Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most commonly reported adverse reactions are injection site pain, erythema, and dysgeusia ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Blue Earth Diagnostics, Ltd at 1-855-AXUMIN1 (1-855-298-6461) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 MBq 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.
5 WARNINGS AND PRECAUTIONS Image interpretation errors can occur with Axumin imaging ( 5.1 ).
Radiation risk: Axumin contributes to a patient's long-term cumulative radiation exposure.
Ensure safe handling to protect patients and health care workers from unintentional radiation exposure ( 2.1 , 5.3 ).
5.1 Risk for Image Misinterpretation Image interpretation errors can occur with Axumin PET imaging.
A negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of recurrent prostate cancer.
Like all medications, Axumin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: