Axumin (Fluciclovine F-18)

Brand Name

Axumin

Generic Name

Fluciclovine F-18

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FDA approval date: May 27, 2016

Classification: Radioactive Diagnostic Agent

Form: Injection

What is Axumin (Fluciclovine F-18)?

Axumin is indicated for positron emission tomography in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment .

Approved To Treat

Prostate Cancer

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Brand Information

Axumin (Fluciclovine F-18)

1INDICATIONS 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.

2DOSAGE FORMS AND STRENGTHS

Injection: supplied as a clear, colorless solution in a 30 mL or 50 mL multiple-dose vial containing 335 MBq/mL to 8,200 MBq/mL (9 mCi/mL to 221 mCi/mL) fluciclovine F 18 at calibration time and date.

3CONTRAINDICATIONS

None

4OVERDOSAGE

In case of overdose of Axumin, encourage patients to maintain hydration and to void frequently to minimize radiation exposure.

5CLINICAL STUDIES

The safety and efficacy of Axumin were evaluated in two studies (Study 1 and Study 2) in men with suspected recurrence of prostate cancer based on rising PSA levels following radical prostatectomy and/or radiotherapy.

Study 1 evaluated 105 Axumin scans in comparison to histopathology obtained by biopsy of the prostate bed and biopsies of lesions suspicious by imaging. PET/CT imaging generally included the abdomen and pelvic regions. The Axumin images were originally read by on-site readers. The images were subsequently read by three blinded independent readers.

The detection rate of Axumin seems to be affected by PSA levels

Study 2 evaluated the concordance between 96 Axumin and C11 choline scans in patients with median PSA value of 1.44 ng/mL (interquartile range = 0.78 ng/mL to 2.8 ng/mL). The C 11 choline scans were read by on-site readers. The Axumin scans were read by the same three blinded independent readers used for Study 1. The agreement values between the Axumin and C11 choline reads were 61%, 67% and 77%, respectively.

6PATIENT COUNSELING INFORMATION

Instruct patients to avoid significant exercise for at least a day before the PET scan.
Instruct patients not to eat or drink for at least 4 hours before the PET scan (other than sips of water for taking medications).
Instruct patients to try to urinate approximately 30 minutes to 60 minutes prior to planned start time of the PET scan and to avoid further urination until after the scan has been completed.

Marketed by Blue Earth Diagnostics Ltd. Oxford, UK OX4 4GA