Axumin
Generic: FLUCICLOVINE F-18
Basic Information
Manufacturer
Blue Earth Diagnostics
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
389a502e-a7d5-43dd-b6bf-f022ff23f3b9
Indications & Usage
1 INDICATIONS AND USAGE Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
Axumin 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 ( 1 ).
Axumin 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 ( 1 ).
Adverse Reactions
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.
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.