine F 18 Intravenous Injection)