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.
DOSAGE AND ADMINISTRATION
Radiation Safety - Drug Handling
Axumin is a radioactive drug and should be handled with appropriate safety measures to minimize
radiation exposure during administration [see WARNINGS AND PRECAUTIONS]. Use waterproof gloves
and effective shielding, including syringe shields, when handling and administering Axumin.
Recommended Dose And Administration Instructions
The recommended dose is 370 MBq (10 mCi) administered as an intravenous bolus injection.
- Inspect Axumin visually for particulate matter and discoloration before administration. Do not use
the drug if the solution contains particulate matter or is discolored.
- Use aseptic technique and radiation shielding when withdrawing and administering Axumin.
- Calculate the necessary volume to administer based on calibration time and date, using a suitably
calibrated instrument. The recommended maximum volume of injection of undiluted Axumin is 5mL.
- Axumin may be diluted with Sodium Chloride Injection, 0.9%.
- After the Axumin injection, administer an intravenous flush of sterile Sodium Chloride Injection,
0.9% to ensure full delivery of the dose.
- Dispose of any unused drug in a safe manner in compliance with applicable regulations.
Patient Preparation Prior To PET Imaging
- Advise the patient to avoid any significant exercise for at least one day prior to PET imaging.
- Advise patients not to eat or drink for at least 4 hours (other than small amounts of water for taking
medications) prior to administration of Axumin.
Image Acquisition Guidelines
Position the patient supine with arms above the head. Begin PET scanning 3 to 5 minutes after
completion of the Axumin injection. It is recommended that image acquisition should start from midthigh
and proceed to the base of the skull. Typical total scan time is between 20 to 30 minutes.
Image Display And Interpretation
Localization of prostate cancer recurrence in sites typical for prostate cancer recurrence is based on
fluciclovine F 18 uptake in comparison with tissue background. For small lesions (less than 1cm in
diameter) focal uptake greater than blood pool should be considered suspicious for prostate cancer
recurrence. For larger lesions, uptake equal to or greater than bone marrow is considered suspicious
for prostate cancer recurrence.
The radiation absorbed doses estimated for adult patients following intravenous injection of Axumin are
shown in Table 1. Values were calculated from human biodistribution data using OLINDA/EXM (Organ
Level Internal Dose Assessment/Exponential Modeling) software.
The (radiation absorbed) effective dose resulting from the administration of the recommended activity
of 370 MBq of Axumin is 8 mSv. For an administered activity of 370 MBq (10 mCi), the highestmagnitude
radiation doses are delivered to the pancreas, cardiac wall, and uterine wall: 38 mGy, 19
mGy, and 17 mGy, respectively. If a CT scan is simultaneously performed as part of the PET procedure,
exposure to ionizing radiation will increase in an amount dependent on the settings used in the CT
Table 1: Estimated Radiation Absorbed Doses in Various Organs /Tissues in Adults
who Received Axumin
||Mean Absorbed Dose per Unit Administered
|Lower large intestine wall
|Small intestine wall
|Upper large intestine wall
|Red bone marrow
|Urinary bladder wall
Dosage Forms And Strengths
Injection: supplied as a clear, colorless solution in a 30 mL multiple-dose vial containing 335 to 8200
MBq/mL (9 to 221 mCi/mL) fluciclovine F 18 at calibration time and date.
Storage And Handling
Axumin is supplied as a clear, colorless injection in a 30 mL multiple-dose glass vial containing
approximately 26 mL solution of 335-8200 MBq/mL (9-221 mCi/mL) fluciclovine F 18 at calibration
time and date.
30 mL sterile multiple-dose vial: NDC 69932-001-30
Store Axumin at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Axumin does not
contain a preservative. Store Axumin within the original container in radiation shielding.
This preparation is approved for use by persons under license by the Nuclear Regulatory Commission
or the relevant regulatory authority of an Agreement State.
Marketed by: Blue Earth Diagnostics Ltd. Oxford, UK OX4 4GA. Revised: Aug 2016